Postmarket Study of Silimed's Silicone Gel Polyurethane Foam-covered Breast Implants: Interim Results (2018-2024)

Silimed silicone gel polyurethane (PU) foam-covered breast implants are used worldwide. There is extensive clinical experience with the long-term use of these implants, but scientific evidence on this topic remains limited. This report assessed the interim data on the performance and safety of these implants.

This is a postmarketing, phase IV, open-label, nonrandomized, single-arm trial. Participants were selected consecutively based on their attendance at the research center during the enrollment period. The main eligibility criteria were primary or revision augmentation and the absence of conditions possibly increasing the short-term risk of adverse events. Silimed's PU breast implants were the intervention. Safety was assessed by monitoring adverse events. Outcomes of major interest were implant rupture, reoperation, and capsular contracture. Efficacy was measured through satisfaction, and quality of life was measured by the BEQ55 questionnaire. Patient demographics, surgical details, implant characteristics, and postoperative results were recorded.

This study enrolled 342 patients. The satisfaction rate was 88.69% for primary augmentation and 86.00% for revision. After 5 years, no instances of capsular contracture or implant rupture were reported. Reoperations occurred in 1.76%: 5 involved implant replacement, and 1 did not. The seromas identified during the study occurred within 8 weeks after surgery; therefore, there were no cases of breast implant-associated anaplastic large cell lymphoma .

Silimed PU breast implants demonstrated favorable safety and high efficacy over the follow-up period. The low incidence of capsular contracture and the absence of breast implant-associated anaplastic large cell lymphoma support the use of PU implants in breast augmentation.