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• Breast Mesh Problems Prompted FDA Warnings Over Off-Label Use

  October 15, 2025

  Russell Maas

  Federal regulators warned years ago that mesh implants were never approved for use in breast surgery, yet manufacturers continued marketing them as internal bra devices for reconstruction and cosmetic augmentation. As complication reports rise and more women undergo revision surgery, lawsuits are now being investigated against companies that promoted mesh for off-label breast procedures despite FDA warnings and no breast-specific safety data.