Evaluation Of Outcomes In Breast Reconstruction Patients Following Textured Implant Exposure: A 25-year Institutional Review

PURPOSE: An estimated 1 in 20 women globally are diagnosed with breast cancer in their lifetime, and for patients undergoing surgical intervention, breast implants are a common post-mastectomy option for reconstruction. In 2019, Biocell macrotextured breast implants and tissue expanders were recalled globally due to their association with an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This prompted the need to identify, educate, counsel, and follow-up patients with textured implants, both macro- and micro-textured. Evidence on long-term outcomes and management after textured implant exposure remains limited, reflecting gaps in post-market surveillance. To address this, we evaluated a 25-year institutional cohort of patients exposed to textured implants to assess outcomes, interventions, and the effectiveness of Textured Device Clinics. METHODS: Following the recall, patients with textured implants placed by senior authors between 2000-2020 were identified from operative logbooks, contacted and offered counseling, education, and clinical assessment through Textured Device Clinics. An Ethics Board approved retrospective review was conducted to evaluate clinical outcomes, patient disposition, and textured implant interventions, stratified by exposure duration (15 vs. ≥15-years) and recall period (pre- vs. post-2019). Surgical management options (implant exchange, explantation, and autologous reconstruction) were further compared across pre- and post-device recall periods. RESULTS: 288 patients were identified. Among 227 patients with follow-up data (n=181 with 15-years and n=46 with ≥15-years exposure; n=143 with Biocell and n=85 with microtextured implants), 61% (n=141) retained textured implants and 39% (n=86) terminated exposure through implant exchange (84%), explantation (8%), or autologous reconstruction (8%). Of those who underwent intervention (Table 1), 37% were exposed for 15-years and 41% were exposed for ≥15-years. Indications for intervention extended beyond BIA-ALCL risk and included symptomatic presentation (pain, swelling, rupture, contracture), recurrent breast cancer, cosmetic concerns, and anxiety related to textured device retention. Post-recall, implant exchange was the most frequent intervention in both exposure groups. Explantation and autologous reconstruction were less common overall but represented a higher proportion of procedures in patients with ≥15-years of exposure compared to those with shorter duration. Two BIA-ALCL cases occurred in patients (0.9%) with Biocell macrotextured implants exposed 15-years. Implant rupture (6.0%) was proportionally greater in the ≥15-year group. Overall, 66% attended a Textured Device Clinic, and patients with 15-years of exposure were more likely to retain textured implants (n=114, 63%). 88 patients (38.8%) have been lost to follow-up and 5 patients are deceased, with 134 patients (59%) continuing in long-term annual implant follow-up clinics. CONCLUSION: While BIA-ALCL is uncommon, textured device-related complications and management decisions continue to impact patients, and not all breast reconstruction patients desire surgical intervention. These findings highlight the need for ongoing surveillance of textured implant-related outcomes, increased survivorship resource support, and structured response when necessary to identify and counsel at-risk patients with medical devices. This data will inform shared decision-making and future time-to-event analyses to further characterize outcomes in textured implant management. Table 1. Outcomes and Surgical Management by Textured Implant Exposure Duration and Recall Period Clinical Outcome or Surgical Intervention 15 years textured breast implant exposure (n=181) n(%, CI) ≥15 years textured breast implant exposure (n=46) n(%, CI) Implant exchange pre-recall 16 (8.8%, CI 5.1-14.0%) 0 (0.0%, CI 0.0-7.7%) Implant exchange post-recall 42 (23.2%, CI 17.3-30.0%) 14 (30.4%, CI 17.7-45.8%) Explantation pre-recall 3 (1.7%, CI 0.3-4.8%) 0 (0.0%, CI 0.0-7.7%) Explantation post-recall 1 (0.6%, CI 0.0-3.0%) 3 (6.5%, CI 1.4-17.9%) Autologous reconstruction pre-recall 3 (1.7%, CI 0.3-4.8%) 0 (0.0%, CI 0.0-7.7%) Autologous reconstruction post-recall 2 (1.1%, CI 0.1-3.9%) 2 (4.3%, CI 0.5-14.8%) Patients planning surgical intervention 13 (7.2%, CI 3.9-12.0%) 4 (8.7%, CI 2.4-20.8%) Patients retaining textured implants 114 (63.0%, CI 55.5-70.0%) 27 (58.7%, CI 43.2-73.0%) Patients still in follow-up 88 (48.6%, CI 41.1-56.1%) 22 (47.8%, CI 32.9-63.1%) Implant rupture 10 (5.5%, CI 2.7-9.9%) 3 (6.5%, CI 1.4-17.9%) BIA-ALCL diagnosis 2 (1.1%, CI 0.1-3.9%) 0 (0.0%, CI 0.0-7.7%) Microtextured implant exposure 79 (43.6%, CI 36.3-51.2%) 6 (13.0%, CI 4.9-26.3%) Macrotextured implant exposure 102 (56.4%, CI 48.8-63.7%) 41 (89.1%, CI 76.4-96.4%)