Prevalence of rupture in poly implant Prothèse silicone breast implants, recalled from the European market in 2010.

BACKGROUND Known complications of silicone breast implants are rupture and silicone leakage, complications that are related not only to generation and implant age but also to the manufacturer. Implants from the French manufacturer Poly Implant Prothèse showed more rupture than expected and were banned from the European market in 2010. Clinics in Europe recalled their patients, but prevalence of rupture in these implants has not been previously reported. METHODS All women who underwent breast augmentation in 2000 and 2001 in the Jan van Goyen Clinic, Amsterdam, The Netherlands, were informed about concerns regarding the quality of their implants. Medical records were used to trace manufacturer and implantation specifics. One hundred twelve women with proven Poly Implant Prothèse implants were enrolled in this study. All women underwent physical examination and magnetic resonance imaging and were interviewed for complaints to determine the prevalence of symptomatic and asymptomatic rupture. RESULTS Two hundred twenty-four Poly Implant Prothèse implants were evaluated with a mean implant age of 122 months. Of these 224 implants, 54 had ruptured. Magnetic resonance imaging showed that 33 percent of women had at least one ruptured implant. There was no significant difference in rupture rate of implants manufactured in 2000 and 2001. CONCLUSIONS One third of the women who had undergone breast augmentation with Poly Implant Prothèse implants were shown to have at least one ruptured implant after 10 years; 45.9 percent had bilateral rupture and 13.5 percent had extracapsular leakage. These were mostly asymptomatic ruptures. The rupture prevalence rate for Poly Implant Prothèse implants after 10 years is 24 percent. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, IV.