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.

Breast Implant-Associated Anaplastic Large-Cell Lymphoma: Updated Systematic Review and Analysis of Treatment Strategies.

BACKGROUND: Although guidelines have been published on treatment of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), there has been no comprehensive analysis of BIA-ALCL treatment variation based on the available literature. The authors sought to assess current treatment strategies of BIA-ALCL relative to current guidelines. METHODS: Database searches were conducted in June of 2020. Included articles were case reports and case series with patient-level data. Collected variables included clinicopathologic features, implant characteristics, diagnostic tests, ALCL characteristics, treatment, and details of follow-up and outcome. Treatment data from before and after 2017 were compared with National Cancer Center Network guidelines. RESULTS: A total of 89 publications were included and 178 cases of BIA-ALCL were identified. Most patients presented with seroma ( n = 114, 70.4 percent), followed by a mass ( n = 14, 8.6 percent), or both ( n = 23, 14.2 percent). Treatment included en bloc capsulectomy of the affected implant in 122 out of 126 cases with treatment details provided (96.8 percent). Radiation therapy was given in 38 cases (30.2 percent) and chemotherapy was given in 71 cases (56.3 percent). Practitioners used less chemotherapy for local disease after treatment guideline publication in 2017 ( p < 0.001), whereas treatment for advanced disease remained unchanged ( p = 0.3). There were 10 recurrences and eight fatalities attributable to BIA-ALCL, which were associated with advanced presentation (29 versus 2.1 percent; OR, 19.4; 95 percent CI, 3.9 to 96.3; p < 0.001). CONCLUSIONS: BIA-ALCL remains a morbid but treatable condition. Current guidelines focus treatment for local disease and reduce nonsurgical interventions with radiation or chemotherapy. Patients presenting with advanced BIA-ALCL experience higher rates of recurrence and mortality.

Reflections on a Career in Plastic Surgery: A National Survey of Retired Surgeons.

Introduction: Retired plastic surgeons can provide valuable insights for the greater plastic surgery community. The purpose of this study was to gather demographics, personal reflections, and advice for a career in plastic surgery from retired American plastic surgeons. Methods: An email survey was distributed to 825 members of the American Society of Plastic Surgeons during September 2021. The survey distribution was designed to engage members of the plastic surgery community, who were retired from surgical practice in the United States. The form consisted of 29 questions, five of which were free response. Descriptive statistical analyses were performed. Results: A total of 214 completed surveys were received, with a response rate of 25.9%. The average age at retirement was 67.6 years. The majority of respondents were men (87.6%) and White (93.3%); 46.9% of surgeons practiced at individual private practice. Ninety percent of surgeons indicated that they would choose to practice as a plastic surgeon again. Free responses provided positive career reflections and advice for young plastic surgeons regarding navigating the changing landscape of healthcare. Conclusions: Retired plastic surgeons are interested in engaging with the plastic surgery community and demonstrate continued interest in the future of the field. Efforts can be made to avail the field of their expertise and experience.

Understanding Breast Implant-Associated Illness: A Delphi Survey Defining Most Frequently Associated Symptoms.

BACKGROUND: Increased understanding of the constellation of symptoms referred to as breast implant illness is necessary to better address patient concerns, provide evidence-based care, and inform prospective patients about potential risks. The aim of this study was to reach consensus on the symptoms most frequently associated with breast implant illness, which will subsequently inform the development of a symptom severity scale. METHODS: A literature search of peer-reviewed and gray literature was performed to identify a comprehensive list of symptoms associated with breast implant illness. This was followed by an online, three-round, modified Delphi survey where the list of symptoms was reviewed by an international panel to determine the top 20, 10, and five symptoms associated with breast implant illness. A virtual meeting of panelists was held to reach consensus on the symptoms to be included in a symptom severity scale. RESULTS: A total of 44 symptoms were identified through the literature search. The modified Delphi survey panel consisted of patient research partners [n = 9 (34.6 percent)], plastic surgeons [n = 10 (38.5 percent)], researchers [n = 6 (23.1 percent)], and a member of the U.S. Food and Drug Administration [n = 1 (3.8 percent)]. The response rates of round 1, 2, and 3 were 85, 96, and 100 percent, respectively. Consensus was reached on the top 19 and top six symptoms to be included in long and short forms of a symptom severity scale. CONCLUSIONS: There was a high level of agreement on the symptoms to be included in a symptom severity scale. The next steps include conducting in-depth qualitative interviews with women with these symptoms and breast implants to understand the experience and impact of these symptoms and develop the preliminary scale.

Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Initial Report of Findings, 2012-2018.

BACKGROUND: In January of 2011, the US Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large cell lymphoma (ALCL). In August of 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 a patient registry entitled the "Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology" (PROFILE). METHODS: The first report of the registry findings is presented here. RESULTS: From August of 2012 to March of 2018, a total of 186 distinct cases of breast implant-associated ALCL (BIA-ALCL) in the United States were reported to PROFILE. At the time of this present analysis, complete detailed case report forms have been received for 89 (48%) cases. Median time from implantation of any device to BIA-ALCL diagnosis was 11.0 years (range = 2-44 years; n = 89). At the time of presentation, 96% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was a periprosthetic fluid collection seen in 86% of patients. All patients had a history of a textured device; there were no patients who had a smooth-only device history. At the time of initial case report submission, 3 deaths were reported. CONCLUSIONS: The PROFILE Registry has shown to be an essential tool in unifying the collection of data pertaining to BIA-ALCL. These data have broadened our understanding of the disease and emphasize the critical importance of detailed tracking of BIA-ALCL cases.