November 14, 2023
FDA last week released a statement informing healthcare providers about labeling updates for Becton, Dickinson and company (BD) mesh products, reminding individuals that the use of surgical mesh products in breast surgery has not been determined by the administration to be safe and effective.
The labels were updated on the following products:
Phasix ST Mesh
Phasix Plug and Patch
Phasix ST Mesh with Open Positioning System (OPS)
Phasix ST Mesh with Echo 2 Positioning System, and
GalaFLEX Lite Scaffold
GalaFLEX 3D Scaffold
GalaFLEX 3DR Scaffold
The products, which are cleared for the repair and reinforcement of soft tissue where weakness exists, saw updates to their warnings and precautions.
FDA said that it is aware of increased use of surgical mesh products in breast surgery but that “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined,” according to the statement. Currently, there are no surgical mesh products cleared or approved by FDA for use in breast surgery.
The administrations stance affirms previously communicated recommendations from the General and Plastic Surgery Devices Panel held March 25-26, 2019. Of note, FDA is not recommending reoperation or removal of implanted surgical mesh in asymptomatic patients.
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