Controversial silicone breast implants pulled off European market

Maker Allergan stands behind benefits vs. risk of implants

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Monday, January 7, 2019

Allergan has taken its textured silicone breast implants off the market in Europe, following a mandatory recall by the French equivalent of the FDA.

The company has suspended sales of the implants and similar tissue expanders, and is withdrawing any remaining supplies.

The implants have been linked to cases of a rare cancer, anaplastic large cell lymphoma.

France's Agence Nationale de Securite du Medicament (ANSM) issue the recall after the expiration of the CE Mark for these products, not on any new scientific information.

The company says it stands behind the benefit/risk profile of its breast implant products.

The ANSM will hold a scientific forum in early February, to discuss all the known scientific data on textured implants.

Many plastic surgeons prefer the textured implants, because they cause scar tissue to form around them, securing them in place, looking and feeling more natural for a woman.

The lymphoma forms in that scarring,and along the surface of the implant.

Chances of the lymphoma are small, and it resolves in most women after the implants are removed.

However, some do need radiation and chemotherapy.

The ANSM did renew certification for Allergan's smooth implants, so they remain on the market.

Sales in the United States are unaffected by the European action.