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Surgical mesh has been used for years to repair hernias and reinforce weakened soft tissue. Over the past decade, plastic surgeons began using BD's GalaFLEX and Phasix mesh products in breast surgery as an "internal bra," supporting implants, reducing sagging, and reinforcing tissue after mastectomy reconstruction. The problem is that none of these products were ever cleared by the FDA for breast surgery, and that gap between approved use and actual practice now sits at the center of breast mesh litigation.
BD's mesh products reached the market through the FDA's 510(k) pathway, which allows a manufacturer to sell a device by showing it is substantially equivalent to products already on the market. The original clearances covered:
Breast reconstruction, breast augmentation, breast lifts, and internal bra procedures were never part of that clearance. Surgeons adopted the products for these uses off-label, a legal practice when a physician judges it medically appropriate, but one that leaves patients relying on a use the FDA never evaluated.
In a letter to healthcare providers, the FDA stated that it had not determined the safety and effectiveness of surgical mesh for breast augmentation or reconstruction, despite seeing a rise in this kind of use. The agency asked providers to review BD's updated labeling before using these products in breast procedures.
The wording here makes an important distinction, since the FDA stopped short of calling the mesh unsafe and instead said there isn't enough evidence to confirm it performs as intended when used in the breast, a narrower finding that still carries weight for anyone who had one of these devices implanted.
Following talks with the FDA, BD revised the labeling for several products to state plainly that they have not been studied for breast reconstructive surgery:
A common misconception holds that this mesh was recalled, when in fact the FDA never banned the products, never issued a recall, and never recommended removing mesh from patients who aren't showing symptoms. Instead, the agency required new label language and put providers on notice that the clinical evidence behind breast use remains thin, since some published studies report good outcomes in select patients while others document complications and revision surgery, a gap the FDA has said still needs to be closed.
Patients who received this mesh in breast procedures have reported a range of complications, including:
The FDA has not concluded that the mesh directly causes these outcomes, and its position instead centers on the fact that the products were never adequately evaluated for breast surgery in the first place, which makes it difficult to say with confidence what risks patients were actually taking on.
The FDA's communication doesn't establish legal liability on its own, but it has become a central reference point in breast mesh lawsuits. Plaintiffs point to a few recurring arguments:
The distance between what the 510(k) pathway actually proved and how surgeons applied the product in practice is the gap plaintiffs are now asking courts to examine.
If you or a family member had GalaFLEX or Phasix mesh used in a breast procedure and later experienced infection, chronic pain, implant complications, or needed revision surgery, your case may be part of this litigation. Atraxia Law can review your medical history, identify which product was used, and help you understand whether your situation supports a claim. Reach out today for a free, confidential case evaluation.