Breast implants made by Irish-headquartered Allergan that have been linked to an uncommon form of cancer are being taken off the market in Europe.
The implants, which have a textured or slightly roughened surface, rather than a smooth covering, cannot be manufactured or sold in Europe for the time being, and the ones kept on hand at health centres are being recalled.
Announcing the move, France’s National Agency for the Safety of Medicines and Health Products said it had not “identified any immediate risk for the health of women carrying the implants concerned”, and it did not mention the unusual cancer.
The products, particularly the textured ones, have been linked to a disease called breast implant-associated anaplastic large-cell lymphoma. The lymphoma is not breast cancer, but is a malignancy of the immune system that develops years after the implant surgery, often seven or eight years later.
Removing the implant usually gets rid of the disease. But in some cases, the cancer spread, and women died.
The French action affects members of the European Union as well as other countries in Europe that require a stamp of approval called a CE marking for medical devices. The ruling does not affect the marketing of implants in the United States.
Textured implants are used more commonly in Europe than in the United States, where smooth ones are more often recommended.
Allergan’s prior CE mark expired Sunday. The company had applied for renewal, but French health officials requested additional data on the textured implants, which the company said it could not provide before the expiration date. The company had expected to supply the requested information within the next few months, but when it did not deliver by the expiration date, the CE was taken away.
Allergan’s permission to market its smooth implants was renewed, and those remain available in Europe.
In a statement, the company, best known as the maker of wrinkle-easing drug Botox, said, “Allergan stands behind the benefit/risk profile of our breast implant products.” It also said the recall was “not based on any new scientific evidence regarding these products”.
The company said it would continue working with French regulators “on determining the appropriate next steps”.
In a notice posted on its website in August, the US regulator, the Food and Drug Administration, said that, as of September 30th, 2017, it had received 414 reports of the lymphoma, including nine cases that were fatal. The implant surface was known in only 272 of those cases, and in 242 of those it was textured.
The FDA also noted that the real number of cases and size of the risk was not known because there was a lack of information about how many women in the United States and worldwide had received implants. The best estimate is that the lymphoma may occur in one in 3,817 to one in 30,000 women with textured implants.
Symptoms include pain, lumps, swelling or breast asymmetry, and women with implants are advised to consult a doctor if those problems occur. If there are no symptoms, there is no reason to remove the implants. All women who have implants are advised to have regular checkups as advised by their doctors. – New York Times
