Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation.
TL;DR: Evidence is provided that submuscular placement and textured implants, in addition to other factors, are significant in reducing the incidence of capsular contracture in primary augmentation patients.
Abstract: Background:Although there are a few broadly agreed on contributory factors, the multifaceted causes of capsular contracture have remained unresolved for decades. This study investigates a variety of potential risk factors that contribute to capsular contracture in primary augmentation patients.Metho
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TL;DR: Treatment requires a combination of surgery and a prolonged antibiotic treatment regimen to successfully eliminate the remaining bacteria, and most authors suggest a course of 3 to 6 months of antibiotic treatment, including 2 to 6 weeks of intravenous treatment with a beta-lactam.
Abstract: Propionibacterium acnes is known primarily as a skin commensal. However, it can present as an opportunistic pathogen via bacterial seeding to cause invasive infections such as implant-associated infections. These infections have gained more attention due to improved diagnostic procedures, such as sonication of explanted foreign materials and prolonged cultivation time of up to 14 days for periprosthetic biopsy specimens, and improved molecular methods, such as broad-range 16S rRNA gene PCR. Implant-associated infections caused by P. acnes are most often described for shoulder prosthetic joint infections as well as cerebrovascular shunt infections, fibrosis of breast implants, and infections of cardiovascular devices. P. acnes causes disease through a number of virulence factors, such as biofilm formation. P. acnes is highly susceptible to a wide range of antibiotics, including beta-lactams, quinolones, clindamycin, and rifampin, although resistance to clindamycin is increasing. Treatment requires a combination of surgery and a prolonged antibiotic treatment regimen to successfully eliminate the remaining bacteria. Most authors suggest a course of 3 to 6 months of antibiotic treatment, including 2 to 6 weeks of intravenous treatment with a beta-lactam. While recently reported data showed a good efficacy of rifampin against P. acnes biofilms, prospective, randomized, controlled studies are needed to confirm evidence for combination treatment with rifampin, as has been performed for staphylococcal implant-associated infections.
448 citations
TL;DR: The incidence of contracture developing is lower with the use of textured implants, submuscular placement and theUse of polyurethane coated implants, while recent research has focussed on preventing capsular contracture from occurring, or treating it with autologous fat transfer.
Abstract: Capsular contracture is the most common complication following implant based breast surgery and is one of the most common reasons for reoperation. Therefore, it is important to try and understand why this happens, and what can be done to reduce its incidence. A literature search using the MEDLINE database was conducted including search terms 'capsular contracture breast augmentation', 'capsular contracture pathogenesis', 'capsular contracture incidence', and 'capsular contracture management', which yielded 82 results which met inclusion criteria. Capsular contracture is caused by an excessive fibrotic reaction to a foreign body (the implant) and has an overall incidence of 10.6%. Risk factors that were identified included the use of smooth (vs. textured) implants, a subglandular (vs. submuscular) placement, use of a silicone (vs. saline) filled implant and previous radiotherapy to the breast. The standard management of capsular contracture is surgical via a capsulectomy or capsulotomy. Medical treatment using the off-label leukotriene receptor antagonist Zafirlukast has been reported to reduce severity and help prevent capsular contracture from forming, as has the use of acellular dermal matrices, botox and neopocket formation. However, nearly all therapeutic approaches are associated with a significant rate of recurrence. Capsular contracture is a multifactorial fibrotic process the precise cause of which is still unknown. The incidence of contracture developing is lower with the use of textured implants, submuscular placement and the use of polyurethane coated implants. Symptomatic capsular contracture is usually managed surgically, however recent research has focussed on preventing capsular contracture from occurring, or treating it with autologous fat transfer.
224 citations
Cites background or result from "Risk factor analysis for capsular c..."
...It is commonly accepted that a submuscular placement, where the implant is placed behind the pectoralis major muscle, leads to a lower inci dence of capsular contracture than when the implant is placed just under the skin, in a subglandular placement subglandular [14,49,57]....
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...This finding was supported by a recent risk analysis, which concluded that smooth implants resulted in increased odds of capsular contracture [49]....
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TL;DR: In this article, the authors analyzed the long-term safety and efficacy outcomes of patients with breast implants and found that despite the number of patients having breast implants followed by United States Food and Drug Administration (US FDA).
Abstract: Objective:To analyze the long-term safety and efficacy outcomes of patients with breast implants.Summary Background Data:Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration la
192 citations
TL;DR: Prepectoral implant placement and complete coverage with porcine acellular dermal matrix (ADM) represents a novel approach and a feasible alternative to subpectoral implants placement after NSM and implant-based breast reconstruction for patients who prefer their PMM to be left intact.
Abstract: Summary Background Nipple-sparing mastectomy (NSM) and implant-based breast reconstruction are increasingly replacing conventional mastectomy for risk-reducing purposes in high-risk patients as well as for therapeutic purposes in breast cancer patients. For implant-based breast reconstruction, generally, subpectoral implant placement with partial detachment of the pectoralis major muscle (PMM) is recommended. The advantage of a potentially better cosmetic result has to be balanced with the disadvantages, such as partial injury of the PMM with subsequent muscular deficit, breast animation, and postoperative pain. We hypothesize that prepectoral implant placement and complete coverage with a porcine acellular dermal matrix (ADM) may provide an alternative to subpectoral implant placement with an excellent cosmetic result, avoiding the disadvantages of subpectoral implant placement. Methods In a total of 22 breasts in 13 patients (nine bilateral and four unilateral), NSM and immediate direct-to-implant breast reconstruction were performed with prepectoral implant placement. The implant was completely covered by a porcine ADM, which was sutured to the fascia of the PMM and the inframammary fold to keep the implant in place. Results The cosmetic results were excellent and patients were fully satisfied at a median follow-up of 6 months. Breast animation and implant dislocation could not be observed. Implant rims were not visible, and capsular contractures grade III and IV could not be observed. The complications comprised minimal nipple necrosis in two patients and hemorrhage with evacuation in one patient. Conclusion Prepectoral implant placement and complete coverage with porcine ADM represents a novel approach and a feasible alternative to subpectoral implant placement after NSM and implant-based breast reconstruction for patients who prefer their PMM to be left intact.
185 citations
TL;DR: Although many barriers stand in the way of calculating accurate estimates of the incidence and risk of developing BIA-ALCL, steady progress, international registries, and collegiality between research teams are for the first time allowing early estimates.
Abstract: Background:With breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) now accepted as a unique (iatrogenic) subtype of ALCL directly associated with textured breast implants, we are now at a point where a sound epidemiologic profile and risk estimate are required. The aim of this artic
166 citations
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TL;DR: This work proposes a modification to AIC, where the likelihood is replaced by the quasi-likelihood and a proper adjustment is made for the penalty term.
Abstract: Correlated response data are common in biomedical studies. Regression analysis based on the generalized estimating equations (GEE) is an increasingly important method for such data. However, there seem to be few model-selection criteria available in GEE. The well-known Akaike Information Criterion (AIC) cannot be directly applied since AIC is based on maximum likelihood estimation while GEE is nonlikelihood based. We propose a modification to AIC, where the likelihood is replaced by the quasi-likelihood and a proper adjustment is made for the penalty term. Its performance is investigated through simulation studies. For illustration, the method is applied to a real data set.
2,233 citations
TL;DR: Breast implants are associated with a significant rate of local complications and reoperation, and there are marked differences in outcomes as a function of implant surface type and surgical indication.
Abstract: Background:Breast implants have been used worldwide for more than 40 years. Despite extensive clinical experience, there is continued concern about the safety of these devices. The purpose of this study was to compare the efficacy, complication rates, frequency of reoperation, and degree of patient
434 citations
TL;DR: The results of this meta-analysis demonstrate the superiority of textured over smooth breast implants in decreasing the rate of capsular contracture.
Abstract: Background:Capsular contracture is a common complication associated with the use of breast implants. Numerous randomized controlled trials addressing the efficacy of textured surface breast implants in reducing capsular contracture have yielded nonuniform results. This meta-analysis addresses the us
311 citations
TL;DR: It is suggested that implant texturization reduces the incidence of early capsular contracture in subglandular breast augmentation and is one (albeit a very important factor) of many facets in patient overall satisfaction.
Abstract: Background:There are conflicting recommendations in the literature regarding the use of textured implants to reduce capsular contracture in subglandular breast augmentation. The authors reviewed the literature to evaluate the effectiveness of surface texturization in reducing capsular contracture.Me
280 citations
TL;DR: Triple antibiotic breast irrigation is clinically associated with a low incidence of capsular contracture compared with other published reports, and its clinical efficacy supports previously published in vitro studies.
Abstract: BACKGROUND Capsular contracture remains one of the most commonly reported complications in aesthetic and reconstructive breast patients. Previous in vitro studies from the authors' laboratory have recommended a new triple antibiotic povidone-iodine irrigation (2000) and subsequently a triple antibiotic non-povidone-iodine-containing irrigant (2001) to optimize broad-spectrum coverage of various bacteria implicated in capsular contracture; however, the clinical efficacy of these in vitro studies remains unproven. The purpose of this study was to determine the clinical efficacy for the previously reported triple antibiotic breast irrigation. The cost-effectiveness of universal application of irrigation solutions in breast prosthesis surgery was analyzed as well. METHODS Patients undergoing aesthetic and reconstructive breast implant procedures were treated with a standardized operative technique, including the use of triple antibiotic breast irrigation by a single surgeon. Capsular contracture was assessed using a simplified Baker scale and graded by two independent caregivers to maximize objectivity and consistency. Additional complications were also recorded, including reoperation. Patient charges for antibiotic irrigation and reoperation for contracture were determined and compared. RESULTS A total of 335 patients operated on since 1997 were evaluated prospectively. They ranged in age from 18 to 86 years, and the mean follow-up was 14 months (range, 6 to 75 months). The rate of grade III/IV capsular contracture in the study groups was 1.8 percent for patients undergoing primary breast augmentation. Patients undergoing augmentation-mastopexy had a grade III/IV contracture rate of 0 percent. Breast reconstruction patients had a 9.5 percent rate of grade III/IV contracture. CONCLUSIONS Triple antibiotic breast irrigation is clinically associated with a low incidence of capsular contracture compared with other published reports, and its clinical efficacy supports previously published in vitro studies. Application of triple antibiotic irrigation is recommended for all aesthetic and reconstructive breast procedures and is cost effective.
279 citations