Patients must be warned of breast implant risks, FDA says
A decade after scientists identified a link between certain implants and cancer, the US Food and Drug Administration has ordered “black box” warnings and a new checklist of risks for patients to review.
Federal regulators have placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery.
Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.
Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments.
That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment.
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 conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner.
But Dr. Mark Clemens, a professor at M.D. Anderson Cancer Center in Houston who serves a liaison to the F.D.A. for the American Society of Plastic Surgeons Society, said the black box warning and checklist represented “a huge step forward for patient safety and implants.”
Source: The New York Times, 27 October 2021