French authorities withdraw approval for Allergan textured implants, popular in UK
Breast implants that have been linked to a rare form of cancer have been pulled from the market in Europe.
The recall of Allergan textured implants, one of the most popular types in the UK, came after French authorities announced they had withdrawn approval for their sale in Europe.
The move comes after a global investigation involving the Guardian raised concerns about the link between textured implants, which have a roughened surface, and a rare cancer of the immune system called anaplastic large cell lymphoma (ALCL).
In a statement issued on Tuesday, France’s national agency for the safety of medicines and health products (ANSM) said it was suspending the CE (Conformité Européenne) safety approval for Allergan’s Microcell and Biocell products. It means that, for now, the implants cannot be manufactured or sold in Europe and those held at clinics are being recalled. Last month, the ANSM advised surgeons to stop using the implants.
French authorities said they had not “identified any immediate risk for the health of women carrying the implants concerned”, and the statement did not mention ALCL.
However, there is growing concern about the link with the cancer, with figures collected by plastic surgeons suggesting there have been at least 615 cases of the disease associated with breast implants and 16 deaths.
The cancer forms in the scar capsule around the implant and normally begins with pain and swelling in the breast. Women who have the implants and capsules removed can make a full recovery, but if left untreated the disease can spread throughout the body and become life-threatening.
The British Association of Aesthetic Plastic Surgeons (Baaps) has advised its members to stop using the implants immediately, but said the scientific data did not suggest the need to remove or exchange any current implants.
The president of Baaps, Paul Harris, said the news would be “a cause for understandable concern for many patients”. He added: “It is important, however, to recognise that this is a precautionary step taken by the regulators whilst the link between breast implant surface and BIA [breast implant-associated] ALCL becomes clear.”
Harris said surgeons had been moving away from using the Allergan implants over the past five years as concerns grew over their link to ALCL. He said that a decade ago Allergan may have had as much as 50% of the UK market.
He stressed that women who already had the implants should not panic, adding that the risk of going through unnecessary surgery far outweighed the risk of a condition that could be identified and treated.
Suzanne Turner, a Cambridge University scientist who is researching the link between textured implants and ALCL, welcomed the news. She said textured implants should be removed from the market until more is known about the cancer link.
“In the interim, there remain many unanswered questions that can only be addressed with thorough, independent research,” she said. “Other manufacturers should follow suit and remove their textured implants from the market.”
In a statement, Allergan said the CE mark had been suspended because “the routine review and renewal of our file has not been completed” and it would engage with the French regulator on determining appropriate next steps.
The company said: “Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and any action, is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants.”
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