Moving towards patient-reported outcomes in routine clinical practice: implementation lessons from the BREAST-Q.

PURPOSE: Longitudinal, routine utilization of patient-reported outcome measures (PROMs) in clinical care has been challenging. The purpose of this study is to describe a quality improvement initiative to improve patient engagement with the BREAST-Q, a gold-standard PROM for breast reconstruction. METHODS: In 2011, we implemented the BREAST-Q as part of routine care. In 2018, we began a quality improvement initiative to increase BREAST-Q patient participation. The BREAST-Q was administered at every clinic visit via an institutional patient portal or an in-clinic tablet; digital dashboard technologies were used to improve workflow integration, real-time accountability, and immediate data availability at clinic visits. High clinical staff engagement was encouraged by assigning "BREAST-Q Champions." BREAST-Q completion data and patient characteristics were examined to understand non-response to the assessment. RESULTS: Following quality improvement, the average annual BREAST-Q completion rate increased from 42.8% in 2011-2017 to 87.6% in 2019, the last full year of our study period. High completion rates were maintained January-July 2020; however, a significantly larger proportion of BREAST-Qs were completed at home in 2020 versus the same period in 2019 (49.7 vs. 38.8%, p < 0.001), potentially due to the COVID-19 pandemic. Compared with non-responders, responders were younger (49.7 vs. 52.2 years, p < 0.001), more likely to be white (76.9 vs. 73.6%, p < 0.001), and had private insurance (79.4 vs. 69.8%, p < 0.001). CONCLUSION: Our quality improvement initiative successfully increased routine completion of the BREAST-Q. Similar implementation techniques may prove beneficial at other institutions interested in incorporating PROMs into routine care.

Autoimmune Disease and Breast Implants: Systematic Review of Outcomes.

ABSTRACT: Given that the use of breast implants for both cosmetic and reconstructive purposes is growing in the United States, an evaluation of factors that may affect the outcome of breast implant surgery is needed. A systematic review was conducted to evaluate the question: Does a personal or family history of autoimmune disease affect outcomes in breast implant surgery? The literature search yielded 2425 records, but after removal of duplicates, abstract screening, and full-text assessment, only 2 studies met the inclusion criteria for the final review. Both studies provided level III evidence and the average Methodological Index for Non-Randomized Studies score was 16.5 (range, 15-18 of 24), indicating a fair level of evidence overall. This systematic review found no evidence to support that a diagnosis of an autoimmune disease and/or a family history of autoimmune diseases will lead to poor surgical outcomes in breast implant surgery. Further study is warranted.

BREAST-Q REACT: Clinical Reference Values for the BREAST-Q in Post-mastectomy Breast Reconstruction Patients.

BACKGROUND: The BREAST-Q is the most commonly used patient-reported outcome measure (PROM) for breast reconstruction research. However, clinical implementation of this PROM has been impeded by a lack of context for score interpretation. The aim of this study was to define reference values for the BREAST-Q at discrete timepoints following surgery, generating a tool for real-time score interpretation. METHODS: BREAST-Q scores were prospectively obtained in women who underwent implant or autologous post-mastectomy breast reconstruction preoperatively and for 2 years following surgery at Memorial Sloan Kettering Cancer Center (MSK). Descriptive statistics were used to create reference values for BREAST-Q satisfaction and quality-of-life subscales. Reference values were externally validated by comparing patient characteristics and BREAST-Q scores between the MSK and the Mastectomy Reconstruction Outcomes Consortium (MROC) study cohorts. RESULTS: Overall, 3268 MSK patients and 2814 MROC patients were included for analysis. When MSK and MROC cohorts were compared for validation, there were some statistical differences in BREAST-Q scores; however, most of these differences did not meet the minimal clinically important difference of 4 points. Reference values were used to create the BREAST-Q Real-time Engagement and Communication Tool (REACT). CONCLUSIONS: Using a large cohort of patients, we have defined BREAST-Q reference values for post-mastectomy breast reconstruction patients for use in clinical practice. The BREAST-Q REACT will help breast reconstruction providers gauge patient wellbeing and satisfaction relative to the "average" breast reconstruction patient and determine which patients may benefit from additional intervention.

Matched Preliminary Analysis of Patient-Reported Outcomes following Autologous and Implant-Based Breast Reconstruction.

BACKGROUND: Comparisons of autologous breast reconstruction (ABR) and implant-based breast reconstruction (IBR) involve unavoidable confounders, which are often adjusted for in post hoc regression analyses. This study compared patient-reported outcomes between ABR patients and IBR patients by using propensity score matching to control for confounding variables upfront. METHODS: Propensity score matching analysis (2:1 nearest-neighbor matching with replacement) was performed for patients who underwent ABR or IBR without radiotherapy. Matched covariates included age, body mass index, history of psychiatric diagnosis, race-ethnicity, smoking status, and laterality of reconstruction. Outcomes of interest were BREAST-Q questionnaire scores for breast satisfaction and well-being. RESULTS: Of the 2334 patients identified, 427 were included in the final analysis: 159 who underwent ABR and 268 who underwent IBR. The ABR group matched the IBR group in the selected characteristics. ABR patients did not differ significantly from IBR patients in breast satisfaction or well-being at either 1 or 2 years after reconstructive surgery. CONCLUSIONS: This preliminary analysis of immediate breast reconstruction patients not requiring radiation therapy with similar propensities for ABR or IBR suggests comparable levels of breast satisfaction and well-being within 2 years after reconstructive surgery. Further research is needed with larger sample sizes, statistical power, and follow-up to better understand patient reported outcomes in this population, as the current findings differ from studies where patients were not matched on baseline characteristics.

Breast Implant-associated Anaplastic Large Cell Lymphoma Incidence: Determining an Accurate Risk.

OBJECTIVE: This study sought to estimate the incidence and incidence rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) at a high-volume single institution, which enables vigorous long-term follow-up and implant tracking for more accurate estimates. SUMMARY BACKGROUND DATA: The reported incidence of BIA-ALCL is highly variable, ranging from 1 in 355 to 1 in 30,000 patients, demonstrating a need for more accurate estimates. METHODS: All patients who underwent implant-based breast reconstruction from 1991 to 2017 were retrospectively identified. The incidence and incidence rate of BIA-ALCL were estimated per patient and per implant. A time-to-event analysis was performed using the Kaplan-Meier estimator and life table. RESULTS: During the 26-year study period, 9373 patients underwent reconstruction with 16,065 implants, of which 9589 (59.7%) were textured. Eleven patients were diagnosed with BIA-ALCL, all of whom had a history of textured implants. The overall incidence of BIA-ALCL was 1.79 per 1000 patients (1 in 559) with textured implants and 1.15 per 1000 textured implants (1 in 871), with a median time to diagnosis of 10.3 years (range, 6.4-15.5 yrs). Time-to-event analysis demonstrated a BIA-ALCL cumulative incidence of 0 at up to 6 years, increasing to 4.4 per 1000 patients at 10 to 12 years and 9.4 per 1000 patients at 14 to 16 years, although a sensitivity analysis showed loss to follow-up may have skewed these estimates. CONCLUSIONS: BIA-ALCL incidence and incidence rates may be higher than previous epidemiological estimates, with incidence increasing over time, particularly in patients exposed to textured implants for longer than 10 years.

The Impact of Obesity on Patient-Reported Outcomes Following Autologous Breast Reconstruction.

BACKGROUND: Obesity is a significant public health concern and clear risk factor for complications following breast reconstruction. To date, few have assessed patient-reported outcomes (PROs) focused on this key determinant. OBJECTIVE: Our study aimed to investigate the impact of obesity (body mass index ≥ 30) on postoperative satisfaction and physical function utilizing the BREAST-Q in a cohort of autologous breast reconstruction patients. METHODS: An Institutional Review Board-approved prospective investigation was conducted to evaluate PROs in patients undergoing autologous breast reconstruction from 2009 to 2017 at a tertiary academic medical center. The BREAST-Q reconstruction module was used to assess outcomes between cohorts preoperatively and at 6 months, 1 year, 2 years, and 3 years after reconstruction. RESULTS: Overall, 404 patients underwent autologous breast reconstruction with abdominal free-tissue transfer (244 non-obese, 160 obese) and completed the BREAST-Q. Although obese patients demonstrated lower satisfaction with breasts preoperatively (p = 0.04), no significant differences were noted postoperatively (p = 0.58). However, physical well-being of the abdomen was lower in the obese cohort compared with their non-obese counterparts at long-term follow-up (3 years; p = 0.04). CONCLUSION: Obesity significantly impacts autologous breast reconstruction patients. Although obese patients are more likely to present with dissatisfaction with breasts preoperatively, they exhibit comparable PROs overall compared with their non-obese counterparts, despite increased complications.

Long-term Patient-reported Outcomes Following Postmastectomy Breast Reconstruction: An 8-year Examination of 3268 Patients.

OBJECTIVE: To better understand the long-term patient-reported outcomes (PROs) in satisfaction and health-related quality of life (QOL) following post-mastectomy reconstruction (PMR) using the BREAST-Q, comparing PROs from patients undergoing implant-based breast reconstruction (IBR) or autologous breast reconstruction (ABR). SUMMARY OF BACKGROUND DATA: Multiple studies have demonstrated growth in mastectomy rates and concurrent increase in PMR utilization. However, most studies examining PMR PROs focus on short postoperative time periods-mainly within 2 years. METHODS: BREAST-Q scores from IBR or ABR patients at a tertiary center were prospectively collected from 2009 to 2017. Mean scores and standard deviations (SDs) were calculated for satisfaction with breast, satisfaction with outcome, psychosocial well-being, physical well-being of the chest, and sexual well-being. Satisfaction with breasts and physical well-being of the chest were compared using regression models at postoperative years 1, 3, 5, and 7. RESULTS: Overall, 3268 patients were included, with 336 undergoing ABR and 2932 undergoing IBR. Regression analysis demonstrated that ABR patients had greater postoperative satisfaction with breast scores at all timepoints compared with IBR patients. Postoperative radiation and mental illness adversely impacted satisfaction with breast scores. Furthermore, mental illness impacted physical wellbeing of the chest at all timepoints. IBR patients had satisfaction scores that remained stable over the study period. CONCLUSION: This study presents the largest prospective examination of PROs in PMR to date. Patients who opted for ABR had significantly higher satisfaction with their breast and QOL at each assessed time point, but IBR patients had stable long-term satisfaction and QOL postoperatively.

Impact of Bilateral Prophylactic Mastectomy and Immediate Reconstruction on Health-Related Quality of Life in Women at High Risk for Breast Carcinoma: Results of the Mastectomy Reconstruction Outcomes Consortium Study.

BACKGROUND: Although bilateral prophylactic mastectomy (BPM) can reduce the risk of breast cancer, the decision to proceed surgically can have significant consequences and requires careful deliberation. To facilitate decision making for women at high risk for breast carcinoma, the risks and benefits of BPM should be well-elucidated. We sought to determine the effects of BPM and immediate reconstruction on health-related quality-of-life outcomes among a multisite cohort of women at high risk for breast carcinoma. METHODS: Patient-reported outcome data were prospectively collected as part of the Mastectomy Reconstruction Outcomes Consortium Study, and data on a subgroup of 204 high-risk women who elected to have BPM and immediate reconstruction were evaluated. Baseline scores were compared with scores at 1 or 2 years after reconstruction. RESULTS: Satisfaction with breasts and psychosocial well-being were significantly higher at both 1 and 2 years (p < 0.01); however, anxiety was significantly lower at 1 or 2 years (p < 0.01) and physical well-being of the chest and upper body was significantly worse at 1 year (p < 0.01). CONCLUSION: Our results highlight the impact of BPM and immediate reconstruction on health-related quality-of-life outcomes in this setting. BPM and reconstruction can result in significant, positive, lasting changes in a woman's satisfaction with her breasts, as well as her psychosocial well-being. Furthermore, presurgery anxiety was significantly reduced by 1 year post-reconstruction and remained reduced at 2 years. With this knowledge, women at high risk for breast carcinoma, and their providers, will be better equipped to make the best individualized treatment decisions.

Quality of life among patients after bilateral prophylactic mastectomy: a systematic review of patient-reported outcomes.

PURPOSE: Bilateral prophylactic mastectomy (BPM) is effective in reducing the risk of breast cancer in women with a well-defined family history of breast cancer or in women with BRCA 1 or 2 mutations. Evaluating patient-reported outcomes following BPM are thus essential for evaluating success of BPM from patient's perspective. Our systematic review aimed to: (1) identify studies describing health-related quality of life (HRQOL) in patients following BPM with or without reconstruction; (2) assess the effect of BPM with or without reconstruction on HRQOL; and (3) identify predictors of HRQOL post-BPM. METHODS: We performed a systematic review of literature using the PRISMA guidelines. PubMed, Embase, PsycINFO, Web of Science, Scopus and Cochrane databases were searched. RESULTS: The initial search resulted in 1082 studies; 22 of these studies fulfilled our inclusion criteria. Post-BPM, patients are satisfied with the outcomes and report high psychosocial well-being and positive body image. Sexual well-being and somatosensory function are most negatively affected. Vulnerability, psychological distress and preoperative cancer distress are significant negative predictors of quality of life and body image post-BPM. CONCLUSION: There is a paucity of high-quality data on outcomes of different HRQOL domains post-BPM. Future studies should strive to use validated and breast-specific PRO instruments for measuring HRQOL. This will facilitate shared decision-making by enabling surgeons to provide evidence-based answers to women contemplating BPM.

Successful Salvage of Late Anastomotic Thrombosis after Free Tissue Transfer.

Background Anastomotic thrombosis following free tissue transfer (FTT) on or after day 5 ("late thrombosis") is reported to have extremely low rates of salvage. Analysis of our institution's experience with FTT was performed to make recommendations about the optimal management of late thrombosis, and to identify any variables that are correlated with increased salvage rates. Methods The study included patients who underwent FTT between 1986 and 2014, then suffered anastomotic thrombosis on or after postoperative day 5. Twenty-six variables involving demographic information, flap characteristics, circumstances of the thrombotic event, and details of any salvage attempt were analyzed. Patients whose FTT were successfully salvaged and those whose were not were statistically compared. Results Of the 3,212 patients who underwent FTT, 23 suffered late thrombosis (0.7%), and the salvage rate was 60.8% (14 of 23). The salvage rate for reconstruction of the head and neck was 53.3%, breast was 66.7%, and extremity was 100%. There was a statistically significantly greater salvage rate in flaps performed after 1998 than in those performed before 1998 (p = 0.023). There was a nonstatistically significant trend toward increased salvage rates in patients who had no anastomotic thrombotic risk factors, reconstruction using fasciocutaneous flaps, and anastomotic revision using new recipient vessels. Conclusion Our data demonstrate that flap survival after episodes of late thrombosis can be higher than what the literature has previously reported. This underscores the importance of rigorous postoperative monitoring, as well as the importance of exploration at the earliest instance of concern for threatened flap viability.

Venous Thrombosis in Handsewn versus Coupled Venous Anastomoses in 857 Consecutive Breast Free Flaps.

BACKGROUND: The anastomotic coupling device has demonstrated safety and efficacy; however, the coupler has never been compared directly to handsewn venous anastomoses exclusively in breast reconstruction. We hypothesized that rates of venous thrombosis would be lower using the coupler versus handsewn anastomoses in free flap breast reconstruction. METHODS: We performed a retrospective review utilizing clinic records, hospital records, and operative reports for 857 consecutive breast free flaps at a single institution from 1997 to 2012. Data were collected on reconstruction type, recipient vessels, timing, laterality, preoperative radiation, chemotherapy, venous thrombosis, and flap outcome. We compared rates of venous thrombosis between handsewn and coupled anastomoses for breast free flaps. Chi-square test was used to calculate statistical significance. RESULTS: A total of 857 consecutive free flaps were performed for breast reconstruction in 647 patients over 16 years. The venous anastomosis was handsewn in 303 flaps, and the anastomotic coupler was used in 554 flaps. The rate of venous thrombosis requiring anastomotic revision in the handsewn group was 0.04% (12/303), compared with 0.01% in the coupled group (8/554; p = 0.02). CONCLUSION: The anastomotic coupler was more effective in preventing venous thrombosis than handsewn anastomoses in our series. While our study demonstrates improved patency rates using the venous coupler in breast reconstruction, we were unable to definitively separate this finding from potential confounding variables due to the low rates of thrombosis in both the groups. Our data are consistent with current literature, which suggests that the coupler is a safe and effective alternative to hand sutured anastomoses.

Safety of the supraclavicular artery island flap in the setting of neck dissection and radiation therapy.

BACKGROUND: The supraclavicular artery island flap (SAIF) has recently been repopularized as a versatile and reliable option for reconstruction of oncological head and neck defects. Prior ipsilateral neck dissection or irradiation is considered a relative contraindication to its use. The aim of this study was to describe the safety and utility of the SAIF for head and neck reconstruction in the setting of neck dissection and radiation. METHODS: A retrospective chart review was performed of consecutive SAIF reconstructions at two institutions between May 2011 and 2014. In addition to demographic data, comorbidities, indications, surgical characteristics, data about radiation treatment, and neck dissection were specifically recorded. Donor and recipient site complications were noted. Fisher exact test was performed to analyze if neck dissection or radiation were associated with complications. RESULTS: A total of 22 patients underwent SAIF reconstruction for an array of head and neck defects. Donor site infection was noted in one patient. Recipient site complications included, wound dehiscence (n = 2), orocutaneous fistula (n = 1), carotid blowout (n = 1), and total flap loss (n = 1). There was no association between prior neck dissection or radiation treatment and flap loss (p = 1.00). CONCLUSION: The SAIF is safe for use in patients who have had an ipsilateral neck dissection involving level IV or V lymph nodes and/or radiation treatment to the neck. It can be used alone or in combination with other flaps for closure of a variety of head and neck defects.

Chest and upper body morbidity following immediate postmastectomy breast reconstruction.

OBJECTIVE: The performance of a mastectomy for the treatment or prophylaxis of breast cancer may have long-term implications for both physical and mental well-being in women. The development of breast numbness and phantom breast sensations following mastectomy is well-known; however, relatively little is known about physical morbidity following postmastectomy breast reconstruction. The primary objective of this study was to evaluate the level of physical morbidity experienced following three surgical approaches: mastectomy alone, postmastectomy tissue expander/implant reconstruction, and postmastectomy autogenous tissue reconstruction. METHODS: We conducted a cross-sectional survey of a sample of women who had undergone mastectomy with or without reconstruction. Chest and upper body morbidity were evaluated using the BREAST-Q. Physical well-being was compared across three types of breast surgery. RESULTS: In total, 308 of 452 women who received a questionnaire booklet returned completed questionnaires. There was an overall difference in physical morbidity attributable to surgical treatment (P < 0.001). Patients who underwent autogenous tissue reconstruction had the highest (i.e., best) mean physical well-being score. Women who underwent expander/implant reconstruction also had less chronic physical morbidity than women who underwent mastectomy alone (P < 0.05). CONCLUSIONS: Our findings suggest that women who undergo immediate autogenous tissue reconstruction experience significantly less chest and upper body morbidity than those who undergo either mastectomy with implant-based reconstruction or mastectomy alone. This information can be used to facilitate clinical decision-making, to validate individual experiences of breast cancer survivors, and to inform future innovations to decrease the long-term physical morbidity associated with breast cancer surgery.

Implant breast reconstruction and radiation: a multicenter analysis of long-term health-related quality of life and satisfaction.

BACKGROUND: Indications for radiotherapy in breast cancer treatment are expanding. Long-term satisfaction and health-related quality of life (HR-QOL), important outcomes after alloplastic breast reconstruction and radiation, have not been measured in irradiated patients by using a condition-specific, validated patient-reported outcomes instrument. The aim was to evaluate patient satisfaction and HR-QOL in patients with implant breast reconstruction and radiotherapy. METHODS: A multicenter cross-sectional survey of patients who underwent implant-based breast reconstruction from three centers in the United States and Canada, with and without radiation, was performed. Satisfaction with breasts, satisfaction with outcome, psychosocial well-being, sexual well-being, and physical well-being outcomes were evaluated using the BREAST-Q(©) (Reconstruction Module). Multivariable analysis was performed to evaluate the effect of radiotherapy on patient satisfaction with breasts with adjustment by patient and treatment characteristics. RESULTS: The response rate was 71 %, with 633 completed questionnaires returned. Mean follow-up was 3.3 years for irradiated patients (n = 219) and 3.7 years for nonirradiated patients (n = 414). Patients with radiation had significantly lower satisfaction with breasts (58.3 vs. 64.0; p < 0.01), satisfaction with outcome (66.8 vs. 71.4; p < 0.01), psychosocial well-being (66.7 vs. 70.9; p < 0.01), sexual well-being (47.0 vs. 52.3; p < 0.01), and physical well-being (71.8 vs. 75.1; p < 0.01) compared with nonirradiated patients. Multivariable analysis confirmed the negative effect of radiotherapy on satisfaction with breasts (ß = -2.6; p = 0.03) when adjusted for patient and treatment factors. CONCLUSIONS: Radiotherapy has a negative effect on HR-QOL and satisfaction with breasts in patients with implant reconstruction compared with nonirradiated patients. The information provided here can inform decision-making and help set appropriate expectations for patients undergoing implant breast reconstruction and radiation.

Textured versus Smooth Tissue Expanders: A Comparison of Complications in 3526 Breast Reconstructions.

BACKGROUND: Increased understanding of breast implant-associated anaplastic large-cell lymphoma has led to a shift away from textured breast devices. A few small studies have compared the complication rates of textured and smooth tissue expanders (TEs). The aim of this study was to compare complication profiles in patients undergoing two-stage postmastectomy breast reconstruction with either textured or smooth TEs. METHODS: The authors performed a retrospective review of female patients who underwent immediate breast reconstruction with textured or smooth TEs from 2018 to 2020 at their institution. Rates of seroma, infection/cellulitis, malposition/rotation, exposure, and TE loss were analyzed in the overall cohort and subgroups undergoing prepectoral and subpectoral TE placement. A propensity score-matched analysis was used to decrease the effects of confounders comparing textured and smooth TEs. RESULTS: The authors analyzed 3526 TEs (1456 textured and 2070 smooth). More frequent use of acellular dermal matrix, SPY angiography, and prepectoral TE placement was noted in the smooth TE cohort ( P < 0.001). Univariate analysis suggested higher rates of infection/cellulitis, malposition/rotation, and exposure in smooth TEs (all P < 0.01). Rates of TE loss did not differ. After propensity matching, no differences were noted in infection or TE loss. Prepectoral smooth expanders had increased rates of malposition/rotation. CONCLUSIONS: TE surface type did not affect rates of TE loss, although increased rates of expander malposition were noted in the smooth prepectoral cohort. Further research is needed to examine breast implant-associated anaplastic large-cell lymphoma risk with temporary textured TE exposure to improve decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCW: Therapeutic, III.

Breast Implant Associated Anaplastic Large Cell Lymphoma: Evidence-Based Consensus Conference Statement From The American Association of Plastic Surgeons.

BACKGROUND: In the absence of high-quality evidence, there is a need to provide guidelines and multidisciplinary consensus recommendations on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The purpose of this expert consensus conference was to evaluate the existing evidence regarding the diagnosis, and management of BIA-ALCL caused by textured implants. The aim is to provide evidence-based recommendations regarding the management and prevention of BIA-ALCL. METHODS: A comprehensive search was conducted in the MEDLINE, Cochrane Library, and Embase databases, supplemented by manual searches of relevant English language articles and "related articles" sections. Studies focusing on breast surgery and lymphoma associated with breast implants were included for analysis. Meta-analyses were performed and reviewed by experts selected by the American Association of Plastic Surgeons by a Delphi consensus method. RESULTS: 840 articles between January 2011 and January 2023 were initially identified and screened. Full-text of 188 articles were assessed. An additional 43 articles were excluded for focus, and 145 articles were included in the synthesis of results, with 105 of them being case reports or case series. The analysis encompassed a comprehensive examination of the selected articles to determine the incidence, risk factors, clinical presentation, diagnostic approaches, and treatment modalities related to BIA-ALCL. CONCLUSIONS: Plastic surgeons should be aware of the elevated risks by surface type, implement appropriate patient surveillance, and follow the recommendations outlined in this statement to ensure patient safety and optimize outcomes. Ongoing research on pathogenesis, genetic drivers, and preventative and prophylactic measures is crucial for improving patient care.

Clinical Implications and Management of Non-BIA-ALCL Breast Implant Capsular Pathology.

SUMMARY: The breast implant capsule is a dynamic structure that forms following the implantation of a device. Although normally benign, increased awareness of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) highlights that disease may arise from the capsule. BIA-ALCL presents as a late seroma or mass but explains few of the late seromas found in breast implant patients. To date, many of these seromas lack a clear cause and are often described as "idiopathic." Several benign and malignant breast implant capsular diseases can cause a late seroma or mass, including breast implant-associated squamous cell carcinoma. Similar to early reports of BIA-ALCL, these conditions are rare and largely limited to case reports or series. The purpose of this special topic is to present a narrative review highlighting capsular abnormalities that contribute to the formation of late seroma or mass in an attempt to broaden the differential diagnosis and help plastic surgeons identify the cause. Specifically, we review the presentation and management of BIA-ALCL, synovial metaplasia, capsular epithelialization, late hematoma, double capsule, breast cancer, squamous cell carcinoma, mesenchymal tumor, and B-cell lymphoma. Although rare, plastic surgeons should consider these capsular conditions as causes of late seromas and masses. Usually, these conditions may be diagnosed by following the National Comprehensive Cancer Network screening guidelines for BIA-ALCL. Thorough evaluation and workup of late seromas and masses may lead to improved characterization of these rare breast implant capsular conditions and improve our understanding of their pathophysiology and management.

Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated Report 2012-2020.

BACKGROUND: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry. METHOD: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication. RESULTS: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification). CONCLUSIONS: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL.