Textured breast implants that have been linked to a rare form of lymphoma are being taken off the market in Europe after French regulators announced they had suspended their approval of the device.
The recall of Allergan’s Microcell and Biocell implants was announced Tuesday by France’s National Agency for the Safety of Medicines and Health Products. Allergan issued a statement Wednesday saying that while it “disagrees" with the request, "the company is fully cooperating.”
The implant-related lymphoma is a newly recognized cancer of the immune system that is caused by implants used for cosmetic and reconstructive surgeries. The scientific consensus is that implants with roughened surfaces -- not smooth surfaces -- cause the disease, called breast implant-associated anaplastic large-cell lymphoma.
Since the first report of implant lymphoma in 1997, there have been 570 cases and 16 deaths reported worldwide, including 230 cases and five deaths in the United States, according to a July update from the American Society of Plastic Surgeons.
The cancer typically takes about nine years to develop, and the first sign is usually swelling around the implant. The disease is readily cured if promptly diagnosed and treated.
The value of texturing is now hotly debated, and some plastic surgeons say the rough-surface devices should be abandoned. When texturing was introduced in the early 1990s, it was touted as a way to reduce breast hardening, called capsular contracture, a major reason for repeat surgeries. It was also supposed to prevent the rotation of teardrop-shaped implants.
At the urging of the American Society of Plastic Surgeons, Allergan this year began offering a novel warranty with its textured implants: $7,500 toward surgical removal if the devices cause the lymphoma.
Last month, the French health agency recommended against all use of textured implants because of concerns about the lymphoma. The agency also requested more data from Allergan as part of a routine five-year review of the device’s stamp of approval, called a CE mark, required for marketing in the European Union.
The agency’s Tuesday statement did not explain why it took away the CE mark, although it said it “had not identified any immediate risk for the health of women carrying the implants."
The agency’s expert panel will meet in early February to review the latest scientific evidence and consider restoring the CE mark.
Allergan said it “looks forward to participating in the scientific forum" and “stands by the benefit/risk profile of our breast implant products.”
European sales of Allergan’s smooth-surface implants are not affected. However, textured implants account for 85 percent of the French market. They comprise about 13 percent of U.S. sales.
In a statement issued Wednesday, the U.S. Food and Drug Administration said it had communicated with French regulators, is considering “new steps to protect public health,” and will hold a public meeting in 2019 to discuss breast implant safety. The FDA says both textured and smooth implants come with a small risk of the lymphoma.