Abstract P2-15-10: Impact of the withdrawal of textured breast implants from the market on breast reconstruction practices

Abstract

Abstract Background: In November 2018, the SOFCPRE (Société Française de chirurgie plastique, reconstructrice et esthétique) recommanded that textured Biocell© implants should no longer be used because of a potential risk of anaplastic large cell lymphoma (ALCL). This decision was confirmed in April 2019 by the French Medicines Agency (ANSM, Agence nationale de sécurité du médicament), and the French Medical Regulatory Authority. In the Georges-François Leclerc Cancer Center (Dijon, France), we suspended the use of textured Biocell© implants from November 2018 onwards, in favour of smooth surface, round implants. Objective: To assess the impact of textured implant withdrawal on surgical practices in breast reconstruction (BR) in a single French cancer center. Methods: This is a retrospective, single-centre study in the Georges-François Leclerc Cancer Center (Dijon, France). Surgical practices of BR and complications were compared between 2 periods: before the withdrawal of textured implants from the market (Period 1: September 2017-November 2017) and after (Period 2: December 2018-March 2020). Patients were included if they were operated on for the first time for immediate or secondary BR in either period. Univariate analysis was performed to compare before vs after groups, and to analyse surgical practices (rates of autologous techniques and breast implant) of BR and complications ((defined as any complication grade IIIB or higher according to the Clavien Dindo classification) between the 2 periods. Results: Data from 168 and 159 BR were collected from Periods 1 and 2 respectively. Characteristics were comparable between groups.The rate of BR with implants was significantly lower in period 2 compared with period 1 (23.9% vs 53.6%; p< 0.001). Similarly, autologous BR increased significantly in period 2 for muscle sparing latissimus dorsi (2.4% vs 12.6%; p< 0.001) and exclusive fat grafting (9.5% vs 21.5%; p< 0.01). Others autologous techniques was comparable between the two periods (DIEP and latissimus dorsi). The number of complications decreased in period 2 (10% vs 18.4% in period 1, p=0.04). Conclusion: After the withdrawal of textured implants, we observed a significant change in surgical practices for BR in our center. The rate of reconstruction with implants decreased in favour of autologous techniques. This change in practice was accompanied by a decrease in complications. Surgical techniques for breast reconstruction between the two periods Period 1: September 2017-November 2017;Period 2: December 2018-March 2020. DIEP, Deep Inferior Epigastric Perforator; SD, Standard deviation Citation Format: CLEMENTINE JANKOWSKI, Maxime Martinez, Vincent Laura, Pierre Burnier, CHARLES COUTANT. Impact of the withdrawal of textured breast implants from the market on breast reconstruction practices [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-15-10.