Allergan on Wednesday announced a global recall of the company's Biocell textured breast implants, after FDA found a link between the implants and a sharp increase in cases of and deaths involving a rare cancer.
FDA first reported an association between the cancer, called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implants in 2011. BIA-ALCL is not a breast cancer, but rather a type of non-Hodgkin's lymphoma found in scar tissue and fluid near implants.
FDA in February warned that there have been hundreds of confirmed cases of the rare cancer, and at least nine patients have died from the disease since 2010. FDA in a letter sent to health care providers wrote that it had confirmed 457 of the 660 unique cases of BIA-ALCL reported worldwide. The agency wrote, "Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL."
However, FDA in the letter noted that a lack of data on the number of individuals who receive breast implants in the United States and internationally has made it difficult to determine the risks associated with breast implants. FDA said most of the limited research to date demonstrates BIA-ALCL occurs in patients who have breast implants with textured surfaces, rather than smooth surfaces.
In May, FDA said it would not at that time ban textured breast implants because there was not enough data to support such a ban in the United States as dictated by the Federal Food, Drug and Cosmetic Act.
FDA says Allergan's textured breast implants linked to hundreds of cancer cases
However, FDA on Thursday released new U.S. and global data showing there have been reports of 573 cases of BIA-ALCL and 33 deaths from the disease since 2011, when FDA first began tracking the association between breast implants and anaplastic large cell lymphoma. The agency attributed 481 of the BIA-ALCL cases—and 12 of the 13 patient deaths in which the implant's manufacturer was known—to Allergan's Biocell textured breast implants.
FDA said the data indicate the risk of BIA-ALCL is six times higher for patients with Allergan's textured implants than for patients with other types of textured implants available in the United States. Overall, FDA said textured breast implants account for about 10% of the U.S. market, and Allergan's textured breast implants make up less than 5% of the market.
Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said the latest data prompted the agency to ask Allergan to voluntarily pull the Biocell textured breast implants from the market.
Allergan voluntarily recalls Biocell textured breast implants
Following FDA's request, Allergan on Wednesday announced that it is voluntarily recalling its Biocell textured breast implants and tissue expanders from all markets where the products currently are available. Allergan said the global recall does not apply to the company's Natrelle smooth or Microcell breast implants and tissue expanders, and published a list of breast implants and tissue expanders that have been recalled.
Biocell textured breast implants already have been banned or the European and Canadian markets.
Allergan currently faces more than one dozen lawsuits in the United States and Canada claiming the company's breast implants caused patients to develop lymphoma. The lawsuits allege Allergan failed to warn patients about the breast implants' risks.
An Allergan spokesperson declined to comment on the pending cases, the Wall Street Journal reports.
Diana Zuckerman, president of the National Center for Health Research, applauded the recall. Zuckerman said, "We are very glad they have done it. I think they could have done it months ago and I hope a lot of women have not been getting these implants in the meantime."
Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, criticized FDA for the amount of time it took the agency to request the recall. "This is not the first time that the FDA has lagged behind other countries in its responsibility to protect the public's health," Wolfe said, adding, "This delay has unnecessarily put American women at risk" (McGinley, Washington Post, 7/24; Balu/Mishra, Reuters, 7/24; Alltucker, USA Today, 7/24; Aubrey/Laidlaw, "Shots," NPR, 7/24; Loftus, Wall Street Journal, 7/24; Roza, Inside Health Policy, 7/24 [subscription required]).