Women considering surgery to receive breast implants should be warned 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 patients considering surgery. It will be left to doctors to review those risks with women seeking breast implants.
The measures are not mandatory and are now open to public comment and industry input. But the recommendations reflect a growing acknowledgment at the agency that implants may cause more harm in women than previously known.
Several years ago, the agency linked implants to a rare form of immune system cancer called anaplastic large cell lymphoma. In July, at the request of the F.D.A., one manufacturer, Allergan, recalled textured breast implants linked to the cancer.
More recent studies have reported higher rates of autoimmune disease among women with breast implants. Advocates for women with these complications called the F.D.A.’s proposals on Monday “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.
She said surgeons should be required to go over the checklist with prospective patients before they put down a deposit.
“If breast implants can cause cancer of the immune system, doesn’t it make sense they can cause other systemic problems of the immune system?” Dr. Zuckerman asked.
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.
But 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 conditions.
Dr. Zuckerman has found that most breast implant studies were carried out by manufacturers or plastic surgery associations and did not track long-term outcomes, or lost so many participants to follow-up that results were not meaningful.
The studies focused on well-defined illnesses, she said, ignoring debilitating symptoms that lacked specific diagnoses, and most were too small to detect rare diseases.
Earlier this year, the agency warned two implant manufacturers that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.
The proposed checklist and boxed warning were developed in response to demands by patients who testified last March at an advisory panel meeting about illnesses they blamed on their implants.
Many said they had no idea there were risks associated with implants before having surgery. More than 70,000 women have since signed a petition demanding the F.D.A. to require the checklist.
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.”
The F.D.A. now wants a boxed warning on the packaging that tells patients that implants do not last a lifetime, and that the chances of developing complications increase the longer they have implants and may require another operation to resolve.
The warnings should also tell women that implants are linked to anaplastic large cell lymphoma, the agency said, and that patients have reported symptoms that cleared up when the implants were removed.
The checklist would go into even greater detail, warning women that if they smoke or have medical conditions like diabetes or autoimmune disease, they may not fare well after surgery.
All women may be left with chronic pain, loss of sensation or asymmetrical breasts, among other complications, the agency said. The proposed checklist would also warn that some women who had babies or breastfed after getting breast implants had reported health problems in their children.
The proposed checklist also would say that more than half of patients experience adverse events like a painful tightening of scar tissue around the implant.
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Implant manufacturers are also encouraged to list the ingredients in implants. The agency’s example lists 20 heavy metals in the devices — including mercury, lead, arsenic and platinum — as well as dozens of chemicals that can be extracted from implants or are released as gases.
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.
It also suggests that manufacturers provide more detailed information on a card patients receive that tells them exactly what kind of implant they have.
The wording of the boxed warning and checklist 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.
Dr. Alan Matarasso, the immediate past president of the American Society of Plastic Surgeons, said he did not believe the warnings would scare women away from implants.
“At the end of the day, breast implants are an extremely popular operation and have been shown to have tremendous benefit from a physical and emotional perspective,” he said.
He said the F.D.A. has acknowledged a constellation of symptoms in some patients, but that more data is needed to define the syndrome and link it to implants.
Jamee Cook, 42, grew so ill after having breast implant surgery at age 21 that she quit her job as a paramedic and ultimately had the implants removed. She agreed more research is needed, adding, “We should have had the data a long time ago.”
Attitudes among doctors are shifting, she noted.
“Two years ago, there were surgeons who completely dismissed it,” Ms. Cook said. “Now they’re saying, ‘There may be a subset of people who are affected. I don’t necessarily believe you, but I’m going to listen to you.’”