Dec 19, 2018
By Lauren Dunn
Allergan's textured breast implants recalled by French authorities
French regulatory officials are asking breast implant manufacturer Allergan to recall its textured implants after the company lost approval to market the devices, according to a statement released Tuesday.
Textured implants used in cosmetic and reconstructive breast surgeries account for 85 percent of the French market. They are linked to a type of non-Hodgkin's lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. There have been more than 600 cases of the illness reported worldwide, most of them in the U.S. Sixteen women have died.
According to France’s National Agency for the Safety of Medicines and Health Products (ANSM), Allergan’s textured breast implants can no longer be marketed in France and Europe. Women in France and Europe who currently have the Allergan textured breast implants are advised to continue to be monitored by their doctors.
Allergan issued a statement Tuesday saying it had suspended sales of textured implants and tissue expanders as of Monday in 33 countries that require certification a product has met European Union health, safety, and environmental standards, citing an incomplete "routine review and renewal" of the file.
"Allergan is evaluating the subsequent request from ANSM and the Company will continue to engage the French regulator on determining the appropriate next steps," the statement said.
"Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and any action, is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants,” it added.
The decision comes after an NBC News investigation, in conjunction with the International Consortium of Investigative Journalists, found that ALCL could be more common than previously thought.
On Wednesday, the Food and Drug Administration responded that it has been tracking the relationship between textured breast implants and breast implant-associated ALCL (BIA-ALCL).
"The FDA is aware of the recent decision by the French Notified Body to not renew the CE mark for Allergan textured breast implants," according to the FDA statement. "We have been in contact with French regulatory authorities discuss the issue."
The FDA is meeting next year to review the safety of all breast implants.
"Breast implants, regardless of surface texture, are associated with a small risk of BIA-ALCL," the FDA said in the statement. "There may be multiple factors involved in the development of BIA-ALCL such as patient characteristics, operative procedure history, breast implant characteristics — including surface characteristics, and duration the breast implant is in place."More than 600 cases of cancer worldwide linked to a specific type of implant.
출처 : NBC UNIVERSAL
원문바로가기 : https://www.nbcnews.com/health/womens-health/allergan-s-textured-breast-implants-recalled-french-authorities-n949656