FDA Recommends Strongest Possible Warning Label For Breast Implants

(CNN) — The US Food and Drug Administration on Wednesday released draft guidance recommending a “boxed warning” on labeling materials for breast implants. Boxed warnings, which alert health care providers and consumers to serious risks associated with a drug or device, are the strongest form of warning required by the FDA for labeling.
An example of the boxed warning states that “breast implants are not considered lifetime devices” and “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma.” The draft guidance also proposes that patients considering breast implants review a “decision checklist” that outlines risks with their physicians, among other recommendations.
The recommendations have been put forth by the FDA for public comment and review. They are draft guidance and have not yet been finalized.
“The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device’s labeling, update recommendations for patient screening for device rupture and more,” FDA Principal Deputy Commissioner Dr. Amy Abernethy and Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement on Wednesday.
“Taken as a whole we believe this ...

Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - October 23, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Syndicated CBSN Boston breast implant illness CNN Source Type: news