According to a recent study, patients undergoing hernia surgery may face a risk of complications that may offset the benefits of hernia mesh.

The study was published by the Journal of the American Medical Association in October 2016.

While researchers reported that hernia mesh surgery patients generally had a lower risk of hernia recurrence over five years, the use of that mesh put those patients at risk for complications they would not have otherwise had.

Surgical mesh has been used for decades to repair hernias. Of the approximately 190,000 abdominal hernia surgical repairs performed in the U.S. in 2012, about half of them used a prosthetic mesh to support the repair.

In the JAMA study, researchers examined the records from over 3,200 patients who underwent elective surgery repair in Denmark between 2007 and 2010. Some of those surgeries involved the use of hernia mesh, and others used no mesh.

Over the five-year follow-up period, researchers noticed a number of mesh-related complications. Patients’ records showed reports of bleeding, late abscesses, bowel obstruction and bowel perforation.

The researchers reported that with mesh-based repairs, complications occurred at a rate of 5.6 percent for patients who underwent open surgery and at 3.7 percent for those who underwent laparoscopic surgery.

But patients who underwent non-mesh repair enjoyed a much lower complication rate of 0.8 percent, the researchers said.

The researchers pointed out that the complete spectrum of benefits and risks associated with hernia mesh is not fully known, thanks in part to an expedited FDA approval process.

According to the researchers, most mesh implants qualify for expedited FDA approval under what’s known as the 510(k) process. This process allows faster approval for new products that are similar to other products already on the market.

Products approved through this process aren’t subject to the same rigorous clinical trials that other, newer products have to go through. Because most mesh implants qualify for 510(k) approval, there’s less relevant clinical data about their risks and benefits, the researchers say.

Complications Get Ethicon Hernia Mesh Withdrawn from Market

One of the products approved through this expedited process ended up being taken off the market due to a high number of reports of complications.

In May 2016, Johnson & Johnson subsidiary Ethicon Inc. withdrew the Physiomesh Flexible Composite Mesh after more than six years on the market.

Patients who had been implanted with that particular mesh ended up undergoing follow-up surgery to fix complications at a rate that was higher than the manufacturer had expected.

Among the complications reported in conjunction with the Physiomesh were pain, swelling, adhesions, bacterial infections and migration of the mesh. In some cases, patients suffered from recurrence of their hernias, requiring further surgical repair.

Some patients who suffered complications after implantation with a Physiomesh implant have taken to the court system, arguing that Ethicon failed to properly warn them about the potential complications.

They challenge the instructions and warnings provided with the Physiomesh, and they claim that Ethicon left it on the market longer than it should have, even after reports of complications started rolling in.