FDA Updates Their Position On Hernia Mesh
For a long time, the FDA held the position publicly that hernia mesh repair with and without hernia mesh carried the same risk. The FDA had also never acknowledged that polypropylene and polyester hernia mesh devices degrade and shrink once implanted in the human body. That all changed however on July 13, 2023, when the FDA published the article Surgical Mesh Used for Hernia Repair.
FDA Admits Hernia Mesh Degrades
The hernia mesh lawsuits have long alleged that the polypropylene and polyester-based hernia mesh devices undergo degradation after being implanted in humans. Many hernia mesh instructions for use (IFUs) even claim that the hernia mesh devices are inert and do not undergo degradation. Furthermore, the hernia mesh defendants have put on experts in court that claim that polypropylene hernia mesh does not undergo degradation in the human body. The FDA has finally sided with the hernia mesh plaintiffs and on page 5 of the FDA’s hernia mesh article, the FDA notes “non-absorbable mesh will remain in the body indefinitely but may undergo some degradation over time.” However, the FDA did not go as far as linking hernia mesh degradation to any complications. Furthermore, the FDA has not yet required any hernia mesh manufacturers to recall their polypropylene or polyester hernia mesh devices due to degradation. Regardless, the FDA admitting that hernia mesh devices undergo degradation after implantation is a huge step in the right direction.
FDA Admits Hernia Mesh Can Shrink/Contract
The hernia mesh lawsuits have also long alleged that polypropylene and polyester hernia mesh devices shrink or contract after they are implanted. The hernia mesh instructions for use do not typically warn that the hernia mesh will shrink or contract over time. In court, many of the hernia mesh defendants have put forth experts who claim that polypropylene hernia mesh devices can’t shrink. The defendant’s hernia mesh experts claim that the wound where the hernia mesh is placed is actually contracting, making the mesh appear contracted, even though the mesh itself didn’t shrink. The FDA has now publicly sided with the hernia mesh plaintiffs on the issue of hernia mesh shrinkage and contracture, stating on page 6 of the FDA’s hernia mesh article, “for hernia repair with mesh, additional adverse events include migration or shrinkage (contraction) of the mesh itself, which may more likely be associated with the previously mentioned complications of hernia repair.” Previously, the FDA listed the following as complications of hernia repair:
- Hernia recurrence
- scar-lie tissue that sticks tissues together (adhesions)
- Blockage of the large or small intestines (obstruction)
- Abnormal connection between organs, vessels, or intestines (fistula)
- Fluid build-up at the surgical site (seroma)
- Hole in neighboring tissues or organs (perforation)
The FDA did not provide an explanation as to why the hernia mesh devices shrink and contract over time. Our hernia mesh attorney has alleged in hernia mesh lawsuits that the reason the hernia meshes undergo shrinkage and contraction is because the hernia mesh devices are degrading.