On Nov. 9, the FDA issued a Letter to Health Care Providers about labeling updates for Becton, Dickinson and Company (BD) surgical mesh products.
The FDA is aware of increased use of surgical mesh products in breast surgery. The safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA. There are no surgical mesh products cleared or approved by FDA for use in breast surgery, including in augmentation or reconstruction.
FDA has the letter.