In two recent hernia mesh lawsuits, plaintiffs allege their health complications after hernia surgeries were the fault of defective Ethicon Physiomesh.
Ethicon, a unit of pharmaceutical giant Johnson & Johnson, has voluntarily recalled Physiomesh in several countries. The U.S. Food and Drug Administration (FDA) approved the mesh in 2010 through its fast-track 510(k) clearance program, which allows expedited approval of a device that is deemed to be substantially similar to a product already on the market. Plaintiffs wonder if Physiomesh would have been approved if it had been subjected to the slower approval process.
The medical device attorneys at Parker Waichman note that Atrium Medical and C.R. Bard also face injury complaints and lawsuits over hernia mesh performance.
A hernia occurs when an internal organ pushes through a tear or weak point in the muscle or tissue that normally holds it in place. For example, the intestines may protrude through a weakened area in the abdominal wall. A hernia can be painful, especially when the person coughs or sneezes, bends over, or lifts a heavy object. Most hernias are not immediately life threatening, but since a hernia does not heal on its own, it must eventually be surgically repaired to prevent dangerous complications.
According to the FDA, hernias have a high rate of recurrence. Surgical mesh can strengthen the hernia repair and reduce the rate of recurrence and in 2012, the FDA says about half of hernia repairs in the U.S. used surgical mesh to support the repair.
Ethicon Physiomesh is normally inserted laparoscopically through a small incision. Laparoscopic surgery is becoming the new standard for certain procedures because it minimizes blood loss and the smaller incision speeds healing and reduces the length of the hospital stay. Guided by a camera, the surgeon can perform the procedure without having to open the abdomen.
Study Shows Higher Complication Rate with Hernia Mesh
A 2016 in the Journal of the American Medical Association (JAMA) 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. Researchers examined the records from more than 3,200 Danish patients who had hernia repair surgery between 2007 and 2010. Some of those patients received hernia mesh, others did not. During a five-year follow-up period, researchers noted a number of mesh-related complications including bleeding, abscesses, bowel obstruction, and bowel perforation.
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. 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.
New Physiomesh Lawsuits
One of the new plaintiffs had hernia repair surgery with Physiomesh Composite mesh in 2016. Soon after the surgery, she began to experience complications including adhesion of the mesh to her organs. The woman had to undergo a second procedure to have the problematic mesh removed. The plaintiff filed her hernia mesh lawsuit in U.S. District Court for the Middle District of Florida in December 2016.
The second plaintiff is a Georgia woman who experienced severe pain and vomiting after hernia repair done with Physiomesh. This woman also had a second surgery to remove the Physiomesh. During the second surgery doctors discovered a tear in the Physiomesh patch through the woman’s intestines were protruding. Her lawsuit was filed in February 2017.
Some plaintiffs in Physiomesh lawsuits allege that Ethicon failed to properly warn them about the potential complications. Plaintiffs claim Ethicon left Physiomesh on the market longer than it should have, even as reports of complications started accumulating.
Help for People Injured by Hernia Mesh
If you or someone you know has suffered a hernia recurrence or an injury possibly linked to a Ethicon Physiomesh or other hernia mesh, the attorneys at Parker Waichman can provide advice about your legal rights. For a free, no-obligation case evaluation, contact Parker Waichman by filling out the online contact form or by calling 1-800-YOURLAWYER (1-800-968-7529).