Women considering surgery to receive breast implants should be warned in advance of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration said on Wednesday.
Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, and to provide a checklist spelling out the risks for prospective patients to review before making a decision and putting down a deposit on the surgery.
The measures are not mandated by the agency; they are proposals now open to public comment and industry input. Advocates for women with complications linked to breast implants called the FDA’s proposals “an important step,” but noted that the action is only a recommendation.
“What matters most is what happens next,” said Diana Zuckerman, president of the National Center for Health Research in Washington, who has analyzed breast implant studies and has been advising patients.
Millions of women have implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomy for breast cancer.
Breast augmentation with implants is the most popular cosmetic surgical procedure. Some 313,000 augmentations were performed in 2018, a 4 percent increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.
Thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue, a constellation of symptoms some experts call “breast implant illness.”
Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases. Implants have also been linked to a rare cancer of the immune system called anaplastic large cell lymphoma, which can be fatal. Most of the cancer cases developed in women with textured implants.
Dr. Zuckerman has found that most breast implant studies did not track long-term outcomes, or lost so many participants that results were not meaningful.
The studies, funded by implant manufacturers or plastic surgery associations, focused only on well defined diseases, she added, ignoring debilitating symptoms without specific diagnoses. Most studies were too small to detect rare diseases.
A connection between implants and disease was largely dismissed by the medical community, but more recently has drawn the attention of the F.D.A. The agency warned two implant manufacturers earlier this year that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.
At an advisory panel meeting in March, women with breast implants testified about their illnesses and implored the agency to take action. More than 70,000 women signed a petition demanding the F.D.A. to require the checklist.
Advocates urged agency officials to require the long-term safety studies that were promised and to start patient registries to track outcomes. Some women asked the F.D.A. to ban breast implants altogether.
Agency officials said they had “heard loud and clear” that there was “a distinct opportunity to do more to protect women who are considering implants.”
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the agency said in a news release. “They’ve stated they need more information to facilitate meaningful conversation with their doctors and to make appropriate decisions for themselves.”
The agency wants manufacturers to warn patients that implants do not last a lifetime, that the chances of developing complications increase the longer they have the implants and may require another operation to resolve, and that implants are linked to anaplastic large cell lymphoma.
The F.D.A. also wants implant manufacturers to list the ingredients in implants, in an easy-to-understand format for patients, so that women know about chemicals and heavy metals in the products.
But the precise labeling will be left to the device makers, who can take the agency up on its recommendations or “choose other methods,” the F.D.A. said.
And since patients rarely see a medical device before a procedure, it will be up to plastic surgeons to make sure women are fully informed of both the risks and benefits.
The agency also is proposing new screening recommendations for women who already have silicone gel implants, saying they should undergo imaging scans to look for ruptures beginning five to six years after the surgery and every two years after that.
The agency is suggesting that manufacturers provide more detailed information and warnings on the card that patients get that tells them exactly what kind of implant they have.
At the request of the F.D.A., Allergan in July recalled textured breast implants linked to the unusual cancer.