Federal regulators placed black box warnings on breast implant packaging on Wednesday, telling manufacturers to only sell the devices to healthcare providers who review the potential risks to patients before surgery.
A new checklist that advises both warnings and patients about risks and side effects states that breast implants are linked to an immune system cancer and a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion. muscle aches and chronic fatigue.
Surprisingly, the checklist identifies certain types of patients who are at higher risk for disease after breast implant surgery. The group includes breast cancer patients who have had or plan to have chemotherapy or radiation therapy.
This represents a large percentage of women encouraged to have breast reconstructions with implants following their treatment so far.
The Food and Drug Administration also wants manufacturers to disclose for the first time the ingredients used to make breast implants, information patient advocates have long sought. Information must be made public within 30 days.
It is unclear how the new requirements will apply, and patients are unlikely to see a warning label on a packaged sterile medical device that is typically used only by a surgeon. FDA officials said in a statement that patients “should be given the opportunity” to sign the checklist.
The agency’s new warnings have been made for years. A decade ago, the FDA 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 testimonies from dozens of women about their battle with cancer and a constellation of other debilitating medical issues that developed after implant surgery, conditions. This is often referred to as breast implant disease.
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 adequately communicated to patients by plastic surgeons willing to reassure patients that the procedure was safe, and that the new checklist would be treated condescendingly.
Critics also said the checklist was overly long and written in broad language. “It’s better than nothing, but not as good as it could be,” said scientist Diana Zuckerman, chair of the National Center for Health Research and a member of the working group that advises the FDA on implant safety.
Dr. “They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma actually originates from implants,” Zuckerman said. “If you say, ‘Breast implants can cause lymphoma,’ people will understand.”
He worried that surgeons would not take the time to adequately review patient information.
“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 worried that this is going to happen.”
But Dr., who is a professor at the MD Anderson Cancer Center in Houston and liaises with the FDA for the American Society of Plastic Surgeons. Mark Clemens said the black box warning and checklist “represents a huge step forward for patient safety and implants.” ”
But he added that higher-quality data is needed on long-term outcomes for women with implants.
The FDA has also released updates on the ongoing work that implant manufacturers must conduct. According to the agency, four out of five so-called postmarketing studies made “inadequate progress.”
The patient checklist clearly states that there are certain medical conditions that should prevent women from getting implants. (Listed under Considerations for a successful breast implant candidate.)
These conditions include, in addition to treated breast cancer, active infections, existing cancer or pre-cancer of the untreated breast, pregnancy and breastfeeding.
Women with diabetes, which can complicate recovery, and women with lupus, which prevent blood from clotting, are also listed as having a higher risk of poor outcomes. So do smokers and ex-smokers.
One-third of women who have breast implant surgery will experience breast pain, breast tenderness or loss of tenderness, or asymmetry, the agency said.
Half will experience a painful compression of scar tissue around the implant, and a third will have implants that rupture or leak. About 60 percent will need reoperation.
The new warnings will say “Breast implants are not considered lifetime devices.” “The longer it stays in people, the higher their chance of developing complications, some of which will require further surgery.”
In the United States, approximately 400,000 women receive breast implants each year — 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies to treat or prevent breast cancer.