WASHINGTON – Breast implant maker Allergan has issued a worldwide recall of its textured Biocell models, which have been linked to a rare form of cancer, the U.S. Food and Drug Administration said Wednesday.
The recall came at the FDA’s request, and means that the implants can no longer be sold, and that doctors who have them in stock are supposed to return them
The regulatory agency did not ban the devices altogether, as authorities have done in France and Canada.
It also stopped short of recommending that women who have the implants get them removed. The risk of surgery is considered to be greater than the relatively low risk of developing anaplastic large cell lymphoma, a type of non-Hodgkins lymphoma.
Biocell implants have a textured surface to prevent slippage. Other breast implants used in the United States have a smooth surface or are covered in polyurethane.
Starting in 2011, health authorities in several countries noticed that certain implants were associated with an increase in incidence of anaplastic large cell lymphoma, or ALCL.
The disease causes swelling and accumulation of fluid around the implant.
Friction between the implant surface and the surrounding tissue may cause inflammation, but the reason why women are developing ALCL remains unknown.
So far, the vast majority of these lymphoma cases have been detected in women with Allergan implants — 84 percent of 573 known cases worldwide as of July 6, according to FDA figures.
The FDA has recorded 33 deaths from this cancer around the world — in the 13 cases where the type of implant is known, 12 are Allergan products.
The FDA said that its research showed the risk of developing breast-implant associated (BIA) ALCL with Allergan’s Biocell textured implants was “approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the US.”
So-called macro-textured implants, the kind that Allergan makes, account for less than 5 percent of all breast implants sold in the United States.
While the FDA acknowledged that the overall number of cases of BIA-ALCL remained “relatively low,” it asked for a recall “once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm,” said the agency’s deputy commissioner, Amy Abernethy.
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