November 9, 2023
The U.S. Food and Drug Administration (FDA) is informing health care providers about labeling updates for Becton, Dickinson and Company (BD) mesh products:
- Phasix Mesh
- 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 Scaffold
- GalaFLEX 3D Scaffold
- GalaFLEX 3DR Scaffold
These surgical mesh products are cleared for the repair and reinforcement of soft tissue where weakness exists.
The FDA is aware of increased use of surgical mesh products in breast surgery. However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.
BD has updated their labeling for these products, including updated warnings and precautions. The FDA is issuing this letter to ensure that health care providers are aware of these labeling updates, and are aware that surgical mesh products, including BD’s mesh products, have not been determined by the FDA to be safe and effective for use in breast surgery.
The FDA recommends health care providers:
- Read BD’s updated labeling and carefully follow instructions for use and recommendations.
The FDA is not recommending reoperation or removal of implanted surgical mesh in asymptomatic patients.
The FDA stresses the importance of clinical evaluations to evaluate the safety, effectiveness, and benefit-risk profile of these products when used for breast surgery. There are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including in augmentation or reconstruction.
The FDA communicated about this issue at the General and Plastic Surgery Devices Panel held March 25-26, 2019. The panel’s recommendations have not changed.
The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with BD’s mesh products or the surgical mesh products of other manufacturers.
- You can submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
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