Breast Implant Illness as a Clinical Entity: A Systematic Review of the Literature.

BACKGROUND: Breast implant illness (BII) has become a contentious subject in recent years. While some studies have reported associations between breast implants and autoimmune diseases, others have failed to establish a definitive link. OBJECTIVES: The objective of this study is to provide a comprehensive, up-to-date evaluation of the literature surrounding BII, with an emphasis on identifying patient-related factors that may be associated with BII. METHODS: A systematic review was performed following PRISMA guidelines using Pubmed (MEDLINE), EMBASE, and Cochrane databases to search for relevant studies published in the last twenty years. RESULTS: Thirty-one studies were included with a total of 39,505 implant patients and mean age of 44.2 ± 9.30 years. Fifteen studies reported implant explantation status with 72.4% patients choosing to remove their implants. Among these, nine studies reported symptom improvement in 83.5% patients. Fifty-three percent of patients undergoing explantation had total capsulectomy. Twenty-eight studies documented total numbers of patients experiencing symptoms related to BII, with 31.3% patients reporting such symptoms. Among these, sixteen studies of 4,109 BII patients distinguished whether the reason for implantation was cosmetic augmentation or reconstruction. When specified, more patients experiencing BII-related symptoms received implants for "cosmetic" versus "reconstructive" reasons (Cosmetic: 3,864/4,109; 94.0% vs. Reconstruction: 245/4,109; 5.96%, p < 0.001). CONCLUSIONS: This review provides an overview of the current state of knowledge regarding BII. Our study highlights a potential relationship between BII and indication for implants (cosmetic vs. reconstructive) among other variables, offering valuable insight on factors associated with BII and directions for future research.

Minimizing Nipple-Areolar Complex Complications in Prepectoral Breast Reconstruction After Nipple-Sparing Mastectomy.

PURPOSE: Nipple-areolar complex (NAC) viability remains a significant concern following prepectoral tissue expander (TE) reconstruction after nipple-sparing mastectomy (NSM). This study assesses the impact of intraoperative TE fill on NAC necrosis and identifies strategies for mitigating this risk. METHODS: A chart review of all consecutive, prepectoral TEs placed immediately after NSM was performed between March 2017 and December 2022 at a single center. Demographics, mastectomy weight, intraoperative TE fill, and complications were extracted for all patients. Partial NAC necrosis was defined as any thickness of skin loss including part of the NAC, whereas total NAC necrosis was defined as full-thickness skin loss involving the entirety of the NAC. P < 0.05 was considered statistically significant. RESULTS: Forty-six patients (83 breasts) with an average follow-up of 22 months were included. Women were on average 46 years old, nonsmoker (98%), and nondiabetic (100%) and had a body mass index of 23 kg/m2. All reconstructions were performed immediately following prophylactic mastectomies in 49% and therapeutic mastectomies in 51% of cases. Three breasts (4%) were radiated, and 15 patients (33%) received chemotherapy. Mean mastectomy weight was 346 ± 274 g, median intraoperative TE fill was 150 ± 225 mL, and median final TE fill was 350 ± 170 mL. Partial NAC necrosis occurred in 7 breasts (8%), and there were zero instances of complete NAC necrosis. On univariate analysis, partial NAC necrosis was not associated with any patient demographic or operative characteristics, including intraoperative TE fill. In multivariable models controlling for age, body mass index, mastectomy weight, prior breast surgery, and intraoperative TE fill, partial NAC necrosis was associated with lower body mass index (odds ratio, 0.53; confidence interval [CI], 0.29-0.98; P < 0.05) and higher mastectomy weight (odds ratio, 1.1; CI, 1.01-1.20; P < 0.05). Prior breast surgery approached significance, as those breasts had a 19.4 times higher odds of partial NAC necrosis (95% CI, 0.88-427.6; P = 0.06). CONCLUSIONS: Nipple-areolar complex necrosis following prepectoral TE reconstruction is a rare but serious complication. In this study of 83 breasts, 7 (8%) developed partial NAC necrosis, and all but one were able to be salvaged.

Merit-Based Incentive Payment System: How Are Plastic Surgeons Performing?

PURPOSE: Merit-based incentive payment system (MIPS) is a payment model implemented to promote high-value care through performance-based adjustments of Medicare reimbursements. Higher scores indicate superior performance in healthcare quality, efficiency, and interoperability, which can result in financial advantages. Given the paucity of literature, we aimed to characterize plastic surgery performance in MIPS. METHOD: The Centers for Medicare and Medicaid Services (CMS) online data repository was queried for data on MIPS performance of plastic surgeons from 2019-2021. Descriptive analyses and multivariable logistic regression were conducted to identify predictors of receiving bonus payment for exceptional performance. RESULTS: Approximately 1400 surgeons were sampled in each year. The median number of Medicare beneficiaries and percent of dually eligible beneficiaries-eligible for Medicare and Medicaid-were higher in 2019 (p<0.001). Beneficiary median HCC risk score, which measures expected healthcare costs and needs based on health status, was lower in 2021 (p<0.001). The most common reporting schema was reporting as a group. Total MIPS score increased from 2019 to 2020 to 2021 (90.2 vs 96.4 vs 98.3, p<0.001), but quality score progressively decreased (98.8 vs 95.5 vs 89.90, p<0.001). Fewer physicians received positive adjustment and bonus payments in 2020 and 2021. Predictors of receiving bonus payments were reporting as an alternative payment model, practice size >24, and having 10-49% of dually eligible beneficiaries (p<0.05). CONCLUSION: Understanding performance of plastic surgeons in MIPS can guide future policy direction and ensure that high-quality care translates into improved patient outcomes across all fields and levels of social vulnerability.

Differential preferences in breast aesthetics by self-identified demographics assessed on a national survey.

There is a paucity of literature examining how preferences differ amongst various demographic groups. This study aimed to assess how perceptions of the ideal breast differ between respondents stratified by self-identified demographic factors. A cohort of 25 patients from the senior surgeon's practice presenting for breast surgery was assembled. Pre-operative anteroposterior photographs of these patients were distributed via Qualtrics (Seattle, WA) to a large sample designed to be representative of the demographics of the United States. Survey questions aimed to measure respondents' impressions of 'breast attractiveness'. Respondents were asked to rate breasts on a Likert scale. Survey responses were analysed for differences in breast aesthetic preferences by sex, gender, sexual orientation, and race. Males rated all breasts higher on the Likert scale for attractiveness than females (2.8 vs 2.5, p < 0.001). Despite this discrepancy, ratings amongst male and female respondents were highly correlated with one another (R = 0.940; p < 0.0001). Considering sexual orientation, individuals attracted to women provided significantly higher attractiveness ratings to all breasts compared to individuals attracted to men only (2.8 vs 2.5, p < 0.001). White or Caucasian individuals ascribed significantly higher breast attractiveness ratings than Asian individuals (2.7 vs 2.2, p < 0.001), but not Black or African American individuals (2.7 vs 2.4, p = 0.23). Despite these racial discrepancies in mean breast attractiveness, ratings amongst the three groups were highly correlated. In a sample representative of the United States, a difference in breast aesthetic appraisal was observed by demographic factors. These findings merit further investigation to understand these trends and observations.

Artificial Intelligence as a Triage Tool during the Perioperative Period: Pilot Study of Accuracy and Accessibility for Clinical Application.

Background: Given the dialogistic properties of ChatGPT, we hypothesized that this artificial intelligence (AI) function can be used as a self-service tool where clinical questions can be directly answered by AI. Our objective was to assess the content, accuracy, and accessibility of AI-generated content regarding common perioperative questions for reduction mammaplasty. Methods: ChatGPT (OpenAI, February Version, San Francisco, Calif.) was used to query 20 common patient concerns that arise in the perioperative period of a reduction mammaplasty. Searches were performed in duplicate for both a general term and a specific clinical question. Query outputs were analyzed both objectively and subjectively. Descriptive statistics, t tests, and chi-square tests were performed where appropriate with a predetermined level of significance of P less than 0.05. Results: From a total of 40 AI-generated outputs, mean word length was 191.8 words. Readability was at the thirteenth grade level. Regarding content, of all query outputs, 97.5% were on the appropriate topic. Medical advice was deemed to be reasonable in 100% of cases. General queries more frequently reported overarching background information, whereas specific queries more frequently reported prescriptive information (P < 0.0001). AI outputs specifically recommended following surgeon provided postoperative instructions in 82.5% of instances. Conclusions: Currently available AI tools, in their nascent form, can provide recommendations for common perioperative questions and concerns for reduction mammaplasty. With further calibration, AI interfaces may serve as a tool for fielding patient queries in the future; however, patients must always retain the ability to bypass technology and be able to contact their surgeon.

Low Cancer Occurrence Rate following Prophylactic Nipple-Sparing Mastectomy.

BACKGROUND: Nipple-sparing mastectomy (NSM) has become widely available for breast cancer prophylaxis. There are limited data on its long-term oncologic safety. The objective of this study was to determine the incidence of breast cancer in patients who underwent prophylactic NSM. METHODS: All patients undergoing prophylactic NSM at a single institution from 2006 through 2019 were retrospectively reviewed. Patient demographic factors, genetic predispositions, mastectomy specimen pathology, and oncologic occurrences at follow-up were recorded. Descriptive statistics were performed where necessary to classify demographic factors and oncologic characteristics. RESULTS: A total of 871 prophylactic NSMs were performed on 641 patients, with median follow-up of 82.0 months (standard error 1.24). A total of 94.4% of patients ( n = 605) underwent bilateral NSMs, although only the prophylactic mastectomy was considered. The majority of mastectomy specimens (69.6%) had no identifiable pathology. A total of 38 specimens (4.4%) had cancer identified in mastectomy specimens, with ductal carcinoma in situ being the most common (92.1%; n = 35). Multifocal or multicentric disease was observed in seven cases (18.4%) and lymphovascular invasion was identified in two (5.3%). One patient (0.16%), who was a BRCA2 variant carrier, was found to have breast cancer 6.5 years after prophylactic mastectomy. CONCLUSIONS: Overall primary oncologic occurrence rates are very low in high-risk patients undergoing prophylactic NSM. In addition to reducing the risk of oncologic occurrence, prophylactic surgery itself may be therapeutic in a small proportion of patients. Continued surveillance for these patients remains important to assess at longer follow-up intervals. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, IV.

Preauthorization Inconsistencies Prevail in Reduction Mammaplasty.

Background: Despite evidence documenting the physical and psychological benefits of breast reduction, third-party payer approval remains a cumbersome process. The objective of this study was to assess differences in medical necessity criteria for reduction mammaplasty among US insurance carriers while analyzing trends in claim denials and appeals. Methods: The medical necessity criteria for reduction mammaplasty were retrieved from seven large health insurance carriers. Data were extracted from each policy, including claim requirements for approval. Additionally, prospective data on claims and denials submitted from January through August 2022 were collected from The Auctus Group, a medical consulting firm. Results: All the policies have been updated since January 2020. Five of the seven policies specifically listed what documentation was required for preauthorization approval, with five third-party payers requiring photograph documentation. Policies required documentation of one to three symptoms lasting from 6 weeks to 1 year. All companies reported a tissue resection estimate threshold, but cutoffs varied. Of 380 reduction mammaplasties performed, 158 (41.6%) received a denial on initial insurance submission. Considering appeals, a total of 216 denials were reviewed with an average of 1.37 denials per patient. Of the 158 initial denials, 104 (65.8%) of these were from claims that received preauthorization. In 12 cases, third-party payers stated that no prior authorization was necessary yet still denied the claim. Conclusions: Wide variability exists in medical necessity criteria for reduction mammaplasty policies among major insurance carriers. These nuances introduce inefficiencies for practices contributing to high denial and appeal rates while delaying surgical care for patients.

No Cancer Occurrences in 10-year Follow-up after Prophylactic Nipple-sparing Mastectomy.

Prophylactic nipple-sparing mastectomies (NSM) have become increasingly common, although there is little long-term data on its efficacy in prevention of breast cancer. The objective of this study was to assess the incidence of breast cancer in a cohort of patients undergoing prophylactic NSM with a median follow-up of 10 years. Methods: Patients receiving prophylactic NSM at a single institution from 2006 to 2019 were included in a retrospective nature. Patient demographics, genetic mutations, operative details, and specimen pathology were recorded, and all postoperative patient visits and documentation were screened for cancer occurrence. Descriptive statics were performed where appropriate. Results: Two hundred eighty-four prophylactic NSMs were performed on 228 patients with a median follow-up of 120.5 ± 15.7 months. Roughly, a third of patients had a known genetic mutation, with 21% BRCA1 and 12% BRCA2. The majority (73%) of prophylactic specimens had no abnormal pathology. The most commonly observed pathologies were atypical lobular hyperplasia (10%) and ductal carcinoma in situ (7%). Cancer was identified in 10% of specimens, with only one case of lymphovascular invasion. Thus far, there have been no incidences of locoregional breast cancer occurrence in this cohort. Conclusions: The long-term breast cancer occurrence rate in this cohort of prophylactic NSM patients at the time of this study is negligible. Despite this, continued surveillance of these patients is necessary until lifetime risk of occurrence following NSM has been established.

Maximizing volume in autologous breast reconstruction: stacked/conjoined free flaps.

Since the first report of abdominally based tissue breast reconstruction with a free flap of rectus abdominis muscle to reconstruct mastectomy defects, autologous breast reconstruction has continually increased in popularity due to improved cosmesis, patient satisfaction, and quality of life. While abdominal tissue is frequently used as the principal donor site, other flap options are available, including from the buttocks, thighs, and back. Microsurgical advancements in recent years have continued to improve patient outcomes and decrease operative times. One innovative technique is the use of stacked or conjoined free flaps which can be used when more breast volume is needed than can be provided by one free flap alone. These stacked or conjoined free flaps can be used unilaterally or bilaterally and can include combinations of nearly every free flap depending on the volume of tissue desired for the reconstruction. Though these flaps are increasing in popularity, there is limited comparative data on the safety and efficacy of stacked or conjoined free flaps as compared to single free flaps. In this review, we aim to highlight the use of stacked/conjoined free flaps for autologous breast reconstruction, as well as highlight recent data on this technique and provide recommendations for its safe use.

The Underused Superomedial Pedicle Reduction Mammaplasty: Safe and Effective Outcomes.

BACKGROUND: The superomedial pedicle for reduction mammaplasty remains less commonly performed than the inferior pedicle. This study seeks to delineate the complication profiles and outcomes for reduction mammaplasty using a superomedial pedicle technique in a large series. METHODS: A retrospective review was conducted of all consecutively performed reduction mammaplasty cases at a single institution by two plastic surgeons over a 2-year period. All consecutive superomedial pedicle reduction mammaplasty cases for benign symptomatic macromastia were included. RESULTS: A total of 462 breasts were analyzed. Mean age was 38.3 ± 13.38 years, mean body mass index was 28.5 ± 4.95, and mean reduction weight was 644.4 ± 299.16 g. Regarding surgical technique, a superomedial pedicle was used in all cases; Wise-pattern incision was used in 81.4%, and short-scar incision was used in 18.6%. The mean sternal notch-to-nipple measurement was 31.2 ± 4.54 cm. There was a 19.7% rate of any complication, the majority of which were minor in nature, including any wound healing complications treated with local wound care (7.5%) and scarring with intervention in the office (8.6%). There was no statistically significant difference in breast reduction complications and outcomes using the superomedial pedicle, regardless of sternal notch-to-nipple distance. Body mass index ( P = 0.029) and breast reduction specimen operative weight ( P = 0.004) were the only significant risk factors for a surgical complication, and with each additional gram of reduction weight, the odds of a surgical complication increased by 1.001. Mean follow-up time was 40.5 ± 7.1 months. CONCLUSION: The superomedial pedicle is an excellent option for reduction mammaplasty, portending a favorable complication profile and long-term outcomes. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Analysis of Incidentally Found Proliferative Lesions in Oncoplastic and Macromastia Breast Reductions.

BACKGROUND: Reduction mammaplasty pathologic specimens can reveal incidentally found proliferative lesions. However, there is a lack of data investigating the comparative incidences and risk factors for such lesions. METHODS: A retrospective review was conducted of all consecutively performed reduction mammaplasty cases at a single large academic medical institution in a metropolitan city by two plastic surgeons over a 2-year period. All reduction mammaplasties, symmetrizing reductions, and oncoplastic reductions performed were included. There were no exclusion criteria. RESULTS: A total of 632 breasts were analyzed-502 reduction mammaplasties, 85 symmetrizing reductions, and 45 oncoplastic reductions-in 342 patients. Mean age was 43.9 ± 15.9 years, mean body mass index was 29.2 ± 5.7 kg/m 2 , and mean reduction weight was 610.0 ± 313.1 g. Patients who underwent reduction mammaplasty for benign macromastia had a significantly lower incidence (3.6%) of incidentally found breast cancers and proliferative lesions compared with patients with oncoplastic reductions (13.3%) and symmetrizing reductions (17.6%) ( P < 0.001). On univariate analysis, personal history of breast cancer ( P < 0.001), first-degree family history of breast cancer ( P = 0.008), age ( P < 0.001), and tobacco use ( P = 0.033) were all statistically significant risk factors. Using a backward elimination stepwise reduced multivariable logistic regression model for risk factors associated with breast cancer or proliferative lesions, age ( P < 0.001) was the only retained significant risk factor. CONCLUSIONS: Proliferative lesions and carcinomas of the breast found in reduction mammaplasty pathologic specimens may be more common than previously reported. The incidence of newly found proliferative lesions was significantly lower in cases of benign macromastia compared with oncoplastic and symmetrizing reductions. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Modern Approaches to Implant-Based Breast Reconstruction.

The modern approach to implant-based breast reconstruction encompasses an evolution in surgical techniques, patient selection, implant technology, and use of support materials. Successful outcomes are defined by teamwork throughout the ablative and reconstructive processes as well as appropriate and evidence-based utilization of modern material technologies. Patient education, focus on patient-reported outcomes, and informed and shared decision-making are the key to all steps of these procedures.

Quantifying Surgical Complications for Reduction Mammaplasty in Adolescents.

BACKGROUND: Reduction mammaplasty is a safe, effective procedure to alleviate symptoms of adolescent macromastia. However, there remain limited data on surgical complications associated with reduction mammaplasty in adolescents, which may not be concordant with those cited for adults seeking reduction mammaplasty. METHODS: A retrospective review was conducted of all consecutively performed reduction mammaplasty cases for symptomatic macromastia in patients aged 20 years and younger over a 7-year period from 2014 to 2021. RESULTS: One hundred sixty total breasts were analyzed in 80 patients. Mean age was 18.3 ± 1.4 years, with an age range from 15 to 20 years. Mean body mass index was 27.17 ± 5.49 kg/m 2 . Mean reduction weight was 584.79 ± 261.19 g. A medial pedicle was used in 91%, and an inferior pedicle was used in 9%. For skin incision, a Wise pattern was used in 60%, and a short-scar was used in 40%. There was a 16.3% rate of any surgical complication, which included wound healing by secondary intention treated with local wound care. There were no significant risk factors for a surgical complication in reduction mammaplasty, and no differences in surgical complications related to skin incision type, pedicle use, or breast reduction weight. Performance of a receiver operating characteristic curve for age at surgery and complication demonstrated that there was no age cutoff where the risk of surgical complication was appreciably increased or decreased. CONCLUSIONS: Age was not identified as a risk factor for surgical complications in adolescent reduction mammaplasty. Overall, complication rates were very low and minor in nature for adolescent reduction mammaplasty, with no significant risk factors identified. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Patient Decision-Making for Management of Style 410 Anatomical Implants in Breast Reconstruction.

BACKGROUND: In July of 2019, the U.S. Food and Drug Administration (FDA) recalled the Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Textured Breast Implants because of a heightened risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The objective of this study was to describe patient decision-making in management of preexisting 410 textured implants. METHODS: A single-institution retrospective chart review was conducted to determine all patients who received 410 anatomical implants from two surgeons. Patients who received these implants were contacted in July to September of 2019 regarding the FDA recall and asked to schedule a consultation to discuss explant/exchange versus surveillance. Outcomes analyzed included decision of surveillance versus explantation and subsequent reconstructive operations. RESULTS: Eighty-nine patients had received 410 implants from 2013 to 2017. Of the 147 breasts that were reconstructed, 58.5% were oncologic mastectomies and 41.5% were prophylactic. The majority of patients (71.9%) cited BIA-ALCL as the predominant influencing factor in their decision for management. Other factors included appearance, implant concerns unrelated to BIA-ALCL, and other medical conditions. Twenty patients (22.5%) underwent explantation of the Style 410 implants. The remaining 77.5% of patients elected for monitored surveillance. There was a significant association between a history of breast cancer and explantation of the Style 410 implants ( P = 0.0335). CONCLUSIONS: The majority of patients with Style 410 textured implants elected to undergo surveillance for BIA-ALCL. When deciding to explant or exchange the Style 410 implants, plastic surgeons should work in conjunction with their patients to carefully outline management options.

Aesthetic Characteristics of the Ideal Female Breast.

The female breast is a subject of significant focus within plastic surgery. Little work to date has examined public perceptions of attractiveness with respect to breast anatomy and morphology. This study provides a comprehensive assessment of anatomic and aesthetic breast characteristics valued by the general population. Methods: A single-institution retrospective review was conducted of patients presenting for aesthetic or reconstructive breast surgery between 2009 and 2019. A cohort of 25 patients were included in a nationwide survey designed to assess subjective impressions of overall "breast attractiveness." Survey responses were assessed, and the five patients with the highest mean scores were identified. An in-depth analysis of this subgroup was performed, evaluating anatomic metrics on both two-dimensional photographs and three-dimensional imaging. Statistical analysis examined correlations between objective breast characteristics and subjective perceptions of "attractiveness." Results: There were 1021 survey responses. Across the entire patient cohort, the mean age was 47.4 years and mean BMI was 24.9 kg/m2. On a five-point Likert scale, the mean "breast attractiveness" score for the highest-scoring subgroup patients (n = 5) was 3.1 ± 0.1. Within this group, all patients had minimal ptosis and a projected contour. Average breast size was moderate, with mean volume of 299.4 ± 115.8 cm3. Conclusions: This study reverse engineers the aesthetically appealing female breast, beginning with overall impressions of attractiveness and subsequently analyzing the influence of objective anatomic parameters on subjective perceptions. In surveying a large and diverse population, moderately sized, projected breasts with upper pole fullness were found to be associated with increased "attractiveness" scores.

Management of complications following implant-based breast reconstruction: a narrative review.

Background and Objective: Complications associated with implant-based reconstruction have a spectrum of severity with sequelae ranging from mild aesthetic deformities to additional surgery, reconstructive failure and systemic illness. The purpose of this narrative review of the literature is to provide updated evidence-based information on the management of complications in implant-based reconstruction. Methods: A systematic search of PubMed, OVID MEDLINE and the Cochrane Library databases was performed to identify common complications associated with implant-based breast reconstruction, incidences of occurrence as well as preventative and management strategies. Key Content and Findings: Pertinent short and long-term complications of implant-based breast reconstruction include hematoma, implant infection, seroma, skin envelope necrosis, capsular contracture, rupture, malposition, animation and contour deformities, implant-associated anaplastic large cell lymphoma, and breast implant illness. Important preventative measures for short term complications include meticulous sterile technique and antibiotic irrigation, adequate drainage and critical evaluation of mastectomy flaps. Management of short-term complications requires early recognition and aggressive treatment to prevent reconstructive failure as well as long-term complications such as capsular contracture. Important technological advances include dual-port expanders for seroma drainage, indocyanine green angiography for mastectomy flap perfusion evaluation, cohesive form-stable implants for treatment of rippling, and various biologic and synthetic mesh products for pocket control and correction. Conclusions: Important principles in management of short-term complications in implant-based reconstruction include aggressive and early intervention to maximize the chance of reconstructive salvage. Contemporary technological advances have played an important role in both prevention and treatment of complications. Over-arching principles in management of implant-based reconstruction complications focus on preventative techniques and preoperative patient counseling on potential risks, their likelihood, and necessary treatments to allow for informed and shared decision-making.

Catch-22: Acellular Dermal Matrix and U.S. Food and Drug Administration Premarket Approval-How Can We Construct Studies?

SUMMARY: As a biologic product derived from human tissue, acellular dermal matrices did not require premarket approval for their initial use as a soft-tissue support product. Since their first use in breast surgery, acellular dermal matrices have allowed for numerous advances in breast reconstruction. They quickly gained popularity in breast surgery and are used frequently in various applications. During an investigation into potential factors leading to breast implant-associated anaplastic large-cell lymphoma, the U.S. Food and Drug Administration made an official statement that acellular dermal matrices were not approved for use in breast reconstruction and that using them in breast surgery was considered off-label. This special topic article details the history of acellular dermal matrices in breast surgery and describes the ongoing evolution of the relationship between the U.S. Food and Drug Administration and acellular dermal matrices.