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Subclinical infection as a possible cause of significant breast capsules

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... 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. ...
... [8][9][10] Historically, research on capsular contracture has focused mainly on reducing bacterial contamination through antibiotic solutions, identifying the principle pathogenic cause of subclinical infection. 7,[11][12][13][14][15][16][17][18][19][20][21][22][23][24] Only secondary studies have focused on pharmacological control of the inflammation process. Several colleagues tried to irrigate the implant pocket using steroids 25 and, successively, a liposome-delivered prednisolone, which resulted in a reduction in capsular contracture. ...
Article
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Background: One of the most common complications of the use of foreign material, in both reconstructive and cosmetic breast surgery, is capsular contracture. Historically, research on capsular contracture has focused mainly on reducing bacterial contamination through antibiotic solutions. Only secondary studies have focused on pharmacological control of the inflammation process, with particular attention paid to the main inflammation pathway, the arachidonic acid cascade. An important role in the arachidonic acid cascade is played by the omega-3 fatty acids, which are found mainly in oily fish and food supplements. The goal of the present study was to investigate the effects of omega-3 supplements on capsule contraction. Methods: Female C57BL/6 mice were implanted with custom-made silicone gel implants and divided into two groups. The treated group received omega-3 oil daily while the control group received water daily by gavage. After mice were euthanized, samples of capsules were collected to evaluate thickness and transforming growth factor (TGF)-β expression. Results: The results showed that capsules in the omega-3 group were thinner and more transparent than those found in the control group. In addition, a significant downregulation of the TGF-β2 gene transcript was observed in the omega-3 group. Conclusions: Omega-3 supplementation seems to be effective in reducing the occurrence of capsular formation, mainly through inhibition of the TGF-β pathway and impairment of collagen deposit. Omega-3 supplementation is a simple and promising method that could be used to prevent or at least reduce capsular contracture after silicone implant surgery.
... 4 La teoría afirma que las bacterias crecientes en la superficie del implante pueden causar inflamación leve persistente en el tejido circundante que conduce a la formación de fibrosis capsular y la contractura resultante. 5 A fin de evitar estas complicaciones se han establecido protocolos quirúrgicos con acciones en diferentes momentos de la cirugía, entre ellos se mencionan el lavado y protección adecuada de todos los miembros del equipo quirúrgico, protección de los pezones con pezoneras y lavado del área quirúrgica con soluciones antisépticas. En cuanto a los implantes, se han asociado los texturizados con una menor incidencia de infecciones debido a la forma en que interactúan con el tejido circundante. ...
... Breast augmentation with silicone gel implants (SGIs) is one of the most common esthetic breast surgery procedures 1,2 ; since the first introduction of these implants in the 1960s, breast augmentation techniques have progressed. 3 Contact between skin and SGI is described as an agent of implant contamination and subclinical infection, 4 and biofilms have also been associated with SGI complications including capsular contracture (CC) 5,6 and double capsule. 7 More recently, the infectious theory related to bacterial contamination has been indicated as one etiology of breast implantassociated anaplastic large-cell lymphoma (BI-ALCL). ...
Article
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Contact between silicone implants and skin/breast parenchyma has been described as an agent of implant contamination and biofilm formation, resulting in implant complications. The no-touch technique was introduced to avoid implant contact and reduce skin/breast contamination. The authors propose an easily available sleeve option using a saline sterile plastic container that provides elastic and transparent protection for inserting silicone implants. These sterile containers can be easily converted into a sleeve by cutting off the narrow end of the container, which then easily fits into the small inframammary, periareolar, and transaxillary incisions. The authors have performed this technique in 10 patients (20 implants) undergoing primary breast augmentation or revision breast surgery, with microtexturized implants ranging in size from 255 to 500 ml (mean, 325 ml) and obtained satisfactory results with no cases of complications. Our clinical outcome shows that this new sleeve does not interact with the implant or the patient's skin and soft tissues and has the added advantage of low cost compared with similar available devices, but further randomized and controlled studies are required to corroborate this effect.
... 10,12 Known risk factors, such as surgical technique, 13 hematoma, 14 bacterial infections, and biofilm formation, are most likely to impact early capsular development. 15,16 However, very little is known about the factors that may influence long-term cumulative risk such as pregnancy, lactation, 14 and the implant's outer shell mechanical fatigue 17,18 or its weakening with time, 19 among others. Marques et al 20 performed a long-term follow-up of CC rates in patients who underwent breast implant surgery for cosmetic or reconstructive reasons. ...
... This, along with soaking of the implant, has been shown to reduce the risk of infection as well as capsular contracture, which has been theorized to be related to persistent low-grade infection. 17,[72][73][74] Adams et al analyzed 63 implant-based breast-reconstructive procedures and the efficacy of triple-antibiotic solution (50,000 U bacitracin, 80 mg gentamicin, 1 g cefazolin in 500 mL normal saline) in reducing capsular contracture. 73 There was a 9.5% rate of capsular contracture, which was lower than historical rates. ...
Article
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Implant-based procedures are the most commonly performed method for postmastectomy breast reconstruction. While donor-site morbidity is low, these procedures are associated with a higher risk of reconstructive loss. Many of these are related to infection of the implant, which can lead to prolonged antibiotic treatment, undesired additional surgical procedures, and unsatisfactory results. This review combines a summary of the recent literature regarding implant-related breast-reconstruction infections and combines this with a practical approach to the patient and surgery aimed at reducing this risk. Prevention of infection begins with appropriate reconstructive choice based on an assessment and optimization of risk factors. These include patient and disease characteristics, such as smoking, obesity, large breast size, and immediate reconstructive procedures, as well as adjuvant therapy, such as radiotherapy and chemotherapy. For implant-based breast reconstruction, preoperative planning and organization is key to reducing infection. A logical and consistent intraoperative and postoperative surgical protocol, including appropriate antibiotic choice, mastectomy-pocket creation, implant handling, and considered acellular dermal matrix use contribute toward the reduction of breast-implant infections.
... Moreover, the use of the Alexis retractor protects surgical wounds from contamination, thus preventing infection (12). This represents an additional advantage because skin contact of breast prostheses is regarded as a cause of ongoing subclinical infection leading to subsequent symptomatic capsular contracture (20)(21)(22). Many surgeons employ a notouch technique, aiming to lower capsular contracture rates by eliminating skin contamination. ...
Article
Background: We present our experience in using a disposable wound retractor commonly used in abdominal surgery named Alexis(®) (Applied Medical Resources Corporation, Rancho Santa Margarita, CA, USA), during breast augmentation in order to improve outcomes, particularly final scar length. Methods: Between January 2010 and November 2012, 40 patients undergoing breast augmentation with an inframammary approach were enrolled in the present study. Patients were randomly assigned to two groups: group 1 underwent breast augmentation with the standard technique; group 2 underwent breast augmentation by using the Alexis(®) (Applied Medical Resources Corporation) device. Patients were followed-up for a 12-month period. The time of surgery, the days of drain duration and the length of the incisions were recorded for both groups and statistical significance was evaluated with the Wilcoxon rank sum test. Also, final scar appearance was evaluated using a visual analogue scale (VAS). Results: Patients in group 2 reported a lower incidence of hematomas and had shorter drain duration. The difference in scar length between the two groups was statistically significant (P<0.05). Surgeons and patients were mostly satisfied with the final appearance of the scar. Conclusions: The use of the Alexis(®) (Applied Medical Resources Corporation) device has proven useful in reducing the length of the inframammary incision. Interestingly, the increased visibility obtained with the use of the Alexis device allowed a better hemostasis, as suggested by the shorter drain duration and lower incidence of hematomas. However, its use prolongs the operative time, for which we recommend surgeons to allow themselves some time to become familiar with the device. Level of evidence: level I, evidence obtained from at least one properly designed randomized controlled trial.
... 4 Adherent microorganisms growing on the implant surface as biofilms, may cause chronic, persistent, and lowgrade inflammation around the implant, leading to formation of capsular fibrosis and subsequent contracture. 3,[5][6][7] Biofilm has a three-dimensional structure consisting of adherent microorganisms embedded in an extracellular matrix. The infectious hypothesis as the cause for capsular fibrosis is supported by the fact that unilateral contractures may occur after bilateral augmentation surgery with identical implants, making systemic (host-related) or implant (material-related) causes unlikely. ...
Article
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Introduction: Capsular contracture is a feared complication following both reconstructive and aesthetic breast surgery. The etiology is uncertain, but bacterial biofilms have been suggested as trigger for chronic peri-implant inflammation, eventually leading to capsular contracture. Methods: Data were extracted from patient records included in a prospective cohort between 2008 and 2010. We compared patients who underwent submuscular breast reconstruction using expander implants and those needing implant removal for capsular contracture after aesthetic submuscular breast augmentation. Results: Of 36 included breast implants from 27 patients, 18 implants were inserted for reconstructive reasons and 18 for aesthetic reasons. The median indwelling time was 3 years for aesthetic implants and 3 months for reconstructive expanders. Overall, sonication cultures were positive in 13 implants (36%). In aesthetic implants, sonication cultures were positive in 28% and sonication cultures were positive in expander implants in 44%. Propionibacterium acnes and coagulasenegative staphylococci were predominant. Conclusion: Sonication cultures were positive in approximately 33% of removed breast implants and were comparable for reconstructive expander and aesthetic implants. These findings support the hypothesis that bacterial biofilms play a role in the pathogenesis of capsular contracture, especially after expander reconstruction, as these implants are at the highest risk of contamination during repeated implant-filling procedures.
... Possible explanations for this important complication include chemical interference of the implant in the surrounding tissues, mechanical impact by the anatomical position of the implant, and the effect of bacteria growing in biofilms on the implant surface [68]. Another possible cause of capsular contracture is the presence of bacteria growing as biofilm on the surface, which may cause persistent low-grade inflammation of the surrounding tissue, leading to formation of capsular fibrosis and subsequent contracture [69,70]. A significant correlation between the degree of capsular contracture and the presence of biofilm on breast implants was demonstrated by several authors, especially when using a sonication technique [9,10,71]. ...
Article
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The role of Propionibacterium acnes in acne and in a wide range of inflammatory diseases is well established. However, P. acnes is also responsible for infections involving implants. Prolonged aerobic and anaerobic agar cultures for 14 days and broth cultures increase the detection rate. In this paper, we review the pathogenic role of P. acnes in implant-associated infections such as prosthetic joints, cardiac devices, breast implants, intraocular lenses, neurosurgical devices, and spine implants. The management of severe infections caused by P. acnes involves a combination of antimicrobial and surgical treatment (often removal of the device). Intravenous penicillin G and ceftriaxone are the first choice for serious infections, with vancomycin and daptomycin as alternatives, and amoxicillin, rifampicin, clindamycin, tetracycline, and levofloxacin for oral treatment. Sonication of explanted prosthetic material improves the diagnosis of implant-associated infections. Molecular methods may further increase the sensitivity of P. acnes detection. Coating of implants with antimicrobial substances could avoid or limit colonization of the surface and thereby reduce the risk of biofilm formation during severe infections. Our understanding of the role of P. acnes in human diseases will likely continue to increase as new associations and pathogenic mechanisms are discovered.
... 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. ...
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: The reinsertion of an infected implant when peri-prosthetic infection occurs early after breast augmentation or breast reconstruction remains controversial. In this experimental study, the authors tried to remove bacteria, and their biofilm, from the colonized surface of breast prostheses, without damaging their integrity. Materials and methods: A total of 112 shell samples of silicone breast prostheses, smooth (SPSS) and textured (TPSS), were colonized by S. epidermidis (SE) or S. aureus (SA) strains, all able to produce biofilms. After 15 days, all the samples were removed from the contaminated culture broth and constituted 4 groups of 20 contaminated samples: SPSS/SE (group I), SPSS/SA (group II), TPSS/SE (group III), TPSS/SE (group IV). In another group-group SEM-, 16 colonized samples were used for documentation with scanning electron microscopy (SEM). The remaining 16 samples were used to test the limits of detection of the sterility test. All samples of groups I-IV and 8 samples of group SEM were « washed » with a smooth brush in a povidone-iodine bath and rinsed with saline solution. A subset of the washed samples was sent for SEM and the others were immersed in sterile broth and were incubated at 35 °C for 3 weeks (groups I-IV). Results: Fifteen days after contamination, all the samples in groups I-IV were colonized. In the SEM group, SEM images attested to the presence of bacteria in biofilm attached to the shells. After cleaning, SEM did not reveal any bacteria and there was no visible alteration in the outer structure of the shell. Sterility tests performed after decontamination in groups I-IV remained negative for all the samples. Conclusion: Breast prostheses recently contaminated with Staphylococci, frequently involved in peri-prosthetic breast implant infection and capable of producing biofilms, can be efficiently decontaminated by the procedure used in this study. Our decontamination procedure did not alter the surface structure of the prostheses. This decontamination procedure could allow reinsertion of an infected implant when peri-prosthetic infection occurs early after breast augmentation or breast reconstruction and when a salvage procedure is indicated. No level assigned: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. 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 .
Polyurethane-coated breast implants seem to be associated with lower medium- and long-term capsular contracture rates in comparison to textured or smooth implant surfaces. Although the etiology of capsular contracture is uncertain, bacterial biofilms have been suggested to trigger chronic peri-implant inflammation, eventually leading to capsular contracture. It is unknown whether polyurethane-coated implants are less prone to biofilm colonization than other implant surfaces. We extracted data from patient records included in a prospective cohort between 2008 and 2011. All patients who underwent removal of polyurethane-coated implants were included in this current study and screened for presence of biofilms by sonication. In addition, implant- and patient-related data were analyzed. Of the ten included polyurethane-coated breast implants, six had been inserted for reconstructive purposes and four for aesthetic reasons. The median implant indwelling time was 28.3 mo. Overall, sonication cultures were positive in 50% of implants. Propionibacterium acnes and coagulase-negative staphylococci were the predominant pathogens isolated from biofilm cultures. Like other implant surfaces, polyurethane-coated implants are prone to biofilm colonization. Further investigations are needed to determine why capsular contracture rates seem to be lower in polyurethane implants than in other implant surfaces. Notably, in this study, 40% of the implants were explanted from breasts with severe capsular contracture.
Article
Capsular contracture remains a common and preventable complication of implanted breast prostheses. As our understanding of the pathophysiology continues to develop, it is prudent to reexamine existing beliefs in a contemporary context. This article presents a current summary of clinical and laboratory evidence, expressed as an interaction between potentiating and suppressing factors, and how this understanding can be applied to practice.
Article
Breast implants are used for cosmetic breast enlargement, correction of asymmetries and congenital defects and for reconstruction after mastectomy for breast cancer or cancer risk reduction. Breast implant associated complications still represent a significant challenge for clinicians and have a significant negative impact on patient satisfaction, hospital length of stay, and associated costs. Breast implant related infection is one of the leading causes of morbidity that complicates breast implantation representing around 2 % of interventions in most series. Cellulitis, periimplant infection, fistula presence and/or implant exposure often mandate immediate device removal. However, there been some reports of attempted implant salvage in certain patients. Other potential complication is capsular contracture. Contracture of this capsule around a soft implant leads to a painful, tight capsular contracture. It has been postulated that contracture might be related to a chronic infection with propionibacteria, coagulase-negative staphylococcus and other skin organisms. Rates of capsular contracture may range between 1 and 33 %. Cause of capsular contracture and, accordingly, treatment and prevention, remains to be elucidated.
Article
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While microbial biofilms have been recognized as being ubiquitous in nature for the past 40 years, it has only been within the past 20 years that clinical practitioners have realized that biofilm play a significant role in both device-related and tissue-based infections. The global impact of surgical site infections (SSIs) is monumental and as many as 80 % of these infections may involve a microbial biofilm. Recent studies suggest that biofilm- producing organisms play a significant role in persistent skin and soft tissue wound infections in the postoperative surgical patient population. Biofilm, on an organizational level, allows bacteria to survive intrinsic and extrinsic defenses that would inactivate the dispersed (planktonic) bacteria. SSIs associated with biomedical implants are notoriously difficult to eradicate using antibiotic regimens that would typically be effective against the same bacteria growing under planktonic conditions. This biofilm-mediated phenomenon is characterized as antimicrobial recalcitrance, which is associated with the survival of a subset of cells including "persister" cells. The ideal method to manage a biofilm-mediated surgical site wound infection is to prevent it from occurring through rational use of antibiotic prophylaxis, adequate skin antisepsis prior to surgery and use of innovative in-situ irrigation procedures; together with antimicrobial suture technology in an effort to promote wound hygiene at the time of closure; once established, biofilm removal remains a significant clinical problem.
Article
Myofibroblasts provide a force to decrease the surface area of breast implant capsules as the collagen matrix matures. Seventeen-β-oestradiol promotes myofibroblasts differentiation and contraction. The aim of the study was to investigate the expression of Oestrogen Receptors α and β in capsular tissue. The study enrolled 70 women (80 capsules) who underwent expander or implant removal following breast reconstruction. Specimens were stained with Hematoxylin/Eosin, Masson trichrome, immunohistochemistry and immunofluorescence for alpha-Smooth Muscle Actin (α-SMA), Oestrogen Receptor-alpha (ER-α) and Oestrogen Receptor-beta (ER-β). The relationship between anti-oestrogenic therapy and capsular severity was evaluated. A retrospective analysis of 233 cases of breast reconstruction was performed. Myofibroblasts expressed ER-α, ER-β or both. In the whole sample, α-SMA score positively correlated with ER-α (p=0.022) and ER-β expression (p<0.004). ER-β expression negatively correlated with capsular thickness (p<0.019). In capsules surrounding expanders α-SMA and ER-α expressions negatively correlated with time from implantation (p=0.002 and p=0.016, respectively). The incidence of grade III-IV contracture was higher in patients who did not have anti-oestrogenic therapy (p<0.036); retrospective analysis of 233 cases confirmed this finding (p<0.0001). This study demonstrates the expression of oestrogen receptors in myofibroblasts of capsular tissue. A lower contracture severity was found in patients who underwent anti-oestrogenic therapy.
Article
Breast augmentation offers a high rate of satisfaction but the local complications remain frequent. These are mainly capsular contracture, malpositions of implant, acute or infraclinical infections. The causes of these complications are multifactorials. The goal of this chapter is to determine the effect of the surgical technique on the result. We think that if no routine procedure can be proposed, a reflexion on the objectives of the breast augmentation and the adaptation of the surgical technique is necessary for each surgeon. We identify twelve aims and discuss them: rigorous preoperative planning, determination of the position of the implant, creation of an adapted implant pocket, as much atraumatic as possible dissection, no bacterial contamination, no foreign particles, respect of the implant, drainage or not, efficient suture, pain and discomfort control, need for contension and clear postoperative advices. These objectives being precised, we integrate them in a chronological surgical process under the form of questions. Each surgeon can then choose his answers by evaluating the arguments, which led to his choices.
Article
Background: It has been hypothesized that bacterial biofilms on breast implants may cause chronic inflammation leading to capsular contracture. The association between bacterial biofilms of removed implants and capsular contracture was investigated. Methods: Breast implants explanted between 2006 and 2010 at five participating centres for plastic and reconstructive surgery were investigated by sonication. Bacterial cultures derived from sonication were correlated with patient, surgical and implant characteristics, and the degree of capsular contracture. Results: The study included 121 breast implants from 84 patients, of which 119 originated from women and two from men undergoing gender reassignment. Some 50 breast prostheses were implanted for reconstruction, 48 for aesthetic reasons and 23 implants were used as temporary expander devices. The median indwelling time was 4·0 (range 0·1-32) years for permanent implants and 3 (range 1-6) months for temporary devices. Excluding nine implants with clinical signs of infection, sonication cultures were positive in 40 (45 per cent) of 89 permanent implants and in 12 (52 per cent) of 23 temporary devices. Analysis of permanent implants showed that a positive bacterial culture after sonication correlated with the degree of capsular contracture: Baker I, two of 11 implants; Baker II, two of ten; Baker III, nine of 23; and Baker IV, 27 of 45 (P < 0·001). The most frequent organisms were Propionibacterium acnes (25 implants) and coagulase-negative staphylococci (21). Conclusion: Sonication cultures correlated with the degree of capsular contracture, indicating the potential causative role of bacterial biofilms in the pathogenesis of capsular contracture. Registration number: NCT01138891 (http://www.clinicaltrials.gov).
Article
The use of postoperative prophylactic antibiotics following augmentation mammaplasty remains a controversial topic, with many surgeons opting for extended prophylaxis. The authors evaluate the role of postoperative prophylactic antibiotics in both primary and secondary cosmetic breast augmentation. A five-year retrospective chart review was performed on all patients undergoing cosmetic breast augmentation at a single institution from January 2005 to December 2009. The four attending physicians in this study utilized similar perioperative protocol and implant materials. Patients were divided into two cohorts: those who had received three days of postoperative antibiotics (primarily cephalosporins) and those who had not. End points of particular interest included infection, capsular contracture (CC), and local wound complications. The mean follow-up time was 3.8 years. A total of 605 implants were included over the five-year study period. The overall infection rate was 0.66%. For primary augmentation, 493 implants were studied, with 52% of those patients having received postoperative antibiotics. There was no statistically significant reduction in infection, CC, or total complication rate for those receiving postoperative antibiotics. Similarly, 112 implants were studied for secondary augmentation, and again, postoperative antibiotics were not associated with a reduction in complications. The data suggest that there was no reduction in the overall rate of total complications, infection, or CC with postoperative prophylactic antibiotics for either primary or secondary cosmetic breast augmentation. This study provides Level 3 evidence in support of discontinuing prophylactic postoperative antibiotics following cosmetic breast augmentation.
Article
Patients who have undergone prior chest wall irradiation can present as challenging candidates for implant reconstruction because of troublesome rates of infectious complications. The issue of antibiotic prophylaxis remains controversial, and evidence-based postoperative strategies to reduce implant infections have not been well described in the literature. The purpose of this study was to determine the efficacy of extended trimethoprim/sulfamethoxazole therapy in preventing implant infections in the irradiated chest wall. A retrospective chart review of hospital and office records was performed on all patients undergoing implant reconstruction performed by a single surgeon (J.M.S.) from August of 2005 to March of 2008. Before 2007, the senior author used 5 to 7 days of cephalosporin prophylaxis. Subsequent to this period, the prophylactic regimen was amended to provide patients with previous chest wall irradiation prophylactic trimethoprim/sulfamethoxazole for 30 days after implant insertion. Fifty-one implant reconstructions, in the setting of prior ipsilateral chest wall irradiation, were performed. The mean follow-up time was 39 months. The infection rate for the routine cephalosporin group was 35 percent as compared with 8 percent for the extended trimethoprim/sulfamethoxazole group (p = 0.038). After multivariate analysis, extended trimethoprim/sulfamethoxazole remained the only significant factor that influenced the rate of infection (p = 0.05). The mean time to infection was 13 weeks for the routine cephalosporin group and 1.5 weeks for the extended trimethoprim/sulfamethoxazole group (p = 0.044). Extended trimethoprim/sulfamethoxazole therapy demonstrates preliminary evidence as an effective adjunctive measure for reducing the rate of implant infections in breast reconstruction. Therapeutic, III.
Article
The aim of this article was to review the current literature on capsular contractures, focusing in particular on the epidemiology, risk factors, cause, and treatment modalities, to provide the plastic surgeon with an up-to-date review of the current available evidence. A literature search was undertaken of the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases. The search strategy was conducted using three groups of key words, with the first relating to the organ involved (breast), the second relating to the surgical procedure performed and related technical issues, and the third relating to the surgical complications. Potentially relevant articles were identified by means of the title and the abstract, and full articles were obtained and assessed in detail. Only a few studies have included large enough sample sizes, were conducted in a prospective manner, were adequately randomized, and achieved adequate follow-up periods to obtain a true measure of rates of capsular contraction occurrence. Recent advances in molecular biology, microbiology, immunology, and basic pathology have outlined some of the mechanisms that underlie this phenomenon. Revision surgery remains the only effective treatment option available but is limited by its high associated risk of recurrences. No adequate preventative measures exist in practice, beyond the avoidance of risk factors. Although a great deal of progress has been made over the past few decades, the exact nature and contribution of molecular, immunologic, and microbiological factors remain unclear. It is hoped that future studies will focus on attempting to resolve some of the issues highlighted in this review.
Article
Capsular fibrosis is a severe complication after breast implantation with an uncertain etiology. Microbial colonization of the prosthesis is hypothesized as a possible reason for the low-grade infection and subsequent capsular fibrosis. Current diagnostic tests consist of intraoperative swabs and tissue biopsies. Sonication of removed implants may improve the diagnosis of implant infection by detachment of biofilms from the implant surface. Breast implants removed from patients with Baker grades 3 and 4 capsular contracture were analyzed by sonication, and the resulting sonication fluid was quantitatively cultured. This study investigated 22 breast implants (6 implants with Baker 3 and 16 implants with Baker 4 capsular fibrosis) from 13 patients. The mean age of the patients was 49 years (range, 31-76 years). The mean implant indwelling time was 10.4 years (range, 3 months to 30 years). Of the 22 implants, 12 were used for breast reconstruction and 10 for aesthetic procedures. The implants were located subglandularly (n = 12), submuscularly (n = 6), and subcutaneously (n = 4). Coagulase-negative staphylococci, Propionibacterium acnes, or both were detected in the sonication fluid cultures of nine implants (41%), eight of which grew significant numbers of microorganisms (>100 colonies/ml of sonication fluid). Sonication detected bacteria in 41% of removed breast implants. The identified bacteria belonged to normal skin flora. Further investigation is needed to determine any causal relation between biofilms and capsular fibrosis.
Article
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.
Article
Capsular contracture can be an ongoing problem in breast augmentation even with good surgical technique. In the author's practice, a higher incidence of capsular contracture was observed with the use of a periareolar incision than with an inframammary incision. A review of breast augmentations performed from November 2004 through June 2006 was conducted. This analysis included the incision used, the procedure performed, and the development of capsular contracture. The incidence of contracture was 0.59% in the inframammary group and 9.5% in the periareolar group. This increase in capsular contracture with a periareolar incision was statistically significant. Capsular contracture occurring with augmentation performed at the time of a periareolar mastopexy was 8%, which was statistically significant compared with the inframammary group. The difference in contracture rates between a periareolar incision alone and a periareolar mastopexy was not statistically significant. Breast augmentation through a periareolar incision has a higher incidence of capsular contracture than observed with an inframammary incision. This most likely occurs due to an increase in contamination of the breast pocket with intraductal material colonized by bacteria. The periareolar incision is, and will remain, a standard of care. Therefore, this information can help clinicians make a more informed decision regarding incision placement for breast augmentation.
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
The use of central venous catheters impregnated with either minocycline and rifampin or chlorhexidine and silver sulfadiazine reduces the rates of catheter colonization and catheter-related bloodstream infection as compared with the use of unimpregnated catheters. We compared the rates of catheter colonization and catheter-related bloodstream infection associated with these two kinds of antiinfective catheters. We conducted a prospective, randomized clinical trial in 12 university-affiliated hospitals. High-risk adult patients in whom central venous catheters were expected to remain in place for three or more days were randomly assigned to undergo insertion of polyurethane, triple-lumen catheters impregnated with either minocycline and rifampin (on both the luminal and external surfaces) or chlorhexidine and silver sulfadiazine (on only the external surface). After their removal, the tips and subcutaneous segments of the catheters were cultured by both the roll-plate and the sonication methods. Peripheral-blood cultures were obtained if clinically indicated. Of 865 catheters inserted, 738 (85 percent) produced culture results that could be evaluated. The clinical characteristics of the patients and the risk factors for infection were similar in the two groups. Catheters impregnated with minocycline and rifampin were 1/3 as likely to be colonized as catheters impregnated with chlorhexidine and silver sulfadiazine (28 of 356 catheters [7.9 percent] vs. 87 of 382 [22.8 percent], P<0.001), and catheter-related bloodstream infection was 1/12 as likely in catheters impregnated with minocycline and rifampin (1 of 356 [0.3 percent], vs. 13 of 382 [3.4 percent] for those impregnated with chlorhexidine and silver sulfadiazine; P<0.002). The use of central venous catheters impregnated with minocycline and rifampin is associated with a lower rate of infection than the use of catheters impregnated with chlorhexidine and silver sulfadiazine.
Article
Fibrous capsular contracture is by far the most common cause of unsatisfactory results following augmentation mammaplasty. This article reviews the evidence for its various proposed etiologies, the techniques advocated for its prevention, and the procedures currently available for its correction.
Article
Fibrous capsules surrounding silicone implants were investigated in a new guinea pig model to delineate some of the factors leading to capsular contracture. Both the implant surfaces and tissue capsules were examined by light and scanning transmission electron microscopy (STEM + SEM) with x-ray energy spectroscopy (XES). The capsular tissues were qualitatively similar to those recovered clinically, showing dense parallel collagen deposits, fibroblasts, myofibroblasts, macrophages, and foreign-body giant cells. Silicone was positively identified within intercellular vacuoles and the rough endoplasmic reticulum of macrophages by XES. Tissue recovered from the capsules that surrounded implants that were contaminated with S. aureus presented a qualitatively similar histologic spectrum. The contaminated specimens did show an accelerated response. SEM showed a cellular invasion of the silicone envelopes. We conclude that the model accurately simulates the clinical situation and suggests that immune mechanisms may play a key role in capsular contracture.
Article
A more direct measurement of implant capsule contracture is needed for the laboratory study of this phenomenon. Most of the previous methods for quantitation of contracture rely on measurements of deformability. Because contraction of an implant capsule is in fact a decrease in the surface area of the capsule, a method is proposed for the calculation of capsule surface area from measurements of height and base diameter.
Article
During the last decade great inroads have been made concerning the appropriate use of antibiotic prophylaxis in the surgical patient. Well-controlled, prospective, blinded studies have outlined many of the areas in which antibiotic prophylaxis is of benefit, as well as those clinical situations in which the risks of antibiotic prophylaxis outweighed the expected value. Historically, the most common errors in usage include the widespread use of antibiotic prophylaxis in clean surgery and the faulty timing of administration. The most common error today (in the use of prophylactic antibiotics in surgical practice) is continuation of the agents beyond the time necessary for maximal benefit. In order to appropriately administer prophylactic antibiotics in the various clinical settings on the surgical service, in which this practice has been of proved value, one must be aware of the following nuances including (1) choice of the antibiotic agent based on the type of organisms usually causing infection, (2) route of its administration, (3) the dosage necessary to attain efficacious tissue or serum levels, and (4) the timing of administration which offers the maximum benefits without risking the adverse effects.
Article
The most important principle in surgical antibiotic prophylaxis is to ensure high blood levels of antibiotic at the time of anticipated wound contamination. This is best achieved by intravenous administration commenced at the time of induction of anesthesia. The continued efficacy of prophylaxis depends on the implementation of policies that minimize the opportunities for bacteria to acquire resistance to antibiotics. Prophylaxis should, therefore, be used judiciously and restricted to operations for which it is of established benefit. These are mainly operations in which a viscus colonized by bacteria is opened and in which bacterial contamination is unavoidable. Prophylaxis is also used for certain cardiovascular and orthopedic implant operations in which septic complications are a major threat to a successful outcome and to the life of the patient. The choice of antibiotic should be based on knowledge of the bacterial species likely to contaminate the wound and cause infection. The duration of prophylaxis should be short, and should not be extended beyond the minimum period known to be effective. Controlled trials have established that a single dose of antibiotic is sufficient for many operative procedures and that there is no benefit in prolonging prophylaxis beyond the period when the open wound is exposed to bacterial contamination.
Article
The true incidence of positive breast periprosthetic cultures in the absence of overt infection is not clearly established. We retrospectively reviewed data from 389 implants that were removed for reasons other than clinical infection. Many of these patients presented with a variety of musculoskeletal ailments. Others had symptomatic capsular contracture as the presenting complaint. In a few a known implant rupture was the reason for explantation. We identified a positive culture rate of 23.5 percent from capsule tissue. Most of these organisms were coagulase-negative staphylococci and anaerobic diphtheroids, but fungi and other organisms (generally felt to be more pathogenic than the less virulent coagulase-negative staphylococci) also were cultured. In an attempt to identify the clinical relevance of these positive cultures, we statistically evaluated the culture results for associations with capsular contracture, implant rupture, type of implant, and location of implant. Of these, the only statistically significant correlation was between positive culture result and symptomatic capsular contracture (Baker class IV).
Article
Capsular contracture prevents a natural "feel" to an augmented breast and is frequently a source of patient and physician dissatisfaction postoperatively. The degree of hardness of a breast is difficult to quantitate. We have developed a rodent model that measures the pressure rise in a capsule in response to increasing intraluminal volume, generating a pressure-volume curve. The curve's break point determines the volume contained within the capsule and the slope of the steep part of the curve to the right of the break point determines capsule resistance to stretch and deformation. In a group of 14 rats, resistance to distension increased progressively over a 14-week period whereas capsule surface area, break point volume, and resting intraluminal pressure remained relatively constant. This model allows the assessment of changes in capsule contracture over time without having to kill the animal.
Article
Possible adverse effects of microbial organisms have been implicated in symptomatic silicone implant patients. In the literature, numerous authors have investigated the possible role of infection with respect to implant problems. To date, various bacterial species have been reported, including Staphylococcus aureus, Staphylococcus epidermidis, peptostreptococci, and Clostridium perfringens. Infections in polyurethane-coated prostheses also have been shown to prolong morbidity. Antibiotic use has been relatively empirical in this regard. The purpose of this study was, first, to determine the frequency, type, and clinical relevance of microbial colonization on implant surfaces removed from symptomatic patients and, second, to determine possible effects of microbial colonization on implant integrity (gel bleed, rupture). A total of 139 implants from 72 symptomatic patients were entered into the prospective clinical study between February of 1993 and July of 1994 at the UCLA Medical Center. The implant shell types included smooth (79 percent), polyurethane (8 percent), textured (7 percent), and smooth and Dacron (6 percent). The implant locations were subglandular (71 percent), submuscular (28 percent), and subcutaneous (1 percent). Of the 139 implants removed, 69 percent were intact and 31 percent were ruptured. Forty-seven percent of 139 implants were culture-positive. Propionibacterium acnes was isolated most frequently (57.5 percent), followed by Staphylococcus epidermidis (41 percent), and then Escherichia coli (1.5 percent). No fungal infections were identified. Culture positivity was not significantly associated with systemic symptoms. Sixty-seven percent of the positive culture implants were intact; 33 percent were ruptured. The frequency (47 percent) and types (P. acnes and S. epidermidis) of microbial colonization are determined in symptomatic silicone implant patients.
Article
Subclinical infections have been implicated in the etiology of capsular contracture. Intraoperatively, breast pocket irrigation with povidone-iodine or other antibiotic solutions has been popularized; however, detrimental effects on wound healing for these agents have been reported and their efficacy against common organisms found around breast implants has not been studied. The purpose of this study was to compare the in vitro efficacy of serial dilutions of povidone-iodine and two double antibiotic solutions DAB-1 (gentamicin/polymyxin B) and DAB-2 (gentamicin/cefazolin), against organisms most commonly found around breast implants. In phase I trials, serial dilutions of povidone-iodine and DAB were combined 1:1 with cultures of five common organisms found around implants. In phase II, povidone-iodine was serially diluted in DAB-1 rather than saline. In phase III, povidone-iodine was serially diluted with DAB-2. Efficacy for all phases was determined by plating the mixture onto agar plates and incubating at 37 degrees C for 48 hours. Povidone-iodine was 100 percent effective at a dilution of 12.5% against Staphylococcus epidermidis and 25% against Staphylococcus aureus but relatively ineffective against Escherichia coli and Pseudomonas, DAB-1 was found to be ineffective against S. epidermidis but effective against S. aureus, Propionibacterium acnes, E. coli, and Pseudomonas. In phase II trials, a concentration of 12.5% povidone-iodine in DAB was effective at killing all experimental bacteria. In phase III trials, 10% povidone-iodine in DAB-2 was effective at killing all bacteria tested. In conclusion, to maximize bacterial control of common breast implant organisms and to minimize the detrimental effects on wound healing, 10% povidone-iodine in gentamycin/cefazolin may be used with excellent results and its use clinically may reduce the incidence of capsular contracture.
Article
In an effort to evaluate quality-of-life benefits of ablative head and neck cancer surgery and microvascular reconstruction, a longitudinal study was undertaken in which patients with T3 or T4 oropharyngeal cancers without systemic metastases at presentation were administered both general and disease-specific quality-of-life instruments preoperatively and postoperatively. In an initial prospective pilot study, 17 cancer patients were evaluated both preoperatively and postoperatively using the Medical Outcomes Short-Form Health Survey questionnaire (SF-36) and the Performance Status Scale for Head and Neck Cancer Patients. In the second part of the study, the need was recognized for a different disease-specific measure, for more frequent intervals of longitudinal follow-up (rather than be limited by a single data collection point), and for a noncancer control group. Since then, 17 more cancer patients were evaluated in the second part of the study and were compared with patients who had similar reconstructions after suffering head and neck trauma and also with age-matched controls. Instead of the performance status scale, the University of Washington Head and Neck Quality of Life questionnaire was substituted. Interval assessments were done at 1, 3, 6, and 12 months and preoperatively. Whereas many of the general and disease-specific quality of life subclasses initially worsened following extensive surgery and radiation therapy, most returned to the preoperative baseline by 6 months following conclusion of treatment and surpassed pretreatment values at 1 year. It can be concluded, based on this study, that large resections and reconstructions for head and neck cancer patients are justified in terms of outcome; the resection controls the local disease, and the microvascular reconstruction restores quality of life and functional status.
Article
Bacterial colonization of mammary implants is a prelude to clinical infection and has been implicated in the etiology of capsular contracture. Antimicrobial impregnation of a variety of medical devices with the combination of minocycline and rifampin has recently emerged as a potentially effective method for preventing device colonization and device-related infection. The objective of this animal study was to examine in vivo the antimicrobial efficacy of minocycline/rifampin-impregnated, saline-filled silicone implants. A rabbit model of Staphylococcus aureus colonization and infection of subcutaneously placed implants was used. A total of 48 saline-filled silicone implants (24 antimicrobe-impregnated and 24 control unimpregnated implants) were suspended in a 106 colony-forming units/ml bacterial suspension of S. aureus for 30 minutes at room temperature, allowed to dry for 60 minutes, and then implanted subcutaneously in the back of 12 rabbits (two antimicrobe-impregnated and two control implants were placed in each rabbit). Rabbits were monitored daily, then killed either at 2 weeks (10 rabbits) or at 4 weeks (two rabbits) and cultured. The antimicrobe-impregnated implants were 12 times less likely to be colonized than control unimpregnated implants (two of 24 versus 23 of 24; p < 0.001), and they were a significantly less likely cause of implant-related infection (0 of 24 versus 22 of 24; p < 0.001) and implant-related abscess (0 of 24 versus 21 of 24; p < 0.001) than control implants. The minocycline/rifampin-impregnated implants routinely demonstrated zones of inhibition against S. aureus at the time of explantation. These results indicate that minocycline/rifampin-impregnated implants can significantly decrease the rate of bacterial colonization, implant-related infection, and implant-related abscess. Antimicrobe-impregnated implants also have the potential of reducing the likelihood of capsular contracture.
Article
Because bacterial colonization of medical devices may result in clinical infection, it is conceivable that antimicrobial impregnation of tissue expanders may reduce the rate of infection. The objective of this in vitro study was to examine the spectrum, durability, and shelf-life antimicrobial activity of minocycline/rifampin-impregnated silicone tissue expander shells. The impregnated devices exhibited zones of inhibition at baseline against Staphylococcus epidermidis, Staphylococcus aureus, and Escherichia coli. The impregnated devices exhibited strong residual activity against S. epidermidis and S. aureus after suspension in serum at 37 degrees C for 4 weeks. There was no significant decrease in the size of zones of inhibition after storing the impregnated devices at room temperature for 1 year. These results indicate that minocycline/rifampin-impregnated tissue expander shells provide broad-spectrum and durable antimicrobial activity and that the shelf-life antimicrobial activity exceeds 1 year. These findings prompt future exploration of the anti-infective efficacy of these antimicrobial-impregnated devices.
  • Burkhardt
  • Darouiche
  • Shah