Macro-textured breast implants, which studies have shown to be associated with higher risks of a rare immune-system cancer, will continue to be sold in the U.S. as authorities gather more data about their safety, according to a statement released by the U.S Food and Drug Administration.
“The FDA does not believe that, on the basis of all available data and information, the device meets the banning standard” provided under U.S. law, senior FDA officials Amy Abernethy and Jeff Shuren said in the statement.
Thousands of women around the world have reported serious health problems after receiving breast implants, including the cancer known as breast implant associated anaplastic large cell lymphoma, the International Consortium of Investigative Journalists reported last November in its global Implant Files investigation.
ICIJ also found that the FDA had allowed breast implant manufacturers to keep reports of injuries and complications linked to breast implants hidden from public view by reporting large numbers of events in summary reports that were not disclosed to the public. Hundreds of thousands of incidents were buried in this way, ICIJ revealed in March.
Breast implant patient advocates expressed dismay at the FDA’s decision.
“I’m pretty discouraged,” said Jamee Cook, the founder of Breast Implant Victim Advocacy, a group for women who suffered health problems after receiving breast implants that calls for stricter oversight of the products.
“Our lymphoma patients are pretty upset that they’re not upholding the decisions that other countries are making.”
Although it stopped short of a ban, the FDA said it will take several steps to better protect and inform patients.
The agency said that it will require manufacturers to publicly report injuries and other complications on an individual basis going forward, and that it will disclose all previous summary reports linked to breast implants.
The FDA also took its most concrete step toward recognizing breast implant illness, a condition characterized by symptoms including fatigue, muscle pain and memory loss that many women have reported after receiving breast implants. The agency, as well as many plastic surgeons, have long maintained that these complaints are scientifically unfounded.
Now, the FDA says that while it does not have “definitive evidence” that breast implants cause these symptoms, the problems reported by patients are real.
“The current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed,” Abernethy and Shuren said.