The Food and Drug Administration (“FDA”) oversees the regulation and safety of drugs and medical devices. In doing so, it publishes important safety notices on its website. The FDA recently provided information on its website regarding the use of hernia mesh for hernia repair.
Why did the FDA issue a hernia mesh notice?
The communication was meant to encourage patients to discuss treatment options with their physicians. Also, it was issued to provide patients with a better understanding of the benefits and risks of hernia mesh medical devices.
What information does the hernia mesh notice include?
The FDA’s communication includes:
- Types and causes of hernias
- Hernia treatment options
- Surgical option information
- Ways that the FDA monitors the safety of hernia mesh
- How to report problems to the FDA
Importantly, the information discusses nonsurgical and surgical options not involving hernia mesh.
What are nonsurgical options for mesh repair?
Nonsurgical options include monitoring asymptomatic hernias, wearing abdominal binders and trusses.
What are surgical options for hernia repair?
Surgical options to repair hernias include using stitches. Another option is using animal derived mesh. Animal tissue makes up animal derived mesh instead of synthetic polypropylene. Synthetic polypropylene mesh is currently the subject of litigation because of its link to abdominal injuries.
What is the hernia mesh litigation about?
One surgical treatment option, the use of synthetic mesh, is the subject of litigation. Plaintiffs allege that the synthetic mesh material, mesh coating, and overall product design are defective. Further, plaintiffs claim that the manufacturer failed to warn the public and medical community of risks of implantation of hernia mesh.
What injuries can hernia mesh cause?
Up to 20% of hernia repair patients suffer from chronic pain after their mesh implant procedure. Additional complications include mesh migration, organ perforation, bowel obstruction, infection, adhesions, hernia recurrence, and difficulty in removing the mesh requiring multiple revision surgeries.
If you or a loved one have been injured after receiving a hernia mesh implant, contact the FDA. You may also want to consult an attorney to evaluate any claims you may have against the manufacturer of the mesh device.