Allergan recalls textured breast implant linked to rare cancer

Allergan recalls textured breast implant linked to rare cancer
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Pharmaceutical company Allergan on Wednesday issued a worldwide recall of a type of textured breast implant due to a risk of a rare type of cancer.

The Food and Drug Administration (FDA) had asked for the recall after new information showed a direct link between Allergan’s BIOCELL textured breast implants and tissue expanders and a rare type of lymphoma, called breast implant-associated anaplastic large cell lymphoma.

The FDA said it has found 573 unique cases of cancer, and 33 patient deaths across the world. Specifically, of those 573 cases, 481 are attributed to Allergan implants. Of the 33 patient deaths, the manufacturer is known in 13 cases. Of those, 12 are Allergan implants.

Textured breast implants overall are less common in the U.S. compared with other countries, the FDA said, and represent only 10 percent of breast implants sold domestically. Allergan products make up less than 5 percent of the market, FDA said.

The products have already been banned or recalled from the market in other countries.

The FDA said the cancer link was first discovered in 2011, but new evidence linked the disease with Allergan’s implants specifically. As recently as a few months ago, the agency was not taking any action.

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action,” FDA deputy commissioner Amy Abernethy said in a statement.

The agency said the incidences of developing the cancer are rare, and recommended that if patients are not showing any symptoms they do not need to have their breast implants removed.