FDA requests recall of Allergan textured breast implants linked to cancer
In a major reversal, the Food and Drug Administration announced Wednesday they are asking breast implant maker Allergan to recall its textured implants after the agency found a higher risk of cancer linked to those devices.
The move comes after 38 countries already recalled the implant because of the higher risk of breast implant associated-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,” said FDA principal deputy commissioner Dr. Amy Abernethy in a statement.
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, said women's health advocate Dr. Diana Zuckerman.
"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 who get breast implants each year, about one in 10 has textured implants.