Regulatory Action In France Due To Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Cases
There have been more than 600 cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) reported worldwide, which is a type of non-Hodgkin's lymphoma.
In December 2018 France’s National Agency for the Safety of Medicines and Health Products (ANSM) announced that Allergan textured breast implants can no longer be marketed in France and elsewhere in Europe.
From this December 20, 2018 news report, "Allergan Textured Breast Implant Sales Halted in Europe Amid Safety Controversy", we get these details about this breast implants recall:
Allergan, one of the world’s largest manufacturers of breast implants, has been blocked from selling several popular products in Europe amid growing concerns over a link to a rare form of cancer.
The company has been unable to renew safety certificates, known as CE marks, for two of its textured surfaces — Microcell and Biocell — used in products such as its Natrelle range of breast implants.
Breast implants, like all medical devices, must have CE marks in order to be sold in 33 European countries.
The loss of Allergan’s certificates comes after French regulator Agence Nationale de Sécurité du Médicament (ANSM) last month recommended smooth-shell breast implants be used instead of textured-shell products, citing links between the latter and anaplastic large cell lymphoma (ALCL).
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As regards what the FDA is doing on this developing medical device safety issue, we turn to this NBC News piece, "Allergan's textured breast implants recalled by French authorities":
On [December 19, 2018], 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."
For more information about breast implants being associated with lymphoma, which is a blood cancer, you can visit our Breast Implants Cases Overview page, where you will find links to these more in-depth topics:
Summary of Information
Frequently Asked Questions
➤ About the Disease
➤ Risk Factors
We have been reviewing breast implant lymphoma cases as possible lawsuits against Allergan and other manufacturers since March 2017, and will continue to do so. If interested, you can use our Breast Implants Cancer Case Evaluation Form.