Regulatory Authorities in France declared on Tuesday, December 18, 2018, that the breast implant manufacturer, Allergan will stop selling its textured implants. Allergan lost permission to sell its textured implants in market.
Textured implants constitute 85% of the total market in France, and they are mostly used in cosmetic and breast enhancement surgeries. According to the reports in the media, these implants were considered responsible for a kind of non-Hodgkin’s lymphoma, a cancer related to the immune systems. So far, 600 cases of this cancer have been reported and most of the cases are from the US, from which 16 women have already died.
French government agency which deals with medicines and health related issues have released advisory for the women who have gone through textured breast implants from Allergan that they should follow up with their doctors.
Allergan made it official on Tuesday that across 33 countries, they have stopped selling tissue expanders and textured implants, since Monday. The company said that the product needs certification from the European Agency which deals with environmental standards, safety and health and found it to be incomplete due to routine renewal and review of the products. The company also confirmed that they are following up with the French regulator about next course of the actions. Allergan is supporting risk or benefits of their breast implant products. The company said that regulator’s request is not based on any scientific evidence in this regard and regulator has not found any immediate risk with their products.
The decision has been taken after International Consortium of Investigative Journalists and NBC News Investigation found that chances of cancer ALCL are more than it was considered before. FDA said that it is studying link between textured breast implant and cancer BIA-ALCL. FDA is familiar with the French regulator’s decision of not certifying breast implant products of Allergen and we will be following up this issue with the French regulatory authority.
FDA has decided to meet in 2019 to ensure that all breast implants meets safety standards.