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Federal regulators on Wednesday placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery.
Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.
Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments.
That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment.
The Food and Drug Administration is also requiring manufacturers for the first time to disclose the ingredients used to make breast implants, information that patient advocates have long sought. The information must be made public in 30 days.
It is not clear how the new requirements will be enforced, and patients are highly unlikely to ever see a warning label on a packaged sterile medical device that is usually handled only by a surgeon. F.D.A. officials said in a statement that the patients “must be given the opportunity” to sign the checklist.
The agency’s new warnings have been years in the making. A decade ago, the F.D.A. first identified a possible link between breast implants with a textured surface and a particular cancer, anaplastic large cell lymphoma.
In early 2019, after receiving hundreds of thousands of reports of adverse side effects linked to implants over the years, the agency heard testimony from dozens of women about their struggles with cancer and a constellation of other debilitating medical problems that developed after implant surgery, conditions that are often referred to as breast implant illness.
Reactions to the new requirements were mixed. While some doctors welcomed the new warning system, others worried that the potential risks and side effects would not be conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner.
Critics also said the checklist was overly long and written in obtuse language. “It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist who heads the National Center for Health Research and was a member of the working group that advised the F.D.A. on implant safety.
“They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants,” Dr. Zuckerman said. “People understand it if you say, ‘Breast implants can cause lymphoma.’”
She worried that surgeons would not take the time to adequately review the information with patients.
“What if a surgeon says, ‘Here’s a checklist — I know it’s long, so it’s up to you if you want to read it or not’?” Dr. Zuckerman said. “Patient groups are very concerned that will happen.”
But Dr. Mark Clemens, a professor at M.D. Anderson Cancer Center in Houston who serves a liaison to the F.D.A. for the American Society of Plastic Surgeons Society, said the black box warning and checklist represented “a huge step forward for patient safety and implants.”
But more high-quality data about long-term outcomes for women with implants is needed, he added.
The F.D.A. also issued updates regarding ongoing studies that implant manufacturers are required to carry out. Four of the five so-called post-marketing studies have made “inadequate progress,” according to the agency.
The patient checklist states explicitly that there are some medical conditions that should preclude women from getting implants. (They are listed under the heading “Considerations for a candidate for successful breast implantation.”)
In addition to breast cancer that has been treated, those conditions include active infections, existing cancer or pre-cancer of the breast that has not been treated, pregnancy and nursing.
Women with diabetes, which can make healing difficult, and lupus, which interferes with blood clotting, are also listed as having a higher risk of a poor outcome. So, too, are smokers and former smokers.
One-third of women who have breast implant surgery will experience breast pain, sensitivity or loss of sensitivity in the breast, or asymmetry, the agency said.
Half will experience a painful tightening of scar tissue around the implant, and one-third will have implants that rupture or leak. Nearly 60 percent will need a repeat operation.
“Breast implants are not considered lifetime devices,” the new warnings will say. “The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.”
About 400,000 women in the United States get breast implants every year — 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies performed to treat or prevent breast cancer.
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