Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority.

Alexandre Leduey,Françoise Rimareix,Nicolas Leymarie,Frédéric Kolb,Heba Alkhashnam,Benjamin Sarfati,Jean-Rémi Garbay,Chafika Mazouni,Amélie Gaudin

doi:10.1155/2015/519497

Alexandre Leduey, Françoise Rimareix + Show 7 more

Open Access

https://doi.org/10.1155/2015/519497

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Abstract

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.

Highlights

Immediate or secondary breast reconstruction can be performed using a breast implant alone or associated with a flap
We evaluated and compared the rate of and reasons for removal of Poly Implant Prothese (PIP), Allergan, and Perouse breast implants before the ANSM alert to determine whether any significant clinical events could have predicted the corporate fraud
During the study period, 652 patients received a total of 944 breast implants (14% of patients had bilateral breast reconstruction) following breast cancer surgery

Summary

Introduction

Immediate or secondary breast reconstruction can be performed using a breast implant alone or associated with a flap. Breast implants are manufactured as pliable silicone elastomer shells that are filled with silicone gel or saline solution. Many studies on the rate of complications, especially the rupture of silicone breast implants, during aesthetic or reconstructive surgery have demonstrated that silicone implants are safe and effective [4,5,6,7]. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. The complications and removal rates of the different implant brands used (PIP, Allergan, and Perouse) were evaluated and compared. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel

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Conclusion