FDA on Wednesday posted draft guidance recommending manufacturers include boxed warnings on certain breast implants after the agency found a link between the implants and a sharp increase in cases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 a cancer of the immune system, 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.
In July, the agency 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.
The agency also 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, prompting Allergan to voluntarily pull the Biocell textured breast implants and tissue expanders from the market.
Draft guidance details
FDA now has issued draft guidance that recommends manufacturers include boxed warnings for breast implants that warn patients of the potential health risks of the implants.
FDA recommends the labels include a warning that "breast implants are not considered lifetime devices" and that they "have been associated with the development of" BIA-ALCL, the agency said. The agency also said the labels should include descriptions of the metals and chemicals found in the implants, as well as recommendations for screening for ruptured implants.
FDA also advised that manufacturers provide clinicians with a decision checklist they can use to inform their patients of the risks.
The agency said it will leave the draft guidance open for public comment before adopting a final policy.
"[O]nce the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations," FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement.
Diana Zuckerman, president of the National Center for Health Research, praised the draft guidance but said FDA should take stronger action to ensure manufacturers include the boxed warnings. It all "depends on how much pressure the FDA puts on manufacturers," Zuckerman said (Martino, CNBC, 10/23; Budryk, The Hill, 10/23; Bacon, USA TODAY, 10/23; McGinley, Washington Post, 10/23).