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No, as of 2026, there is no surgical mesh that the FDA has approved or cleared specifically for breast augmentation, reconstruction, lifts, or other related procedures. In a November 9, 2023 letter to health care providers, the FDA stated plainly that no surgical mesh products are cleared or approved for breast surgery, including reconstruction or augmentation. This applies to products marketed by Becton, Dickinson and Company under the GalaFLEX and Phasix lines.
Despite this, some plastic surgeons use surgical mesh off-label during procedures such as:
Off-label use occurs when a physician uses an FDA-cleared device for a purpose not included in its authorized labeling. The FDA regulates how manufacturers market their products but generally does not regulate how physicians use them in practice, meaning off-label use is legal while manufacturers cannot market these products as approved for breast surgery.
The FDA’s 2023 letter followed an uptick in the use of mesh in breast procedures. It worked with BD to revise the labeling on several products, making clear that these had not been shown to be safe and effective for breast surgery.
The FDA did not recall these products, ban their use, or recommend removal in patients without symptoms. The agency has also not concluded that mesh is inherently unsafe for breast procedures, only that current evidence is insufficient to establish safety and effectiveness for this use.
Our team has over 35 years of experience evaluating defective medical device claims involving off-label surgical products. If complications followed a breast procedure that involved surgical mesh, we can review your medical records to see whether you qualify to file a claim. Eligible patients are connected with an attorney who can pursue the compensation they may be owed. Reach out today to get started.