Patient Safety News: Complications can offset benefits of hernia mesh

For patients who have surgery to repair a hernia, the use of mesh lowers the risk of recurrence. However, the benefits of hernia mesh are at least partially offset by complications, according to a study published by the Journal of the American Medical Association.

For more than 50 years, hernia mesh implants have been used to repair abdominal hernias. Similar to other medical devices, however, hernia mesh can cause serious adverse reactions and sometimes permanent injuries to a patient. Complications can include bowel obstruction, bowel perforation, bleeding, and late abscess.

Elective incisional hernia repair is one of the most commonly performed general surgical operations. Prosthetic mesh is used to reinforce the repair in at least half of the abdominal wall hernia repairs performed in the United States.

Researchers Dunja Kokotovic, Frederik Helgstrand, and Thue Bisgaard conducted a study that included 3,242 patients with elective incisional hernia repairs in Denmark from January 2007 to December 2010. The team compared outcomes for hernia repair using mesh, versus repair without use of mesh. The study showed that for mesh patients, the long term complication rate was roughly 3-5 percent higher than the non-mesh patients.

“The study highlights the need to assess the long term safety of interventions before making definitive conclusions about their benefits. Demonstration of long term safety is required for drugs in the United States but not for some devices, such as hernia meshes, which are not subject to similarly strict documentation,” the researchers reported.

Some mesh manufacturers, like Ethicon’s Physiomesh and Atrium’s C-QUR, use polypropylene which is known to deteriorate and cause infection, inflammation, and adhesion.

Patients who have suffered complications after hernia mesh surgery continue to file lawsuits against companies including Johnson & Johnson, Atrium, C.R.Bard and others. The plaintiffs claim the manufacturers and distributors knew about the risks of the implants but failed to properly warn consumers and healthcare providers.

Susan Faunce, an attorney at Berman & Simmons who handles cases involving dangerous drugs and medical devices, is accepting clients who developed harmful complications due to the use of hernia mesh implants. Faunce said the study is yet another troubling red flag about the long-term health hazards posed by hernia mesh.