The U.S. FDA on Thursday reminded healthcare providers that “there are no surgical mesh products cleared or approved by FDA for use in breast surgery, including in augmentation or reconstruction.”
The regulatory agency says it has not determined the safety and effectiveness of surgical mesh in breast surgery specifically, but notes that its use there by surgeons is increasing.
The FDA is also not recommending reoperation or removal of already-implanted surgical mesh in asymptomatic patients.
The FDA’s notice, which some are calling a warning, accompanies a labeling update for Becton, Dickinson and Company (BD) surgical mesh products.
BD acquired Tepha, Inc., a manufacturer of surgical meshes, including the popular GalaFLEX line, in July 2021. BD defines the mesh products as a “bioresorbable scaffold for soft tissue support” used to “repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome.”
“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.”U.S. FDA, “Labeling Updates for BD Mesh Products – Letter to Health Care Providers,” November 9, 2023
The FDA on Thursday stated that BD’s mesh products “are cleared for the repair and reinforcement of soft tissue where weakness exists.”
This FDA clearance, issued in May 2014, does not, however, cover the use of these or any other surgical mesh products in the breasts or in breast surgery, the safety and efficacy of which has not yet been determined by the FDA.
- 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
As to the background of its letter, the agency says it “stresses the importance of clinical evaluations to evaluate the safety, effectiveness, and benefit-risk profile of these products when used for breast surgery,” adding again that, “There are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including in augmentation or reconstruction.”
“The FDA is not recommending reoperation or removal of implanted surgical mesh in asymptomatic patients.”U.S. FDA, “Labeling Updates for BD Mesh Products – Letter to Health Care Providers,” Nov. 9, 2023
The FDA says it encourages health care providers to report adverse events or suspected adverse events with any surgical mesh product, through its MedWatch Safety Information and Adverse Event Reporting program.