FDA Asking for Stronger Warnings on Breast Implants
FDA Presses for Better Warnings About Breast Implants
The Food and Drug Administration (FDA) is seeking stronger warnings on breast implants in an effort to properly educate women seeking the enhancements. The FDA has suggested that warnings be added to the product that are highlighted by a box, which is considered to be the most serious type of warning on a product. The FDA has also suggested that patients begin completing a checklist prior to undergoing surgery that explains to them the side effects of breast implants. These side effects include scarring, rupture, pain, and a rare form of cancer.
Statement from the FDA
The FDA released the following statement regarding breast implants and the suggestions regarding warnings:
“We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information. The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and health care professionals when breast implants are being considered.”
Recommendations from the FDA
Aside from issuing a warning to patients highlighted by a box and having patients complete a checklist, the FDA also made the following recommendations in its press release:
- Have companies explain that many implants need repeat surgeries
- Have companies explain to patients that implants are not meant to last for life
- Have companies tell patients that 1 out of every 5 women need to have implants removed 8 to 10 years after being implanted for cosmetic reasons
The FDA is going to hold a public comment period regarding the recommendations before putting any of them in place. Breast augmentation is the most common cosmetic surgery procedure in the United States, with 400,000 procedures each year. More than 100,000 women undergo the procedure after undergoing surgery for cancer.
“Our actions reflect the agency’s commitment to advancing policies that enhance the FDA’s oversight of device safety, including device therapies unique to women. We look forward to continuing to engage with patients, manufacturers, the medical community and other stakeholders on these draft recommendations,” the FDA stated.
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