Surveillance et changement des implants mammaires en gel de silicone : étude rétrospective a propos de 130 cas de rupture d’implants

Abstract

A recent report from "Agence Nationale de sécurité du medicament et des produits de santé" (ANSM) assesses the rupture of silicone gel breast implants without proposing rules for follow-up and replacement of implants. To demonstrate that systematic follow-up surveillance of silicone breast implants could improve early diagnosis of ruptures; to propose a surveillance protocol based on the findings. This is a multicentric, retrospective study which reports cases of ruptured silicone gel breast implants from January 2006 to June 2014. Using Case-notes from ANSM and quotations from CCAM certificates, 130cases were gathered from 6 centers. The average time between implantation and the diagnosis of ruptures was 9.24 years (± 6.19). Forty cases of ruptured implants (30.8%) originated from original reconstruction or symmetrisation in the context of a breast carcinoma; and 90 (69.2%) originated from augmentation mammaplasty. The average length in reconstructive group was 6.97 years (± 3.33). The difference in the lifetime of the implants between both groups was statistically significant (P = 0.0291). A clinical abnormality led to an imaging assessment in only 19.7% of cases; rupture was thus mainly discovered incidentally either during a systematic breast screening (59.8%), or during a preoperative examination for an aesthetic surgery (20.5%) (P = 0.0082). The results suggest that implant ruptures of silicone gel breast implants are under diagnosed. Clinical follow-up seems insufficient to diagnose implant ruptures. Ultra sound surveillance (± MRI) could be proposed 4 years, 7 years and 10 years after the initial surgery. It does not seem appropriate to propose a systematic change of implant without the incidence of a rupture.