FDA highlights updated labeling for some surgical mesh products, cautions against use of mesh in breast surgery

The US Food and Drug Administration (FDA) issued a letter to healthcare providers to make sure they are aware of updated warnings and precautions for certain surgical mesh products produced by Becton, Dickinson and Company (BD), which are included in updated product labeling.
 
FDA also reminded providers that the agency has not determined the safety and effectiveness of surgical mesh products, including the BD products, when used in breast surgery.
 
In total, BD updated labeling for nine mesh products that are cleared for the repair and reinforcement of soft tissue where weakness exists. The products include:
 

• 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
• GalaFLEX Lite Scaffold
• GalaFLEX Scaffold
• GalaFLEX 3D Scaffold 
• GalaFLEX 3DR Scaffold  

 
Health care providers should follow the instructions in the updated labeling, but FDA is not recommending reoperation or removal of implanted surgical mesh in asymptomatic patients.
 
Mesh in breast surgery
 
FDA noted that there has been an increase in the use of surgical mesh products in breast surgery.
 
“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,” FDA wrote.
 
This is not the first time the agency has cautioned against the use of surgical mesh products in breast surgery. FDA raised the issue of surgical mesh being used in breast reconstruction procedures and mastopexy during a General and Plastic Surgery Devices Advisory Committee Meeting held in 2019, and issued a safety communication in March 2021 to patients and health care providers about the use of certain acellular dermal matrix (ADM) products in breast surgery.
 
“Over the past several years, the use of ADM has increased and is now commonly used off-label in implant-based breast reconstruction,” Binita Ashar, director of FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, stated in the 2021 safety communication. “We strongly encourage patients to discuss all the possible benefits and risks related to breast reconstruction procedures with their surgeon, including the pros and cons of the use of different brands of ADM.”
 
The agency recommends that health care providers use MedWatch to submit voluntary reports of adverse events or suspected adverse events with surgical mesh products, and follow the FDA’s user facility reporting requirements if the health care provider works at a facility subject to those reporting requirements.
 
Letter to health care providers