title: 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.
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.
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Leduey
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Chafika
authors.initials: C
authors.lastname: Mazouni
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Leymarie
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Heba
authors.initials: H
authors.lastname: Alkhashnam
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Sarfati
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Jean-Rémi
authors.initials: JR
authors.lastname: Garbay
authors.affiliation: Department of Pharmacology, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Gaudin
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Kolb
authors.affiliation: Department of Breast and Plastic Surgery, Gustave Roussy, 94805 Villejuif, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Rimareix