Breast mesh lawsuits allege that some manufacturers promoted or allowed their mesh products to become widely used in breast reconstruction, augmentation, and revision procedures despite the fact that FDA has not cleared or approved any surgical mesh product for use in breast surgery. The FDA has specifically stated that the safety and effectiveness of surgical mesh in breast surgery, including augmentation and reconstruction, has not been determined.
These internal bra lawsuits allege that manufacturers of products such as AlloDerm, GalaFLEX, Phasix, AlloMax, FlexHD, Strattice, and DuroSorb marketed their devices for breast reconstruction, augmentation, and revision surgeries even though those breast-specific applications had not been adequately studied or cleared by the FDA. Patients were not warned. Surgeons were not given enough information. So when complications developed, including infection, mesh failure, chronic pain, implant loss, breast deformity, and the need for additional surgery, many women had no reason to connect their injuries to the mesh product placed inside them.