Patients must be warned of breast implant risks, say USFDA officials

Federal regulators on Wednesday 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 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. The FDA is also requiring manufacturers for the first time to disclose the ingredients used to make breast implants, information that patient advocates have long sought. The information must be made public in 30 days. It is not clear how the new requirements will be enforced, and patients are highly unlikely to ever see a warning label on a packaged sterile medical device that is usually handled only by a surgeon. FDA officials said in a statement that the patients “must be given the opportunity” to sign the checklist.