Two surgical mesh products that are commonly used off-label in breast reconstruction surgery are linked to “significantly higher major complication rates,” according to a warning from the FDA.
Patients who were implanted with FlexHD (made by MTF Biologics) or AlloMax (made by BD) were more likely to suffer from infections, explantation, or problems that required another surgery within 2 years compared to patients who were treated with other mesh or no mesh.
FlexHD and AlloMax are both made of human or animal skin, also known as an Acellular Dermal Matrix (ADM). The FDA has approved some types of ADMs for hernia surgeries — but no ADMs are FDA-approved for post-mastectomy breast reconstruction surgeries.
Despite the lack of FDA approval, the FDA is concerned because “over the past several years, the use of ADM has increased and is now commonly used off-label in implant-based breast reconstruction.”
At this time, the FDA is not recommending re-operation or removal of ADM. Instead, the agency is asking patients who had problems after breast reconstruction with ADM to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting System.