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FDA issues BIA-ALCL update, qualifies BREAST-Q

August 25, 2020 10:23 AM | Anonymous

The FDA issued an update to its breast implant safety webpages on Aug. 20 regarding adverse events reported to the Agency related to breast implants, including Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and data on medical device reports (MDR) the FDA has received on "Breast Implant Illness." The BIA-ALCL update cites a total of 733 unique cases of BIA-ALCL and 36 patient deaths globally, representing an increase of 160 new cases (64 from the United States) and three deaths since the July 2019 update.

The update calls for no changes in recommended routine follow-up care for patients with breast implants.

The FDA also announced that the BREAST-Q – a patient-reported, quality-of-life outcomes measure for breast surgery funded by The PSF and developed by ASPS member Andrea Pusic, MD, MHS – has been approved as a qualified Medical Device Development Tool, which means it may be used in clinical outcomes assessment and regulatory decision-making for breast implant devices.

For the complete story, click here.  

ASPS provides a wealth of up-to-date resources on BIA-ALCL for physicians and the public at PlasticSurgery.org/ALCL. These resources include:

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