Annales de chirurgie plastique et esthetique · 2015
[Changing and follow-up of silicone gel-filled breast implants: Multicentric, retrospective study about 130 rupture cases].
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Pineau V, De Runz A, Fyad J-P, Simon E, Marchal F
Аннотация
SUBJECT: 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.
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 6 centers.
RESULTS: 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).
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 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.
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 6 centers.
RESULTS: 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).
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 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.