By Ankur Banerjee and Michael Erman
NEW YORK (Reuters) – Drugmaker Allergan Plc said on Wednesday it would take its textured breast implants off the market in Europe, a day after a French regulatory body ordered a recall of the implants, which have been linked to a rare form of cancer.
Allergan defended the safety of its breast implants, but its shares fell 7.4 percent to $135.94 on Wednesday as some Wall Street analysts questioned whether the company would have to face any future product liability costs.
France’s National Agency for the Safety of Medicines & Health Products (ANSM) said late on Tuesday that it was recalling Allergan’s Microcell and Biocell textured breast implants because its safety certification had not been renewed by another agency.
Textured breast implants, which have a rough surface and are more commonly used in Europe than in the United States, have been linked to a rare type of cancer known as anaplastic large cell lymphoma.
As of Sept. 30, 2017, the U.S. Food and Drug Administration had received https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm481899.htm a total of 414 medical device reports of breast implant-associated anaplastic large cell lymphoma, including nine deaths. Of those the FDA, in a notice in August, said 272 reports included surface information on the implants, with 242 being of the textured variety.
The FDA did not immediately respond to request for comment on Wednesday.
The French agency said it has not identified any immediate health risk for the women who have received the implants. ANSM, which has been studying the health effects of breast implants since 2015, recommended in November that medical professionals use smooth implants instead. That followed a previous warning about risks related to the textured implants.
Allergan said the recall in Europe was not based on any new scientific evidence.
Textured implant sales in Europe are expected to be about $60 million in 2018, Allergan said. Suspension of sales in Europe does not affect implant sales in the United States, the company said.
While the financial impact is minimal, this is not helpful for the stock at a time the company is facing concerns over incremental competition for its top-selling Botox wrinkle treatment and is likely to face generic rivals to its Restasis eye drug over the near term, Citi analyst Liav Abraham said.
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 company said marketing of its smooth implants, whose CE mark was renewed, would not be affected.
Allergan said it will withdraw any remaining supply of the textured implants in Europe and is fully cooperating with the French authority.
Several plastic surgery websites say that the textured implants stay in place better than smooth versions, but also have a higher incidence of leaking.
(Reporting by Sudip Kar-Gupta in Paris, Saumya Sibi Joseph in Bengaluru and Michael Erman and Ankur Banerjee in New York, Editing by Maju Samuel, David Gregorio and Bill Berkrot)