Allergan Recalls Textured Breast Implant Tied to Rare Cancer
The Food and Drug Administration said it called for the removal after new information showed Allergan's Biocell breast implants account for a disproportionate share of rare lymphoma cases.
Medical device maker Allergan Inc. is recalling a type of breast implant linked to a rare form of cancer.
The company Wednesday announced a worldwide recall of implants with a textured surface.
The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan's Biocell breast implants account for a disproportionate share of rare lymphoma cases. The move follows similar bans by regulators in France, Australia and Canada.The FDA is not recommending women with the implants have them removed if they are not experiencing problems.
The recalled implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Such models account for just 5% of the U.S. market. Most U.S. breast implants are smooth.
"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," said FDA deputy commissioner Amy Abernethy in a statement.
The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.
The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.
There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.
Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.
"Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so," Zuckerman said in an email.
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