Patients should be wary of breast implant risks, FDA says
Federal regulators on Wednesday placed so-called black box warnings on breast implant packaging and asked manufacturers to only sell the device to health providers who review potential risks with patients before surgery.
Both the warnings and a new checklist that advises patients of the risks and side effects suggest that breast implants have been linked to cancers of the immune system and a number of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion. Muscle aches and chronic fatigue.
Shockingly, the checklist identifies specific types of patients who are at higher risk of disease after breast implant surgery. This group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatment.
This represents a large percentage of women who were until now encouraged to have breast reconstruction with implants after their treatment.
The Food and Drug Administration also required manufacturers for the first time to disclose ingredients used to make breast implants, information patient advocates have long sought. The information must be made public within 30 days.
It is unclear how the new requirements will be implemented, and patients are highly unlikely to see a warning label on a packaged sterile medical device that is usually handled by only one surgeon. FDA officials said in a statement that patients “should be given the opportunity” to sign off on the checklist.
The agency’s new warnings have taken years to form. A decade ago, the FDA 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 associated with implants over the years, the agency asked dozens of women about their struggles with cancer and a slew of other debilitating medical problems that developed after transplant surgery. Heard the testimony. Which is often referred to as breast implant disease.
Reaction to the new requirements was mixed. While some doctors welcomed the new alert system, others were concerned that the potential risks and side effects would not be adequately conveyed by plastic surgeons who were eager to reassure patients that the procedure was safe and dismissed the new checklist in a dismissive manner. will be handled.
Critics also noted that the checklist was too long and written in ambiguous 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 FDA on implant safety. was given.
“They say, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by implants,” Dr. Zuckerman said. “People understand it if you say, ‘Breast implants can lead to lymphoma.'”
She was concerned 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 whether you want to read it or not’?” Dr Zuckerman said. “Patient groups are very concerned that this will happen.”
But Dr. Mark Clemens, a professor at the MD Anderson Cancer Center in Houston who liaises with the FDA for the American Society of Plastic Surgeons, said the black box warnings and checklists “are a huge step forward for patient safety and implants.” . “
But more high-quality data is needed about long-term outcomes for women with implants, he said.
The FDA has also issued an update about ongoing studies that implant manufacturers need to complete. According to the agency, four of the five so-called post-marketing studies have made “insufficient progress.”
The patient checklist clearly states that there are certain medical conditions that prevent women from having implants. (They are listed under the heading “Considerations for a Candidate for Successful Breast Implants.”)
In addition to breast cancer that has been treated, those conditions include active infection, existing cancer or pre-cancer of the breast that has not been treated, pregnancy and nursing.
Women with diabetes, which can make treatment difficult, and lupus, which impedes blood clotting, are also listed as having a higher risk of a poor outcome. So, too, are smokers and former smokers.
The agency said that a third of women who have breast implant surgery will experience breast pain, tenderness, or a lack of sensitivity or asymmetry in the breast.
Half will experience painful tightening of the scar tissue around the implant, and a third will have implants that rupture or leak. About 60 percent will require a repeat operation.
“Breast implants are not supposed to be a lifelong device,” the new warnings say. “The longer people have it, the more likely they are to develop complications, some of which will require more surgery.”
About 400,000 women in the United States get breast implants each year – 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies performed to treat or prevent breast cancer.
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