ABSTRACT
On 29 march 2010, the French authorities (Afssaps) issued a health alert concerning breast implants manufactured by the company Poly Implant Prothèse, because of a high rupture rate. Marketing authorization was suspended and the use of PIP breast implants was prohibited. In our hospital department, 630 patients had received these prostheses since 2001. We conducted a retrospective study of all patients who underwent explantation between May 2010 and January 2012, corresponding to 434 explanted prostheses and 217 patients, all operated on by the same surgeon. Median age was 42 years and the prostheses had been implanted an average of 4 years 7 months earlier. We found that 38 implants (8.7%) had ruptured, in 33 patients (15.2%). Five patients had bilateral rupture. Preoperative ultrasonography, performed in 166 patients, detected 30 ruptures that were confirmed at surgery, but missed a further 9 cases (8%). Biopsy samples of capsular tissue were obtained in 103 cases, revealing granulation tissue possibly due to silicone exposure in 33 cases, 22 of which were associated with intact implants. Surgical complications included three hematomas, with no infections. Despite the low false-negative rate of ultrasonography, we recommend systematic preventive explantation, owing to the risk of silicone impregnation of capsular tissue even in the absence of rupture.
