Hernia Mesh Repair. A hernia occurs when an organ pushes through an opening in the muscle or tissue that holds it in place. For example, the intestines may break through a weakened area in the abdominal wall. Most hernias are not immediately life threatening, but a hernia does not go away on its own and usually requires surgical repair to prevent dangerous complications.
A recent study shows that patients who undergo hernia repair with a mesh device risk complications that could offset the benefits of the mesh.
The study was published in October 2016 in the Journal of the American Medical Association (JAMA). The researchers reported that hernia mesh patients had a lower risk of hernia recurrence over five years, but the patients were at risk for complications they would not otherwise have had.
The Food and Drug Administration (FDA) explains that hernias have a high rate of recurrence, and surgical mesh can strengthen the hernia repair and reduce the rate of recurrence. In 2012, of the approximately 190,000 abdominal hernia surgical repairs performed in the U.S., about half of them used surgical mesh to support the repair.
The medical device attorneys at Parker Waichman are well informed on the issues surrounding surgical mesh and can answer questions about filing a surgical mesh lawsuit.
In the JAMA study, researchers examined the records from more than 3,200 Danish patients who had hernia repair surgery between 2007 and 2010. Some of those surgeries used hernia mesh, others did not. Over a five-year follow-up period, researchers noticed a number of mesh-related complications. Patient records showed reports of bleeding, 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 experienced a much lower complication rate of 0.8 percent, the researchers said.
The researchers noted that all the benefits and risks of hernia mesh are not known, in part because most of the devices did not undergo clinical testing. Most mesh implants obtain clearance under the FDA’s 510(k) device clearance process, which allows faster approval for a device that is deemed similar to a product already on the market. Under 510(k), the product is not subject to rigorous clinical trials. Because most mesh implants qualify under 510(k) approval, the medical community has less relevant clinical data about their risks and benefits, the researchers say.
The FDA has received many reports of complications related to hernia repair with surgical mesh. Pain, infection, hernia recurrence, adhesion, bowel obstruction, and organ perforation are the most common complications associated hernia mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.
Johnson & Johnson’s Ethicon Hernia Mesh Withdrawn from Market
Ethicon’s Physiomesh Flexible Composite Mesh-has been taken off the market after reports of a high number of complications. Ethicon, a subsidiary of Johnson & Johnson, withdrew the product in May 2016, after more than six years on the market.
Patients who had surgeries with Physiomesh ended up undergoing follow-up surgery to fix complications at a higher rate than the manufacturer expected. Among the complications reported with 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 filed lawsuits, arguing that Ethicon failed to properly warn them about the potential complications. The lawsuits challenge the instructions and warnings provided with the Physiomesh. The plaintiffs claim Ethicon left Physiomesh on the market longer than it should have, even after reports of complications started accumulating.
Surgical mesh can be made synthetic materials either absorbable or non-absorbable or a combination of the two. Animal-derived mesh-made from processed animal tissue such as intestine or skin-is absorbable. Non-absorbable mesh remains in the body indefinitely and is considered a permanent implant to provide reinforcement to the hernia repair. Absorbable mesh, which degrades over time, is not intended to provide long-term reinforcement to the repair site. New tissue growth is intended to provide strength to the repair.