The FDA does not believe the product — a kind of textured implant — meets the legal standard for being banned at this time, based on available data and information, according to a statement issued Thursday by Amy Abernethy, FDA principal deputy commissioner, and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.
Some other countries have banned or restricted sales of certain textured implants because of concerns about what is called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
Some of those devices are not sold in the United States, the FDA said. In addition, although textured implants make up as much as 80 percent of the market share in some other countries, they represent only 10 percent or less of the implants sold in the United States, the agency said.
The majority of women who develop the implant-related cancer have textured implants, but there are some cases in which cancer patients have implants with smooth surfaces, the FDA said. And in many of the lymphoma cases, the agency does not know whether the implants were smooth or textured.
As of Sept. 30, the FDA had identified 457 cases of implant-related lymphoma and nine deaths worldwide. The American Society of Plastic Surgeons reported 16 disease-related deaths worldwide as of Jan. 1.
The FDA officials also addressed “breast implant illness,” a constellation of autoimmune problems, which includes joint and muscle pain and allergies and fatigue — a topic that was repeatedly raised at the March hearing. The agency said it “doesn’t have definitive evidence demonstrating breast implants cause these symptoms,” but added that evidence supports “that some women experience systemic symptoms that may resolve when their breast implants are removed” — and that women should be made aware of the risk before getting implants.
That statement, said Diana Zuckerman, president of the National Center for Health Research, is the closest the FDA has come to acknowledging breast implant illness. “That’s definitely progress,” she said.
She added that she was disappointed the FDA did not ban certain textured implants, but said it was not surprising considering the agency has only banned two devices in its history — powdered surgeons’ gloves and prosthetic hair fibers.
At the two-day hearing before an FDA advisory committee in late March, women who said they had been harmed by implants demanded the agency take steps to protect consumers, including providing more information about risks and banning certain devices. Many said they were not given adequate information about possible problems before getting implant surgery. Committee members echoed their concerns, urging the agency to ensure patients have a clearer understanding of the risks.
Responding to such concerns, the agency said it is considering requiring implants to carry what’s called a boxed warning — the agency’s strongest safety warning. And it may require doctors and patients to sign risk checklists to make sure patients have the necessary information to make an informed decision.
Jamee Cook, who had her breast implants removed in 2015 and co-founded Breast Implant Victim Advocacy, said she was ″very disappointed” that the FDA did not ban the textured devices. But she said she was pleased by the agency’s other steps.
“They are not moving as far forward as we wanted, but I think they are making an effort to address our concerns,” said Cook. She said she had “high hopes” that the agency would require a boxed warning and a patient decision checklist.
The agency, in its statement, also said it will now require breast implant manufacturers to file individual medical device reports for problems involving the products. The agency has been criticized for allowing manufacturers to file reports under a program known as “alternative summary reporting” — which resulted in many fewer cases of complications being made public.
About 400,000 women get implants annually in the United States — 75 percent for cosmetic reasons and most of the rest for breast reconstruction after cancer surgery.