Breast implants tied to rare cancer recalled

WASHINGTON — 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 U.S. 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. The brand accounts for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. 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 the 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.

“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.

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. Regulators estimate that the risk of the disease is six times higher with Allergan’s implants than textured implants made by other manufacturers.

FDA officials said they decided to act after receiving 116 new reports of the cancer. Those reports increased the number of deaths tied to the disease from 9 to 33, including at least 12 cases in women with Allergan 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 range from 1 in 3,000 patients to 1 in 30,000 patients.

Researchers have offered different theories for why textured implants can trigger lymphoma, including that their surfaces cause an inflammatory response.