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Abstract

Infection is the leading cause of morbidity that occurs after breast implantation and complicates 2.0-2.5% of interventions in most case series. Two-thirds of infections develop within the acute post-operative period, whereas some infections may develop years or even decades after surgery. Infection rates are higher after breast reconstruction and subsequent implantation than after breast augmentation. Risk factors for infection associated with breast implantation have not been carefully assessed in prospective studies with long-term follow-up. Surgical technique and the patient's underlying condition are the most important determinants. In particular, breast reconstruction after mastectomy and radiotherapy for cancer is associated with a higher risk for infection. The origin of infection in women with implants remains difficult to determine, but potential sources include a contaminated implant, contaminated saline, the surgery itself or the surgical environment, the patient's skin or mammary ducts, or, as suggested by many reports, seeding of the implant from remote infection sites. Late infection usually results from secondary bacteraemia or an invasive procedure at a location other than breasts. Diagnostic and management strategies are proposed and the value of peri-operative surgical prophylaxis is revisited. The current hypothesis of the possible role of low-grade or subclinical infection in the origin of capsular contracture is also reviewed.

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... Other possible complications are tissue necrosis, hematomas, and seromas. 1,[12][13][14][15] Although the implants used for breast reconstruction are covered by the muscle, adipose tissue, or acellular dermal matrix, wound dehiscence can lead to implant exposure and to local breast infections. [12][13][14][15][16] Breast implant removal and delayed breast reconstruction is the procedure of choice when the implant is exposed, and even more so if there is some degree of infection. ...
... 1,[12][13][14][15] Although the implants used for breast reconstruction are covered by the muscle, adipose tissue, or acellular dermal matrix, wound dehiscence can lead to implant exposure and to local breast infections. [12][13][14][15][16] Breast implant removal and delayed breast reconstruction is the procedure of choice when the implant is exposed, and even more so if there is some degree of infection. 1,15,16 Nevertheless, in this study, we kept the implant and salvaged the breast reconstruction as an alternative in those cases where there was a mild local infection of the breast tissue. ...
... It can be aggravated by the presence of infection and ultimately lead to failure of the surgical procedure. [12][13][14][15][16] In most patients who undergo mastectomy, their treatment may be accompanied by chemotherapy and/ or radiotherapy before or after surgery, which can alter the cellular process necessary for healing and cause dehiscence of the surgical wound or infection. [12][13][14] Assessment of the quality of the skin and soft tissues is critical when wound dehiscence occurs. ...
Article
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Multiple techniques have been described for breast reconstruction surgery after breast implant exposure; breast implant removal and delayed breast reconstruction is the procedure of choice. However, in some mild exposures and infections, we propose an alternative treatment. Methods: This is a case series of a 14-year study in 16 female patients with mild exposure of a breast implant after breast reconstruction surgery. Salvage surgery was performed on these cases. The defects were between 1 and 6 cm, with a median size of 3.9 × 2.9 cm. Eighteen intercostal artery perforator flaps were used with an island of skin from the inframammary fold; 83.3% were anterior intercostal artery perforator flaps' and 16.7% were lateral intercostal artery perforator flaps. Results: Thirteen of the 16 patients presented infection (81.25%). There was no necrosis of any flap, and the success rate of salvage surgery was 62.5% of all patients. The success of surgery was 53.8% in patients with breast infection and 100% in patients without infection. Seven patients received chemotherapy and radiotherapy, six received only chemotherapy, and nine patients received only radiotherapy. Five of the six patients whose salvage surgery failed were treated with radiotherapy. Conclusion: This technique can be used as an alternative when there is exposure of the implant' even in cases with a mild breast infection and in patients undergoing radiotherapy and chemotherapy.
... 18 However, these coatings are too thin to achieve a sustained or prolonged release of a functional drug molecule, and the researchers later proposed another method of using a silk barrier layer to suppress the initial burst release of functional molecule. 25 Thicker coatings typically will have a poor cracking resistance under mechanical deformation. ...
... The SF protein in aqueous solutions shows an absorbance at 275 cm −1 , and this absorbance was used to estimate the amount of SF released from the coating. 25 The total amount of SF present on each disc can be estimated to be about 0.34 mg. The amount of silk fibroin released before annealing was around 50−60% of the total SF. ...
... The nanoscratch test was performed on PDMS, SF-O 2 -PDMS, and SF-APTES-PDMS substrates, with a scanning load of 3 μN and a scratch of 1 mm was done. Representative optical 25 Charitidis et al. demonstrated that nanoindentation is used to measure nanomechanical properties, creep behavior, and adhesive forces of PDMS. 17,26 We performed the nanoindentation test using an established method where an indenter tip with a sphero-conical geometry is driven into a specific region of the material to be tested, by applying an incremental normal load. ...
Thesis
My research has focused on the design and development of natural polymers (primarily silk fibroin) coatings, their blends for breast implant application to improve biocompatibility and mechanical stability. The failure of breast implants is primarily due to the formation of the fibrous structure and due to the formation of biofilm after breast cancer treatment. I have used surface modification/surface coatings methods to improve the biocompatibility or to reduce the post-implantation failure of silicone breast implants. The development of natural polymer composite coatings on silicone surface results in improved mechanical stability. I have also developed in lab protocols to quantify mechanical deformation under different modes of strains such as bending, tensile, and torsion. I have used AFM force spectroscopy to understand the interaction of modified polymer surface and coating material (Natural polymer such as Silk Fibroin).
... The patient developed a subcapsular hematoma, which has also been associated with a higher risk of contracture [12]. There are multiple theories for the pathogenesis of contracture, such as involving post-implant infections, especially subclinical infections, where biofilm formation is an important mechanism [13]. ...
... Although a late-onset infection is mainly caused by hematogenous seeding of bacteria, the delay to infection onset varies greatly in the literature, ranging from 8 months to 40 years after implant surgery [3,4,13]. Hematogenous seeding results from bacteremia stemming from a variety of infectious foci and is associated with different organisms. ...
... However, seven years later, the bacteria were idiopathically activated. Organisms have been reported to gain entry to the implant in some cases [13,15], and P. aeruginosa can form biofilms, allowing it to lay dormant in the tissue and protect against antibiotics, consequently inducing chronic inflammation which causes capsular contracture. Cases of capsular contracture related to subclinical Staphylococcus epidermidis infections have been described. ...
Article
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Introduction and importance Around 1% of all complications associated with breast implants are attributable to infection, classified as acute, subacute, or late-onset, with late-onset infections being the rarest. Even when symptoms are not obvious, an infection may still be lingering. Sub-clinical presentations have been implicated in the pathophysiology of breast implant capsular contracture. Organisms can establish dormancy through biofilm formation, and can also be idiopathically activated, and present as a late-onset infection, as has been clearly described in the literature with the infamous Enterococcus avium. Case presentation We report the case of a 44-year-old woman who underwent bilateral augmentation mastopexy seven years ago complicated by an acute perioperative infection that was resolved with a full course of antibiotics. She presented to the clinic complaining of left breast pain and swelling accompanied by fever for four days. Ultrasonic imaging showed moderate peri-implant fluid positive for Pseudomonas aeruginosa upon aspiration. The patient therefore underwent bilateral breast exploration and capsulectomy. Clinical discussion We believe that the dormant P. aeruginosa contributed to the capsular contracture and was idiopathically activated, manifesting as a late-onset infection seven years post-augmentation mastopexy. Conclusion To the best of our knowledge, no previous studies or case reports have described a late-onset infection due to idiopathic activation, where dormant P. aeruginosa is isolated from an implant capsule many years after augmentation mastopexy. More studies are required to examine the role of dormant bacteria in capsular contracture and their idiopathic activation considering the consequences on patient outcomes.
... BRSPM procedures have a higher incidence of infections compared with cosmetic breast augmentation [9]. Sources of infection include environmental contamination of the implant or surgical milieu, breaches in skin integrity and haematogenous or contiguous spread [12][13][14]. Risks for infection have not been formally quantified, however mastectomy and previous radiotherapy are thought to predispose to poorer reconstructive outcomes and surgical site infection [12][13][14]. ...
... Sources of infection include environmental contamination of the implant or surgical milieu, breaches in skin integrity and haematogenous or contiguous spread [12][13][14]. Risks for infection have not been formally quantified, however mastectomy and previous radiotherapy are thought to predispose to poorer reconstructive outcomes and surgical site infection [12][13][14]. ...
... Coagulase negative staphylococci, Staphylococcus aureus and Cutibacterium acnes are common causes of breast implant infections, however the range of potential pathogens is broad including Gram-negative bacteria, non-tuberculous mycobacteria and yeasts [9,12,14]. Prosthetic devices predispose to formation of biofilms which are three-dimensional structures comprised of organisms and exopolysaccharides that are resistant to phagocytosis and antimicrobials. In vitro studies demonstrate that Prototheca spp. ...
Article
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We report the first published case of Prototheca wickerhamii breast implant infection. This occurred after mastectomy, chemotherapy, radiotherapy, breast reconstruction, implant revisions and breast seroma aspirations and was preceded by polymicrobial infection. Definitive treatment required implant removal and intravenous liposomal amphotericin B. The management of breast prosthesis infections is discussed.
... Intraoperative factors include duration of the operation, lymph node dissection, higher amount of blood loss or tissue ischemia, and postoperative factors associated with increased risk include elevated serum glucose, seroma, or hematoma formation and surgical drains. 1,[4][5][6][7] Perioperative antimicrobial prophylaxis and appropriate skin antisepsis are associated with decreased SSI risk. 4 Infection is the leading cause of morbidity that occurs after breast implantation and complicates 0.27%-2.5% of interventions in most case series. ...
... 4 Infection is the leading cause of morbidity that occurs after breast implantation and complicates 0.27%-2.5% of interventions in most case series. 1,2,4,[6][7][8][9][10] In a worldwide survey conducted in 1970, the incidences of early and late onset infections in 10,941 women who underwent breast augmentation were 1.7% and 0.8%, respectively. 9 Patients with early onset infections typically present with breast pain, swelling, and erythema, with or without fever. ...
... The studies by Brand in 54.661 implantations for 73 plastic surgeons, with 60 infections and a rate infection of 0.27%, and by Cholnoky of 10.941 women who underwent breast augmentation with 1.7% early rate infection, 4,[7][8][9][10] and other studies that report up to 2.5% place us with a very low infection rate worldwide. 1,2,6,11 Saline solution prostheses were not placed; so it cannot be established if the type of prosthesis is related to the appearance of infections. The most commonly used implants were textured and some were smooth. ...
Article
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Background: This study presents a review of a single retrospective cohort of patients who underwent surgery for breast augmentation with implants, during a period of 5 years, aged 17-60 years (mean 32 years), in a single institution, IQ Interquirofanos, a private clinic in the city of Medellín, Colombia. Method: A single retrospective cohort study was carried out, in which the database of patients who underwent breast augmentation with implants during 5 years was analyzed. Results: In this period of time, 9,691 female patients and a total of 19,382 breast implants implanted by 66 plastic surgeons underwent breast augmentation surgery. All the breast prostheses used were round, made of silicone gel in all cases and textured in most of them. 37 patients presented infection at the surgical site, 33 were unilateral and four bilateral, with an incidence of 0.38% per patient. The form of presentation was cellulitis in 46% of the cases, followed by seroma and hematoma in 25%. It was found that there is no difference in the incidence of infection between patients with breast augmentation for the first time and implant replacement due to different causes (OR 1.25, 95% CI 0.66-2.3, P = 0.49). One of the surgeons was associated with 37.8% of the infections and was found to be an asymptomatic carrier of Staphylococcus aureus, requiring medical treatment. The relationship of the infection with the treating surgeons was also analyzed and it was found that there is an association between these two variables. The infection appeared in the first 2 weeks after surgery in 92.7% of the cases. The main isolated germ was Staphylococcus aureus, followed by Pseudomona aeruginosa, Staphylococcus epidermidis, Serratia marcescens, Candida parapsilosis, Enterobacter cloacae, and a patient with Mycobacterium fortuitum in both breasts. Of the 37 patients with infection, six breast implants were required to be explanted in five patients, who were repositioned 3-6 months later without complications. Conclusions: Incidence of infection in augmentation mammoplasty with implants was 0.38% in patients infected in one or both breasts, during 5 years. There is a relationship between the presence of breast infection and the surgeon who performed the intervention. The most frequent germs found in breast implant infections continue to be Staphylococcus aureus followed by Pseudomonas aeruginosa.
... Cependant, une véritable comparaison entre les différentes disciplines chirurgicales parmi les différents pays n'est pas possible. En ce qui concerne la chirurgie mammaire, selon la littérature, le taux d'infections nosocomiales lors d'une augmentation mammaire prothétique est de 2-3 % dans les pays riches en ressources des zones tempérées [4][5][6][7]. Malheureusement en l'absence de données fiables avec l'impossibilité d'obtenir le nombre total des cas de tourisme de chirurgie mammaire à l'étranger, le taux d'infections nosocomiales dans les pays destinataires n'est pas calculable. Cependant, notre revue a permis de mettre en évidence que 47 % des germes, découverts chez les patientes traitées dans notre service pour une infection après une chirurgie mammaire à l'étranger, étaient multirésistants. ...
... Outre que le taux de germes multirésistants, le type de microbiologie peut aussi changer en fonction des ressources du pays, les programmes d'hygiène hospitalière et/ou son climat. Tandis que les pathogènes classiques d'une infection de prothèse sont les staphylocoques coagulasenégatifs ainsi que d'autres germes cutanés tels que les corynebactéries ou des propionibacteries [5], les germes les plus fréquents dans notre série étaient des P. aeruginosa et le M. abscessus. Dans le cadre des complications du tourisme médical, la littérature scientifique récente met aussi le focus sur les germes exotiques et/ou résistants tels que les mycobactéries atypiques [11]. ...
... Ces spécificités rendent le diagnostic plus difficile [14], mais quand il s'agit d'une infection du site opératoire, la recherche de ces mycobactéries doit faire partie intégrante du bilan microbiologique. Une attention particulière doit être portée à ce diagnostic quand l'intervention a eu lieu dans un pays en voie de développement où la littérature récente a démontré un taux élevé d'incidents d'infection à mycobactérie atypiques [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]. Ces infections peuvent survenir seules, mais aussi en épidémies [13,18,19], alors que la source des déclenchements peut varier [20]. ...
Article
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INTRODUCTION Surgical tourism is a growing phenomenon, causing a surge demand for the management of its complications. In this study, we aimed to evaluate complications that occur after cosmetic breast surgery abroad; and their costs for the public health system. MATERIAL AND METHODS We reviewed the medical files of patients treated in our department for a complication after cosmetic breast surgery outside Switzerland and assessed all complications requiring hospitalization; and estimated the overall medical costs. RESULTS Over a two-year period, 26 patients were treated for 39 complications. The main complication was infection (71% of cases), mainly with a multidrug-resistant organism (47%) and atypical mycobacteria. Of the 16 patients with breast prosthesis, 7 implants were removed. The effective average costs incurred for the hospital care of these cases was estimated to 14'724 Swiss Francs (∼12'963 Euros) per patient. CONCLUSION The high rate of multidrug-resistant and mycobacterial atypical infections are a major public health problem. It is necessary to inform patients much better about the risks of surgical tourism. Furthermore, the danger of transfer of multidrug-resistant or atypical germs from abroad should not be overlooked. Physicians should be informed about this risk and take necessary measures for treatment and diagnosis of these complications.
... [25][26][27] In contrast to breast augmentation procedures, implant-based reconstructive surgeries following mastectomy are associated with significantly higher rates of infection (1.1%-2.5% versus 1%-35%, respectively). 25,[27][28][29] This is largely due to an increased risk of implant and tissue exposure to endogenous flora during reconstructive procedures, and the greater association of risk factors with breast cancer patients, relative to healthy patients seeking breast augmentation. 27,29 Although the overall risk of infections among breast augmentation and breast reconstructions remains lower than that of other surgical procedures, 24,29 adherence to strict prophylactic and intraoperative aseptic techniques, and postoperative monitoring, diagnostic, and treatment protocols, is essential to ensure patient safety and avoid the progression to sepsis and death. ...
... 25,[27][28][29] This is largely due to an increased risk of implant and tissue exposure to endogenous flora during reconstructive procedures, and the greater association of risk factors with breast cancer patients, relative to healthy patients seeking breast augmentation. 27,29 Although the overall risk of infections among breast augmentation and breast reconstructions remains lower than that of other surgical procedures, 24,29 adherence to strict prophylactic and intraoperative aseptic techniques, and postoperative monitoring, diagnostic, and treatment protocols, is essential to ensure patient safety and avoid the progression to sepsis and death. 30 BIA-ALCL has drawn significant attention within the medical literature in recent years due to its strict iatrogenic nature and categorical association with textured breast implants. ...
... 25,[27][28][29] This is largely due to an increased risk of implant and tissue exposure to endogenous flora during reconstructive procedures, and the greater association of risk factors with breast cancer patients, relative to healthy patients seeking breast augmentation. 27,29 Although the overall risk of infections among breast augmentation and breast reconstructions remains lower than that of other surgical procedures, 24,29 adherence to strict prophylactic and intraoperative aseptic techniques, and postoperative monitoring, diagnostic, and treatment protocols, is essential to ensure patient safety and avoid the progression to sepsis and death. 30 BIA-ALCL has drawn significant attention within the medical literature in recent years due to its strict iatrogenic nature and categorical association with textured breast implants. ...
Article
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Introduction: Since the 1992 moratorium by the Food and Drug Administration (FDA), the debate on the association of breast implants with systemic illnesses has been ongoing. Breast implant-associated anaplastic large cell lymphoma has also raised significant safety concerns in recent years. Methods: A systematic search of the Manufacturer and User Facility Device Experience (MAUDE) database was performed to identify all cases of breast implant-associated deaths reported to the FDA. Results: The search identified 50 reported cases of apparent implant-related mortality; breast implant-associated anaplastic large cell lymphoma comprised the majority of fatal outcomes (n = 21, 42%), followed by lymphoma (n = 4, 8%), breast cancer (n = 3, 6%), pancreatic cancer (n = 2, 4%), implant rupture (n = 2, 4%), and postoperative infections (n = 2, 4%). Single cases (n = 1, 2% each) of leukemia, small bowel cancer, lung disease, pneumonia, autoimmune and joint disease, amyotrophic lateral sclerosis, liver failure, and sudden death, and 2 cases (4%) of newborn deaths, to mothers with breast implants, were also identified. A literature review demonstrated that 54% of alleged implant-related deaths were not truly associated with breast implant use: the majority of these reports (82%) originated from the public and third-party sources, rather than evidence-based reports by health-care professionals and journal articles. Conclusions: Although there exists a need for more comprehensive reporting in federal databases, the information available should be considered for a more complete understanding of implant-associated adverse outcomes. With only 46% of FDA-reported implant-related deaths demonstrated to be truly associated with breast implant use, there exists a need for public awareness and education on breast implant safety.
... Infection is one of the most common causes of failure of generative treatment for breast cancer patients who have undergone mastectomy. Surgical site infection (SSI) in patients requiring the use of a synthetic breast implant can currently be observed in about 1-53% of cases [1,2]. ...
... The most often isolated bacterial strains responsible for the occurrence of SSI are saprophytic Gram-positive bacteria (49-67%) [1,[3][4][5][6]. Pathogens belonging to opportunistic in-hospital flora are Gram-negative rods or fungal wound infections, which may lead to complications [1,4,7]. ...
... The most often isolated bacterial strains responsible for the occurrence of SSI are saprophytic Gram-positive bacteria (49-67%) [1,[3][4][5][6]. Pathogens belonging to opportunistic in-hospital flora are Gram-negative rods or fungal wound infections, which may lead to complications [1,4,7]. SSI caused by these is characterized by a more severe course and a longer period of necessary treatment. ...
... In contrast, cosmetic augmentation in the cisgender population, which has consistently been the most common aesthetic procedure performed in the United States, 20,21,29-31 has been extensively described in the literature. 5,[32][33][34][35][36][37][38][39][40] Despite some natal sex differences in chest wall and mammary anatomy between cisgender and transgender females, the technical aspects of the operation are broadly similar. 18 Furthermore, with widespread use of testosterone blockers and estrogen therapy in transfeminine patients, the hormonal environment between these groups is also quite similar. ...
... For centuries, breasts have been viewed as a powerful representation of femininity, often emphasized throughout literature, fashion, art, and medicine. [1][2][3][4][5] Importantly, the relationship between breasts and the female construct exists regardless of one's natal sex. For transgender females yet to undergo surgical transition, the absence of breasts is often associated with negative body image, dissatisfaction with physical appearance, and lower quality of life. ...
... Infection has been frequently reported as an important complication following augmentation, with rates as high as 2.5%. 5,33,35,59 However, only 1 (0.4%) patient in our transfeminine cohort and 4 patients (0.4%) in the cisgender cohort experienced an infectious complication. One possible explanation for this discrepancy is that postoperative outcomes are only collected for 30 days after the time of surgery, something that substantially limits our study. ...
Article
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Background: Breast augmentation in transgender women can be an important first step in addressing gender incongruence and improving psychosocial functioning. The aim of this study was to compare postoperative outcomes of augmentation mammoplasty in transgender and cisgender females. Methods: We queried the American College of Surgeons National Surgical Quality Improvement Program database from 2006 to 2017 to establish 2 cohorts: (1) transgender females undergoing gender-affirming breast augmentation ("top surgery") and (2) cisgender females seeking cosmetic breast augmentation (CBA). Demographic characteristics and postoperative outcomes were compared between the 2 cohorts. Multivariable regression analysis was used to control for confounders. Results: A total of 1,360 cases were identified, of which 280 (21%) were feminizing top surgeries and 1,080 (79%) were CBA cases. The transfeminine cohort was significantly older, had a higher average body mass index, and was more racially diverse than the CBA cohort. Transfeminine patients also had higher rates of smoking, diabetes, and hypertension. The rates of all-cause complications were low in both cohorts, and differences were not significant (1.6% transfeminine versus 1.8% CBA, P = 0.890) for the first 30-days after operation. After controlling for confounding variables, transfeminine patients had postoperative complication profiles similar to their cisgender counterparts. Multivariable regression analysis revealed no statistically significant predictors for all-cause complications. Conclusions: Transfeminine breast augmentation is a safe procedure that has a similar 30-day complication profile to its cisgender counterpart. The results of this study should reassure and encourage surgeons who are considering performing this procedure.
... In early infections, patients may present with local inflammatory signs or even sepsis. 8,16,17 However, late infections can be more subtle and present with vague breast pain or swelling. 8,17 The diagnosis of BII is typically established on clinical basis. ...
... 8,16,17 However, late infections can be more subtle and present with vague breast pain or swelling. 8,17 The diagnosis of BII is typically established on clinical basis. Ultrasound-guided aspiration of fluid collections may help with tailoring antimicrobial therapy. ...
... Unfortunately, patients often fail conservative treatment and require implant explantation. 17 Management varies depending on the severity of clinical presentation, where stable patients with local symptoms may be managed on an outpatient basis and those with systemic symptoms may be hospitalized and treated with intravenous antibiotics. 8,17 A stepwise evidence-based approach for BII management remains lacking. ...
Article
Background: Postsurgical complications have been an increasing concern for hospitals, particularly in light of payment reform. The costs to the health care system are increasing in light of Medicare penalties for readmissions for certain conditions. Surgical site infection following implant-based breast reconstruction (IBR) remains challenging. The rates of positive cultures and isolated microorganisms in IBR are unknown. This systematic review summarizes the reported microorganisms and positive culture rates in the existing literature. Methods: A systematic review was performed using the guidelines outlined in Preferred Reporting Items for Systematic Reviews and Meta-analyses. Articles were included if breast implant infection rates and culture results were reported. Further subgroup analysis of culture positive infections was performed. Results: A total of 25 studies were included, encompassing 25,177 IBR. Implant infections were reported in 1356 reconstructions (5.4%). Cultures were positive in 74.5% of infections. Gram-positive bacteria were the most common (68.6%), of which Staphylococcus species (51%) was the most isolated pathogen, followed by Pseudomonas. A subgroup analysis showed that early infections (63% vs 88%), radiotherapy (82% vs 93%), and acellular dermal matrix use (90% vs 100%) were associated with lower positive culture rates than their respective counterparts. Patients who received chemotherapy had higher positive culture results (94% vs 83%). Isolated microorganisms also varied among the subgroups. Conclusions: This systematic review outlines reported microorganisms in IBR. Staphylococcus species and Pseudomonas were the most frequently reported microorganism. Negative cultures were reported in up to 25.5% of infections. Patients with early infections, radiotherapy, and acellular dermal matrix demonstrated higher negative culture rates. This review can help guide the use of empirical antimicrobial therapy in IBR.
... The most frequent complications include infections; it is estimated that up to 29% (mean 5.8%) of breast reconstruction surgery is complicated by infection (Phillips et al. 2013). Infection is cost-intensive and 70-80% of patients ultimately require removal of the implant (Pittet et al. 2005;Seng et al. 2015). ...
... Infections are also triggered by factors associated with the surgery itself: an immediate breast reconstruction with the use of a final prosthesis is more often complicated by infection than deferred reconstruction. The prolonged (> 2 h) duration of surgery and post-operative drainage also have an unfavorable effect (Pittet et al. 2005;Araco et al. 2007). ...
... However, currently, many authors advise against such a procedure, pointing to the side effects that accompany it, namely the increase in resistance among microorganisms responsible for SSI (McCullough et al. 2016). In accordance with the idea of perioperative prophylaxis, a single dose of the first-generation cephalosporin is sufficient to ensure the proper concentration of the antibiotic at the incision site and to prevent infections mainly caused by methicillin-sensitive staphylococci (Pittet et al. 2005). Under the recommendations of scientific societies, it is also not suggested to continue treatment with antibiotics after discharge from the hospital, and the guidelines of the American Society of Plastic Surgeons recommend discontinuation of antibiotics at 24 hours after surgery. ...
Article
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The aim of the study was to analyze the reasons for removing implants after breast reconstruction in the course of treatment of breast cancer. The study involved 428 patients, who underwent a total of 648 breast reconstruction procedures using artificial implants. 47 out of 648 cases (7.3%) were identified in which the implant had to be removed. Of the 47 cases, 57.4% had undergone deferred reconstruction, and 42.6% immediate reconstruction; 27.7% had undergone pre-operative chemotherapy and radiotherapy, 27.7% pre-operative chemotherapy, and 2.1% pre-operative radiotherapy; 6.4% were diabetic, 4.3% active smokers, and more than 50.0% had BMI greater than 25 kg/m2. In 83.0% of the analyzed cases, the reason for removal of the implant was infection, in 8.5% it was local recurrence of breast cancer, in 4.3% it was damage (leakage) of the implant, and in 2.1% it was post-operative pain. About 87.0% of infections appeared within one year of implantation; however, less than a half developed within 90 days of the reconstructive surgery, and up to 30 days only about 13.0% had appeared. Among the etiological agents of infections were: coagulase-negative Staphylococcus (31.3%), Staphylococcus aureus (18.7%), Enterococcus faecalis (9.4%), Enterobacter cloacae (18.8%), Pseudomonas aeruginosa (12.5%), Acinetobacter lwoffii (3.1%), and other Gram-negative fermenting rods accounted for 6.2%. Infections were the most common reason for removing the implant after breast reconstruction. and occurred most often as late infections (> 30 days after surgery). The time of observation for infectious complications should be at least 1 year.
... There existed in Mesopotamia a well-established profession of ''Asu'' that could make early diagnosis of infection and apply pharmaceuticals before 1000 B.C. [4]. Currently, surgical site infections remain problematic in breast augmentation despite the improved surgical technique and antibiotic coverages [5,6]. Many studies show that implant infection can result in explantation, breast deformity, septic shock, and even death [5][6][7]. ...
... Currently, surgical site infections remain problematic in breast augmentation despite the improved surgical technique and antibiotic coverages [5,6]. Many studies show that implant infection can result in explantation, breast deformity, septic shock, and even death [5][6][7]. Therefore, early infection diagnosis and treatment are important in minimizing morbidity and mortality in breast augmentation with implants [8]. ...
Article
Background: Breast implant infection remains a problem despite various prevention methods. Common pathogens such as staphylococcus aureus typically present acutely with fever, erythema, swelling, and pain. However, with the increasing occurrence of mycobacterial infections, associated early signs and symptoms are typically absent, making early detection difficult. Method: A retrospective chart review of patients who underwent esthetic breast augmentation by senior surgeon FDP in an outpatient surgical facility from 1992 to 2021 was conducted. Cases of infections and related information including infection onset, presenting signs and symptoms, and culture results were recorded. Presentation differences between infections caused by common pathogens and mycobacteria were compared. Results: A total of nine infections were reported in 365 patients. Seven cases were due to common pathogens: staphylococcus aureus, pseudomonas aeruginosa, methicillin-resistant staphylococcus aureus (MRSA), and staphylococcus epidermidis. Fever, erythema was presented within an average of 10 days after surgery. Two cases were due to mycobacterium chelonae (non-tuberculous mycobacterium) infection. In the latter, the earliest signs and symptoms consisted of mild pain and swelling in the absence of fever and erythema, which began on average of 54 days after the operation. Conclusion: Common breast implant infection pathogens usually present early with fever and erythema. However, our study found that non-tuberculous mycobacteria infections occur much later and fever and erythema are typically absent. The purpose of this study is to increase the awareness of clinicians with this rare but rapidly increasing variety of infections and to advise the operating surgeon to include mycobacteria infections in the differential diagnosis. Level of evidence iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
... The human breast contains endogenous flora originated from the nipple ducts, similar to that of the healthy skin [3]. Staphylococcal skin flora are commensally resided and commonly cultured from surgical sites following breast reconstruction (BR) [20]. ...
... Postoperative infections have existed as a challenging complication following BR. Surgical procedure (i.e., surgical environment, contaminated saline, contaminated implant during surgery) and the underlying clinical condition of the patient are the main contributing factors for breast implant-associated infections [3]. Regarding orthopedic implants, bacterial antibiotic resistance made routine surgical procedures, such as hip and knee replacements, a looming challenge because of a foreseeable risk of contracting a life-threatening untreatable bacterial infection [4,103]. ...
Article
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Staphylococcus aureus is a notorious pathogen that colonizes implants (orthopedic and breast implants) and wounds with a vicious resistance to antibiotic therapy. Methicillin-resistant S. aureus (MRSA) is a catastrophe mainly restricted to hospitals and emerged to community reservoirs, acquiring resistance and forming biofilms. Treating biofilms is problematic except via implant removal or wound debridement. Nanoparticles (NPs) and nanofibers could combat superbugs and biofilms and rapidly diagnose MRSA. Nanotheranostics combine diagnostics and therapeutics into a single agent. This comprehensive review is interpretative, utilizing mainly recent literature (since 2016) besides the older remarkable studies sourced via Google Scholar and PubMed. We unravel the molecular S. aureus resistance and complex biofilm. The diagnostic properties and detailed antibacterial and antibiofilm NP mechanisms are elucidated in exciting stories. We highlight the challenges of bacterial infections nanotheranostics. Finally, we discuss the literature and provide “three action appraisals”. (i) The first appraisal consists of preventive actions (two wings), avoiding unnecessary hospital visits, hand hygiene, and legislations against over-the-counter antibiotics as the general preventive wing. Our second recommended preventive wing includes preventing the adverse side effects of the NPs from resistance and toxicity by establishing standard testing procedures. These standard procedures should provide breakpoints of bacteria’s susceptibility to NPs and a thorough toxicological examination of every single batch of synthesized NPs. (ii) The second appraisal includes theranostic actions, using nanotheranostics to diagnose and treat MRSA, such as what we call “multifunctional theranostic nanofibers. (iii) The third action appraisal consists of collaborative actions.
... Other Gram-positive pathogens, such as Enterococcus spp. 17 and Streptococcus pyogenes, 15 are potential causes of implant-associated infections, raising concern about their impact on breast augmentation surgeries and the occurrence of secondary outcomes. 6,11,18 In the present study, we tested the ability of biofilm formation by strains of 4 major Gram-positive bacterial pathogens under different conditions and on different surfaces, and verified their structures and cell viability on the outer surface material of breast implants. ...
... 22,28 In breast augmentation surgeries, the preferential surface of mammary implantable devices remains controversial due to the adhesion to surrounding tissue, biofilm formation, and risk for capsular contracture and BIA-ALCL. 3,10,17,[29][30][31] Here, we demonstrated that microtextured and/or standard textured silicone surfaces were more prone to biofilm formation by most species tested. Similarly, a previous study had shown more biofilm formation by S. epidermidis, P. aeruginosa, and Ralstonia pickettii on textured surfaces than on smooth silicone surfaces. ...
Article
Background Bacterial biofilm on surfaces of mammary implants is a predisposing factor for several outcomes. Since Gram-positive bacteria are potential agents of biomaterial-associated infections (BAIs), their abilities to form biofilm on breast implants should be elucidated. Objectives To evaluate biofilm formation on different mammary prosthesis surfaces by major Gram-positive bacterial pathogens involved in BAIs. Methods We initially evaluated biofilm formation on polystyrene plates with and without fibrinogen or collagen for one reference strain and one clinical isolate of Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis and Streptococcus pyogenes. We also tested the ability of clinical isolates to form biofilm on four different implant surfaces: polyurethane foam and smooth, microtextured and standard textured silicone. Biofilm structure and cell viability were observed by scanning electron microscopy (SEM) and confocal laser scanning microscopy (CLSM). Results All strains showed strong biofilm formation on polystyrene. After fibrinogen or collagen treatment, biofilm formation varied. With fibrinogen, reference strains of S. aureus and S. pyogenes increased biofilm formation (p<0.05). Reference strains of all species and the clinical isolate of S. pyogenes increased biofilm formation after collagen treatment (p<0.05). In general, S. aureus showed higher capacity to produce biofilm. SEM showed biofilm attached to all surfaces tested, with the presence of extracellular polymeric substances and voids. Viable cells were more frequent for E. faecalis and S. pyogenes. Conclusions All species produced biofilm on all prosthesis surfaces and under different conditions. Micrographies indicated thicker bacterial biofilm formation on microtextured and/or standard textured silicone by all species, except E. faecalis.
... [5][6][7][8][9] The higher rate of infections in reconstructive surgery is most probably caused by tissue ischemia with skin-saving mastectomy, the severing of the mammary gland tissue and thus the opening of the glandular ducts, the su- 0.524 perficial implant position, and possible preoperative radiotherapy. 13 When postoperative infections occur after the insertion of breast implants, a distinction must be made between superficial and deep periprosthetic infections. In this study, only periprosthetic infections or contaminations were analyzed. ...
... In addition to the spread of germs from the patient's skin or milk ducts, septic spreads of infectious foci are also discussed. 13 A very rare but life-threatening form of acute infection is the toxic shock syndrome (TSS), which occurs on average four days after implantation and is characterized by septic shock with comparatively inconspicuous local findings. 15 In our study, the median time interval between insertion and removal of the implants was 1.5 months in case of clinical suspicion of infection, and 6.8 years in patients without clinical suspicion of infection. ...
Article
Periprosthetic infections are feared complications in esthetic and reconstructive breast surgery. The purpose of our study is to evaluate our institution's specific culture data and to identify most common organisms and suitable antibiotics for prophylaxis and first-line treatment. We evaluated all patients with a change or removal of breast implants from 01.01.2012 to 31.12.2017 retrospectively. Based on the medical records, the surgical indications were identified and specifically analyzed for signs of infection, reasons for primary and secondary surgery, and all available microbiological data of these interventions. A total of 666 implant removals or exchanges were performed in 431 patients. Microbiological smears were gathered from 291 patients (449 implants). Bacteria were cultured from 63 implants (56 patients). In six additional patients (ten implants), a periprosthetic infection was seen, without bacteria detection. Advanced capsular contracture correlated with a higher proportion of positive swabs (p<0.05). In 11.5% of smears, bacterial contamination was found despite absence of clinical signs of infection. Coagulase-negative staphylococci were the dominant pathogen in clinical inapparent infections, while Staphylococcus aureus was when there was clinical evidence of infection. All pathogens were sensitive to vancomycin. In the majority of cases, bacterial contamination was an incidental finding, which was more common in the presence of advanced capsular contracture. In our institution, cefuroxime and amoxicillin/clavulanic acid have been proven to be reasonable choices for prevention and treatment of periprosthetic infections. In the treatment of fulminant infections and for the prophylaxis during implant replacement due to advanced capsular contracture, vancomycin became our first choice.
... Determining the origin of implant infections is still a challenge but potential sources of early post-operative infections include a contaminated prosthesis, the surgical environment, the patient's mammary ducts or skin, and the prosthesis contamination from remote infection sites. On the contrary, late infections usually are consequent to secondary bacteremia or an invasive procedure in other body districts [139]. Depending on severity of the infection, patients are treated with empiric intravenous or oral antibiotics and closely monitored [138]. ...
... Furthermore, delayed implant re-insertion may be technically more difficult due to tissue fibrosis. Breast implant infections are overall responsible for 2.0-2.5% of re-interventions performed in breast surgery [139] and low-grade or subclinical infections probably have a role also in the origin of capsular contracture. Therefore, new materials to coat breast prostheses able to reduce contaminations are expected to improve the success rate of these prostheses. ...
Article
Full-text available
Bacterial colonization of implanted biomedical devices is the main cause of healthcare-associated infections, estimated to be 8.8 million per year in Europe. Many infections originate from damaged skin, which lets microorganisms exploit injuries and surgical accesses as passageways to reach the implant site and inner organs. Therefore, an effective treatment of skin damage is highly desirable for the success of many biomaterial-related surgical procedures. Due to gained resistance to antibiotics, new antibacterial treatments are becoming vital to control nosocomial infections arising as surgical and post-surgical complications. Surface coatings can avoid biofouling and bacterial colonization thanks to biomaterial inherent properties (e.g., super hydrophobicity), specifically without using drugs, which may cause bacterial resistance. The focus of this review is to highlight the emerging role of degradable polymeric micro- and nano-structures that show intrinsic antifouling and antimicrobial properties, with a special outlook towards biomedical applications dealing with skin and skin damage. The intrinsic properties owned by the biomaterials encompass three main categories: (1) physical–mechanical, (2) chemical, and (3) electrostatic. Clinical relevance in ear prostheses and breast implants is reported. Collecting and discussing the updated outcomes in this field would help the development of better performing biomaterial-based antimicrobial strategies, which are useful to prevent infections.
... S kin contact of breast prostheses is considered by many to be a significant cause of ongoing subclinical infection leading to subsequent symptomatic capsular contracture (1)(2)(3)(4)(5). Many surgeons employ a no-touch technique, aiming to lower capsular contracture rates by eliminating skin contamination. ...
... According to China cosmetic surgery industry development prospect and investment risk forecast analysis report, the scale of China's cosmetic surgery market increased from 52 billion yuan to 151.8 billion yuan from 2014 to 2019, becoming the second largest cosmetic surgery market in the world [2]. Although more and more people are opting for cosmetic surgery, some potential risks are easily overlooked, such as chronic numbness of facial expression, chronic pain, and infections [3][4][5]. Additionally, cosmetic surgery is associated with some negative psychological problems, such as depression, body dysmorphic disorders, and social isolation [6,7]. Given the increasing number of undergraduates choosing cosmetic surgery as a strategy for changing their appearance and the potential risks of cosmetic surgery, it is now necessary to develop a better understanding of the psychological mechanisms involved in actively pursuing cosmetic surgery. ...
Article
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Background Several studies have examined the relationship between celebrity worship and cosmetic surgery; however, few have discussed the mediating role of self-concept. To fill this research gap, the present study aims to examine the mediating roles of self-concept clarity and self-objectification in the association between celebrity worship and cosmetic surgery. Methods A sample of 1,089 Chinese undergraduates ( M age = 20.32; SD age = 2.60) completed measures of celebrity worship, actively considering cosmetic surgery, self-concept clarity, and self-objectification. Mediating effect analysis was used to test the hypothesis. Results The results showed that celebrity worship, cosmetic surgery consideration, and self-objectification were positively correlated, whereas self-concept clarity was negatively correlated with all three variables. Mediation analysis revealed that celebrity worship predicted consideration of cosmetic surgery not only directly but also through three indirect paths through the mediating role of (1) self-concept clarity, (2) self-objectification, and (3) the chain mediating role of self-concept clarity and self-objectification. Conclusions These findings broaden our understanding of the psychological processes that underlie the association between celebrity worship and considering cosmetic surgery and afford practical guidance on reducing the risks associated with cosmetic surgery.
... The infection rate during the standard phase of the study was 3.45%, which is consistent with other reported studies. 6,31,38,52 This study shows that implant infection not only ruins the outcome of an otherwise uneventful aesthetic operation but also significantly impacts patient well-being and opinion of the breast implants. A high proportion of patients who developed infection reported they would not recommend implant surgery to friends ( Table 2). ...
Article
Background: Intraoperative contamination of the surgical field during aesthetic breast augmentation may lead to implant infection with devastating consequences. This study covers a period of 30 years and is divided into 2 phases: a retrospective phase from 1992-2004 when a standard approach was used and a prospective phase from 2004-2022 when a no-touch approach was implemented to avoid contamination. Methods: Patients in the standard and no-touch groups underwent aesthetic breast augmentation by the same senior surgeon (FDP) in the same outpatient surgical facility during the 30-year period of the study. Patients are divided into 2 groups: from 1992-2004 and from the implementation of the no-touch protocol in 2004-2022. Results: Patients who underwent breast augmentation using the no-touch approach developed no infections, whereas the standard group had an infection rate of 3.54% (P = .017). The validity of this finding is discussed. Conclusions: The no-touch approach as described in this article was effective in reducing implant infection rate when performing aesthetic breast augmentation by 1 surgeon at 1 surgical center during an 18-year observation period. Multicenter prospective cooperative studies are necessary to validate perioperative iatrogenic contamination as the cause of implant infection and to explore optimal approaches that could eliminate implant contamination.
... Despite the growing popularity of the approach, infection is a major complication after breast implant surgery. In particular, breast reconstruction after mastectomy and cancer radiotherapy is associated with a higher risk of infection (4). ...
Article
Full-text available
PurposeInfection is the most common complication following breast implant surgery. Nevertheless, the systematic administration of antibiotics after breast implant surgery has been subjected to controversial debate. In this study, we sought to elucidate the association between infection and the use of antibiotics as an aftermath of breast implantation surgical procedures.Methods Relevant studies were identified from PubMed, Web of Science, and EMBASE search mining. The extracted data included study type, basic characteristics, administrated antibiotic information, and clinical outcomes. Random-effects models were utilized to estimate outcomes, while study quality, statistical bias, and heterogeneity were also analyzed.ResultsA total of 7 studies involving a total of 9,147 subjects were included. The results demonstrated that the use of antibiotics after breast implantation reduced the incidence of infection (risk ratio [RR]: 0.65, 95% CI, 0.46–0.90). Nevertheless, smoking, obesity and diabetes type II are risk factors for postoperative infections. Sensitivity analysis verified the robustness of the results.Conclusions Our study identified the administration of antibiotics after breast implantation as an intervention that decreased the incidence of infection. Smoking, obesity, and diabetes type II are risk factors for postoperative infections. These findings strongly suggest that timely and effective antibiotic interventions will be crucial in future clinical practice, which may reduce the risk of postoperative infection following breast implantation.
... Patients undergoing implant-based breast reconstruction now commonly receive preoperative prophylactic systemic administration of antibiotics targeted at those microorganisms most likely to cause infection, typically a first or second-generation cephalosporin (such as cefazolin) targeted at susceptible staphylococci or vancomicin/gentamicin for patients allergic to penicillins. 117,155,156 According to a study by Ballard et al. assessing trends and changes in breast augmentation surgery, administration of preoperative antibiotics increased dramatically between 2011 (3.8%) and 2015 (98.7%). 4 In many instances, the intention here is to prevent immediate post-operative wound infection. ...
Article
Full-text available
Capsular contracture is a common complication associated with breast implants following reconstructive or aesthetic surgery in which a tight or constricting scar tissue capsule forms around the implant, often distorting the breast shape and resulting in chronic pain. Capsulectomy (involving full removal of the capsule surrounding the implant) and capsulotomy (where the capsule is released and/or partly removed to create more space for the implant) are the most common surgical procedures used to treat capsular contracture. Various structural modifications of the implant device (including use of textured implants, submuscular placement of the implant, and the use of polyurethane-coated implants) and surgical strategies (including pre-operative skin washing and irrigation of the implant pocket with antibiotics) have been and/or are currently used to help reduce the incidence of capsular contracture. In this article, we review the pharmacological approaches—both commonly practiced in the clinic and experimental—reported in the scientific and clinical literature aimed at either preventing or treating capsular contracture, including (i) pre- and post-operative intravenous administration of drug substances, (ii) systemic (usually oral) administration of drugs before and after surgery, (iii) modification of the implant surface with grafted drug substances, (iv) irrigation of the implant or peri-implant tissue with drugs prior to implantation, and (v) incorporation of drugs into the implant shell or filler prior to surgery followed by drug release in situ after implantation.
... 18 As potenciais fontes de contaminação incluem: prótese contaminada; soro fisiológico injectável contaminado; ambiente cirúrgico não estéril; flora cutânea ou ductos mamários; e invasão bacteriana com origem noutros locais. 19 O próprio tecido mamário pode ser fonte de infecção, sendo os locais de maior concentração bacteriana as áreas cujo tecido ductal é maior, como sejam a região peri-areolar ou infra-mamária. 20 Vários estudos prospectivos apresentam resultados estatisticamente significativos entre a existência de infecção e a presença de CC grave. ...
Article
Introdução: A contractura capsular é a complicação crónica mais frequente da mamoplastia de aumento com próteses mamárias e a principal causa de insatisfação da doente e do cirurgião plástico. A cápsula mamária consiste num tecido fibroso que circunda a prótese e que pode contrair, alterando a forma e a consistência da mama. No estádio mais avançado é acompanhada de deformidade acentuada, rigidez e dor, tendo indicação para tratamento cirúrgico. Material e Métodos: Foram revistos todos os artigos indexados na PubMed através da pesquisa ‘capsular contracture’ (2000 - Janeiro 2012), dos quais foram inseridos os artigos de maior interesse em termos de etiologia, profilaxia e tratamento. Artigos referenciados em publicações relevantes foram também analisados. Resultados: Tudo indica que a sua etiologia é multifactorial; a etiopatogenia da contractura capsular mamária continua a ser alvo de múltipla investigação pré-clínica. Vários são os estudos realizados de forma a prevenir a ocorrência de contractura capsular e, embora os resultados sejam promissores, pouco está definido em termos da sua aplicação na prática clínica. Relativamente ao tratamento a capsulectomia/capsulotomia continua a ser o gold-standard, no entanto o futuro poderá passar por técnicas não invasivas, pelo menos em estádios mais leves da doença. Conclusão: Apesar das técnicas cirúrgicas e a qualidade das próteses mamárias terem vindo a melhorar drasticamente nos últimos anos, a contractura capsular mamária mantém-se uma complicação real, com incidência elevada e que continua a afectar milhares de mulheres no mundo.
... 6 , 7 Periprosthetic infection is a dreadful occurrence that a sterile environment, adequate surgery, and antibiotic prophylaxis attempt to avoid. 6 In breast implant infections, a conservative management with antibiotics can be successful in 25% of cases. 8 Nevertheless, for the rest, a revision surgery may become necessary. ...
Article
Post-operative implant infection is generally rare after breast augmentation, but it can occur in up to 35% of cases in post mastectomy breast reconstruction. Standard treatment consists in the administration of antibiotics, implant removal and delayed prosthesis replacement leading to multiple operations, with a negative impact on patient's clinical, economical and psychological outcomes. There is little information published in Literature on the management of periprosthetic infection following pre- pectoral reconstructions. Capsule's removal from a pre-pectoral plane brings the risk of excessive tissue thinning and the compromise of skin flaps viability. In this preliminary multicenter case series, eight patients diagnosed with implant infection following oncological mastectomy and two stage heterologous pre-pectoral breast reconstruction underwent the same protocol, consisting in tissue expander removal and conservative surgical revision supplemented by an antibiotate pulse lavage of the pocket surface. All patients achieved a successful infection resolution with immediate prosthesis replacement switching the temporary expander to definitive implant. No additional surgical revision was registered during follow-up. The intermittent irrigation is meant to disrupt the biofilm structure and to restore antibiotic susceptibility. Moreover, pulse lavage allows the cleansing of the prosthetic capsule, thus avoiding the vascular stress associated to subcutaneous capsulectomy. As far as we know this is the first series report- ing on the use of Pulsavac in periprosthetic infection following pre-pectoral breast reconstruction, in an attempt to set the basis for an alternative conservative protocol to manage breast implant infection. A thorough literature review on pulse lavage in breast surgery was carried out.
... Still, there are certain challenges in the utilization of biomaterials such as corrosiveness, brittleness, low stiffness, less uniformity, and infection due to biofilm formation resulting in a second surgery [7,16]. For instance, polymeric biomaterials such as residual methyl methacrylate monomer in poly(methyl methacrylate), silicones, and poly (ethylene terephthalate) in addition to having phenomenal desirable characteristics can cause cell deterioration, eyes and skin infection, disturb blood flow, and induce clots [17][18][19]. In order to counter these shortcomings, surface modifications can be helpful for avoiding undesirable interaction [10]. ...
Article
Full-text available
Decades of intense scientific research investigations clearly suggest that only a subset of a large number of metals, ceramics, polymers, composites, and nanomaterials are suitable as biomaterials for a growing number of biomedical devices and biomedical uses. However, biomaterials are prone to microbial infection due to Escherichia coli (E. coli), Staphylococcus aureus (S. aureus), Staphylococcus epidermidis (S. epidermidis), hepatitis, tuberculosis, human immunodeficiency virus (HIV), and many more. Hence, a range of surface engineering strategies are devised in order to achieve desired biocompatibility and antimicrobial performance in situ. Surface engineering strategies are a group of techniques that alter or modify the surface properties of the material in order to obtain a product with desired functionalities. There are two categories of surface engineering methods: conventional surface engineering methods (such as coating, bioactive coating, plasma spray coating, hydrothermal, lithography, shot peening, and electrophoretic deposition) and emerging surface engineering methods (laser treatment, robot laser treatment, electrospinning, electrospray, additive manufacturing, and radio frequency magnetron sputtering technique). Atomic-scale engineering, such as chemical vapor deposition, atomic layer etching, plasma immersion ion deposition, and atomic layer deposition, is a subsection of emerging technology that has demonstrated improved control and flexibility at finer length scales than compared to the conventional methods. With the advancements in technologies and the demand for even better control of biomaterial surfaces, research efforts in recent years are aimed at the atomic scale and molecular scale while incorporating functional agents in order to elicit optimal in situ performance. The functional agents include synthetic materials (monolithic ZnO, quaternary ammonium salts, silver nano-clusters, titanium dioxide, and graphene) and natural materials (chitosan, totarol, botanical extracts, and nisin). This review highlights the various strategies of surface engineering of biomaterial including their functional mechanism, applications, and shortcomings. Additionally, this review article emphasizes atomic scale engineering of biomaterials for fabricating antimicrobial biomaterials and explores their challenges.
... 2 Prosthesis-based breast reconstruction is still the most common form of breast reconstruction in the United States, but rates of peri-prosthetic breast infection remain unchanged, ranging from 1% to as high as 35%. [3][4][5][6][7] Thus, as more women seek breast reconstruction after mastectomy, we must continue to improve reconstructive outcomes and increase success of these seemingly inevitable complications, which can be devastating for patients and costly for hospital systems. ...
Article
Full-text available
Introduction: Existing salvage protocols for infected breast prostheses using negative pressure wound therapy with instillation and dwell (NPWTi-d) require multiple returns to the operating room and prolonged length of stay. We present our expedited salvage protocol and discuss outcomes and associated costs savings. Methods: Using a retrospective review, we identified 25 consecutive patients (27 breasts) with peri-prosthetic breast infection. Nine patients (10 breasts) underwent removal of infected breast prostheses followed by autologous or staged implant-based reconstruction. Sixteen patients (17 breasts) underwent our single application salvage protocol. A cost analysis was performed comparing the two groups, and an economic model was used to project the cost savings associated with using single application NPWTi-d protocol. Results: Fifteen of the 16 patients (94%) who underwent single application NPWTi-d had successful implant salvage. Average duration of NPWTi-d was 2 days, 7 hours, and average length of stay was 4.43 days. Compared to control, patients who received the single application protocol required significantly fewer hospitalizations and office visits. A total savings of $58,275 could have been achieved by using the single application NPWTi-d protocol in the patients who did not undergo NPWTi-d. Conclusions: Single application of NPWTi-d is a simple, safe, and cost-effective technique for salvage of breast prostheses, with 94% success rate, even in immunocompromised patients and severe infection. Compared to previous protocols, ours requires fewer trips to the operating room, shorter length of stay, and more permanent implants placed during salvage. Our protocol is also associated with fewer office visits and fewer returns to the operating room.
... There have been reports of prostheses such as breast implants and joint prostheses being infected from a secondary source [8,9]. However, there have not been any reports of mesh or seroma infection seeding from secondary infection sites. ...
Article
We present a case of infected chronic seroma post ventral hernia repair using the Rives-Stoppa technique likely from bacterial translocation from ascending cholangitis. After definitive treatment with endoscopic retrograde cholangiopancreatography (ERCP) and drainage of obstructed gallstones, she continued to show signs of sepsis. Percutaneous drainage of seroma was diagnostic for infection, where Escherichia coli (E. coli) was cultured and coupled with IV antibiotics, her infection was treated. To the best of our knowledge, this is the first case of seroma infection from biliary sepsis, and there are no cases of infected seroma from a secondary infection in the literature.
... Breast surgery • Insertion of silicone breast implants if larger breasts are desired [268] • Recommend 1 year of prior HT for best outcome (maximum breast development occurs after 3-5 years) [18] • It is important to explain that there is much individual variation in breast development • It is important to explain that if a prosthesis is too large, then it may cause atrophy of the glandular tissue of the breast • Breast implants carry a lifelong risk of infection [272] • Post-operative antibiotics (Grampositive cover) are routinely given for 2 weeks ...
Technical Report
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We support an affiing approach to managing the transgender and gender diverse (TGD) client, centring on the individual’s agency, autonomy and right to self-determination, as opposed to practices that pathologise and stigmatise TGD identity, imposing barriers to accessing healthcare. TGD persons have long faced discrimination on multiple axes, both globally and in South Africa. Although South Africa enshrines the protection of human rights in its Constitution, TGD persons continue to face marginalisation, prejudice and threats to their safety. Challenges persist – including homelessness, unemployment, poor social support, bullying, harassment and violence – indicating failures of policy development and practice implementation, and a disregard for the human rights of persons in the TGD community. This guideline has been developed primarily with the intention of centring and amplifying voices of TGD persons in order to facilitate access to healthcare that is sensitive, skilled and respectful. We recognise that there are signifiant gaps in the knowledge and skills of healthcare providers, and a lack of understanding of the unique experiences faced by TGD persons. The prevailing sentiment that many healthcare providers hold around TGD individuals, informed by ignorance and conditioning within social and societal structures, are malevolent towards this community and often include harmful assumptions and generalisations. We believe that healthcare providers have an ethical obligation to interrogate these notions, and we promote an attitude of respect for diversity that upholds human rights. It has been well established that access to competent and dignifid gender-affiing healthcare (GAHC) is not only safe, but also plays a signifiant role in improving measurable outcomes for TGD clients. It has also been well established that pathologising approaches and practices that limit access to care can be damaging and harmful. Finally, we recognise that TGD persons have historically endured being undermined, condescended to and pitied by the healthcare system and its providers. We affi a commitment to upholding a strength-based perspective that values and respects the experiences of TGD clients and celebrates individual identity rather than merely accepting or tolerating it. This guideline, which will undoubtedly require ongoing revision, reflction and refiement in consultation with TGD communities and healthcare providers, represents a fist step made in good faith towards creating a practical tool founded in robust scientifi evidence, lodged within a human rights framework, and is intended to facilitate access to skilled and sensitive care that will yield tangible benefi to this unique and important group.
... Previously reported causative pathogens in BIAI. [2][3][4] Gram-positive Gram plications after the procedure are rare, breast implant-associated infections (BIAI) occur in approximately 2% of cases 2 . ...
Article
Full-text available
Breast-implant associated infections (BIAI) occur in approximately 2 % of patients after augmentation mammoplasty. In some cases BIAI can be treated conservatively whereas others need implant removal. Knowledge of uncommon potential pathogens in BIAI is important to ensure optimal treatment of BIAI. In the present case report we describe a case of bilateral late Campylobacter Jejuni mastitis in a 34-year-old female without previous symptoms of gastroenteritis. While staphylococci are common causative pathogen in BIAI, there are numerous potential pathogens. This case highlights the importance of careful consideration of antibiotic treatment and switch to broad-spectrum antibiotic regimen in BIAI not responding to initial treatment.
... The evidence for any benefit of preoperative antibiotics in breast surgery is mixed, but due to the serious issues that infections could cause in breast surgeries, 72 we recommend the use of preoperative antibiotics, although more RCTs are warranted to validate the efficacy of this approach. There is no evidence concerning postoperative antibiotics in breast surgeries except in implant-based breast reconstruction. ...
Article
Background Although many interventions are implemented to prevent surgical site infections (SSIs) in plastic surgery, their supporting evidence is inconsistent. Objectives The goal of this study is to assess the efficacy of methods for decreasing SSIs in plastic surgery. Methods A systematic review and meta-analysis were preformed comparing the effects of SSI prevention methods. All the studies were assessed for quality of evidence using the GRADE assessment. Results Fifty Level-1 randomized controlled trials were included. The most common interventions for preventing SSIs were antibiotic prophylaxis, showering, prepping, draping, and the use of dressings. Current evidence suggests that antibiotic prophylaxis is largely unnecessary and overused in many plastic surgical procedures, with the exception of head and neck oncologic, oral craniofacial, and traumatic hand surgeries. Conclusions Efficacy of antibiotic prophylaxis in plastic surgery is dependent on surgery type. There is a lack evidence that showering and prepping with chlorohexidine and povidone reduces SSIs.
... The causative organisms are mainly gram-positive bacteria such as coagulase-negative staphylococci, Cutibacterium species, Staphylococcus aureus, and streptococci. Gram-negative bacteria, such as [7,8], and in cases of bilateral infection, inflammatory findings of both breast implants are usually apparent at the initial presentation [9,10]. In the present case, the infection was observed only on one side of the breast implant at first, and the contralateral infection presented approximately 8 weeks after her arrival at our hospital. ...
Article
Full-text available
Campylobacter jejuni and Campylobacter coli are the leading causes of bacterial intestinal infections worldwide, while Campylobacter fetus subsp. fetus (C. fetus) has been reported to cause extraintestinal infections, including medical device implant infections. However, breast implant infections have rarely been reported. We describe the case of a 64-year-old woman with breast implant infection and vertebral osteomyelitis due to C. fetus. The patient recovered by surgical removal of the infected left implant and was treated with antibiotics for 6 weeks. However, two weeks after the completion of antibiotics, she experienced an infection in the right implant due to C. fetus, which had developed quinolone resistance with a G91T mutation during the treatment course. This case showed that C. fetus can cause breast implant infections, and although the infection may appear to be unilateral initially, the possibility of sequential contralateral infection should be considered.
... When bacterial contamination inside the breast pocket is not mitigated effectively at the time of revision surgery, infection may persist, and it is hypothesized to lead to serious complications such as capsular contracture, breast implant-associated anaplastic large cell lymphoma, and a prolonged local inflammatory response. 3,6,7,[9][10][11][12] These complications may take on greater importance when textured breast implants and tissue expanders are utilized because these products have been linked to the potential for increased bioburden and biofilm formation. 4 The utilization of antimicrobial solutions, especially those containing triple antibiotics (TAB) and/or 10% povidone-iodine (PI; Betadine), for breast pocket irrigation during revision surgeries, has been common practice for many surgeons over the past few decades. ...
Article
Full-text available
Background Biofilm-associated bacteria have been observed in both breast implant revision and tissue expander-implant exchange surgeries. The utilization of antimicrobial solutions in breast surgery, especially those containing triple antibiotics (TAB) and/or 10% povidone-iodine (PI), may help reduce existing biofilm-associated bacteria, which is particularly important in a mature breast pocket that may contain residual bacteria from a previously colonized implant surface or, theoretically, bacteria that may arrive postoperatively through hematogenous spread. Objectives A series of in vitro assessments was performed to evaluate the antimicrobial utility of TAB and PI, either alone or in combination, against preformed biofilm-associated bacteria. Methods Preformed biofilm-associated gram-positive and gram-negative bacterial strains were exposed to TAB and PI ± TAB for up to 30 minutes in a bacterial time-kill assay. Efficacy of various dilutions of PI and the effects of serum protein on PI efficacy were also investigated. Results TAB was ineffective at the timeframes tested when utilized alone; when utilized in conjunction with PI, significant log reduction of all biofilm-associated bacterial species tested was achieved when treated for at least 5 minutes. PI alone at a concentration of 25% or higher was also effective, although its efficacy was negatively affected by increasing serum protein concentration only for Staphylococcus epidermidis. Conclusions Our data indicate that PI-containing solutions significantly reduce biofilm-associated bacteria, suggesting potential utility for breast pocket irrigation during revision or exchange surgeries. Care should be taken to minimize excessive dilution of PI to maintain efficacy.
... 5 Hypothesized complications associated with bacterial bioburden at the breast implant-tissue interface include infection, capsular contracture, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and a prolonged local inflammatory response. [6][7][8][9][10][11] With an increasing emphasis on the potential contributions of bioburden to these complications, aseptic techniques as reported in the 14-point plan have been touted to help reduce bacterial contamination on and around implants. 1 Point #8 (i.e., perform pocket irrigation with triple antibiotic solution or Betadine®) is particularly germane. The use of antimicrobial solutions such as triple antibiotic solution (TAB) or 10% povidone-iodine (PI) is intended to minimize bioburden either on the implant itself or in the surrounding tissue upon mammary pocket creation in primary breast surgeries. ...
Article
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Background Planktonic bacteria can be inadvertently introduced during breast surgery procedures, which are hypothesized to lead to complications such as infection, capsular contracture, BIA-ALCL, and a prolonged local inflammatory response. The use of antimicrobial solutions such as triple antibiotic solution (TAB) and/or 10% povidone-iodine (PI), in breast pocket irrigation or implant soaking have been proposed to reduce planktonic bacterial attachment and potential complications. Objectives A series of in vitro assessments were performed to evaluate the antimicrobial utility of triple antibiotic solution (TAB) and PI, either alone or in combination, against planktonic bacteria. Methods Planktonic gram-positive and gram-negative bacterial strains were exposed to TAB and PI +/- TAB for up to 10 minutes in a bacterial time-kill assay. Efficacy of various dilutions of PI as well as the effects of serum protein on PI efficacy were also investigated. Results TAB was ineffective at the timeframes tested (≤ 10 minutes) when used alone; however, when used with PI, significant log reduction of all tested planktonic species was achieved. PI alone was also effective, even including dilute concentrations (e.g., 0.5% PI), although the presence of serum proteins required higher concentrations of PI (e.g., 2.5%) to eradicate the bacterial load. Conclusions Our data suggest PI-containing solutions may be preferred over either saline or TAB without PI for primary breast pocket irrigation and implant soaking in primary breast surgeries as a means to significantly reduce planktonic bacteria. These data provide an impetus for surgeons to re-evaluate the efficacy of TAB solution in these clinical settings.
... A retrospective analysis undertaken in the United Kingdom of 3002 women who received aesthetic breast prosthetics found infections were experienced by 33 patients (1.1%) (Araco et al., 2007). Pittet et al. (2005) found in their global survey of 10914 patients, a similar rate of 1.7% reported acute post-operative infection. ...
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Physical disfigurement due to congenital defects, trauma, or cancer causes considerable distress and physical impairment for millions of people worldwide; impacting their economic, psychological and social wellbeing. Since 3000 B.C., prosthetic devices have been used to address these issues by restoring both aesthetics and utility to those with disfigurement. Internationally, academic and industry researchers are constantly developing new materials and manufacturing techniques to provide higher quality and lower cost prostheses to those people who need them. New advanced technologies including 3D imaging, modeling, and printing are revolutionizing the way prostheses are now made. These new approaches are disrupting the traditional and manual art form of prosthetic production which are laborious and costly and are being replaced by more precise and quantitative processes which enable the rapid, low cost production of patient-specific prostheses. In this two part review, we provide a comprehensive report of past, present and emerging soft-tissue prosthetic materials and manufacturing techniques. In this review, part A, we examine, historically, the ideal properts of a polymeric material when applied in soft-tissue prosthetics. We also detail new research approaches to target specific tissues which commonly require aesthetic restoration (e.g. ear, nose and eyes) and discuss both traditional and advanced fabrication methods, from hand-crafted impression based approaches to advanced manufactured prosthetics. We discuss the chemistry and related details of most significant synthetic polymers used in soft-tissue prosthetics in Part B. As advanced manufacturing transitions from research into practice, the five millennia history of prosthetics enters a new age of economic, personalized, advanced soft tissue prosthetics and with this comes significantly improved quality of life for the people affected by tissue loss.
... The drainage tube should be removed after 2 to 3 weeks owing to the increasing risk of an ascending infection that can lead to breast implant failure; the remaining peri-prosthetic seroma can be managed using ultrasound-guided aspiration. [5][6][7] Conversely, if the peri-prosthetic seroma is left unmanaged, the incidence of infection increases and the patient may experience a heavy sensation as well as functional problems. Cosmetic outcomes may worsen because of breast asymmetry. ...
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Background: Peri-prosthetic seroma after implant insertion for breast reconstruction is a common but difficult-to-manage complication. This study aimed to compare peri-prosthetic seroma duration and the number of aspirations associated with intravenous cannula with those associated with conventional needle. Methods: Seventy-one patients who underwent skin- or nipple-sparing mastectomy and implant insertion were treated for peri-prosthetic seroma. When peri-prosthetic seroma was detected, ultrasound-guided aspiration was performed either by using an intravenous cannula (n = 35) or a conventional needle (n = 36); however, the method adopted was randomly selected. We analyzed the participants' clinicopathologic factors after medical record review. Results: There were no significant intergroup differences in mean age (P = .052), mean body mass index (P = .601), total clinical tumor size (P = .107), pathologic tumor size (P = .269), specimen weight (P = .147), implant size (P = .313), or operation time (P = .595). However, the mean total peri-prosthetic seroma volume was significantly higher (105.80 vs 88.58, P = .015) but the number of aspirations was lower (4.48 vs 5.80, P = .043) in the intravenous cannula group than in the conventional needle group. Mean peri-prosthetic seroma volume per aspiration was nonsignificantly higher in the intravenous cannula group (26.92 vs 19.14, P = .291). Conclusion: Ultrasound-guided aspiration performed using an intravenous cannula was comparable to the procedure performed using a conventional needle. Furthermore, the former method can be safer and effective alternative to manage peri-prosthetic seroma.
... Staphylococcal spp. biofilms are one of the frequent causes of certain medical device-associated infections, such as infections related to intravenous catheters [4,5], cardiac pacemakers [6] and mammary implants [7,8]. In prosthetic joint infections, especially Staphylococcus aureus is largely responsible for early post-interventional infection types [9]. ...
Article
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Medical device-associated staphylococcal infections are a common and challenging problem. However, detailed knowledge of staphylococcal biofilm dynamics on clinically relevant surfaces is still limited. In the present study, biofilm formation of the Staphylococcus aureus ATCC 25923 strain was studied on clinically relevant materials-borosilicate glass, plexiglass, hydroxyapatite, titanium and polystyrene-at 18, 42 and 66 h. Materials with the highest surface roughness and porosity (hydroxyapatite and plexiglass) did not promote biofilm formation as efficiently as some other selected materials. Matrix-associated poly-N-acetyl-β-(1-6)-glucosamine (PNAG) was considered important in young (18 h) biofilms, whereas proteins appeared to play a more important role at later stages of biofilm development. A total of 460 proteins were identified from biofilm matrices formed on the indicated materials and time points-from which, 66 proteins were proposed to form the core surfaceome. At 18 h, the appearance of several r-proteins and glycolytic adhesive moonlighters, possibly via an autolysin (AtlA)-mediated release, was demonstrated in all materials, whereas classical surface adhesins, resistance-and virulence-associated proteins displayed greater variation in their abundances depending on the used material. Hydroxyapatite-associated biofilms were more susceptible to antibiotics than biofilms formed on titanium, but no clear correlation between the tolerance and biofilm age was observed. Thus, other factors, possibly the adhesive moonlighters, could have contributed to the observed chemotolerant phenotype. In addition, a protein-dependent matrix network was observed to be already well-established at the 18 h time point. To the best of our knowledge, this is among the first studies shedding light into matrix-associated surfaceomes of S. aureus biofilms grown on different clinically relevant materials and at different time points.
... Infection rates after implant-based breast reconstruction have been reported from 12.3% to 35.4%, in large academic centers (3,4). This wide range is probably explained by the lack of a consensus on the definition and the diagnosis of breast implant infection, and the variation in its clinical presentation (5,6). Traditionally, breast implant infection has been defined using the Centers for Disease Control and Prevention (CDC) criteria for superficial and deep surgical site infections (7). ...
Article
Objective Implant-based breast reconstruction after mastectomy remains the most common reconstructive modality worldwide. Infection is a frequent complication that negatively affects the reconstructive outcome and increases health-care costs. The aim of this study is to evaluate the accuracy of ultrasonography in identifying fluid collections in patients with breast implant infection. Methods After receiving institutional review board approval, a retrospective chart review was performed on patients who presented with breast implant infection after breast reconstruction, during the period 2009–2017. To estimate the sensitivity and specificity of ultrasound (US) in detecting fluid collections, only patients with US evaluation and surgery during the same admission were included. Results In total, 64 patients with 64 infected implants met the inclusion criteria. Infected devices included 44 (69%) tissue expanders, and 20 (31%) implants, of which 40 (62%) were placed in the subpectoral and 24 (38%) prepectoral positions. Periprosthetic fluid was identified by US preoperatively in 45 (70%) of the patients, and a fluid collection was found in 61 (95%) of the patients during surgery. Sensitivity and specificity of US were 74% and 100%, respectively. Inaccurate US results were more likely in patients with silicone implants than patients with saline expander implants. Conclusion Caution should be exercised in interpreting negative US findings in patients with silicone implants in the setting of infection. Other imaging modalities should be explored if US results are negative in cases with high clinical suspicion.
Article
Importance Multiple-dose antibiotic prophylaxis is widely used to prevent infection after implant-based breast reconstruction despite the lack of high-level evidence regarding its clinical benefit. Objective To determine whether multiple-dose antibiotic prophylaxis is superior to single-dose antibiotic prophylaxis in preventing surgical site infection (SSI) after implant-based breast reconstruction. Design, Setting, and Participants This prospective, multicenter, randomized clinical superiority trial was conducted at 7 hospitals (8 departments) in Sweden from April 25, 2013, to October 31, 2018. Eligible participants were women aged 18 years or older who were planned to undergo immediate or delayed implant-based breast reconstruction. Follow-up time was 12 months. Data analysis was performed from May to October 2021. Interventions Multiple-dose intravenous antibiotic prophylaxis extending over 24 hours following surgery, compared with single-dose intravenous antibiotic. The first-choice drug was cloxacillin (2 g per dose). Clindamycin was used (600 mg per dose) for patients with penicillin allergy. Main Outcomes and Measures The primary outcome was SSI leading to surgical removal of the implant within 6 months after surgery. Secondary outcomes were the rate of SSIs necessitating readmission and administration of intravenous antibiotics, and clinically suspected SSIs not necessitating readmission but oral antibiotics. Results A total of 711 women were assessed for eligibility, and 698 were randomized (345 to single-dose and 353 to multiple-dose antibiotics). The median (range) age was 47 (19-78) years for those in the multiple-dose group and 46 (25-76) years for those in the single-dose group. The median (range) body mass index was 23 (18-38) for the single-dose group and 23 (17-37) for the multiple-dose group. Within 6 months of follow-up, 30 patients (4.3%) had their implant removed because of SSI. Readmission for intravenous antibiotics because of SSI occurred in 47 patients (7.0%), and 190 women (27.7%) received oral antibiotics because of clinically suspected SSI. There was no significant difference between the randomization groups for the primary outcome implant removal (odds ratio [OR], 1.26; 95% CI, 0.69-2.65; P = .53), or for the secondary outcomes readmission for intravenous antibiotics (OR, 1.18; 95% CI, 0.65-2.15; P = .58) and prescription of oral antibiotics (OR, 0.72; 95% CI, 0.51-1.02; P = .07). Adverse events associated with antibiotic treatment were more common in the multiple-dose group than in the single-dose group (16.4% [58 patients] vs 10.7% [37 patients]; OR, 1.64; 95% CI, 1.05-2.55; P = .03). Conclusions and Relevance The findings of this randomized clinical trial suggest that multiple-dose antibiotic prophylaxis is not superior to a single-dose regimen in preventing SSI and implant removal after implant-based breast reconstruction but comes with a higher risk of adverse events associated with antibiotic treatment. Trial Registration EudraCT 2012-004878-26
Article
Background: Perioperative antibiotic prophylaxis is an established concept to reduce the risk of surgical-site infections; however, the optimal treatment duration in prosthetic breast reconstruction is still controversial. This study evaluated a potential association between the perioperative antibiotic prophylaxis duration (≤24 hours versus >24 hours) and incidence of postoperative surgical-site infections in immediate implant-based breast reconstruction in breast cancer patients. Methods: A descriptive, retrospective analysis of surgical-site infections after immediate implant-based breast reconstruction in breast cancer patients between January of 2011 and December of 2018 was performed. The incidence of postoperative surgical-site infections in patients with more than 24 hours of perioperative antibiotic prophylaxis was compared to patients treated for 24 hours or less. Results: A total of 240 patients who met criteria were included. There were no relevant epidemiologic, clinical, or histopathologic differences between groups. Surgical-site infections as defined by the Centers for Disease Control and Prevention criteria occurred in 25.8 percent. A risk factor-adjusted analysis by a prespecified multiple logistic regression model showed that 24 hours or less of perioperative antibiotic prophylaxis was not inferior to treatment for more than 24 hours. The upper limit of the one-sided 95 percent confidence interval of the risk difference was 9.4 percent (below the prespecified noninferiority margin of 10 percent leading to statistical significance). Risk factors for a surgical-site infection included obesity and postoperative wound complications. Conclusions: The study found no association between short-course perioperative antibiotic prophylaxis (≤24 hours) and an increased rate of postoperative surgical-site infection. This is of high clinical relevance because short-course treatment can help reduce side effects and the emergence of antimicrobial resistance and prevent surgical-site infections as effectively as a prolonged perioperative antibiotic prophylaxis course. Clinical question/level of evidence: Therapeutic, III.
Chapter
Breast augmentation is one of the most frequently performed aesthetic surgery worldwide. Despite its low incidence, post-augmentation mammaplasty infection can be challenging to manage. Factors like patient comorbidities, surgical technique, skin and milk ducts bacterial flora, skin preparation and draping method, and implant handling and operation room features can sway infection rates and must be considered. Some easy-to-implement preventive measures were shown to reduce chances of post-surgical infections and should be employed. The periprosthetic infection can manifest as acute or late, and in some cases even life-threatening disease. Diagnosis of breast implant infection relies mainly on medical history and clinical examination, supplemented by blood work and in some cases ultrasonographic imaging. Mild to moderate (level 1, 2) periprosthetic infection can be managed conservatively with antibiotics administration, whereas the more severe cases, which include patient instability, implant exposure, fluid drainage, or no response to conservative treatment, will warrant surgical exploration.
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We support an affirming approach to managing the transgender and gender diverse (TGD) client, centering on the individual’s agency, autonomy and right to selfdetermination, as opposed to practices that pathologise and stigmatise transgender identity, imposing barriers to accessing healthcare services. Transgender and gender diverse individuals have long faced discrimination on multiple axes, both globally and in South Africa. Although South Africa enshrines the protection of human rights in its Constitution, TGD individuals continue to face marginalisation, prejudice and threats to their safety. Challenges, including homelessness, unemployment, poor social support, bullying, harassment and violence, persist, indicating failures of policy development, practice implementation and a disregard for the human rights of individuals in the TGD community. This guideline has been developed primarily with the intention of centering and amplifying voices of TGD individuals in order to facilitate access to healthare that is sensitive, skilled and respectful. We recognise that there are significant gaps in the knowledge and skills of healthcare providers, and there is a lack of understanding of the unique experiences faced by TGD persons. The prevailing sentiment that many healthcare providers hold around TGD individuals, informed by ignorance and conditioning within social and societal structures, are malevolent towards this community, and often include harmful assumptions and generalisations. We believe that healthcare providers have an ethical obligation to interrogate these notions, and we promote an attitude of respect for diversity that upholds human rights. It has been well established that access to competent and dignified gender-affirming healthcare (GAHC) is not only safe but also plays a significant role in improving measurable outcomes for TGD clients. It has also been well established that pathologising approaches and practices that limit access to care can be damaging and harmful. Finally, we recognise that TGD individuals have historically endured being undermined, condescended to and pitied by the healthcare system and its providers. We affirm a commitment to upholding a strength-based perspective that values and respects the experiences of TGD clients and celebrates their individual identity rather than merely accepting or tolerating it. This guideline, which no doubt will require ongoing revision, reflection and refinement in consultation with TGD communities and healthcare providers, represents a first step made in good faith towards creating a practical tool founded in robust scientific evidence, lodged within a human rights framework, and is intended to facilitate access to skilled and sensitive care that will yield tangible benefits to this unique and important group.
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In article number 2100229 by Eoin O'Cearbhaill, Garry Duffy and co-workers, the “liquid rope coil effect” is harnessed to produce porous silicone coatings that are additively manufactured onto the surface of soft-tissue implants, aiming to address notorious challenges of long-term tissue integration and fibrosis associated with these implants. In vivo studies show that this coating encourages highly vascularised tissue ingrowth
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Medical devices, such as silicone‐based prostheses designed for soft tissue implantation, often induce a suboptimal foreign‐body response which results in a hardened avascular fibrotic capsule around the device, often leading to patient discomfort or implant failure. Here, it is proposed that additive manufacturing techniques can be used to deposit durable coatings with multiscale porosity on soft tissue implant surfaces to promote optimal tissue integration. Specifically, the “liquid rope coil effect”, is exploited via direct ink writing, to create a controlled macro open‐pore architecture, including over highly curved surfaces, while adapting atomizing spray deposition of a silicone ink to create a microporous texture. The potential to tailor the degree of tissue integration and vascularization using these fabrication techniques is demonstrated through subdermal and submuscular implantation studies in rodent and porcine models respectively, illustrating the implant coating's potential applications in both traditional soft tissue prosthetics and active drug‐eluting devices. Porous silicone coatings are additively manufactured onto the surface of soft‐tissue implants, aiming to address the notorious challenges of long‐term tissue integration and fibrosis. The “liquid rope coil effect” via direct ink writing is combined with atomizing spray deposition to create a multi‐scale “rope coiled” silicone coating architecture. In vivo studies show that this coating encourages highly vascularised tissue ingrowth.
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Background Protective funnels devices are commonly used to deliver implants in primary breast augmentation (BA) yet there is a paucity of evidence-based data describing their safety in the literature. Objectives The purpose of the study was to assess the safety of protective funnels in primary BA within the first 30-days postoperatively. Methods This multi-center, Level 3 study retrospectively reviewed the surgical records of 380 consecutive patients (760 breasts) who underwent primary BA by nine board-certified plastic surgeons using the iNPLANT Funnel (Proximate Concepts LLC, Allendale, NJ, USA) for implant delivery between November 2019 and December 2020. Data was collected pertaining to demographics, implant information, surgery details, and postoperative complications. Results The mean patient age was 33 years and 76% patients had a BMI < 25. Of this cohort, 11.4% were smokers, 0.8% had diabetes, and 83% were ASA class 1. All patients received smooth implants with a median volume of 375cc. A total of 8 (2.1%) complications were reported including: 3 hematomas (0.79%), 1 seroma (0.26%) and 1 superficial infection (0.26%). No patient required explantation. We identified ASA class, BMI, surgery duration, and implant size as potential risk factors. Conclusions The data suggest that use of protective funnels, such as the iNPLANT Funnel, in primary BA are a safe option when used according to the manufacturer’s IFU. Its use led to a low infection rate (0.26%) and a complication rate (2.1%) consistent with the average reported in the literature (2%-2.5%). 1 Implications for clinical practice are encouraging and future research will include a prospective analysis with a larger case series and potentially a control group.
Article
Background Breast prostheses could be associated with complications, despite many studies on surgical materials and techniques. The role of surgical drainage in preventing complications on breast prostheses surgery is controversial. Objectives This study aimed to evaluate the role and effectiveness of vacuum drainage in the augmentation mammoplasty. Methods A prospective multicentric randomized comparative clinical trial was conducted with 150 patients, who were the candidates for breast augmentation. The candidates were split into two groups to analyze the breast drain role. Group1: closed-suction drainage; measurements were taken every 24 h for 48 h. Group2: control (no drainage); all the patients were submitted to a clinical and postoperative ultrasonography evaluation (7th day and 3rd month). The late consultations (1st-, 2nd-, and 3rd-year postoperative time) were carried out to identify any complication, such as infection, seroma, hematoma, asymmetry, hypertrophic scarring, rippling, implant position, visible edges, and sensibility alteration. Results A total of 150 female patients were operated with 300 breast implants placed into subglandular pocket. In the first 24 h postoperative (D1), the drainage volume ranged from 12 ml to 210 ml (mean= 74.90 ml; SD= 43.29 ml). After 24 h, on the second day (D2), the collected volume ranged from 10 ml to 120 ml (mean= 44.76 ml; SD= 24.80 ml). The total drainage volume in the 48 h ranged from 22 ml to 320 ml (mean= 119.7 ml; SD= 62.20 ml). The breast ultrasonography series (BUSGS) analysis was done on the 7th day and 3rd month in both groups. There was no significant difference between G1 and G2 groups (p = 0.05 and 0.25, respectively). In the follow-up, some patients (33–44%) declared sensitivity disturbing on the nipple–areola complex (NAC) and lower breast segment. Conclusions The closed-suction breast drainage in breast augmentation was associated with high cost and time-consuming and not demonstrated any benefit in a recent postoperative time.
Article
Silicone breast implants are used worldwide for breast augmentation. After an axillary, periareolar or inframmary incision has been made to create an adequately sized pocket; the surgeon usually uses his or her fingers to insert the implant. The use of fingers makes the insertion process time-consuming, a few minutes or more. There are some complications, including need to ensure that the incision is long enough for the implant to be inserted, scar hypertrophy caused by implant insertion friction damage to the edge of incision, and the occasional need to ask the surgical assistant to lend more fingers to facilitate satisfactory insertion and placement. In addition, the use of gloved fingers to repeatedly push on the implant can increase the risk of contamination, postoperative silicone microleakage, and capsular contracture. To resolve these problems, we developed an improved silicone breast implant injector (reusable stainless steel 2007; single use polypropylene 2018) that can be used more easily than fingers and other "no touch" devices. From 2013 to 2017, the first author, a plastic surgeon at our clinic, used the 2007 reusable stainless steel injector to perform breast augmentations in 53 patients (Ave. age 23.8 years; range 19-67 years), 5 (8.8%) receiving 250-ml implants, 41 (77.4%) 251-300-ml implants, and 7 (13.8%) 301-400-ml implants. Overall, results were satisfactory except for two patients (3.7%) in whom capsular contracture occurred. There were no ruptures. Use of the injector made it possible to shorten the length of the incisions from the traditional 4-7 to 3-4 cm and expedited insertion time from a few minutes to a few seconds. This "no touch" insertion technique reduced implant damage caused by finger pushing, leading to a decrease in silicone microleakage and capsular contracture rate. It was performed with no friction trauma to the incision edge or harm to the surgeon's fingers. It was found to be an effective alternative operative tool for the insertion of silicone breast implants.Level of evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Article
Introduction: Compared to Staphylococcus aureus, coagulase-negative staphylococci (CoNS) are characterized by a lower capacity to cause acute, live-threatened infections. CoNS are, however, of ever increasing importance as pathogens causing infections in immunocompromised patients and after foreign-material implantation. Typically, antibiotics fail to cure foreign body-related infections and removal of the implanted device is inevitable. Areas covered: This review focuses on the emergence of CoNS species, their pathogenic potential in particular due to their ability to form therapy-refractory biofilms on biotic and abiotic surfaces and evasion strategies to resist host response and antibiotic treatment. Their medical significance and proven and novel therapy strategies are discussed. Expert opinion: CoNS contribute significantly to morbidity and socio-economic costs. The anticipated developments in modern medicine, in particular the increasing use of foreign materials and the rising numbers of immunocompromised patients, as well as the changing demographic and hospital-related factors will inevitable contribute to further emergence of CoNS infections. Increasing rates of (multi-) resistant CoNS strains will limit the therapeutic armamentarium and aggravate treatment strategies. Increased research is necessary to understand their role as resistance and virulence gene reservoir and to reduce CoNS infections by the development of innovative colonization-preventing materials and other CoNS-tailored treatment strategies.
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Mohs micrographic surgery and reconstruction is considered by many as the gold standard for treatment of cutaneous malignancies arising in the periorbital region. It has a high rate of tumor clearance and a low rate of postsurgical complications. One of the most common complications is surgical site infection (SSI). Although SSI occurs in less than 3% of patients, it may result in significant morbidity. Considerable research efforts have been devoted to identifying risk factors associated with the development of a postsurgical infection. We examine the impact of endogenous factors (which determine the efficacy of a patient's immune system), exogenous factors (which influence a patient's exposure to bacterial pathogens), and antimicrobial interventions on the incidence of SSI and propose evidence-based recommendations.
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Background: Surgery has been used as part of breast cancer treatment for centuries; however any surgical procedure has the potential risk of infection. Infection rates for surgical treatment of breast cancer are documented at between 3% and 15%, higher than average for a clean surgical procedure. Pre- and perioperative antibiotics have been found to be useful in lowering infection rates in other surgical groups, yet there is no consensus on the use of prophylactic antibiotics for breast cancer surgery. This is an update of a Cochrane Review first published in 2005 and last updated in 2014. Objectives: To determine the effects of prophylactic (pre- or perioperative) antibiotics on the incidence of surgical site infection (SSI) after breast cancer surgery. Search methods: For this fourth update, in August 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase; and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria: We included randomised controlled trials of pre- and perioperative antibiotics for patients undergoing surgery for breast cancer. Primary outcomes were rates of surgical site infection (SSI) and adverse reactions. Data collection and analysis: Three review authors independently examined the title and abstracts of all studies identified by the search strategy, then assessed study quality and extracted data from those that met the inclusion criteria. We contacted study authors to obtain missing information. We evaluated the certainty of evidence using the GRADE approach. We used standard methodological procedures expected by Cochrane. Main results: A total of 11 randomised controlled trials (2867 participants) were included in the review. No new studies were identified in this update. All studies included breast cancer patients and were based in the hospital setting. Ten studies evaluated preoperative antibiotic compared with no antibiotic or placebo. One study evaluated perioperative antibiotic compared with placebo or no antibiotic. Pooling of the results demonstrated that prophylactic antibiotics administered preoperatively probably reduce the incidence of SSI for patients undergoing breast cancer surgery without reconstruction (pooled risk ratio (RR) 0.67, 95% confidence interval (CI) 0.53 to 0.85; moderate certainty evidence). Anticipated absolute effects were calculated for the outcome incidence of SSI; 105 per 1000 for the none or placebo group and 71 per 1000 (95% CI 56 to 89) for the preoperative antibiotic prophylaxis group. Analysis of the single study comparing perioperative antibiotic with no antibiotic was inconclusive for incidence of SSI (RR 0.11, 95% CI 0.01 to 1.95; very low certainty evidence). No studies presented separate data for patients who underwent reconstructive surgery at the time of removal of the breast tumour.Secondary outcomes were not consistently included in the studies investigating preoperative antibiotic prophylaxis. It is very uncertain whether there is a difference in incidence of adverse events between the treatment and no treatment or placebo groups (10 studies, 2818 participants); very low certainty evidence downgraded one level for serious risk of bias, one level for serious inconsistency and one level for serious imprecision. It is unclear whether there is a difference in time to onset of infection between the treatment and no treatment or placebo groups (4 studies, 1450 participants); low certainty evidence downgraded one level for serious risk of bias and one level for serious inconsistency. It is unclear whether there is a difference in rates of readmission to hospital between the treatment and placebo groups (3 studies, 784 participants); low certainty evidence downgraded one level for serious inconsistency and one level for serious risk of bias. It is unclear whether there is a difference in cost of care between the treatment and no treatment or placebo groups (2 studies, 510 participants); low certainty evidence downgraded one level for serious risk of bias and one level for serious inconsistency. No analysable secondary outcome data were reported for the single study evaluating perioperative antibiotics. Authors' conclusions: Prophylactic antibiotics administered preoperatively probably reduce the risk of SSI in patients undergoing surgery for breast cancer. However, it is very uncertain whether there is an effect on incidence of adverse events. Furthermore, the effects on time to onset of infection, readmission to hospital and cost of care remain unclear. Further studies are required to establish the best protocols for clinical practice.
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The problem of antimicrobial resistance surveillance in Europe has been debated extensively in many excellent documents issued by national committees that often assume the value of national guidelines. However, a comprehensive document addressing the whole matter from a European perspective, as well as reviewing its present status and drafting future perspectives, has been lacking. The present recommendations have been produced by the ESCMID Study Group for Antimicrobial Resistance Surveillance (ESGARS) through a consensus process involving all members of the Study Group. The recommendations focus on the detection of bacterial resistance and its reporting to clinicians, public health officers and a wider—and ever-increasing—audience. The leading concept is that the basis for resistance monitoring is microbiological diagnostics. The prerequisites for resistance monitoring are findings of adequate quality and quantity, which have been recorded properly and evaluated correctly. Different types of surveillance studies should fulfil different requirements with regard to data collection and reporting, the expected use of data, and the prerequisites for networking such activities. To generate relevant indicators, bacterial resistance data should be reported using adequate denominators and stratification. Reporting of antimicrobial resistance data is necessary for selection of empirical therapy at the local level, for assessing the scale of the resistance problem at the local, national or international levels, for monitoring changes in resistance rates, and for detecting the emergence and spread of new resistances types. Any type of surveillance study should conclude, where appropriate, with a proposal for intervention based on the data obtained.
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Thirty-seven cases of rapidly growing mycobacterial wound infections following augmentation mammaplasty were identified between 1979 and 1988. The infections were usually unilateral and had a narrow geographic distribution: almost 60% were from Texas and 92% from five southern coastal states. In Texas a seasonal incidence was observed; 45% of all previously reported and current patients had undergone mammaplasty in April, May, or June. Although these findings suggested a possible common source, analysis of 35 available isolates revealed 19 different phenotype patterns. Five different taxonomic groups were represented, although most isolates (70%) were Mycobacterium fortuitum biovar fortuitum. Plasmid bands were identified in 10 of 15 strains studied, with nine different profiles. An additional 11 cases of breast infection due to rapidly growing mycobacteria not associated with augmentation were also identified, of which nine came from the same states that contributed mammaplasty cases. Rapidly growing mycobacterial infections of the breast are endemic in Texas and other southern coastal states, and the heterogeneity of the isolates suggests that most cases are unrelated.
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It has been proposed that scleroderma in particular orconnective-tissue diseases in general may be caused by exposure to silicone-containing materials used for breast augmentation. We performed a historical cohort study to estimate the point prevalence of this potential complication sometimes referred to as "human adjuvant disease." Three-hundred and seventy-eight patients who underwent augmentation mammaplasty with silicone-containing envelope-type prostheses from 1970 through 1981 were surveyed. Regional musculoskeletal syndromes, fibrositis, or osteoarthritis occurred in a third (38 of 125) of our responders. No patient developed an inflammatory systemic rheumatic disease during the period of observation (mean 6.8 years for the 125 subjects). Using calculations based on risk for development of rheumatic disease, it does not appear likely that augmentation mammaplasty is a significant or major induced of inflammatory connective-tissue diseases in general. However, the number of patients surveyed was small, and our results must be considered preliminary. We could not exclude a specific risk for the development of scleroderma. (C)1988American Society of Plastic Surgeons
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The survival of bacteria was evaluated in custom-made saline breast implants with integral injection ports in vitro and in 10 New Zealand White rabbits for Staphylococcus aureus, Staphylococcus epidermidis, Pseudumonas aeruginosa, and Serratia marcescens. Pseudomonas and Serratia survived in vitro in saline-filled implants and multiplied 24-fold and 22-fold, respectively, from the initial inocula of 300 colony-forming units per cubic centimeter in 21 days. Serratia alone survived in saline implants placed on the dorsum of rabbits, proliferated 80-fold in 7 days, and tapered to 10-fold at the end of 3 weeks. Chemical analysis revealed the presence of glucose in fluid from the implants in the animal study (mean, 1.2 mg per deciliter; standard error of mean [SEM], 0.6) after 21 days and from human subjects (mean, 3.8 mg per deciliter; SEM, 1.0) after 8 months to 10 years. Serratia incubated in human breast implant fluid samples proliferated 7-fold to 30-fold greater than in the saline control in a nonaerated environment. We conclude that some bacteria are able to proliferate in saline in breast implants. Furthermore, their survival may be facilitated by a substance (i.e., glucose) that diffuses across the implant outer shell. (C) Williams & Wilkins 1996. All Rights Reserved.
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Traces the quest for physical perfection through surgery from the turn of the century to the present. Drawing on a range of sources, including personal accounts, medical journals and beauty guides, the text reveals how culture came to see cosmetic surgery as a panacea for both individual and societal problems. As Americans and their surgeons linked the significance of "normal standards of beauty to social adjustment and economic success, they also linked "undesirable" characteristics to psychological conditions such as the inferiority complex, for which cosmetic surgery appeared to offer a cure. The book also explores the new meanings with which the era of plastic surgery endowed race, ethnicity, ageing and femininity, from Fanny Brice's 1923 nose operation to Michael Jackson's race- and gender-bending transformation of the late-1980s.
Article
In a prospective, random, double-blind, and concurrently controlled clinical study of 124 patients having augmentation mammaplasty, using multiple independent subjective judges as well as objective compressibility measurements, the use of a variety of local antibacterials in or around inflatable retromammary prosthetic implants reduced the early postoperative onset of class III to IV capsular contracture by sevenfold (85 percent) and the final incidence by more than half (50 percent) (p less than 0.01). We believe this study provides the most unequivocal evidence to date that the cause of capsular contracture in retromammary augmentation is periprosthetic bacterial contamination. Irrigation with a 5 percent povidone-iodine (50 percent Betadine) solution was as effective as other techniques and is currently our procedure of choice.
Article
To examine the relation between connective tissue disease and related conditions and breast implants. Retrospective cohort study of all women in the Swedish national inpatient registry who underwent breast augmentation surgery with artificial implants during 1964-93, compared with women who underwent breast reduction surgery during the same period. Sweden. 7442 women with implants for cosmetic reasons or for reconstruction after breast cancer surgery and 3353 women with breast reduction surgery. Subsequent hospitalisation for definite connective tissue diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and Sjögren's syndrome) or related disorders. 29 women with implants were hospitalised for definite connective tissue disease compared with 25.5 expected based on general population rates (standardised hospitalisation ratio 1.1 (95% confidence interval 0.8 to 1.6)). There were no diagnoses of systemic sclerosis, and no significant excess in risk for polymyalgia rheumatica, fibromyalgia, and several related disorders. Among women who underwent breast reduction surgery, 14 were hospitalised for definite connective tissue disease compared with 10.5 expected (standardised hospitalisation ratio 1.3 (0.7 to 2.2)). Compared with the breast reduction group, women with breast implants showed a slight reduction for all definite connective tissue disease (relative risk 0.8 (95% confidence interval 0.5 to 1.4)). This large nationwide cohort study shows no evidence of association between breast implants and connective tissue disease.
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Article
Objective. To examine the possible association between augmentation mammoplasty and systemic sclerosis (SSc; scleroderma). Methods. Eight hundred thirty-seven women with a clinical diagnosis of SSc, recruited as a volunteer sample from 3 university-based, tertiary care scleroderma clinical research centers, and 2,507 race-matched local control women, recruited by the technique of random-digit-dialing and frequency-matched on age, completed a questionnaire providing data on history of augmentation mammoplasty, including possible complications of the procedure. The odds ratio (OR) and 95 percent confidence interval (95% CI) for the association of augmentation mammoplasty with SSc were estimated by multivariate logistic regression analysis with adjustment for age, race and center, and by conditional logistic regression analysis with adjustment for age. Results. Eleven (1.31%) of the 837 cases reported a history of augmentation mammoplasty prior to diagnosis of SSc, compared with 31 (1.24%) of the 2,507 controls. The adjusted OR from the unmatched analysis was 1.07 (95% CI 0.53–2.13), while that from the matched analysis was 1.11 (95% CI 0.55–2.24). Conclusion. These results fail to demonstrate a significant association between augmentation mammoplasty and SSc, and are consistent with those reported from other epidemiologic studies.
Article
The focus of our studies was to determine whether the antipolymer antibody assay (APA) as an objective laboratory assay could contribute to the diagnosis in women with a silicone breast implant (SBI) and complaints/symptomatic disease. We investigated whether a population of symptomatic SBI recipients exists with a high prevalence of APA in the Netherlands. The study participants were selected based on self-reported complaints. In one study their physician was approached for additional information on their disease status. Two groups of 42 women were included in the studies, with a mean SBI exposure of 17 and 16 years, respectively. The participants were clinically examined, and the APA level in serum samples determined. The study population of SBI recipients was categorised in severity subgroups based on the functional capacity, and the study physicians general assessment of pain and disease activity. Positive APA levels were found in 10% of the SBI recipients. Also in control groups 8% showed a positive APA response. After categorisation most (65 of 84) SBI recipients belonged to the limited severity subgroup on an increasing scale of limited, mild, moderate and advanced. Eight were categorised in the mild, four in the moderate, and seven in the advanced severity subgroup. None of the APA positive women were found to belong to the moderate or advanced severity subgroup. Seven of the APA positive women belonged to the limited, and one woman to the mild severity subgroup. In conclusion, we were unable to include a large proportion of severely symptomatic SBI recipients in our study populations. So, we cannot confirm the results of Tenenbaum et al. [1] on the presence of APA in symptomatic SBI recipients. However, our failure in two separate studies to recruit symptomatic SBI recipients suggests that the population of severely symptomatic SBI recipients in the Netherlands is rather small. The number of APA positive responses in our study population was low. In addition, also in the normal population a similar low percentage of positively reacting women were observed. Hence, we cannot recommend the use of the APA assay for diagnostic purposes in the clinical evaluation of SBI recipients with severe complaints/symptoms.
Article
In a retrospective study of 41 infected breasts following the insertion of implants, a high incidence of postoperative hematoma was noted. When infection occurred, cultures usually demonstrated the causative organism to be Staphylococcus aureus. Treatment by conservative drainage and vigorous antibiotics was generally successful in salvaging those implants which had been inserted through an areolar incision for simple augmentation, or under the pectoralis muscle (or a dermal pedicle) after a subcutaneous mastectomy. Those patients whose augmentations had been done through an inframammary incision, or whose implant after a subcutaneous mastectomy was under the skin flap, had a statistically higher incidence of implant loss. Most breasts will salvaged implants became firm.
Article
We studied 89 patients who had immediate or delayed placement of implants after subcutaneous mastectomies. The complications of infection, necrosis of the skin or areola, and extrusion of the prosthesis occurred in 28 percent of these patients, and the incidence was the same after immediate or delayed placement. Only one of the 45 patients who received prophylactic antibodies preoperatively developed an infection after insertion of the prosthesis. The late complications in some of these patients indicate the need for long-term follow-up.
Article
On April 16, 1992, the Food and Drug Administration announced that breast implants filled with silicone gel would be available only through controlled clinical studies and that women who need such implants for breast reconstruction would be assured of access to these studies. This decision was especially difficult because even after more than 30 years of use involving more than 1 million women, adequate data to demonstrate the safety and effectiveness of these devices do not exist. They had been allowed to remain on the market after the enactment of the 1976 Medical Device Amendments ("grandfathered") with the understanding that . . .
Article
This retrospective clinical study was made to help determine the signs of infectious or healing problems in candidates for prosthetic breast surgery. It concerns 80 patients with 108 breast implants (44 breast reconstructions, 21 cases of hypoplasia, 8 breast asymmetric, 20 secondary procedures, 15 of them being changes of expansion implants by definitive implants). Thirty one infectious complications (28.7%) were noted. In 22 cases it consisted of a resolutive hyperthermia. Nine cases of local complications were noted, with four implant exposures (3%). Bacteriological samples were analyzed and were positive in four out of nine (Staphylococcus aureus). In 8 out of the 9 cases the initial procedure consisted in a breast reconstruction. All 8 patients underwent postoperative radiotherapy after the initial mastectomy (Patey). The implant type (implantable, pre-filled, expansion prosthesis), its location (retromuscular), the type of surgery (asymmetrical breast musculocutaneous or fasciocutaneous flap) don't seem to be responsible in the genesis of the complications. This retrospective study could not help determine which protocol of antistaphylococcal antibiotherapy suits lest. Infectious problems arose with or without antibiotics.
Article
In order to reexamine the possible association between bacterial presence and capsular contracture, 55 silicone devices (mammary implants or tissue expanders) were cultured at the time of their removal from 40 patients. Special culture techniques were used in an attempt to recover bacteria adhering to the smooth-surfaced implant and encased in glycocalyx biofilm. Bacteria were detected on 56% (15 of 27) of implants surrounded by contracted capsules and on 18% (5 of 28) of those without capsular contracture (p less than 0.05). Only three implants tested positive using routine plating techniques. The predominant isolate was Staphylococcus epidermidis. The concept that capsular contracture is associated with subclinical infection of silicone implants is supported by this study. With changes in the microbiological technique, bacterial recovery and growth occurs at a frequency greater than previously thought.
Article
• A 46-year-old woman developed localized scleroderma after surgical manipulation of her silicone gel-filled breast prostheses. She developed firm, shiny plaques on her legs that progressed to involve the thighs. Histopathologic examination of a deep-skin biopsy specimen confirmed the diagnosis of scleroderma. On surgical removal of the silicone implants, and their replacement with saline-filled implants, the scleroderma gradually resolved. Histopathologic examination of the removed implant capsules revealed evidence of silicone leakage. All new female patients with scleroderma should be questioned and examined regarding augmentation mammoplasty. Until prospective studies are completed on the possible association between scleroderma and silicone breast implants, it would seem prudent to use the saline-filled, elastomeric envelope-type breast implant for augmentation mammoplasty rather than the silicone gel-filled implant. (Arch Dermatol. 1990;126:1198-1202)
Article
We conducted a prospective study of the associations between several biologic and surgical breast factors and the onset of lactation in 319 healthy, motivated, primiparous women who were breastfeeding term, healthy, appropriate for gestational age or large for gestational age infants. During the last trimester of pregnancy, subjects' breasts were examined for surgical incisions, size, symmetry, and nipple protuberance, and women estimated their prenatal breast enlargement. At two visits in the first two weeks postpartum, infants were weighed naked, and mothers reported the magnitude of postpartum breast engorgement when their milk came in. Breastfeeding was evaluated at each visit, and interventions were recommended for problems, with emphasis on maximizing milk yield. Lactation was deemed sufficient when an exclusively breastfed infant achieved an average weight gain of 28.5 g or more per day between the two visits. Infants gaining less than 28.5 g per day with breast milk exclusively, and those requiring formula supplement returned for a third visit at or before 21 days of age, when final lactation outcome was assessed based on weight gain between the second and third visits.
Article
Two patients who developed scleroderma after silicone breast augmentation are described. One patient presented with the classic features of systemic sclerosis, and the other with calcinosis, Raynaud's phenomenon oesophageal dysfunction, sclerodactyly, and telangiectasia (CREST syndrome). The connective tissue diseases associated with mammoplasty are reviewed.
Article
A major problem after breast reconstruction with augmentation mammaplasty is contracture of the fibrous capsule around the prosthesis. In a series of 72 breasts in 65 women, silicone-gel and saline-filled implants were randomly selected prior to breast reconstruction. The results were judged with respect to consistency, tenderness, wrinkles, and sounds by two independent plastic surgeons according to the breast augmentation classification (BAC) and by the patients themselves. Capsular contracture was found by the surgeons in 50 percent of the gel implant group and in 16 percent of the saline implant group, which is in conformity with the results of the follow-up 5 years earlier. The incidence of deflation was 16 percent in the saline group and occurred in different sizes of both overinflated and underinflated prostheses. The degree of slow leakage from saline implants will be discussed. Despite the high rate of contractures in the gel group, 85 percent of all patients were satisfied with the result of the reconstruction.
Article
The quantitative and morphological characteristics of microbial adherence of four organisms--Staphylococcus epidermidis, S. aureus, Escherichia coli and Candida albicans--to the surfaces of different breast prostheses were observed. Semiquantitative adherence studies based on a modification of Maki's roll culture technique even after short contact times showed (1) increased microbial adherence at higher concentrations of the organisms and (2) differences in adherence properties between gram-positive bacteria and other organisms tested, noted also at lower organism concentrations. Scanning electron microscopy (SEM) to identify microorganisms on foam-covered prostheses, however, revealed organisms in the interstitial spaces that were not recovered by the plating technique. Other features on SEM were extracellular "slime" produced by S. epidermidis, which appears to act as a cement by which bacteria are held against prosthetic surfaces. These in-vitro findings suggest that brief exposure of the prostheses to a few organisms, particularly gram-positive bacteria, at the time of implantation would be sufficient inoculum for bacterial adherence to prosthetic surfaces.
Article
Infection following breast implants is an uncommon event. This is somewhat surprising, since the human breast is not a sterile anatomical structure. The flora found in the breast are derived from the nipple ducts and closely resemble those of normal skin. These organisms, predominately S. epidermidis, may in some cases be responsible for firmness secondary to capsular contracture. Treatment of the periprosthetic infection usually involves implant removal, but salvage by systemic antibiotics is sometimes possible. Atypical mycobacteria are very rarely the cause of infection, but can be extremely difficult to eradicate when involved. Toxic shock syndrome has been reported to occur following breast implants and is a life-threatening problem requiring immediate removal of the implant. It may be significant that in some cases with effusion and infection occurring many months or years after implant placement, there has been a preceding event such as a laryngitis or flu-like illness. This suggests the possibility of a bacteremia being involved in the causation of the infection. If this were the case, then these patients should be handled in a fashion similar to those with prosthetic heart valves. Accordingly, in our own practice, we advise that penicillin “V” be given beforehand when a patient with breast implants is to have any dental procedure. It must be stressed that there is no statistical or scientific proof at the present time that this is of any value. In conclusion, when dealing with these large foreign bodies, absolute sterility is essential, and excellent surgical technique to obviate hematoma and the occurrence of tissue ischemia is mandatory. Evidence of severe infection necessitates implant removal, but in less severe cases a trial of intravenous antibiotics is permissible. Having removed an implant, further insertion should be deferred, preferably for 6 months. If the new implant can be placed in a different plane, that is, submuscular, this is desirable. Exposed implants can be salvaged but this requires considerable judgment and one should be prepared for re-exposure or frank infection.
Article
We describe four women who presented with systemic sclerosis several years after cosmetic augmentation mammoplasty with silicone-gel implants. The interval between implantation mammoplasty and the onset of systemic sclerosis ranged from 6 to 15 years. All patients fulfilled the criteria established by the American Rheumatism Association for systemic sclerosis and had Raynaud phenomenon, arthralgia, and evidence of pulmonary or gastrointestinal involvement. Enlargement of lymph nodes draining the prostheses was noted in two patients. Antinuclear antibodies were detected in three patients and showed speckled or nucleolar patterns. Removal of the prostheses in two cases did not result in improvement of systemic sclerosis. Evidence of silicone leakage from the implants included the following. The observation by light microscopy of refractile particles in tissues distant from the prostheses, the observation by electron microscopy of electron-dense structures consistent with silica, and the definitive identification of the element silicon by energy-dispersive analysis in these electron-dense structures. A marked, chronic inflammatory infiltrate containing lymphocytes, "foamy" histiocytes, and larger numbers of multi-nucleated giant cells with vacuoles and asteroid bodies was found at the same sites. Our demonstration that silicone escapes from elastomer-silicone-gel breast implants and appears to be closely associated with a chronic inflammatory reaction suggests that silicone plays a role in the development of certain cases of systemic sclerosis.
Article
Of 33 patients who underwent 49 breast implantations for reconstructive surgery, 8 (24%) patients developed implant infections. All 8 of these patients were among a subgroup of 15 having immediate breast reconstructions with tissue expander implants after simple or modified radical mastectomy (a 53% infection rate). The infection rate increased substantially when bilateral procedures involving implants were performed as opposed to unilateral implants. Nine implants were removed (an overall implant loss rate of 18%). Patients who underwent other breast reconstruction techniques (i.e., including immediate reconstruction with permanent implants or delayed reconstruction with or without tissue expanders) did not develop infection unless they had had simultaneous immediate reconstruction with a tissue expander in the contralateral breast. The most frequently isolated organism was the coagulase-negative staphylococcus. The study concludes that neither the tissue expander nor immediate reconstruction is a risk factor, but the combination may lead to an unacceptable infection rate, especially in the face of bilateral breast procedures.