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New Data Forces Breast Implant Recall

But Allergan's implant shouldn't necessarily be removed, the FDA says
By Newser Editors and Wire Services
Posted Jul 24, 2019 5:30 PM CDT
In this file photo, the Allergan logo appears above a trading post on the floor of the New York Stock Exchange.   (AP Photo/Richard Drew, File)

(Newser) – Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for certain textured models after regulators alerted the company to a heightened cancer risk with the devices, the AP reports. The US Food and Drug Administration said it called for the removal after new information showed Allergan's Biocell breast implants with a textured surface were tied to the vast majority of cases of a rare form of lymphoma. The move follows similar action in France, Australia, and Canada. The FDA is not recommending women with the implants have them removed because the cancer is so rare, but say they should check with their doctor if they have symptoms, which include pain and swelling. Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue.

Those models account for just 5% of the US market. The vast majority of breast implants used in the US have a smooth surface. Wednesday's recall does not affect Allergan's smooth implants or a different Allergan textured implant sold under the Microcell brand. Health authorities first linked breast implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants. As recently as May, the FDA said that the danger did not warrant a national ban on textured devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan's implants not seen with other textured implants. (A woman sued after getting unwanted implants.)


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