Severe capsular contracture in a patient with a history of multiple malignancies - Hematoma or neoplasm recurrence?: A case report.

RATIONALE: Complications associated with breast implants pose a significant obstacle to improving the quality of life for patients undergoing implant-based breast reconstruction. Due to the intricate nature of their presentation, diagnosis often becomes challenging and perplexing. Herein, we present a case report detailing the diagnostic and therapeutic processes employed in managing implant-related complications in a patient with multiple malignancies who underwent immediate breast reconstruction following mastectomy. PATENT CONCERNS: The patient, a 48-year-old woman, presented with severe pain and hardening in her left breast. She had previously undergone nipple-sparing mastectomy followed by immediate implant-based breast reconstruction 3 years ago. DIAGNOSES: Upon admission, we suspected a simple diagnosis of capsular contracture. However, upon investigation, she had a medical history of colon cancer, breast cancer, and acute B-lymphoblastic leukemia. Furthermore, she recently experienced nipple hemorrhage. INTERVENTIONS: Considering her clinical manifestations, we postulated the possibility of tumor recurrence along with potential presence of breast implant-associated anaplastic large cell lymphoma. The situation took a new turn, as diagnostic imaging techniques including breast MRI, and ultrasound revealed indications of potential prosthesis rupture and periprosthetic infection. OUTCOMES: Ultimately, en bloc capsulectomy with implant removal was performed, revealing no evidence of implant rupture or infection but rather indicating delayed hematoma formation. LESSONS: An accurate diagnosis of complications associated with breast prosthesis reconstruction is crucial for effective treatment. The examination and treatment processes employed in this case offer valuable insights toward achieving a more precise diagnosis of prosthesis-related complications, particularly in patients with complex medical histories.

Outcomes in Subfascial Versus Subglandular Planes in Breast Augmentation: A Systematic Review and Meta-analysis.

Breast augmentation is the most commonly performed aesthetic surgery procedure in women worldwide. The use of the subfascial plane has been suggested to decrease the incidence of capsular contracture compared with the subglandular plane, while simultaneously avoiding the complication of animation deformity in the subpectoral plane. The aim of this systematic review and meta-analysis was to compare the adverse outcomes of subfascial vs subglandular planes in breast augmentation. This review was registered a priori on OSF (https://osf.io/pm92e/). A search from inception to June 2023 was performed on MEDLINE, Embase, and CENTRAL. A hand search was also performed. All randomized and comparative cohort studies that assessed the use of the subfascial plane for breast augmentation were included. Outcomes evaluated included the incidences of seroma, hematoma, infection, rippling, capsular contracture, and revision surgery. Ten studies were included in this systematic review. Three randomized controlled trials and 7 comparative cohort studies were used for quantitative synthesis. There was a significant difference favoring subfascial compared with subglandular planes in the incidence of hematoma, rippling, and capsular contracture. All included studies had a high risk of bias. The current evidence suggests that the subfascial plane for breast augmentation decreases the risk of capsular contracture, hematoma, and rippling compared with the subglandular plane. Further randomized evidence with high methodological rigor is still required to validate these findings.

Impact of post-operative infection on revision procedures in breast reconstruction: A marketscan database analysis.

BACKGROUND: Esthetic complications, such as capsular contracture and soft-tissue contour defects, hinder the desired outcomes of breast reconstruction. As subclinical infection is a prevailing theory behind capsular contracture, we investigated the effects of post-operative infections on these issues and revision procedures. METHODS: We conducted a retrospective database study (2007-2021) on breast reconstruction patients from the MarketScan® Databases. Esthetic complications were defined by their associated revision procedures and queried via CPT codes. Severe capsular contracture (Grade 3-4) was defined as requiring capsulotomy or capsulectomy with implant removal or replacement. Moderate and severe soft-tissue defects were determined by the need for fat grafting or breast revision, respectively. Generalized linear models were used, adjusting for comorbidities and surgical factors (p < 0.05). RESULTS: We analyzed the data on 62,510 eligible patients. Post-operative infections increased the odds of capsulotomy (OR 1.59, p < 0.001) and capsulectomy (OR 2.30, p < 0.001). They also raised the odds of breast revision for severe soft-tissue defects (OR 1.21, p < 0.001). There was no significant association between infections and fat grafting for moderate defects. Patients who had post-operative infections were also more likely to experience another infection after fat grafting (OR 3.39, p = 0.0018). In two-stage reconstruction, infection after tissue expander placement was associated with greater odds of infection after implant placement. CONCLUSION: Post-operative infections increase the likelihood of developing severe soft-tissue defects and capsular contracture requiring surgical revision. Our data reinforce the role of infections in the pathophysiology of capsular contracture. Additionally, infections elevate the risk of subsequent infections after fat grafting for moderate defects, further increasing patient morbidity.

Selective Capsulotomies and Partial Capsulectomy in Implant-Based Breast Reconstruction Revision Surgery.

Background: Breast cancer with about 2.3 million diagnoses and 685,000 deaths globally is the most frequent malignancy in the female population. Continuous research has led to oncological and reconstructive advances in the management of breast cancer, thus improving outcomes and decreasing patient morbidity. Nowadays, the submuscular expander and prosthesis (E/P) implant-based breast reconstruction (IBR) accounts for 73% of all reconstructions. Despite its widely accepted efficacy, the technique is not free from complications and up to 28% of cases require revision surgery for mechanical complications such as capsular contracture, implant displacement/rotation, and implant rupture. With this study, the authors report their experience in the management of E/P IBR revision surgery through the technique of Selective Capsulotomies (SCs) and Partial Capsulectomy (PC). Methods: A retrospective study was conducted on patients who had previously undergone E/P IBR and presented for revision reconstruction between January 2013 and May 2023 at the Department of Plastic Surgery of the University of Siena, Italy. Reasons for revision included capsular contracture, implant displacement/rotation, and implant rupture. Revision reconstructions involved SC and PC with implant replacement. Fat grafting was also considered. The complication rate was evaluated by analysis of patients' medical records. Patients' satisfaction with the treatment was assessed through a specific questionnaire. Results: 32 patients underwent revision surgeries. No early complication occurred. Recurrence rate was assessed at 19% with average follow-up of 59 months (range: 13-114 months). The average time between revision surgery and recurrence was 3 years (range: 1-6 years). 23 patients answered the questionnaire and were overall satisfied with the treatments (8.29/10). Conclusions: SC possibly associated to PC is a valuable option for E/P IBR revision surgery with minimal complications, reduced surgical trauma, short operating time, and relatively low recurrence risk. In addition, treated patients are overall satisfied with the results over time.

Development and Validation of a Diagnostic Histopathological Scoring System for Capsular Contracture Based on 720 Breast Implant Capsules.

BACKGROUND: Capsular contracture is traditionally evaluated with the Baker classification, but this has notable limitations regarding reproducibility and objectivity. OBJECTIVES: The aim of this study was to develop and validate procedure-specific histopathological scoring systems to assess capsular contracture severity. METHODS: Biopsies of breast implant capsules were used to develop histopathological scoring systems for patients following breast augmentation and breast reconstruction. Ten histological parameters were evaluated by multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (P < .05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was assessed from the area under the curve (AUC) and the mean absolute error (MAE). RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system, namely, collagen layer thickness, fiber organization, inflammatory infiltration, and calcification, providing a combined maximum score of 26. The AUC and MAE for the augmentation scoring system were 81% and 0.8%, which is considered strong. Three parameters were selected for the reconstruction scoring system, namely, fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system were 72% and 7.1%, which is considered good. CONCLUSIONS: The new histopathological scoring systems provide an objective, reproducible, and accurate assessment of capsular contracture severity. We propose these novel scoring systems as a valuable tool for confirming capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.

Long-term Insights: Histopathological Assessment of Polyurethane Implant Capsules Over 24 Years.

BACKGROUND: Polyurethane (PU)-coated breast implants are known for their strong integration into breast tissue and the formation of capsules around them. However, capsular contracture can pose both aesthetic and clinical challenges. OBJECTIVES: The objectives of this study were to analyze the biological and morphological characteristics of the capsular tissue surrounding PU-coated implants, irrespective of their contracture status, and to assess their potential suitability as a flap in revisional breast surgery for capsular contracture. METHODS: A total of 23 tissue samples were harvested from the capsules surrounding PU-coated breast implants in 12 female patients during replacement or revisional surgery. We evaluated collagen abundance, cellular and vascular density, inflammation, collagen band types and alignment, synovial metaplasia, capsule thickness, and the expression of inflammatory biomarkers and myofibroblasts with immunohistochemical techniques. Scanning electron microscopy was employed to assess implant surface characteristics over time. RESULTS: We found a significant association of capsule contraction with longer implantation durations and greater implant surface roughness (P = .018 and P = .033, respectively). Synovial metaplasia was significantly more frequent in noncontracted capsules (P = .0049). Both capsule types consisted of paucicellular, type I collagen-rich compact fibrous tissue with low vascularization. There was a marked reduction in inflammatory cells within the foreign body granuloma. The expression of inflammatory biomarkers in the capsular tissue was negligible. CONCLUSIONS: Given the reduced levels of inflammatory and vascular components within the dense, fibrous capsular tissue, we consider them to be viable alternatives for capsular flaps in revisional surgery. This strategy has the potential to mimic the reconstruction achieved with acellular dermal matrix.

Comparison of POLYTECH MESMO and Motiva Ergonomix Breast Implants With Focus on Displacement Issues: A Single Surgeon's Experience with 329 Patients.

BACKGROUND: Nanotextured breast implants (classified as smooth implants by the latest ISO 14607:2018) have been described as possibly reducing major textured implant-related complications such as capsular contracture and breast implant-associated anaplastic large cell lymphoma. On the other hand, microtextured breast implants benefit from an optimal safety profile based on a much larger body of literature. OBJECTIVES: The aim of this study was to directly compare the incidence of complications between Motiva Ergonomix (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) and POLYTECH MESMO (POLYTECH Health & Aesthetics GmbH, Dieburg, Germany) breast implants, especially regarding the displacement issues that might arise after breast augmentation. METHODS: Consecutive patients who previously underwent surgery by the same physician for placement of Motiva Ergonomix and POLYTECH MESMO implants were included in this study. They were divided into 2 groups according to the type of implant. The onset of complications was assessed through survival analysis. RESULTS: Data were collected from 329 patients, 185 (56.2%) with POLYTECH MESMO and 144 (43.8%) with Motiva Ergonomix implants. The median follow-up was 8 months for both groups. Of the 42 women (12.8%) who experienced at least one complication, 26 belonged to the Motiva Ergonomix subgroup (P = .013). The most represented complications during this period resulted from displacement issues, with a clear prevalence of bottoming out in the Motiva Ergonomix cohort: 15 cases vs 0 cases in the POLYTECH MESMO cohort (P < .001). For 7 patients, a reoperation was required, more frequently for patients with Motiva Ergonomix implants (4.2% vs 0.5%; P = .046). CONCLUSIONS: POLYTECH MESMO devices provided a more favorable outcome. Motiva Ergonomix devices revealed a concerning incidence of displacement issues during the first postsurgery years, with no advantage over other major complications.

Polyurethane Implants in Revisional Breast Augmentation: A Prospective 5-Year Study.

BACKGROUND: Revisional surgery for aesthetic breast augmentation remains a challenging procedure. Polyurethane (PU) implants have been found to avoid capsular contracture recurrence as well as to prevent implant displacement by bio-integrating with the pocket. OBJECTIVES: Our study aimed to assess the use of PU implants in breast revisional surgery and to provide an algorithm. METHODS: Over a 5-year period, a prospective study was conducted involving consecutive patients undergoing implant revision. Patient demographics, previous breast procedures, and specific surgical details were documented. Postoperative outcomes were followed up. RESULTS: Out of 92 patients (184 breasts), 78 (156 breasts) were included in the analysis. The average age was 47.5, with a BMI of 22.3 and a mean follow-up of 5 years. A majority (63%) represented secondary revisional cases, while 37% were tertiary cases. Implant size averaged 296 cc, with 53% placed in retropectoral position and 47% prepectoral. Significantly more implants in secondary cases were changed from prepectoral to retropectoral (P = .005), and in tertiary changed from retropectoral to prepectoral (P = .002). Complete capsulectomy was performed in 61.5% and partial in 25.6%. Additional lipofilling was performed in 32%, and concurrent mastopexy in 40%. Revisional surgery in our series had a 1.9% acute complication rate, 4.5% longer-term reoperation rate for corrections, 0.6% implant exchange rate, and no recurrent capsular contracture. CONCLUSIONS: This is the first study to provide data on outcomes of revisional breast augmentation surgery with PU implants. It shows that polyurethane implants offer consistent stability and have low rates of recurrent capsular contracture in revisional surgery.

Efficacy of antibiotic prophylaxis for reducing capsular contracture in prosthesis-based breast surgery: a systemic review and meta-analysis.

Antibiotics Prophylaxis to prevent capsular contracture in prosthesis-based breast surgery is common in clinical practice. However, there is currently a dearth of high-quality evidence concerning the effectiveness of antibiotic usage in this field. To identify all pertinent studies prior to January 2023, a comprehensive literature search was conducted in the PubMed, Embase, Web of Science, Cochrane Library, and Medline databases. The extracted data was then subjected to meta-analysis. Fourteen studies were retained in the analysis. According to the results, perioperative antibiotic prophylaxis did not reduce the risk of capsular contracture (RR 1.15, 95% CI 0.82-1.59, p = 0.55) or surgical-site infection (RD 0.01, 95% CI - 0.01 to 0.03, p = 0.59) compared to nonantibiotic prophylaxis. There was no statistically significant difference between extended antibiotic prophylaxis and perioperative antibiotic prophylaxis in terms of preventing capsular contracture, whether calculated by patient numbers (RD 0.01, 95% CI - 0.01 to 0.02, p = 0.87) or by total procedures (RD 0.00, 95% CI - 0.00 to 0.01, p = 0.88), or controlling surgical-site infection (RR 1.05, 95% CI 0.77-1.44, p = 0.27). Additionally, topical antibiotic irrigation did not decrease the risk of infection (RR 0.61, 95% CI 0.34-1.08, p = 0.29) and capsular contracture, regardless of patient number (RR 0.41, 95% CI 0.27-0.63, p = 0.18) or total number of procedures (RR 1.29, 95% CI 0.73-2.28, p < 0.01). Current evidence revealed that both systemic and topical antibiotic prophylaxis may not provide benefits in preventing capsular contracture in prosthesis-based breast surgery. When the occurrence of surgical-site infections is minimized to the greatest extent, the administration of additional antibiotics for reducing capsular contracture should be carefully and judiciously considered.

The Effect of 3-Dimensional-Printed Sequential Dual Drug-Releasing Patch on the Capsule Formation Around the Silicone Implant in a Rat Model.

BACKGROUND: Implant-based breast reconstruction is associated with increased risk of early infection and late-stage capsular contracture. OBJECTIVES: We evaluated the feasibility of a dual drug-releasing patch that enabled the controlled delivery of antibiotics and immunosuppressants in a temporally and spatially appropriate manner to the implant site. METHODS: The efficacy of a dual drug-releasing patch, which was 3-dimensional-printed (3D-printed) with tissue-derived biomaterial ink, was evaluated in rats with silicone implants. The groups included implant only (n = 10); implant plus bacterial inoculation (n = 14); implant, bacterial inoculation, and patch loaded with gentamycin placed on the ventral side of the implant (n = 10), and implant, bacterial inoculation, and patch loaded with gentamycin and triamcinolone acetonide (n = 9). Histologic and immunohistochemical analyses were performed 8 weeks after implantation. RESULTS: The 2 drugs were sequentially released from the dual drug-releasing patch and exhibited different release profiles. Compared to the animals with bacterial inoculation, those with the antibiotic-only and the dual drug-releasing patch exhibited thinner capsules and lower myofibroblast activity and inflammation, indicating better tissue integration and less foreign body response. These effects were more pronounced with the dual drug-releasing patch than with the antibiotic-only patch. CONCLUSIONS: The 3D-printed dual drug-releasing patch effectively reduced inflammation and capsule formation in a rat model of silicone breast reconstruction. The beneficial effect of the dual drug-releasing patch was better than that of the antibiotic-only patch, indicating its therapeutic potential as a novel approach to preventing capsular contracture while reducing concerns of systemic side effects.

Microbiologic Profile of Nipple Swab Culture and its Association With Postoperative Complications in Prosthetic Breast Reconstruction.

BACKGROUND: In breast surgeries, a lactiferous duct leading to lactic glands of breast parenchyma allows direct contamination by normal bacterial flora of the nipple-areola complex. Complete blockage of nipple flora from the intraoperative field is almost impossible. OBJECTIVES: We aimed to analyze the microbiological profile of nipple flora of breast cancer patients who underwent an implant-based immediate breast reconstruction after a total mastectomy, and to evaluate the association of nipple bacterial flora with postoperative complications. METHODS: A retrospective chart review was performed of patients who underwent an implant-based immediate breast reconstruction after a total mastectomy. A nipple swab culture was performed preoperatively. Patient demographics, surgical characteristics, and complications were compared between positive and negative nipple swab culture groups. Microbiological profile data including antibacterial resistance were collected. RESULTS: Among 128 breasts, 60 cases (46.9%) had positive preoperative nipple swab culture results. Staphylococcus epidermidis accounted for 41.4% of microorganisms isolated. A multivariate logistic regression analysis of postoperative complications revealed that the presence of nipple bacterial flora was a risk factor for capsular contracture. Seven cases of postoperative infection were analyzed. In 2 cases (40% of pathogen-proven infection), the causative pathogen matched the patient's nipple bacterial flora, which was methicillin-resistant S. epidermidis in both cases. CONCLUSIONS: Nipple bacterial flora was associated with an increased risk of capsular contracture. Preoperative analysis of nipple bacterial flora can be an informative source for treating clinically diagnosed postoperative infections. More studies are needed to determine the effectiveness of active antibiotic decolonization of the nipple.

Systematic Review of Capsular Contracture Management following Breast Augmentation: An Update.

BACKGROUND: Capsular contracture is one of the most frequent indications for revision following breast augmentation. Management goals focus on restoring breast aesthetics and minimizing subsequent recurrence of capsular contracture. As new data emerge, close review of the data are merited to build evidence-based clinical guidelines to inform surgical practice and management of capsular contracture. METHODS: A systematic review of the MEDLINE, Embase, and Cochrane Database of Systematic Reviews databases was conducted to characterize the surgical management of capsular contracture in revision breast augmentations. The primary endpoint was capsular contracture recurrence rate. RESULTS: The review was conducted in November of 2021. Primary search revealed 14,163 results. Initial screening by title left 1223 articles. Abstract review left 90 articles for full-text review, of which 34 were ultimately included and were all observational in nature. CONCLUSIONS: Capsular contracture management remains an important topic, with limited high-level evidence for establishing clear evidence-based treatment guidelines. Although more evidence is required to assess the effects of capsulectomy, implant exchange, and plane change, these appear to be useful mechanisms for reducing recurrent capsular contracture. There is more evidence regarding the use of acellular dermal matrix, although this still requires long-term follow-up studies. New developments regarding textured implants limit the revision breast augmentation surgeon to smooth devices.

Devil's Advocate: Evidence-Based Recommendation for "One Breast-One Insertion Funnel" Policy.

BACKGROUND: Rates of capsular contracture have reduced significantly since the use of insertion funnels to place breast implants became routine. However, due to financial constraints, the same funnel is usually used for implantation of both sides. OBJECTIVES: The aim of this study was to determine whether the risk of capsular contracture is higher for the second breast when the same insertion funnel is used for both breasts. METHODS: The authors collected a sample of the insertion funnel tip immediately after removing the funnel from its sterile packaging and another tip sample after the funnel had been used to insert the first implant. These samples were sent for microbiological culture evaluations. Capsular contracture rates in the first implanted breast vs the second implanted breast were then retrospectively analyzed. RESULTS: All samples taken from the funnel before the first implantation showed no bacterial growth. All 10 samples taken from the funnel after the first implantation showed organism growth (8 were positive for Staphylococcus epidermidis and 2 for Cutibacterium acnes). Retrospective analysis of the results revealed that the overall capsular contracture rate had reduced after the authors began to use insertion funnels. However, this complication was still more common on the second implanted breast. CONCLUSIONS: Surgeons should consider the use of separate insertion funnels for each breast. This might help to slightly reduce the incidence of capsular contracture.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, and Chinese (Simplified and Traditional) online here: https://doi.org/10.1093/asj/sjad288.

Contextualizing the Impact of Pop Culture on Breast Implant Illness and its Medical Relevance.

INTRODUCTION: Despite a lack of data demonstrating causation, there is growing concern over breast implants and systemic illness. This study examines the impact of rising public interest in breast implant illness (BII) and its implications on breast implant removals (BIR). METHODS: A Google Trends (GT) analysis of each year between 2010 and 2022 was performed globally, and then separately for the United States alone (US), using the search terms "capsular contracture," "breast implant illness," and "breast implant(s) removal". Linear regression was performed to determine significant correlations. Data on BII-related Facebook advocacy groups, relevant pop culture events, numbers of BIR surgeries, and number of BII-related publications were collected and analyzed alongside GT data to determine relevance. RESULTS: For global GT, there was a significant relationship between "breast implant illness" and "breast implant(s) removal" in 2016 (R2=0.62, ß =0.33, p<0.01), 2020 (R2=0.53, ß =0.23, p=0.01), and 2022 (R2=0.60, ß =0.44, p=0.01). In the US, 2016 (R2=0.53, ß =1.75, p=0.01) 2018 (R2=0.61, ß =1.93, p<0.01) and 2020 (R2=0.72, ß=0.91, p<0.01) were significant. In 2020, "capsular contracture" and "breast implant(s) removal" was significant in the US (R2=0.58, ß=0.4, p=0.01). In 2016, Facebook was the platform for the largest BII advocacy group and in 2020 YouTube was the platform for the first BII documentary and TEDx talk. From 2010 to 2020, PubMed publications containing "ASIA" and "BII" increased 24-fold and ASPS reports on BIR rose 70%. CONCLUSION: This study suggests that BII is a topic of global concern and has implications on both academic medicine and clinical practice. LEVEL OF EVIDENCE V: 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 .

CD248 Regulates Inflammation and Encapsulation in Silicone-Related Capsule Formation.

BACKGROUND: Capsular contracture is the most common reason for having a secondary breast implant operation. The failure of the implanted device and discomfort are related to foreign body response, which involves a pathologic encapsulation. An up-regulated expression of CD248 was previously demonstrated to modulate inflammation and fibrosis. The authors hypothesized that CD248 contributes to foreign body reaction and contracture during silicone-stimulated capsule formation. METHODS: A murine capsular contracture model was established to correlate CD248 with capsular contracture. The timing and site of CD248 expression were characterized by protein analysis and histologic examination. The capsules between wild-type mice and CD248 knockout mice were compared in this model to verify the possible role of CD248 in silicone-related capsule formation. RESULTS: CD248 was expressed in the peri-silicone implant capsule by stromal fibroblast and perivascular fibroblast. CD248 was overexpressed on day 4 and down to a constant level, but it was still up-regulated through day 21 to day 56 after silicone implantation. The CD248 knockout mice showed a prolonged inflammation period, whereas the wild-type mice developed a thinner but more collagenous capsule. CONCLUSIONS: In conclusion, an effective murine capsular contracture model was established to study the relationship between CD248 and capsular contracture. CD248 may play a role in inflammation and encapsulation during silicone implantation. CD248 deletion in mice contributed to a loose and irregular collagen bundle in a capsule area, implying a decrease in contracture. Therefore, CD248 could be a potential therapeutic target in capsular contracture. CLINICAL RELEVANCE STATEMENT: CD248 may play a role in inflammation and encapsulation during silicone implantation. It could be a potential therapeutic target in clinical capsular contracture.

Toward a Consensus Aproach for Assessing Capsular Contracture Severity and Progression: A Systematic Review.

BACKGROUND: Breast implants are the most commonly used medical devices in plastic surgery, and capsular contracture (CC) is one of the most common complications. However, our assessment of CC is based largely on Baker grade, which is problematically subjective and affords only four possible values. METHODS: The authors performed a systematic review concluding in September of 2021 in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. It identified 19 articles that propose approaches to measuring CC. RESULTS: In addition to Baker grade, the authors identified several modalities reported to measure CC. These included magnetic resonance imaging, ultrasonography, sonoelastography, mammacompliance measuring devices, applanation tonometry, histologic evaluation, and serology. Capsule thickness and other measures of CC inconsistently correlated with Baker grade, whereas the presence of synovial metaplasia was consistently associated with Baker grade I and II, but not III and IV capsules. CONCLUSIONS: There remains no particular method to reliably and specifically measure the contracture of capsules that form around breast implants. As such, we would recommend that research investigators use more than one modality to measure CC. Other variables that can impact breast implant stiffness and associated discomfort beyond CC need to be considered when evaluating patient outcomes. Given the value placed on CC outcomes in assessing breast implant safety, and the prevalence of breast implants overall, the need for a more reliable approach to measuring this outcome persists.

Efficacy of Acellular Dermal Matrix Type in Treatment of Capsular Contracture in Breast Augmentation: A Systematic Review and Meta-Analysis.

BACKGROUND: Capsular contracture is a known complication of breast augmentation and is among the top reasons for revisional breast augmentation procedures. The use of acellular dermal matrix (ADM) has been shown to reduce the rate of capsular contracture in breast reconstruction and augmentation, theorizing that it acts as a protective barrier between the implant capsule and inflammatory process responsible for capsular contracture. The role of ADM in treatment of capsular contracture has been investigated in numerous studies, with a variety of ADMs. OBJECTIVES: The aim of this study was to perform a systematic review of existing literature on the use of ADM for treatment of capsular contracture in aesthetic breast augmentation patients to investigate differences in efficacy of ADM types. METHODS: The PubMed, Embase, and CINAHL databases were systematically reviewed for articles pertaining to capsular contracture, acellular dermal matrices, and breast augmentation. Number of patients, type of ADM, Baker grade, follow-up time, complication rate, and capsular contracture rate were recorded from identified articles. Data was pooled from studies to calculate a capsular contracture rate for each ADM type, with a chi-squared test performed for analysis. Identified studies with a comparative group were included in a meta-analysis utilizing risk ratio (RR) to assess the efficacy of ADM. RESULTS: Nine articles including ADM for treatment of capsular contracture in breast augmentation met criteria for inclusion, with a total of 481 breasts. Strattice was the most commonly utilized ADM (n = 391), followed by AlloDerm (n = 57). There was a statistically significant difference in efficacy of ADM among the studied ADM types (P < .001). AlloDerm, FlexHD, and DermaMatrix had the lowest capsular contracture rates (0%). NeoForm and SurgiMend had the highest capsular contracture rates (each 25%, but with n = 4 and n = 8, respectively). Strattice had a capsular contracture rate of 1.53% in the pooled data, and meta-analysis showed that Strattice reduced the risk of capsular contracture (RR 0.14 [95% CI 0.06, 0.31]) compared with conventional treatment. CONCLUSIONS: Acellular dermal matrices appear to be effective at treating capsular contracture after breast augmentation while maintaining a low complication rate. Overall capsular contracture rates are low with the use of ADM. There is a statistically significant difference in efficacy among ADM types. Meta-analysis shows that Strattice is effective at reducing the risk of capsular contracture in breast augmentation patients when compared to conventional treatment. Future research, especially in the form of randomized controlled trials, is needed to further investigate the efficacy of various ADMs in the treatment of capsular contracture.

Reducing Peri-implant Capsule Thickness in Submuscular Rodent Model of Breast Reconstruction With Delayed Radiotherapy.

INTRODUCTION: Capsular contracture remains the most common complication following device-based breast reconstruction, occurring in up to 50% of women who also undergo adjuvant radiotherapy either before or after device-based reconstruction. While certain risk factors for capsular contracture have been identified, there remains no clinically effective method of prevention. The purpose of the present study is to determine the effect of coating the implant with the novel small molecule Met-Z2-Y12, with and without delayed, targeted radiotherapy, on capsule thickness and morphologic change around smooth silicone implants placed under the latissimus dorsi in a rodent model. METHODS: Twenty-four female Sprague Dawley rats each had 2 mL smooth round silicone breast implants implanted bilaterally under the latissimus dorsi muscle. Twelve received uncoated implants and twelve received implants coated with Met-Z2-Y12. Half of the animals from each group received targeted radiotherapy (20 Gray) on postoperative day ten. At three and 6 months after implantation, the tissue surrounding the implants was harvested for analysis of capsular histology including capsule thickness. Additionally, microCT scans were qualitatively analyzed for morphologic change. RESULTS: Capsules surrounding Met-Z2-Y12-coated implants were significantly thinner (P = 0.006). The greatest difference in capsule thickness was seen in the irradiated 6-month groups, where mean capsule thickness was 79.1 ± 27.3 µm for uncoated versus 50.9 ± 9.6 µm for Met-Z2-Y12-coated implants (P = 0.038). At the time of explant, there were no capsular morphologic differences between the groups either grossly or per microCT. CONCLUSIONS: Met-Z2-Y12 coating of smooth silicone breast implants significantly reduces capsule thickness in a rodent model of submuscular breast reconstruction with delayed radiotherapy.