A message from the President of ISAPS
Dear ISAPS Member Surgeon,
I want to update you on matters that have occurred in the EU and specifically France regarding Allergan and its textured breast implants/tissue expanders (BioCell® and MicroCell®) that are used for cosmetic and reconstructive breast surgery.
ISAPS has received an announcement from the ANSM agency (Agence Nationale de Sécurité du Médicament, France) which indicates the following:
The ANSM has been informed today that the medical devices of the Allergan Microcell and Biocell ranges (breast implants and tissue expanders) no longer have the CE marking from 17 December 2018. The GMED, which has not renewed the CE marking of these devices in the framework of the procedure which takes place every 5 years, requested additional data from the manufacturer.
From now on, these medical devices can no longer be marketed in France and in Europe. ANSM today asked Allergan to recall products in stock at all health facilities.
The ANSM recalls that it recommended, on 21 November 2018, health professionals to preferably use breast implants with a smooth envelope, pending the opinion of a committee of experts on the use of implants, in particular breast with textured envelopes, in cosmetic and reconstructive surgery.
At this stage, the ANSM has not identified any immediate risk for the health of women carrying the implants concerned. ANSM reminds that women with breast implants should be monitored annually.
We believe that this announcement relates to an association between textured implant surfaces and the late-term development of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). In the case of Allergan, French ANSM made this announcement because the renewal time for the CE Mark was under review. BIA-ALCL has been associated with various types of textured implants from different manufacturers and is not thought to occur with smooth-surface implants. There is no new scientific evidence regarding the safety profile of textured-surface implants that changes the risk/benefit of these devices.
ISAPS recommends that patients’ concerns about their breast implants be addressed by our member surgeons who are the best source for accurate scientific information to answer their questions.
The matter of surface texture and regulatory agencies appears to be evolving over time. ISAPS will update you as we know more.
DIRK F. RICHTER, MD, PhD