Abstract PS1-65: What lessons can be learned from the poly implant prothese scandal ? A french retrospective study

Abstract

Abstract Background : Silicone breast implants from the French manufacturer Poly Implant Prothese (PIP) were recalled from the French market after the use of a non-medical silicone filler has been established. The systematic explantation of the implants had been proposed to women with PIP implants in France, a preventive measure concerning approximately 30,000 patients.Objectives : This study aimed to evaluate the consequences of having at least one PIP breast implant on overall and disease-free survival after breast reconstruction for cancer or prophylactic surgery.Materials and Methods : We performed a multicentric retrospective cohort study on women who underwent immediate or delayed implant-based reconstruction after curative or prophylactic mastectomy between January 01,2002 and March 30,2010 in three French private health institutions of public interest. These dates correspond respectively to the arrival of PIP breast implants on the French market and the decision to withdraw them by the French government. The primary endpoints were disease-free and overall survival, depending on whether or not having a PIP breast implant used during breast reconstruction of prophylactic surgery.Results : We identified 2499 patients with the use of 4106 breast implants between 2002 and 2010.The median age of cancer diagnosis was 47 years (19-77). This patient population selected for breast reconstruction had good prognosis criteria (77% T1 and 68% N0). PIP was the most common brand used between 2002 and 2010 and represented 45% of all breast implants (1764 implants). PIP has been preferentially used in courses with immediate breast reconstruction. On the 1764 PIP, 1408 (80%) were removed, mainly after the preventive measure recommending systematic explantation. Censored data on March 30, 2010, showed that the incidence of PIP implants removal is lower than other brands (Log-rank test : p<0.001). Overall survival of patients who had at least on PIP was no different from that of patients who never had a PIP (Log-rank test : p=0.2). Disease-free survival was also similar between these two populations (Log-rank test : p=0.12).Conclusion : We did not identify any increase in local-regional recurrence or overall mortality associated with the use of PIP. Citation Format: Lea Pauly, Benoit Couturaud, Fabien Reyal. What lessons can be learned from the poly implant prothese scandal ? A french retrospective study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS1-65.