In mid-2016, Ethicon recalled one of its hernia mesh patches after analysis found higher rates of surgical complications. This is part of an ongoing controversy related to hernia mesh patches and plugs that has resulted in lawsuits filed by thousands of injured people.
How Do Hernia Patches Work?
A hernia happens when an organ or fatty tissue pushes through a weak area in the tissue or muscle that holds it in place. Hernias most commonly occur in the inner groin, but they can also appear around the belly button, upper stomach, and upper thigh.
Pressure is the main culprit of a hernia. A combination of pressure and a weak spot in the muscle can force the organ or tissue through the opening. Activities that result in an increase in abdominal pressure cause hernias, including chronic coughing, lifting heavy objects, constipation, and more.
Muscles can occasionally be weak from birth, but they’re more likely to weaken with age due to poor nutrition, smoking, and obesity.
More than one million hernias are repaired each year in the United States alone. There are a few ways to repair hernias. One way is an open repair surgery in which the surgeon uses sutures to repair the weakened muscle.
Using mesh to repair hernias has become increasingly popular since they were introduced more than 50 years ago. Due to the nature of hernias, there’s a high risk of recurrence. To minimize that risk, the mesh—which can be made from synthetic-like material—is sutured under or over the weak spot to fortify the area.
Over time, the patient’s tissue will incorporate the mesh to create a stronger area to prevent future reopenings.
Complications From Hernia Mesh
While the idea behind the hernia mesh is to limit the risk of recurrence, they’re not always successful. The most common adverse events after hernia repair with mesh are pain, infection, hernia recurrence, scar-like tissue that sticks together, and bowel obstruction, according to the U.S. Food and Drug Administration.
Other complications include organ perforation, adverse reaction, mesh migration, mesh shrinkage, fluid build-up, and more.
History of Hernia Mesh Recalls
The latest Ethicon Physiomesh withdrawal is just one example of hernia mesh products being recalled from the market. In December 2005, Davol and C.R. Bard issued an initial recall of select Composix Kugel Mesh hernia patches after complaints of recoil ring breakage.
Over the course of a little more than a year, that recall was expanded multiple times. All of the Davol recalls were categorized by the FDA as Class I, meaning there was a reasonable probability that the products could cause serious adverse effects or death.
Then in 2010, RAM Medical initiated a voluntary recall after it sold counterfeit products falsely labeled under the C.R. Bard/Davol brand. The mesh was found not to be sterile and had a different design than the authentic mesh.
Yet another recall occurred in 2013. Atrium issued a Class II recall on its C-QUR Edge Mesh patches because increased humidity could have caused the coating to get stuck to the inner sleeve.
Hernia Mesh Lawsuits
Accompanying the numerous recalls and reported adverse reactions has been legal action taken against the manufacturers of hernia mesh products.
After the 2005 to 2007 recall of Davol and C.R. Bard’s hernia mesh, several people filed lawsuits for a failure to warn of potential device failure. In one case, a patient named Christopher Thorpe alleged that the device caused him internal injuries due to a defective design. A Rhode Island federal court jury awarded him $1.5 million in 2010.
Just a year later, C.R. Bard agreed to pay roughly $184 million to settle most of the claims against its hernia mesh products. The average payout to the 2,600 people who experienced adverse side effects was $70,000. That 2011 settlement did not include another 1,000 claims.
In 2013, 24 women filed a lawsuit against manufacturers with claims of serious injuries from defective mesh products. The women alleged that the mesh caused pain, bowel obstruction, infections, and more. That same year, a woman filed a lawsuit in Virginia against C.R. Bard for a hernia mesh device implanted in her in 2004.
Lawsuits against Ethicon for the use of its Physiomesh products have already been filed in 2016 as well.
More Hernia Mesh Lawsuits Sure to Follow
In light of the 2016 market withdrawal of Ethicon’s hernia mesh patches, it’s clear that more lawsuits against manufacturers of these medical devices are sure to come. Despite the countless cases of complications and adverse events, the FDA continues to approve untested hernia mesh products. The regulatory agency has issued very few recalls and hasn’t mentioned anything about the latest Ethicon Physiomesh.
If you have suffered adverse reactions after the implantation of hernia mesh, contact one of our hernia mesh lawyers immediately to find out more about your legal options.