Hernia Mesh Lawyers

hernia mesh surgeryHernia mesh products, including Ethicon Physiomesh and Atrium C-Qur Patches, are medical devices used in hernia repair surgeries to close a hernia and help heal the surrounding tissue. A hernia occurs when an organ or tissue pushes through a hole or weakened spot in the abdominal muscle. Hernia repair surgeries are one of the most commonly performed surgeries in the U.S.

Ethicon Physiomesh and Atrium C-Qur Patches are composite mesh devices, which include polypropylene (or plastic) filaments that are woven into a thin mesh and covered in a coating. The coating helps protect the polypropylene from coming into contact with internal organs and causing inflammation. Unfortunately, poor design of the devices has led to severe complications, including:

  • Severe abdominal pain
  • Organ perforation
  • Bowel obstruction
  • Infections
  • Adhesion (scar tissue)
  • Hernia recurrence
  • Allergic reaction
  • Additional surgeries
  • Mesh fractures
  • Mesh migration

Unlike most products that must undergo rigorous clinical trials and testing, hernia mesh products are approved through the U.S. Food and Drug Administration’s 510(k) clearance program, which provides fast-tracked approval of products that are substantially comparable to others already on the market.

In May 2016, just six years after Ethicon’s Physiomesh was approved, the manufacturer issued a worldwide withdrawal of the device from the market following a March 20161 study that found that Physiomesh had a 20 percent higher rate of hernia recurrence than another hernia mesh product.

Another 2016 study2 found that Physiomesh had less tissue integration than other composite hernia mesh products. If the mesh is unable to integrate into the tissue, it can move from its intended location and will not allow the tissue surrounding the hernia to repair.

Similarly, just six years after Atrium C-Qur Patches were approved, the U.S. Food and Drug Administration issued a warning letter3 to the manufacturer noting that it failed to address multiple complaints about infections related to the C-Qur hernia mesh. However, despite a class 2 recall4, the device remains on the market.

If you or a loved one has experienced any of these side effects or complications after undergoing hernia repair surgery, please contact the experienced attorneys at Schlichter Bogard & Denton for a free legal consultation by calling 1-800-873-5297.

1 https://www.ncbi.nlm.nih.gov/pubmed/26139491

2 https://www.ncbi.nlm.nih.gov/pubmed/25903676

3 http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm325084.htm

4 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119924