After seeing its textured breast implants linked by the Food and Drug Administration to a rare form of cancer, Dublin-based Allergan is recalling the product from all markets.
In a statement Wednesday, the FDA said it had seen a spike in cases of the rare lymphoma since February. So far there have been 573 cases reported, an increase of 116 cases since February. Some 84% of those cases have been linked to Allergan’s textured breast implants. Patient deaths now total 33, a 367% increase since February.
The FDA is not recommending the removal of these implants for patients without symptoms due to potential risks.
“We understand that today’s news may be alarming to some patients with breast implants,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health in a statement. “In the safety communication issued today, we’re providing actionable information for individuals with specific breast implants and their health care professionals.”
Allegan implants are not widely used in the United States. The company’s products make up just 5% of all implants sold domestically.
“Although this type of textured breast implant may represent a small proportion of the U.S. market, the continued availability of Allergan BIOCELL textured breast implants pose a public health risk to patients,” said the FDA.
The recall of the Allergan implant has already taken place in France, Canada and Australia, where the use of textured implants is much higher, sometimes as high as 80% of their market share.