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Background: Postmastectomy radiotherapy (PMRT) is associated with altered cosmetic outcomes and higher complication rates in implant-based breast reconstruction (IBR). Conventional wisdom suggests that muscle coverage is somewhat protective against PMRT-related complications. In this study, the authors compared surgical outcomes in patients who underwent two-stage prepectoral versus subpectoral IBR in the setting of PMRT., Methods: The authors performed a retrospective cohort study of patients who underwent mastectomy and PMRT with two-stage IBR from 2016 to 2019. The primary outcome was breast-related complications, including device infection; the secondary outcome was device explantation., Results: The authors identified 179 reconstructions (101 prepectoral and 78 subpectoral) in 172 patients with a mean follow-up time of 39.7 ± 14.4 months. There were no differences between the prepectoral and subpectoral reconstructions in rates of breast-related complications (26.7% and 21.8%, respectively; P = 0.274), device infection (18.8% and 15.4%, respectively; P = 0.307), skin flap necrosis (5.0% and 1.3%, respectively; P = 0.232), or device explantation (20.8% and 14.1%, respectively; P = 0.117). In adjusted models, compared with prepectoral device placement, subpectoral device placement was not associated with a lower risk of breast-related complications [hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.41 to 1.36], device infection (HR, 0.73; 95% CI, 0.35 to 1.49), or device explantation (HR, 0.58; 95% CI, 0.28 to 1.19)., Conclusions: Device placement plane was not predictive of complication rates in IBR in the setting of PMRT. Two-stage prepectoral IBR provides safe long-term outcomes with acceptable postoperative complication rates comparable to those with subpectoral IBR, even in the setting of PMRT., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Despite improvements in prosthesis design and surgical techniques, periprosthetic infection and explantation rates following implant-based reconstruction (IBR) remain relatively high. Artificial intelligence is an extremely powerful predictive tool that involves machine learning (ML) algorithms. We sought to develop, validate, and evaluate the use of ML algorithms to predict complications of IBR., Methods: A comprehensive review of patients who underwent IBR from January of 2018 to December of 2019 was conducted. Nine supervised ML algorithms were developed to predict periprosthetic infection and explantation. Patient data were randomly divided into training (80%) and testing (20%) sets., Results: The authors identified 481 patients (694 reconstructions) with a mean ± SD age of 50.0 ± 11.5 years, mean ± SD body mass index of 26.7 ± 4.8 kg/m 2 , and median follow-up time of 16.1 months (range, 11.9 to 3.2 months). Periprosthetic infection developed in 113 of the reconstructions (16.3%), and explantation was required with 82 (11.8%) of them. ML demonstrated good discriminatory performance in predicting periprosthetic infection and explantation (area under the receiver operating characteristic curve, 0.73 and 0.78, respectively), and identified nine and 12 significant predictors of periprosthetic infection and explantation, respectively., Conclusions: ML algorithms trained using readily available perioperative clinical data accurately predict periprosthetic infection and explantation following IBR. The authors' findings support incorporating ML models into perioperative assessment of patients undergoing IBR to provide data-driven, patient-specific risk assessment to aid individualized patient counseling, shared decision-making, and presurgical optimization., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Opinion regarding the optimal plane for prosthetic device placement in breast reconstruction patients has evolved. The purpose of this study was to assess the differences in complication rates and patient satisfaction between patients who underwent prepectoral and subpectoral implant-based breast reconstruction (IBR)., Methods: The authors conducted a retrospective cohort study of patients who underwent two-stage IBR at their institution from 2018 to 2019. Surgical and patient-reported outcomes were compared between patients who received a prepectoral versus a subpectoral tissue expander., Results: A total of 694 reconstructions in 481 patients were identified (83% prepectoral, 17% subpectoral). The mean body mass index was higher in the prepectoral group (27 versus 25 kg/m 2 , P = 0.001), whereas postoperative radiotherapy was more common in the subpectoral group (26% versus 14%, P = 0.001). The overall complication rate was very similar, with 29.3% in the prepectoral and 28.9% in the subpectoral group ( P = 0.887). Rates of individual complications were also similar between the two groups. A multiple-frailty model showed that device location was not associated with overall complications, infection, major complications, or device explantation. Mean scores for Satisfaction with the Breast, Psychosocial Well-Being, and Sexual Well-Being were similar between the two groups. Median time to permanent implant exchange was significantly longer in the subpectoral group (200 versus 150 days, P < 0.001)., Conclusion: Prepectoral breast reconstruction results in similar surgical outcomes and patient satisfaction compared with subpectoral IBR., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: The impact of obesity on outcomes of prepectoral vs subpectoral implant-based reconstruction (IBR) is not well-established., Objectives: The goal of this study was to assess the surgical and patient-reported outcomes of prepectoral vs subpectoral IBR. The authors hypothesized that obese patients would have similar outcomes regardless of device plane., Methods: We conducted a retrospective review of obese patients who underwent 2-stage IBR from January 2017 to December 2019. The primary endpoint was the occurrence of any breast-related complication; the secondary endpoint was device explantation., Results: The authors identified a total of 284 reconstructions (184 prepectoral, 100 subpectoral) in 209 patients. Subpectoral reconstruction demonstrated higher rates of overall complications (50% vs 37%, P = .047) and device explantation (25% vs 12.5%, P = .008) than prepectoral reconstruction. In multivariable regression, subpectoral reconstruction was associated with higher risk of infection (hazard ratio [HR], 1.65; P = .022) and device explantation (HR, 1.97; P = .034). Subgroup analyses demonstrated significantly higher rates of complications and explantation in the subpectoral group in those with a body mass index (BMI) ≥ 35 and BMI ≥40. The authors found no significant differences in mean scores for satisfaction with the breast (41.57 ± 13.19 vs 45.50 ± 11.91, P = .469), psychosocial well-being (39.43 ± 11.23 vs 39.30 ± 12.49, P = .915), and sexual well-being (17.17 ± 7.83 vs 17.0 ± 9.03, P = .931) between subpectoral and prepectoral reconstruction., Conclusions: Prepectoral reconstruction was associated with significantly decreased overall complications, infections, and device explantation in obese patients compared with subpectoral reconstruction. Prepectoral reconstruction provides superior outcomes to subpectoral reconstruction with comparable patient-reported outcomes., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background:  Following implant-based breast reconstruction (IBR) infection and explantation, autologous reconstruction is a common option for patients who desire further reconstruction. However, few data exist about the outcomes of secondary autologous reconstruction (i.e., free flap breast reconstruction) in this population. We hypothesized that autologous reconstruction following infected device explantation is safe and has comparable surgical outcomes to delayed-immediate reconstruction., Methods:  We conducted a retrospective analysis of patients who underwent IBR explantation due to infection from 2006 through 2019, followed by secondary autologous reconstruction. The control cohort comprised patients who underwent planned primary delayed-immediate reconstruction (tissue expander followed by autologous flap) in 2018., Results:  We identified 38 secondary autologous reconstructions after failed primary IBR and 52 primary delayed-immediate reconstructions. Between secondary autologous and delayed-immediate reconstructions, there were no significant differences in overall complications (29 and 37%, respectively, p  = 0.45), any breast-related complications (18 and 21%, respectively, p  = 0.75), or any major breast-related complications (13 and10%, respectively, p  = 0.74). Two flap losses were identified in the secondary autologous reconstruction group while no flap losses were reported in the delayed-immediate reconstruction group ( p  = 0.18)., Conclusion:  Autologous reconstruction is a reasonable and safe option for patients who require explantation of an infected prosthetic device. Failure of primary IBR did not confer significantly higher risk of complications after secondary autologous flap reconstruction compared with primary delayed-immediate reconstruction. This information can help plastic surgeons with shared decision-making and counseling for patients who desire reconstruction after infected device removal., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Prepectoral implant-based breast reconstruction (IBR) has become the standard of care for many reconstructive surgeons and is often supplemented with coverage using acellular dermal matrix (ADM). However, more clinical data examining the use of ADM in breast reconstruction are needed. The current study compares complications and patient-reported outcomes (PROs) among three different types of ADM used in IBR., Methods: The authors performed a retrospective review of consecutive patients who underwent immediate prepectoral IBR from January of 2018 through December of 2019. Surgical outcomes and PROs (using the BREAST-Q) were compared among the AlloDerm, SurgiMend, and Dermacell ADMs., Results: Overall, 557 breasts (383 patients) were included (78.6% AlloDerm, 14% SurgiMend, 7.4% Dermacell). Patients in the Dermacell group were older ( P = 0.001) and more likely to have diabetes ( P = 0.001) compared with AlloDerm and SurgiMend patients. Other patient characteristics were similar among the three groups. The overall complication rate was equivalent among the three ADM groups (AlloDerm 27% vs SurgiMend 33% vs Dermacell 39%; P = 0.209). Multivariable frailty models demonstrated that the type of ADM was not significantly associated with overall complications, infection, major complications, or device explantation. BREAST-Q satisfaction with breasts, psychosocial well-being, and sexual well-being were also similar among the three ADM groups ( P = 0.109, P = 0.439, P = 0.152, respectively)., Conclusions: Three of the most commonly used ADMs in the United States have similar surgical outcomes and PROs when used for prepectoral IBR. No significant differences in infection, overall complications, or device removal rates were identified among AlloDerm, SurgiMend, and Dermacell., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Postmastectomy breast reconstruction in patients with a history of breast-conserving surgery (BCS) and radiotherapy is challenging, with a paucity of literature on the outcomes of different breast reconstructive techniques. The authors hypothesized that implant-based breast reconstruction (IBR) would be associated with higher complication rates compared to either IBR combined with latissimus dorsi (LD) or free flap breast reconstruction (FFBR)., Methods: The authors conducted a retrospective review of patients who underwent mastectomy with a history of BCS and radiotherapy between January of 2000 and March of 2016. Surgical and patient-reported outcomes (BREAST-Q) were compared between IBR versus IBR/LD versus FFBR., Results: The authors identified 9473 patients who underwent BCS and radiotherapy. Ninety-nine patients (105 reconstructions) met the authors' inclusion criteria, 29% ( n = 30) of whom underwent IBR, 26% ( n = 27) of whom underwent IBR/LD, and 46% ( n = 48) of whom underwent FFBR. The overall complication rate was not significantly different between the three groups (50% in IBR versus 41% in IBR/LD versus 44% in FFBR; P = 0.77), whereas reconstruction failures were significantly lower in the FFBR group (33% in IBR versus 19% in IBR/LD versus 0% in FFBR; P < 0.0001). The time between the receipt of radiotherapy and reconstruction was not a significant predictor of overall complications and reconstruction failure. No significant differences were identified between the three study cohorts in any of the three studied BREAST-Q domains., Conclusions: In patients with prior BCS and radiotherapy, FFBR was associated with lower probability of reconstruction failure compared to IBR but no significant difference in overall and major complication rates. The addition of LD flap to IBR did not translate into lower complication rates but may result in decreased reconstruction failures., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Infection is a dreaded complication of implant-based breast reconstruction. There is a paucity of literature on the outcomes of a secondary reconstruction after infected implant-based breast reconstruction explantation., Methods: The authors conducted a retrospective study of patients who underwent a second implant-based breast reconstruction following a failed infected device between January of 2006 and December of 2019. Surgical and patient-reported outcomes (BREAST-Q) were collected and analyzed., Results: A total of 6093 implant-based breast reconstructions were performed during the study period, 298 (5 percent) of which involved device removal because of infection. Eighty-three patients ultimately received 92 second-attempt breast implants. Thirty-six percent of cases developed at least one postoperative complication, with infection [23 breasts (25 percent)] being the most common. Compared with first-attempt implant-based breast reconstruction, we found significantly higher infection rates among second-attempt cases (9 percent and 21 percent, respectively; p = 0.0008). Patient-reported satisfaction with the breast and sexual well-being were lower after second-attempt than after first-attempt implant-based breast reconstruction ( p = 0.018 and p = 0.002, respectively) reported in the literature. Mean follow-up was 41 ± 35 months. If we exclude patients with prior radiation therapy and those who received device exchange, the success rate is 88 percent., Conclusions: It is reasonable to offer women second-attempt implant-based breast reconstruction after explantation because of infection. However, this patient population has a higher infection and explantation rate and lower patient-reported satisfaction than patients undergoing first-attempt implant-based breast reconstruction. Because of these increased surgical risks and elevated complication rates, patients must be given reasonable expectations during preoperative discussions and when providing informed consent for second-attempt implant-based breast reconstruction., Clinical Question/level of Evidence: Risk, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Implant-based breast reconstruction infections often require implant explantation. Whereas some plastic surgeons pursue autologous reconstruction following the first implant-based breast reconstruction failure caused by infection, others argue that a second attempt is acceptable., Methods: The authors conducted a retrospective study of patients who underwent a second reconstruction attempt with implant-based or free flap breast reconstruction following explantation because of infection between 2006 and 2019. Surgical and patient-reported outcomes were compared between the two groups., Results: A total of 6093 implant-based breast reconstructions were performed during the study period, of which 130 breasts met our inclusion criteria [implant-based, n = 86 (66 percent); free flap, n = 44 (34 percent)]. No significant differences in rates of overall (25 percent versus 36 percent; p = 0.2) or major (20 percent versus 21 percent; p = 0.95) complications were identified between the free flap and implant-based cohorts, respectively. Implant-based breast reconstruction patients were more likely to experience a second infection (27 percent versus 2 percent; p = 0.0007) and reconstruction failure (21 percent versus 5 percent; p = 0.019). Among irradiated patients, reconstruction failure was reported in 44 percent of the implant-based and 7 percent of the free flap cohorts (p = 0.02). Free flap patients reported significantly higher scores for Satisfaction with Breasts (73.7 ± 20.1 versus 48.5 ± 27.9; p = 0.0046)., Conclusions: Following implant-based breast reconstruction explantation because of infection, implant-based and free flap breast reconstruction had similar rates of overall and major complications; however, implant-based breast reconstruction had considerably higher rates of infection and reconstructive failures and lower patient-reported scores for Satisfaction with Breasts. Given the high rates of implant-based breast reconstruction failure in patients with prior radiotherapy and infection-based failure, plastic surgeons should strongly consider autologous reconstruction in this patient population., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Objective: We sought to evaluate patients at a single academic institution in a prospective manner to report patient presentation, clinical course, treatment, and outcomes in breast implant ALCL patients., Background: Breast implant-associated anaplastic large cell lymphoma (breast implant ALCL) is an uncommon T cell lymphoma, which is associated with textured surface breast implants. The disease has received increasing attention over the last 20 years. Previous retrospective studies have begun to outline the clinical course of breast implant ALCL., Methods: We prospectively followed women with cytologically proven breast implant ALCL from 2014 to 2019. Demographic, clinical, treatment, and outcome data were collected and descriptive statistics were performed on variables of interest., Results: We identified 52 women with pathologically confirmed breast implant ALCL. Implants were placed for augmentation in 61.5% of women and reconstruction in 36.5% of women. All of the 41 patients with known implant information had implants with textured surface. The majority of patients presented with delayed seroma (69.2%) and without systemic symptoms (86.5%). Most patients with staging information presented with Stage IA disease. Patient outcomes were excellent with 2 disease recurrence (3.8%) and all patients ultimately achieved complete remission., Conclusions: Further evaluation of the prospective and growing database of patients with breast implant ALCL will further improve our understanding of the disease and its clinical course. Robust participation in the breast implant ALCL PROFILE registry will improve our knowledge of long-term outcomes after implant placement. Finally, increasing awareness for patients and providers will lead to earlier diagnosis and improved outcomes for patients., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is a relative paucity of high-quality outcomes data for use of different ADMs., Objectives: The goal of this study was to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction., Methods: A prospective, single-blinded, randomized controlled trial was conducted to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. Patients with prior radiation to the index breast were excluded. Patient and surgical characteristics were collected and analyzed., Results: From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients (HADM, 36 patients/55 breasts; BADM, 32 patients/48 breasts) included in the final analysis. Baseline characteristics were similar between the 2 groups. No significant differences in overall complication rates were identified between HADM (n = 14, 25%) and BADM (n = 13, 27%) (P = 0.85). Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM patients (n = 4) and 17% of BADM patients (n = 8) (P = 0.14)., Conclusions: Similar complication and implant loss rates were found among patients undergoing immediate tissue expander breast reconstruction with HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration, help to improve outcomes and sustainability in immediate breast reconstruction., (© 2021 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Summary: Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance., Competing Interests: Disclosure:The authors have no associations or financial disclosures to report that create a conflict of interest with the information presented in this article. M.D. Anderson Cancer Center participates in clinical trials for Motiva US Safety Trial (Establishment Labs) and Mentor Corporation., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon type of non-Hodgkin lymphoma occurring in the fluid or capsule adjacent to textured breast implants. Diagnosis of BIA-ALCL of symptomatic patients requires demonstration of large anaplastic cells with uniform expression of CD30 protein on immunohistochemistry., Objectives: The authors investigated a novel, rapid, office-based, and economic in-situ enzyme-linked immunosorbent assay (ELISA) for screening BIA-ALCL patients., Methods: A commercially available in-situ ELISA was standardized and validated for patients with confirmed BIA-ALCL diagnosis with clinical isolates. A panel of 9 pathologically confirmed BIA-ALCL patients was screened by serum, plasma, and periprosthetic effusion specimens and compared against serum, plasma, and nonneoplastic delayed seromas in 7 control patients. Statistical analysis demonstrated assay consistency and reliability., Results: All BIA-ALCL effusions demonstrated CD30 ELISA detection at full and all serial concentrations. BIA-ALCL serum specimens and all control specimens were negative at full concentration and serial dilutions (1:100, 1:250, 1:500, and 1:1000). BIA-ALCL plasma specimens were weakly positive at full concentration and revealed no activity with serial dilution., Conclusions: This is the first study to demonstrate a viable alternative to CD30 immunohistochemistry for the screening of BIA-ALCL. Our study demonstrates 100% sensitivity in seroma fluid with no detectable CD30 in benign seroma samples. A CD30 ELISA represents a novel, low-cost screening test, which may be used to screen suspicious aspirations of delayed periprosthetic fluid collections in an office-based setting., (© 2019 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon T-cell lymphoma associated with textured-surface breast implants. Human leukocyte antigen (HLA) polymorphisms have been described with other forms of lymphoma, but have not been described for BIA-ALCL., Objectives: The aim of this study was to evaluate HLA polymorphisms in BIA-ALCL patients., Methods: We prospectively evaluated HLA alleles in patients with BIA-ALCL. HLA was analyzed by probe-based sequence-specific testing and sequence-based typing. The frequencies of HLA-A, HLA-B, HLA-C, HLA-DRB1, and HLA-DQB1 alleles were evaluated. Allele frequencies in the Caucasian European general population were obtained from the National Marrow Donor Program to serve as normative controls. We estimated the relative risk of BIA-ALCL with 95% confidence intervals from a t test., Results: Thirteen patients who had undergone BIA-ALCL and HLA testing were identified from 2017 to 2018. Patients carried 10, 11, and 9 HLA-A, HLA-B, and HLA-C alleles, respectively. There were 8 DRB1 alleles and 5 DQB1 alleles in the BIA-ALCL patients. The A*26 allele occurred significantly more frequently in the general population compared with BIA-ALCL patients (0.2992 vs 0.07692, P < 0.001)., Conclusions: Our results identify a difference between HLA A*26 in patients who develop BIA-ALCL and the general population, and may signify genetic susceptibility factors responsible for germline genetic variation in HLA in patients with BIA-ALCL. Further work is needed to elucidate if these alleles are predictive for BIA-ALCL in women with textured-surface breast implants.Level of Evidence: 4., (© 2019 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)

Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) most commonly follows an indolent course; however, a subset of patients display more advanced disease marked by recurrent and disseminated growth refractory to treatment. This study evaluated outcomes of advanced disease, specifically bilateral disease, lymph node involvement, organ metastasis, and/or disease-related death., Methods: Published cases of BIA-ALCL from 1997 to 2018 and unpublished cases at the authors' institution were retrospectively reviewed, and patients with advanced disease were selected. Treatment and outcomes were compared against a control of BIA-ALCL subjects without advanced disease., Results: Thirty-nine patients with advanced BIA-ALCL were identified who had bilateral disease (n = 7), lymph node and organ metastasis (stage IIB-IV, n = 24), and disease-related death (n = 8). Sixty-five patients were included in a comparison control group (stage 1A-1C). Treatment types for advanced disease patients were complete surgery, n = 16 (55.2%); limited surgery, n = 19 (65.5%); chemotherapy, n = 26 (89.7%); salvage chemotherapy, n = 11 (37.9%); radiation, n = 15 (51.7%); and autologous stem cell transplant, n = 6 (20.7%). The rates of complete remission for the bilateral and lymphadenopathy groups were 4 of 7 (57%, P < 0.001) and 16 of 24 (67%, P = 0.128), respectively. Compared with the control group, advanced disease patients had significantly longer time from diagnosis to definitive surgery (21 versus 8 months, P = 0.039) and a lower rate of complete surgery (59% versus 88%, P = 0.004)., Conclusions: Advanced disease BIA-ALCL may be a consequence of a delay or suboptimal treatment of BIA-ALCL. Optimal adjuvant chemotherapy and indications for radiation for BIA-ALCL patients with advanced features are not yet clearly defined. Advanced disease is the end of the spectrum of cancer stages, and these patients substantiate the World Health Organization classification of BIA-ALCL as a lymphoma rather than benign or lymphoproliferative.

Background: Standard of care treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) involves surgical resection with implant removal and complete capsulectomy. We report a case series of BIA-ALCL reconstruction with proposals for timing and technique selection., Methods: We retrospectively reviewed and prospectively enrolled all BIA-ALCL patients at 2 tertiary care centers and 1 private plastic surgery practice from 1998 to 2017. Demographics, treatment, reconstruction, pathology staging, patient satisfaction, and oncologic outcomes were reviewed., Results: We treated 66 consecutive BIA-ALCL patients and 18 (27%) received reconstruction. Seven patients (39%) received immediate reconstruction, and 11 (61%) received delayed reconstruction. Disease stage at presentation was IA (T1N0M0 disease confined to effusion or a layer on luminal side of capsule with no lymph node involvement and no distant spread) in 56%, IB in 17%, IC (T3N0M0 cell aggregates or sheets infiltrating the capsule, no lymph node involvement and no distant spread) in 6%, IIA (T4N0M0 lymphoma infiltrating beyond the capsule, no lymph node involvement and no distant spread) in 11%, and III in 11%. Types of reconstruction included smooth implants (72%), immediate mastopexy (11%), autologous flaps (11%), and fat grafting (6%). Outcomes included no surgical complications, but 1 patient progressed to widespread bone metastasis (6%); ultimately, all patients achieved complete remission. Ninety-four percent were satisfied/highly satisfied with reconstructions, whereas 6% were highly unsatisfied with immediate smooth implants., Conclusions: Breast reconstruction following BIA-ALCL management can be performed with acceptable complications if complete surgical ablation is possible. Immediate reconstruction is reserved for disease confined to capsule on preoperative positive emission tomography/computed tomography scan. Genetic predisposition and bilateral cases suggest that BIA-ALCL patients should not receive textured implants. Autologous options are preferable for implant adverse BIA-ALCL patients. Patients with extensive disease at presentation should be considered for 6- to 12-month delayed reconstruction with interval positive emission tomography/computed tomography evaluation.

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 large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported., Methods: This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms., Results: LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations., Conclusions: This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.

Background: Although multiple acellular dermal matrix sources exist, it is unclear how its processing impacts complication rates. The authors compared complications between two preparations of human cadaveric acellular dermal matrix (freeze dried and ready-to-use) in immediate tissue expander breast reconstruction to analyze the effect of processing on complications., Methods: The authors retrospectively reviewed all alloplastic breast reconstructions with freeze-dried or ready-to-use human acellular dermal matrices between 2006 and 2016. The primary outcome measure was surgical-site occurrence defined as seroma, skin dehiscence, surgical-site infection, or reconstruction failure. The two groups were compared before and after propensity score matching., Results: The authors included 988 reconstructions (freeze-dried, 53.8 percent; ready-to-use, 46.2 percent). Analysis of 384 propensity score-matched pairs demonstrated a slightly higher rate of surgical-site occurrence (21.4 percent versus 16.7 percent; p = 0.10) and surgical-site infection (9.6 percent versus 7.8 percent; p = 0.13) in the freeze-dried group than in the ready-to-use group, but the difference was not significant. However, failure was significantly higher for the freeze-dried versus ready-to-use group (7.8 percent versus 4.4 percent; p = 0.050)., Conclusions: This is the largest study comparing the outcomes of alloplastic breast reconstruction using human acellular dermal matrix materials prepared by different methods. The authors demonstrated higher early complications with aseptic, freeze-dried matrix than with sterile ready-to-use matrix; reconstructive failure was the only outcome to achieve statistical significance. The authors conclude that acellular dermal matrix preparation has an independent impact on patient outcomes in their comparison of one company's product., Clinical Question/level of Evidence: Therapeutic, III.

Background: Tracking world cases of breast implant-associated anaplastic large cell lymphoma (ALCL) is currently limited to patient registries at a few academic centers, dependent upon patient referral and case reports in the literature. The purpose of this study was to review and compare federal database adverse event reports of breast implant-associated ALCL encompassing the major breast implant markets worldwide., Methods: Federal implantable device regulatory bodies were contacted and database queries were performed for 40 countries. Demographics, device characteristics, pathology, treatment modalities, and outcomes were assessed when available., Results: For the countries queried, 363 unique cases were reported for breast implant-associated ALCL. Search terms "anaplastic" and "ALCL" were queried of the U.S. Manufacturer and User Facility Device Experience (MAUDE) database and yielded 258 unique cases as of September 2015, of which only 130 had pathologic markers performed. Implant surface was textured significantly more than smooth (50 percent versus 4.2 percent; p = 0.0001). Treatment, when reported (n = 136), included explantation [n = 125 (91.9 percent)], chemotherapy [n = 42 (30.8 percent)], radiation therapy [n = 25 (18.4 percent)], and/or stem cell transplant [n = 9 (6.6 percent)], and five deaths were reported., Conclusions: Federal reporting of breast implant-associated ALCL has limitations in providing clinical history, treatment, and oncologic follow-up. Worldwide and country-specific total and textured implant sales data are needed to determine critical incidence and prevalence analysis. International multi-institutional collaborations and centralized tissue consortiums working in concert with federal authorities are necessary to acquire accurate complete data on breast implant-associated ALCL.

Background: Breast implant-associated anaplastic large cell lymphoma (ALCL) is a distinctive type of T-cell lymphoma that arises around breast implants. Although rare, all cases with adequate history have involved a textured breast implant. The objective of this study was to determine the U.S. incidence and lifetime prevalence of breast implant-associated ALCL in women with textured breast implants., Methods: This is a retrospective review of documented cases of breast implant-associated ALCL in the United States from 1996 to 2015. The incidence and prevalence were determined based on a literature and institutional database review of breast implant-associated ALCL cases and textured breast implant sales figures from implant manufacturers' annualized data., Results: One hundred pathologically confirmed breast implant-associated ALCL cases were identified in the United States. Mean age at diagnosis was 53.2 ± 12.3 years. Mean interval from implant placement to diagnosis was 10.7 ± 4.6 years. Forty-nine patients had breast implants placed for cosmetic reasons, 44 for mastectomy reconstruction, and seven for unknown reasons. Assuming that breast implant-associated ALCL occurs only in textured breast implants, the incidence rate is 2.03 per 1 million person-years (203 per 100 million person-years), which is 67.6 times higher than that of primary ALCL of the breast in the general population (three per 100 million per year; p < 0.001). Lifetime prevalence was 33 per 1 million persons with textured breast implants., Conclusions: This study demonstrates a statistically significant association between textured breast implants and breast implant-associated ALCL. Although women with a textured breast implant have a low risk of developing breast implant-associated ALCL, the current U.S. incidence is significantly higher than that of primary ALCL of the breast in the general population.

Breast implant-associated anaplastic large cell lymphoma (ALCL) is a rare T-cell lymphoma arising around breast implants. Public awareness has increased following a safety communication warning of the association of breast implant-associated ALCL by the U.S. Food and Drug Administration in 2011. Difficulty with determining an accurate assessment of risk, including diagnosis, or standardized treatment regimen has led surgeons to commonly omit preoperative discussion of this rare and frequently misunderstood cancer. Risk disclosure is a form of respect for patient autonomy, and informed consent has positive practical and moral consequences for the practice of plastic surgery. A model of breast implant-associated ALCL informed consent implementation and health care provider education are reviewed with 1-year process follow-up at a tertiary cancer center. Breast implant-associated ALCL should be included during preoperative counseling on the risks of breast implantation when obtaining informed consent. Pertinent aspects of decision-making include disease awareness, presenting symptoms, and resources for concerned patients. Education of health care professionals and provision of patient-focused materials ensures effectiveness of the informed consent process.

Purpose: Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach., Patients and Methods: In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention., Results: The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy., Conclusion: Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL., Competing Interests: Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article., (© 2015 by American Society of Clinical Oncology.)