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Complications Related to Retained Breast Implant Capsules
Abstract
Citing evidence that breast implant-related capsules resolve uneventfully, surgeons have elected to leave the capsules in place when implants are removed because capsulectomy adds both morbidity and expense to the procedure. However, recent clinical and histopathologic evidence suggests that uneventful resolution is not always the case, and several potential problems may arise from retained capsules after removal of the implant. Retained implant capsules may result in a spiculated mass suspicious for carcinoma, dense calcifications that obscure neighboring breast tissue on subsequent imaging studies, and cystic masses due to persistent serous effusion, expansile hematoma, or encapsulated silicone filled cysts. Furthermore, retained capsules are a reservoir of implant-related foreign material in the case of silicone gel-filled implants and textured implants promoting tissue ingrowth. To avoid complications from retained capsules, total capsulectomy or postoperative surveillance should be offered to patients.
... Because it has been reported that silicone implant capsules resolve uneventfully (11), and because capsulectomy can increase patient morbidity and cost, many surgeons have elected to leave breast implant capsules in place, when silicone gel breast implants are removed. Recent findings, however, have indicated that uneventful resolution of breast implant capsules may not always occur (12). Certain complications of retained breast capsules can be diagnosed by mammography. ...
... Recent evidence, however, has suggested that uneventful capsule resolution may not always occur. Several potential problems have been demonstrated from retained capsules (12). ...
... Many authors have advocated the use of capsulectomy on the basis of the fact that this technique prevents calcium deposition. Indeed, Hardt et al reported that retained implant capsules may result in a speculated mass suspicious for carcinoma, dense calcifications that obscure neighbouring breast tissue on imaging, or a cystic mass due to persistent serous effusion, hematoma, or encapsulated silicone-filled cysts [38]. Additionally, Copeland et al reported that capsules that formed around textured implants typically had silicone fragments, findings which were not present in capsules associated with smooth implants [39]. ...
Background
The objective of this clinical review is to provide an overview of the use of breast implants after capsular contracture (CC) surgical treatment, with a focus on type of implants used. Furthermore, our experience in this field is also reviewed.
MethodsMEDLINE, EMBASE, Web of Science, Scopus, the Cochrane Central, and Google Scholar databases were reviewed to identify literature related to surgical treatment of capsular contracture and implant replacement. Each article was reviewed by two independent reviewers to ensure all relevant publications were identified. The literature search identified 54 applicable articles. Of these, 26 were found to have a therapeutic level of evidence. The reference lists in each relevant paper were screened manually to include relevant papers not found through the initial search.ResultsOnly four articles report the replacement of implants after surgical treatment of capsular contracture. Six articles reported an implant exchange with only smooth silicone gel filled implants. Two reviews advice to use smooth implants in implant replacement.Conclusion
With our expertise in the field and the results of this up-to-date literature review, it can be concluded that implant exchange is recommended in case of breast revision for capsular contracture, and the use of subpectoral smooth silicone gel breast implants is a good option after surgical treatment in patients with primary or recurrence Baker III–IV.Level of Evidence IIIThis 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.
... With regard to the equal CC recurrence rates found for implant exchanges after nonruptured implants versus ruptured implants with additional PL, this study encourages open capsulotomies for the management of CC also in case of silicone leakage. However, we agree that partial or total capsulectomies, which in contrast can be more surgically challenging, invasive, and time consuming [11], should be considered in cases of strong calcification, thick, or granulomatous capsules [10,47,48]. Further indications for performing a capsulectomy have been widely discussed previously [12,49]. ...
Introduction
Pulse lavage (PL) irrigation of prosthesis pockets has prior been described for breast implant salvages. However, PL for removal of leaked silicone from prosthesis pockets after implant ruptures has not been studied yet. Since open capsulotomies are regarded as equal treatment of capsular contracture (CC) than capsulectomies, this study analyzed the clinical outcome of PL for silicone removal and subsequent capsulotomy in cases of concurrent CC and breast implant rupture.
Methods
Between 2012 and 2017, 55 patients (75 breasts) with suspected silicone implant rupture and CC (Baker grade III/IV), after primary breast augmentation or implant-based breast reconstruction, were included in a retrospective, observational study. Mean patient follow-up was 12.2 ± 3.6 months.
Results
In all preoperatively suspected ruptured silicone breast implants, around a quarter were intact. In contrast to previously published data, implant exchanges in cases of implant ruptures did not lead to significantly higher CC recurrence rates (27.6% vs. 22.2% in cases of intact implants, p = 0.682), if the prosthesis pockets were treated with PL irrigation followed by open capsulotomy. PL reduced the amount of encapsulated silicone remnants histologically. The age of patients with CC after failed implant-based reconstruction was significant lower for salvage surgeries with flap reconstruction than for implant exchanges, p < 0.05.
Conclusions
PL irrigation of prosthesis pockets prior to open capsulotomy is a safe and effective treatment of CC with concurrent silicone leakage. Remaining silicone remnants in breast capsules may affect the development of a recurrent CC. To avoid CC recurrences, patients should consider conversion to autologous tissue.
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.
... Gel bleed is a phenomenon that is inherent to all types or models of silicone breast implants, regardless whether they are soft and round or cohesive anatomically shaped [10][11][12][13][14]. The bleed retardation layer in the late models, retards the bleeding, but does not abolish it. ...
... Gel bleed is a phenomenon that is inherent to all types or models of silicone breast implants, regardless whether they are soft and round or cohesive anatomically shaped [10][11][12][13][14]. The bleed retardation layer in the late models, retards the bleeding, but does not abolish it. ...
Objective: We studied a patient who died in 2008at the age of 56 and had been exposed to gel bleed from her silicone breast implants for 17 years. Tissue samples and nervous tissue could be obtained for analysis.
Design: During autopsy, a wide range of different tissue samples were collected, frozen and embedded in paraffin and plastic (Epon). The paraffin samples were stained with Hematoxylin and Eosin (HE) as well as with Modified Oil O Red (MORO). Tissues embedded in plastic (Epon) were sectioned and prepared for light microscopy using toluïdin blue staining for Transmission electron microscopy (TEM) and Energy Dispersive X-ray microanalysis (EDX) to measure elemental Silicon (Si).
Results: We found 2 types of silicone material in multiple tissue and brain samples of this patient. The first is a droplet-like form. EDX measurements demonstrated that the droplets are composed of elemental Si. The second is a plaque-like form, these structures are comprised of elemental Si and Ti (Titanium). Occasionally we found that these plaques were located inside the tissue without a lining and sometimes they were located inside the lumen of blood vessels.
Conclusions: The use of EDX analysis over light microscopic examination only, is now a contributing factor for the establishment of silicone bleeding and migration throughout the whole body in high amounts.
... Gel bleed is a phenomenon that is inherent to all types or models of silicone breast implants, regardless whether they are soft and round or cohesive anatomically shaped [10][11][12][13][14]. The bleed retardation layer in the late models, retards the bleeding, but does not abolish it. ...
... However, there is some controversy regarding how the retained capsule may change over time. Hardt et al. [14] reported that retained implant capsules may evolve to take several forms, including a speculated mass similar to a breast carcinoma, dense calcifications that obscure the neighboring breast tissue on imaging studies, or a cystic mass due to persistent serous effusion, expansile hematoma, or encapsulated silicone-filled cysts. However, Fig. 3 A 33 year-old woman. ...
Although capsule formation is a natural-healing process following breast augmentation using implants, a contracted capsule around a poorly positioned implant can act as an obstacle during the corrective procedure to reposition the implant. The ideal treatment of capsular contracture is removal of the capsule and covering the implant with a healthy envelope without scar tissue. However, total capsulectomy in the submuscular space may be difficult, especially if the capsule is firmly attached to the chest wall. This situation may require a highly skilled technique because aggressive capsulectomy could injure the intercostal muscles and vasculature and cause further complications such as pneumothorax. Therefore, the authors have developed a new, less traumatic method of leaving the capsule behind the new implant.
From February 2001 through February 2009, the authors treated 74 patients (139 breasts) using a subpectoral, precapsular implant repositioning technique. These patients suffered from capsular contracture or implant malposition after submuscular breast augmentation. The technique is composed of three parts. First, a plane was developed between the anterior wall of the capsule and the posterior surface of the pectoralis major muscle using a periareolar or inframammary approach. After removing the previous implant, the anterior wall of the capsule was fully released from the posterior surface of the pectoralis major muscle and fixed to the posterior wall of the capsule which adhered to the chest wall. The new implant was inserted into the developed subpectoral space, anterior to the capsule.
The mean age of the patients was 31 years (range = 24-52) and the time between the primary and the secondary augmentation was 42 months (range = 4 months to 12 years). The range for follow-up was from 12 months to 5 years. Median follow-up was 26 months. Postoperative complications included two cases of hematoma but no cases of infection, muscle distortion, or double-bubble deformity.
This technique is a valid alternative treatment for capsular contracture or malpositioned implant after breast augmentation surgery. It may be less traumatic than the conventional method of total capsulectomy. In addition, this technique reduces the relapse rate of capsular contracture significantly compared to a partial capsulectomy or capsulotomy as the new implant is inserted into a scar tissue-free environment. Good aesthetic results and patient satisfaction was achieved using this method. In our experience, this novel technique is a good alternative method of correcting complications of submuscular implant augmentation.
... However, the capsule frequently contracts around the implant, producing due to the incompressibility of the silicone prosthesis, an increase in hydrostatic pressure at the implant site. The breast implant is forced into a spherical shape and the breast turns this way to become firm and in severe cases painful and distorted (9,10). Different approaches have been proposed to quantitatively assess the capsular contracture level (1,11,12); however these attempts have not been fruitful yet, and physicians still commonly classify the contracture severity according to the Baker score (13), as reported in Table I. ...
Contracture of the fibrous connective capsules that form around breast implants is the most frequent complication for silicone mammary prostheses. Capsule contraction is thought to be associated with the alteration in the mechanical properties of the tissue, but to date such a correlation has not been quantified. This study aimed to develop an experimental protocol to investigate the mechanical properties of the periprosthetic tissue and their dependence on the severity of capsular ontracture. Capsule samples were harvested from donors undergoing surgical correction or re-implantation of breast prostheses; strip spec-imens were cut along both the meridian and circumferential directions of the capsular dome. The experimental protocol consisted of mechanical preconditioning, stress relaxation tests and tensile tests to rupture. The capsular tissue exhibited non-linear stress-strain relationships and stress relaxation behavior; nevertheless, both the elastic and the relaxation properties did not depend on the loading direction. In spite of the small number of samples included, to date, in the experimentation, some pre-liminary conclusions can be drawn: the stiffness and the strength of the tissue increases with the contracture severity; the re-laxation seems unaffected by the contracture degree. Some assumptions concerning the modifications in periprosthetic tissue composition following contracture are also drawn.
... In our series, we performed capsulotomy rather than capsulectomy as we believed that capsule formation was a foreign body reaction, 15,16 and would resolve if the implant was removed. Although, there has been reports of calcification of retained capsule making oncological surveillance difficult, [17][18][19] open capsulotomy and replacement with polyurethane-covered implants has shown good results. 20 We have shown that capsulotomy and replacement with autologous implant can also achieve a good aesthetic outcome, with resolution of symptoms. ...
A one step autologous approach to bilaterally correct recurrent complications of breast reconstruction or augmentation with silicone implants is presented together with five cases. This approach resulted in relief of symptoms with good cosmetic outcome avoiding multiple procedures.
The management of patients with breast implants requires secondary procedures through the life of the implant, sometimes in the early postoperative period and more commonly many years after the initial surgery. In performing revisional procedures, removal and replacement of the implants is often required for a variety of reasons. With growing concerns of implant safety, implant exchange or removal with or without a capsulectomy has been increasingly requested by patients. In particular, textured breast implants have been under increased scrutiny secondary to their association with breast implant-associated anaplastic large cell lymphoma. Unfortunately, to date, there are no data and very little guidance as to the appropriate management of patients currently with textured implants as well as patients with a history of having had textured implants placed in the past. The surgeon must not only consider the appropriate management of patients with uncomplicated, asymptomatic textured devices but also consider the appropriate management when faced with another indication for revisional surgery and the need determine the appropriate course of action. An algorithm for the management of the explantation patient in general will be introduced in this review with a focus on the rationale, planning, and management of patients with an uncomplicated, asymptomatic textured implants.
Background:. Silicone gel implants are regarded as esthetically superior to saline implants, offering a more natural consistency. They are also considered less susceptible to rippling. However, objective measurements and patient-reported outcome studies are lacking. Similarly, minimal data are available quantitating animation deformity.
Methods:. A 3-year prospective study was undertaken among 223 women undergoing primary subpectoral breast augmentation using either saline (n = 145) or silicone gel (n = 78) implants. Photographs obtained included frontal views with the patient flexing the pectoral muscles. Images were matched, and vertical differences in nipple position were measured. Breast implants were evaluated using high-resolution ultrasound to detect any ripples or folds at least 3 months after surgery. Outcome surveys were administered. Statistical analysis included the χ2 test, point-biserial correlations, and a power analysis.
Results:. Respondents reported visible rippling in 18% of women and palpable rippling in 32% of patients, with no significant difference between women treated with saline and silicone gel implants. Ripples were detected on ultrasound scans in 24% of women with saline implants and in 27% of women with silicone gel implants (difference not significant). Ripples were more common in women with lower body mass indices. Fifty percent of patients demonstrated nipple displacement
Background:
Capsulectomy has traditionally been recommended as a treatment for capsular contracture after breast augmentation. With the advent of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), and the Food and Drug Administration's decision to ban Biocell textured devices, this operation has taken on new importance. This review was undertaken to better inform clinical recommendations for women with textured devices.
Methods:
An electronic search was performed using PubMed to identify all the available literature on the subject of capsulectomy and open capsulotomy (the alternative treatment).
Results:
Fifty-one articles on this topic were identified. Capsulectomy was widely recommended for treatment of capsular contracture, although many authors recommended leaving thin capsular tissue behind in the absence of symptoms. En bloc resection was recommended only for women with a diagnosis of BIA-ALCL. No information supported a prophylactic role for capsulectomy in asymptomatic women with textured breast implants who are concerned regarding their future risk of BIA-ALCL. Routine pathologic examination in asymptomatic patients was not supported.
Discussion:
Capsulectomy adds substantially to the surgical risk, discomfort, recovery time, and expense. Implant removal or replacement without a simultaneous capsulectomy is atraumatic and poses negligible risk.
Conclusions:
Capsulectomy introduces additional morbidity and is not mandatory for asymptomatic patients. Implant removal or exchange for smooth implants without a capsulectomy may be an acceptable choice for many women who do not demonstrate capsular pathology. However, any symptoms or surgical findings suggesting pathology warrant a capsulectomy. En bloc resections are reserved for patients diagnosed with BIA-ALCL.
Breast augmentation is one of the most popular cosmetic surgery procedures performed in the United States. The reported satisfaction rate is high and varies from 95% to 98%. Capsular contracture, a known complication, is one of the most common reasons for dissatisfaction with the procedure. This chapter will review the literature on the etiology and management of capsular contracture, focusing on non-surgical and surgical options of treatment. To date, there is no clear consensus on the management of this complication. The goal is to manage capsular contracture, prevent recurrence, minimize risk to the patient, and obtain esthetic results. We describe our protocol for treatment of early capsular contracture based on the literature presented. If the patient fails to respond to non-invasive methods of management, then a surgical intervention with a capsulectomy and implant exchange may be indicated. The surgeon must consider the risks versus benefits of performing a total capsulectomy and make the best judgment based on the clinical scenario presented by the patient.
This article reviews the literature on the etiology and management of capsular contracture, focusing on indications for capsulectomy along with explantation of breast implants. This article outlines the clinical factors which should be considered when managing capsular contracture. This article offers the most comprehensive review to date of surgical and nonsurgical management of capsular contracture. The goal of treatment is to prevent recurrence of capsular contracture, minimize risk to the patient, and obtain esthetic results. Capsulectomy is indicated in the majority of cases when breast implants are being removed or replaced in the setting of contracture. However, the surgeon must consider the risks and benefits of capsulectomy.
Mammography is not accurate to predict implant rupture in most patients. Its sensitivity rate is only 11 to 16%. However, two mammographic findings appear to suggest implant rupture: the appearance of large areas of implant herniation, and the appearance of silicone globules lying outside the margins of the implant. Mammography is also helpful to predict capsular calcification and to assess certain complications of retained breast implant capsules. Two patients presented with retained capsules which had not resolved, two and five years after implant removal. One patient developed a spiculated mass, suspicious for carcinoma, that proved to be a cystic mass resulting from persistent serous effusion. The other patient demonstrated a large densely calcified capsule which interfered with breast imaging.
Mammographic breast mass, cyst, calcified mass, papable mass, or hematoma are the possible consequences of leaving some fibrous capsule in place when a breast implant is removed or changed. Indications for total capsulectomy include: calcified fibrous capsule, polyurethane implant, symptoms of autoimmune disease, plans for replacement with a textured implant in the same pocket, ruptured implant, and patient fear of developing autoimmune disease. The decision to perform capsulotomy, partial capsulectomy, or total capsulectomy is up to the operating surgeon according to the facts of the case and the surgeon's experience after consultation with the patient.
Various methods have been used to try to prevent or to reduce the rate of capsule contracture following breast augmentation. Methods commonly used to prevent contracture that have shown some success include the use of low-dose steroids in the implant pocket, antibiotics, implant manipulation with smooth-shelled saline implants, textured implants, and placing the implant in the submuscular position. An excellent means of treating capsule contracture is with partial or total capsulectomy followed by placement of a textured saline implant on the opposite side of the pectoralis major muscle, creating a new implant pocket.
Background:
Capsular contracture is a complication of breast augmentation that frequently requires revision surgery. "Capsulectomy, site change, and implant exchange" has been referred to as the gold standard treatment of clinically significant contractures. However, the actual clinical evidence behind this algorithm remains elusive at best. A systematic review of the literature was performed to clarify the true evidence behind the surgical management of capsular contracture.
Methods:
A search of the MEDLINE database was performed for clinical studies involving the surgical treatment of capsular contracture following breast augmentation. Resulting articles were reviewed using a priori criteria.
Results:
The systematic review was performed in April of 2015. The primary search for "breast augmentation" yielded 9490 articles. When filtered for "treatment of capsular contracture," 461 articles resulted. Review of these articles and pertinent references using a priori criteria yielded 24 final articles. No controlled trials met final inclusion criteria.
Conclusions:
There is limited clinical evidence behind the surgical management of capsular contracture. Site change and implant exchange are associated with reduced contracture recurrence rates and likely play a beneficial role in treating capsular contracture. The data on capsulectomy are less conclusive. Acellular dermal matrix may be a useful adjunct but still requires long-term data.
There have been significant postoperative problems following breast augmentation, including capsule contracture, infection, thinning of tissues over the implant, malposition, implant rupture, rippling, and fear of the silicone implant from the media scare and U.S. Food and Drug Administration. There are occasions when a patient will choose implant removal. Following removal there may be breast tissue loss, ptosis, loss of cleavage, loss of upper-pole fullness, and irregularities. The patient may then desire reconstruction, the type of which is determined by the defect or deficit. Implant reimplantation may be a solution, or autogenous tissue reconstruction may be necessary.
Citing evidence that breast-implant-related capsules resolve uneventfully, some surgeons elect to leave the capsules in place when implants are removed because capsulectomy adds morbidity and expense to the procedure. But clinical and histopathologic evidence suggests that uneventful resolution is not always the case, and several potential problems may arise from retained capsules after removal of the implant. This chapter reviews options for the surgeon faced with explantation and management of the subsequent breast tissue and the remaining capsule. Retained capsules can cause further problems and should be addressed.
A retrospective study was performed to compare reoperative breast implantation surgery before and after the Food and Drug Administration (FDA) hearings in 1991 and 1992 on silicone breast implants. The two groups were compared regarding the motivation, findings, and procedures associated with the operations.
One hundred seventy-one patient records were reviewed covering the years 1989 to 1994, evenly straddling 1991; of those, 146 charts had sufficient data to be included in the study. Each implant and each implantation operation were counted as a separate event. Before November 1991, 64% of reoperations were performed on the senior author's own original patients, whereas after 1991, only 33% were. Fifty-seven percent of the reoperations performed before November 1991 were performed on patients requiring augmentation in contrast to those patients requiring reconstruction; after 1991, 78% of the reoperations were augmentation mammaplasties.
In the early period, reoperation was primarily performed to correct asymmetry (47%) or capsular contracture (47%); it was rarely performed for rupture (3%) or infection (3%) and never for anxiety or pain. In the later period, contracture (44%) and asymmetry (18%) remained as common causes, but anxiety (11%) and pain (8%) appeared as new factors, and rupture was suspected more often (21%). One of the most dramatic, if not surprising, findings was the choice for replacement implant. In the earlier period, saline solution-filled implants were used 12% of the time, whereas in the later period, they were used 80% of the time. Finally, implants removed that were more than 15 years old had ruptured nearly 50% of the time.
The published data relating to breast implants and a variety of diseases are reviewed. The evidence currently available suggests that silicone implants are not responsible for the development of any systemic disorder. Implants do leak silicone and can cause local problems. The terrorization of the breast implant population is discussed and criticized.
We present 3 patients undergoing revisional implant surgery more than 20 years after congenital breast asymmetry correction. All of them had Poland syndrome. In 2 patients, the parietal pleura was inadvertently damaged during capsulectomy, resulting in a pneumothorax in one patient and implant loss in the other. The loss followed a copious accumulation of fluid around the implant, possibly due to a (persistent) communication with the pleural cavity. In the first case the pneumothorax was successfully treated intraoperatively. The third patient suffered no complications during surgery. Predisposing factors for pleural damage during revisional implant surgery for congenital breast asymmetry are discussed, in addition to the merits of total capsulectomy during implant exchange. It is concluded that surgeons should aim to minimize the possibility of pleural damage during this surgery and should proceed with caution when performing total capsulectomy in at-risk patients.
Breast implant capsules are a foreign body immune response to breast implants. It has been proposed that capsulectomy after breast implant removal was unnecessary, as the body resorbs the capsule when the implant, the impetus for the foreign body response, is removed. We report eight women with persistent capsules 10 months to 17 years after silicone breast implant removal.
Native skin-flap necrosis following skin-sparing mastectomy (SSM) is treated by raising a capsular flap, formed as a consecutive physiological reaction around breast implant. Using this highly vascularised thin tissue layer as an implant coverage withdraws pressure from the defect and allocates a good background for wound healing.
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.
In order for silicone from breast implants to have an effect on the immune system, it must be demonstrated that cells with the potential for immune system function have access to silicone. It had long been thought that the fibrous capsule surrounding breast prostheses functioned as an effective barrier between the biomaterial and the host. Implants that ruptured were thought to be innocuous to the host as long as the fibrous tissue capsule surrounding the implant was intact. This was termed “contained rupture.” Thus, the capsule was thought to prevent the egress of foreign material (Bingham et al. 1988)
Foreign-body (FB) carcinogenesis is a classic model of multistage tumour development in rodents. Previous studies have demonstrated that the physical characteristics of the implant, and not the chemical composition, are the critical determinants of tumour development. The recent controversy over silicone breast implants has raised questions regarding the potential carcinogenicity of lifetime tissue exposure to silicone products. The present study was designed to determine whether the inflammatory and fibrotic reactions associated with silicone implants are due to a non-specific foreign-body reaction or whether these responses reflect the unique chemical composition of silicone. F344 rats were implanted subcutaneously with one of three biomaterials: silicone elastomer (Group 1); impermeable cellulose acetate filters (Group 2, positive control); or porous cellulose acetate filters (Group 3, negative control). The silicone and cellulose implants of Groups 1 and 2 have been previously shown to induce fibrosarcomas in rodents, whereas the porous cellulose acetate implants of Group 3 have been shown to be non-carcinogenic. One week and two months after implantation, the pericapsular tissues were evaluated using histopathological and in situ immunohistochemical analyses. Endpoints included expression of leucocyte antigens CD4 (T helper/inducer), CD8 (T suppressor/cytotoxic) and CD11 b/c (macrophage), proliferating cell nuclear antigen (PCNA) as an indicator of proliferation, and in situ end-labelling (ISEL) of 3'OH DNA strand breaks as an indicator of DNA damage and apoptosis. The results indicated that the acute and chronic cellular responses to silicone (Group 1) were not different from impermeable cellulose filters (Group 2) of identical size and shape, suggesting that these responses were not unique to silicone. The inflammatory response to the carcinogenic cellulose and silicone implants (Groups 1 and 2) was attenuated and associated with the formation of a thick fibrotic capsule. In contrast, the porous cellulose filters (Group 3) induced a markedly different cellular response in which the inflammatory reaction was more extensive, prolonged and associated with minimal fibrosis. Within the fibrotic capsule surrounding the tumorigenic implants, but not the non-tumorigenic implants, cell proliferation and apoptotic cell death were increased and associated with persistent DNA strand breaks. Taken together, the results suggest that the micrometre-scale surface morphology of the implant determines the nature of the subsequent cellular response which may predispose to tumour development. Further, these studies serve to emphasize the critical importance of appropriate physical controls in studies designed to evaluate carcinogenic or autoimmune manifestations associated with silicone implants in order to rule out the contribution of the chronic foreign-body reaction.
This retrospective study reviews 720 patients referred for evaluation of their silicone gel-filled breast implants from December of 1992 to January of 1996. Of the 720 patients evaluated, 282 (39.2 percent) subsequently underwent explantation, and 59 of these patients (20.9 percent) had a breast contouring procedure performed at the time of explantation. Our definition of explantation is the operative removal of the implant as well as the implant capsule. The overall complication rate for explantation was 5 out of 282 patients (1.8 percent), whereas the rate of complication among the patients who underwent simultaneous breast contouring was 2 out of 59 patients (3.4 percent). This article presents the management of the breast following explantation, implant removal, and capsulectomy. We review both the preoperative assessment of patients seeking explantation and our technique of explantation. Additionally, we address the importance of preoperative breast ptosis in technique selection and have developed a practical clinical algorithm for guiding simultaneous explantation and breast contouring. We also identify those patients who should undergo delayed breast contouring due to associated risk factors (smoking, need for > 4 cm of nipple movement, and paucity of breast parenchyma).
This article discusses indications for performing a capsulectomy in conjunction with explantation of breast implants. This issue has rarely been addressed in the literature, and there is no consensus on guidelines to assist surgeons in deciding whether a capsulectomy is warranted. The many factors that must be weighed when considering performance of a capsulectomy are outlined, and recommendations for the explantation contexts in which capsulectomy may be considered optional or should usually be performed are given. Capsulectomy may be indicated in the majority of instances when breast implants are removed or exchanged, but the potential risks of capsule removal must always be balanced against the potential benefits.
Calcification of the fibrous capsule surrounding silicone breast implants is a well-recognized occurrence that increases with time following implantation. These mineralized deposits potentially confound mammographic breast cancer surveillance already made difficult by the obscuring effects of silicone breast implants. The authors performed elemental analysis of silicone breast implant-associated calcifications to define better their chemical composition as related to mammographic and clinical significance. Electron probe microanalysis and infrared spectroscopy revealed all of the calcification deposits to be calcium complexed with tribasic phosphate. No evidence of calcium oxalate, calcium carbonate, silicone, or talc was observed. Caution must be employed in interpreting mammograms in women with silicone breast implants as well as those who have had their silicone breast implants removed. High-density mammographic calcifications indicative of calcium phosphate associated with a silicone breast implant may represent an accepted consequence of implantation or nearby carcinoma. We recommend baseline mammography on women who have had their silicone breast implants removed to prevent unnecessary fine-needle aspiration or tissue biopsy of retained breast capsule calcifications during subsequent routine surveillance for carcinoma.
The objective of this study was to determine whether the type of capsulectomy, anterior or total, affects the recurrence of capsular contracture around subglandular silicone-gel breast implants. A retrospective analysis was performed of patients who underwent either anterior or total capsulectomy for Baker grade 3 or 4 subglandular capsular contracture in our unit. All patients were invited to a review clinic where their capsular status was assessed. There were 100 anterior- disc capsulectomies in 60 patients between 1988 and 1997 and 99 total capsulectomies in 60 patients between 1990 and 1998. The follow-up in the former group was a median of 7 years and mean 6.9 years, compared with median 2.5 and mean 3.1 years in the latter group. Eighty-six percent of the implants removed from both groups at capsulectomy were smooth-walled gel-filled implants. Sixty-nine breasts in the anterior group received textured gel implants at capsulectomy; the remaining 31 received polyurethane-coated Meme implants. In the total capsulectomy group, all but two breasts (one patient) received textured gel implants. After review, the capsular status was known in 80 percent of the anterior and 92 percent of the total capsulectomy group. The review clinic found eight new contractures in five patients to have developed in the anterior compared with none in the total group. Recurrent contractures affected 50 percent of patients (46 percent of breasts) in the anterior and 11 percent of patients (10 percent of breasts) in the total capsulectomy group. Kaplan-Meier survival analysis was applied to the data. By including only patients who received textured gel implants at capsulectomy, the Logrank found a statistical difference between the two treatment groups (0.01 < p < 0.5). We believe that this study provides some evidence that total capsulectomy for subglandular silicone breast implant capsular contracture results in a lower capsular recurrence than anterior- disc capsulectomy. The pattern and risk of recurrence after total capsulectomy and exchange for a modern textured prosthesis appear to approach those following primary augmentation.
After removal of a silicone breast implant, if a capsulectomy is not performed, the residual capsule may persist, become calcified, and appear on routine mammograms. The fate of the capsule around saline implants is less clear. The purpose of this study was to determine the fate of the capsule around saline-filled implants in an animal model. Rats were implanted with 6-ml tissue expanders, which were left in place for 4 months. The implants were then removed and the capsules around the injection port (smooth surface) and tissue expander (textured surface) were examined sequentially. The capsules contracted and dissipated gradually over a year in association with a pericapsular vascular proliferation. It may not be necessary to perform a capsulectomy at the time of saline implant removal.
The authors describe a patient who presented with acute onset of a lower back fluctuant mass 12 years after breast reconstruction with a latissimus dorsi musculocutaneous flap and silicone gel implant. Aspiration and subsequent surgical exploration revealed this mass to be free-flowing silicone gel within a cavity that was confluent with the breast implant capsule through an axillary tunnel. Excision of the back cavity, explantation with subtotal capsulectomy, and implant replacement resolved the problem. Although distant migration of extracapsular silicone gel from the breast to the axilla, arm, abdomen, and groin has been described, the authors think this represents the first reported case of distant migration of silicone gel to the lower back.
Although surgical techniques and the quality of mammary prostheses have been improved significantly in recent years, capsular contracture attendant on prosthetic mammary reconstruction remains a major flaw. Although rarely, some patients are confronted with recurrent and intractable capsular contractures with resultant breast deformity, even after multiple attempts at capsulectomies and implant exchange. Patients with recurrent capsular contracture often do not want replacement with a new prosthesis, but desire the maintenance of their breast volume with a safe alternative. In an attempt to maintain breast volume and to improve the aesthetic appearance, secondary breast reconstruction using bilateral deepithelialized free flaps from the lower abdomen was performed in a series of seven patients. Three bilateral muscle-sparing TRAM flaps, two bilateral DIEP flaps, one bilateral SIEA flap, one unilateral SIEA flap, and one unilateral DIEP flap (a total number of 14 flaps) were used following implant removal, total capsulectomy, and prophylactic subcutaneous mastectomy. The early postoperative course was uneventful, and all flaps survived completely with no complications. There were no donor-site problems, except in one patient (case 5), who had partial skin necrosis of the abdominal flap. The long-term results (mean follow-up: 4.8 years) demonstrated an aesthetically satisfactory appearance of the breasts, with no major donor-site problems. Several advantages, as well as drawbacks, are highlighted with this technique.
We describe a technique in which the breast implant capsule is used to fill localized depressions in the breast, including those under the nipple-areola complex. Capsules have been reported to persist long-term and their high vascularity renders them suitable for use as flaps.
A recent wave of adverse publicity regarding silicone breast implants has led increasing numbers of women to undergo removal of their implants. In this pictorial essay, we present the spectrum of mammographic findings after implant removal. These range from a nearly normal appearance to architectural distortion and even residual spiculated silicone granulomas that may simulate malignant tumors. Our examples emphasize that comparison with previous mammograms and a detailed surgical history are essential if unnecessary investigations of postsurgical and residual benign abnormalities are to be avoided.
A technique of capsular stripping, removing a gel implant, and inserting an inflatable implant in front of the old capsule, is described for the relief of the firm breasts which sometimes develop after an augmentation mammaplasty. This technique puts all of the old capsule behind the new implant, and it does not require excessive dissection.
Potential complications of augmentation mammaplasty with silicone gel breast implants have been the subject of much recent debate in the medical and lay communities. Some women have undergone implant removal, and others may follow. The mammographic appearance following submammary implant removal in four women and the histologic appearance in one case are described. Bilateral symmetric soft-tissue masses posterior to the glandular tissue with accompanying calcifications should suggest the diagnosis. The radiologist should be familiar with the mammographic appearance following implant removal. Such knowledge may prevent unnecessary concern and unwarranted biopsy.
A report is presented of a patient who developed a giant cyst in the fibrous pseudosheath after removal of a silicone breast prosthesis. Emphasis is put on the histological features of the capsule which differentiate it from other cystic breast conditions and also preclude its spontaneous resolution. These features are capsular thickness, epidermal lining, calcification and chronic lymphocytic reaction.
Fibroblasts of human granulation tissues develop structural and functional features typical of smooth muscle cells:1.They contain massive bundles of intracytoplasmic microfilaments.2.Their cytoplasm shows immunofluorescent labeling with human antismooth muscle serum.3.The nuclei have multiple indentations and deep folds, indicative of contraction.4.There are cell-to-cell and cell-to-stroma connections whereby cellular contraction could be transmitted to the tissue as a whole.5.Strips of granulation tissue, when tested pharmacologically in vitro, contract or relax similarly to smooth muscle.It is proposed that these modified fibroblasts, or “myofibroblasts,” are responsible for the contraction of granulation tissue, a process useful in closing wounds though potentially harmful in other situations.
In guinea pigs the formation of a pseudosheath around an implanted silicone block was demonstrated within 8 days. This sheath developed its own blood supply and, in some cases, it contained demonstrable nerve fibers. Once the silicone was removed, the resolution of the sheath began. It was rapid and became complete in two weeks. This 3 phase experiment has demonstrated the formation and resolution of a pseudosheath pocket around silicone implants. The findings suggest that if free autogenous grafts were inserted into these pockets, they would gain a new blood supply.