[Changing and follow-up of silicone gel-filled breast implants: Multicentric, retrospective study about 130rupture cases].
Fiche publication
Date publication
août 2015
Auteurs
Membres identifiés du Cancéropôle Est :
Pr MARCHAL Frédéric
Tous les auteurs :
Pineau V, De Runz A, Fyad JP, Simon E, Marchal F
Lien Pubmed
Résumé
SUBJECT: A recent report from "Agence Nationale de securite du medicament et des produits de sante" (ANSM) assesses the rupture of silicone gel breast implants without proposing rules for follow-up and replacement of implants. OBJECTIVE: 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. MATERIALS AND METHODS: 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 6centers. RESULTS: The average time between implantation and the diagnosis of ruptures was 9.24years (+/-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 6.97years (+/-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). CONCLUSIONS: 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 4years, 7years and 10years after the initial surgery. It does not seem appropriate to propose a systematic change of implant without the incidence of a rupture.
Référence
Ann Chir Plast Esthet. 2015 Aug 18. pii: S0294-1260(15)00128-4