STORY FROM: MDL Mass Tort & Class Action Monitor
FDA Draft Guidance Recommends Boxed Warning for Breast Implants
October 23, 2019
WASHINGTON, D.C. — The Food and Drug Administration has recommended a boxed warning for saline and silicone gel-filled breast implants, which would caution doctors and patients of the risk of breast implant-associated anaplastic large cell lymphoma.
In an Oct. 24 draft guidance, the agency says the boxed warning should also state that “breast implants are not considered lifetime devices; the chance of developing complications increases over time; and some complications will require more surgery.
The FDA also suggested including in the devices’ information booklet a patient decision checklist highlighting key information regarding risks. The agency says the body of ...