Hernia mesh lawsuits allege that hernia mesh manufacturers’ products failed and led to severe injuries that required additional surgeries to resolve. Plaintiffs claim these products are defective, the products weren’t properly tested, and manufacturers failed to warn the public about the risk of injury.
Injuries claimed in lawsuits include bowel obstruction, fistulas, perforation, adhesions and other severe injuries.
According to the FDA, Americans undergo about one million hernia operations each year and most surgeons use mesh. Surgeons use hernia meshes to repair hernias, weakened spots in muscle or connective tissue that allow organs or fatty tissue to squeeze through. These meshes are intended to be permanent implants and are the gold standard of care because they have lower hernia recurrence rates than non-mesh repairs.
The FDA allowed many newer hernia mesh products, including C-QUR by Atrium and Ethicon’s Physiomesh, on the market through the 510(k) clearance process. This clearance pathway allows manufacturers to sell products without intensive clinical trials as long as the product is comparable to a product already on the market.
According to hernia mesh lawsuits, the problems with newer hernia mesh devices often stem from polypropylene, the material most meshes are made of. Manufacturers claim polypropylene is inert, or chemically inactive. But studies have shown that polypropylene may cause immune responses in the body, leading to mesh degradation and severe adverse reactions. Manufacturers may also add coatings to the mesh, such as fish oil, that are supposed to combat inflammation. However, these coatings may pose problems when they come into contact with tissue.
Some hernia mesh complications require patients to undergo additional corrective surgery to remove the hernia mesh, adding further costs and distress. In addition, some injuries may be permanent, resulting in chronic pain, health problems, financial hardship, emotional suffering, and reduced quality of life.