The warning on breast implant packaging is a part of a series of new guidelines after women developed a type of lymphoma.
ST. PETERSBURG, Fla. — The Food and Drug Administration is putting a new black box warning on the packaging for breast implants. This new guidance is part of a series of recommendations from an advisory panel that met back in 2019.
Here are the changes the FDA is putting in place:
- Restricting the sale and distribution of breast implants and only allowing health care providers who use their Patient Decision Checklist to be able to purchase them. Patients are required to sign it, acknowledging the risks of getting implants.
- Updating guidelines for screening women who have silicone implants to make sure their implants don't rupture.
- Manufacturers must update their websites with new information on the labeling in the next 30 days.
More than 730 patients have reported a problem to the FDA. According to the American Society of Plastic Surgeons…