Allergan Stops Sales of Textured Breast Implants in Europe

By Reuters Staff

December 20, 2018

PARIS (Reuters) - Drugmaker Allergan said on Wednesday it would take its textured breast implants off the market in Europe, a day after a French regulatory body ordered the move because the implants have been linked to a rare form of cancer.

France's National Agency for the Safety of Medicines & Health Products (ANSM) said late Tuesday that the decision concerned Allergan's Microcell and Biocell textured breast implants.

Textured breast implants have been linked to a rare type of cancer known as anaplastic large cell lymphoma.

But Allergan defended the safety of its breast implants and said the ANSM's request was not based on any new scientific evidence nor has it identified any immediate risk to the health of the women who have used the implants.

The body recommended in November that medical professionals use smooth implants instead, after a previous warning about the risks related to the textured implants.

Allergan Plc said it suspended sales of the textured breast implants in Europe after the ANSM asked for their recall following the expiration of the product's certification in the EU.

Products licensed for sale in the EU receive a "CE mark" by a body called GMED, certifying their safety among other things. The CE mark for the Allergan products expired on Sunday, and the ANSM asked for the recall.

The French regulator said it had not identified any immediate risk for the health of women carrying these implants.

The company said marketing of smooth implants, whose CE mark was renewed, would not be affected.

Allergan, which will withdraw any remaining supply of the implants in Europe, said the decision does not affect sales in the United States.

The company said it is fully cooperating with the French authority.

Several plastic surgery websites say that textured implants stay in place better than smooth implants but have a higher incidence of leaking.