FDA Warns BD Surgical Mesh Products Not Proven Safe for Breast Reconstruction Surgery

Growing use of some Becton Dickenson surgical mesh products for breast reconstruction has led federal regulators to issue a new safety warning, and require a label update alerting doctors that they have not been approved for such use.

The U.S. Food and Drug Administration (FDA) issued a letter to health care providers on November 9, informing doctors about the changes to certain BD mesh product labels, which clarify that the manufacturer has not established that the surgical mesh is safe or effective for breast reconstruction.

While the surgical mesh products are not approved for use in breast surgery, and cannot be marketed by the manufacturer for such uses, doctors can still use the products for “off-label” for any indication they deem appropriate, which appears to be an increasing trend, the FDA notes. However, the agency now indicates BD has agreed to update the labeling, to remind doctors about the lack of FDA approval for breast reconstruction.

“The FDA is aware of increased use of surgical mesh products in breast surgery,” the agency’s letter states. “However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

The BD surgical mesh products receiving the updated label warning 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

The affected mesh products have all been approved for the repair and reinforcement of soft tissue, but not for breast augmentation or reconstruction.

The FDA urges health care providers to carefully follow the instructions for use and label recommendations. However, the agency is not recommending anyone who received the surgical mesh for breast reconstruction have them removed if they have not suffered adverse health effects.

“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,” the agency warned. “There are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including augmentation or reconstruction.”

The agency encourages anyone who has suffered adverse events after receiving a surgical mesh during breast reconstruction or augmentation to file a report with the FDA’s MedWatch adverse event reporting program.