Following a request from the Food and Drug Administration, Allergan is recalling its textured breast implants worldwide, the company said Wednesday.
The move comes after 38 countries already recalled the implant because of the higher risk of anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system.
“Although the overall incidence of BIA-ALCL appears to be relatively low, 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 to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Dr. Amy Abernethy said in a statement.
An analysis from the FDA found that the risk of BIA-ALCL with Allergan’s textured implants was approximately 6 times greater than the risk of the cancer associated with other manufacturers’ textured implants marketed in the U.S.
On Wednesday, the FDA also updated the number of cases of BIA-ALCL to 573 total worldwide. Of those cases, 481 are attributed to Allergan implants. Thirty-three women have died.
In a statement, Allergan said that it is issuing the voluntary worldwide recall as a precaution, based on the information it received from the FDA.
The FDA does not recommend that asymptomatic women with textured breast implants have them removed.
Symptoms of BIA-ALCL include swelling, pain and skin irritation.
The recall is “a very important step” toward reducing this type of lymphoma, women’s health advocate Diana Zuckerman said.
“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” Zuckerman, president of the National Center for Health Research, said in a statement. “This recall will reduce that risk but it won’t eliminate it, because not all women with BIA-ALCL had these specific types of implants.”
Last November, NBC News, along with its partner, the International Consortium of Investigative Journalists, found that BIA-ALCL is an emerging risk for women with textured implants.
In March, the FDA said BIA-ALCL is most likely caused by textured breast implants, which have a suede-like coating. But the agency stopped short of taking the implants off the market, noting it wanted to continue studying the disease and tracking cases. It’s estimated that of the 400,000 women in the United States who get breast implants each year, about 1 in 10 has textured implants.
Vicky Nguyen contributed.