FDA Urges Breast Implant Makers To Add Boxed Warning To Device Labels

By Beth Wang / October 24, 2019 at 12:07 PM
In a new draft guidance published Wednesday (Oct. 23), FDA recommends breast implant manufacturers include a boxed warning and patient decision checklist in the labeling for breast implants. The agency also encourages manufacturers to update recommendations for patient screening for device rupture. FDA is making the recommendations in light of new information about the risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms, commonly referred to as breast implant illness that some patients...

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