In 2013, MSNA was estimated at 346,000 the number of carriers of silicone breast implants in France women (whether for cosmetic or medical reasons) with 30,000 brand PIP. In the explants made from 2001 to 2013, a PIP implant explanted four was considered defective.
Uncertainty as to the long-term effects of these prostheses.
To investigate the potential risks of these implants for healthy women carriers, INSERM, supported by the National Security Agency of Medicines and Health Products (MSNA) launched the national epidemiological cohort LUCIE conducted among female carriers or having breast implants worn and operated in France.
Inserm team led by Florent Vathaire in 1018 Unit "Center for Research in Epidemiology and Population Health" will pilot study.
The establishment of this cohort is to assess and describe the incidence of adverse effects related to the wearing of breast implants silicone gel manufacturer PIP.
The data collected will help to know the health status of women with increased breast implants and silicone gel to study whether there is a possible link between the events reported health (breast cancer or other adverse events such as allergic skin reactions or breaks prostheses) and the wearing of PIP breast implants.
The aim is to include about 100 000 women who underwent breast implant surgery, including 30000 bearing or having borne a PIP implant (other prostheses from other manufacturers).
To achieve this goal the recruitment in this cohort will be in two ways:
1) through the transfer of files to researchers from INSERM, from hospitals and clinics that have implanted or explanted breast implant, regardless of manufacturer since 2001.
2) voluntary registration of women, after signing an online consent, on an "active" site, where they will be brought to complete an online questionnaire.
Those who have agreed to participate will be contacted by email every two to five years to meet a new online questionnaire (major health events since the last contact, lifestyle ...). Monitoring women is planned for a minimum of ten years.
Together, Inserm and MSNA are mobilizing to improve scientific knowledge on the problems associated with breast implants and allow to ensure the safety of these products.
Find this article on the website of the Inserm: click here
