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. 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.

Read Article: The New York Times

FDA finalizes requirements for stronger warnings for breast implants

The AP reports that the FDA “finalized stronger warnings for breast implants, including a new requirement that people receive detailed information about their potential risks and complications before getting them.” The agency “announced the new regulations mainly aimed at implant manufacturers, who are also being required to add a boxed warning message – the most serious type – to their written patient materials.” This is “the latest step in a decades-long effort to manage safety issues with the devices, which are primarily used for breast augmentation, the most common cosmetic surgical procedure in the U.S. Roughly 400,000 people get implants each year, 100,000 of them after cancer surgery.”

Also reporting are the Washington Post, the New York Times, NBC News, CNN, Axios, and The Hill.

From the news release of the American Association for Justice.