Rupture of Poly Implant Prothèse (PIP) breast implants: experience with the removal of 884 implants

In May of 2010, the French Health Products Safety Agency (AFSSAPS) raised a worldwide alarm about irregularities that had been detected in silicone filled gel mammary implants produced by the company Poly Implant Prothèse (PIP). The first report on this matter stated that the manufacturer had changed the gel filled formula and used a medical gel formula that was different from the one authorized by the manufacturing permits. Between November of 2007 and April of 2012, a descriptive, retrospective study was conducted at our center. A total of 443 consecutive patients undergoing an elective PIP implant explant procedure were enrolled, and a total of 884 PIP implants were explanted. These implants had been placed from 2005 to 2010, a period during which a total of 3,002 cohesive silicone gel-filled breast implants manufactured by the French company PIP were implanted. The overall rate of ruptured implants was 10.6 % (94/884), whereas 81.9 % of implants were found to be intact at the time of explantation. The capsular contracture rate was below 1 %. A statistically significant difference was found between the rates of rupture for texturized implants as compared to the smooth-surfaced implants. A rupture rate of 10.6 % was found, which is lower than that reported in another series regarding PIP implants but higher than those reported in series studying prostheses made by other manufacturers. The capsular contracture rate is below 1 % and there is a significantly higher rate of rupture in texturized implants as compared to that in smooth-surfaced ones. In order to avoid future problems, we believe it is important to advise patients to use only implantable medical devices produced in countries with high product control standards. Level of Evidence: Level IV, therapeutic study.