If you’ve undergone hernia repair surgery between the years 2010 and 2016, you may be eligible for compensation if you’re experiencing pain and negative side effects. Your complications may have been caused by the type of hernia patch that was used. Ethicon Physiomesh, a type of hernia mesh created by Johnson & Johnson, was recalled due to severe complications. With the help of a Cincinnati hernia mesh lawyer, you may be able to get help paying for medical bills, removal surgery, and more.
Ethicon Physiomesh Flexible Composite Mesh was rushed to market in 2010 after the manufacturer claimed that the hernia mesh was similar to other types of mesh that were commonly used in surgery. As a result, the FDA did not require the company to test Physiomesh on people. Since 2010, hundreds of patients have come forward reporting a wide range of complications—many of which require additional surgeries and painful, long recovery periods.
Multiple lawsuits are now targeting Johnson & Johnson for victims who have experienced these complications and had to undergo revision surgeries or otherwise had their lives impacted by the Physiomesh patch which was advertised as being safe. The lawsuits state that the manufacturer should have tested the product better and ensured it did not have a faulty design.
Why is Ethicon Physiomesh Hernia Mesh Potentially Dangerous?
Most types of hernia mesh are created with bioabsorbable components that the body uses to naturally build a barrier of tissues that heals the hernia and ensures no perforations occur. These components are usually porous in nature which helps promote natural tissue growth and prevent adhesions.
Ethicon’s Physiomesh flexible composite mesh, however, is completely different—even though the manufacturer advertised that it was “similar to” other types of hernia mesh on the market. Physiomesh is technically an intraperitoneal onlay mesh (IPOM). It’s comprised of a porous inner mesh that’s surrounded by thick polymer films. These films are supposed to give the patch extra support, but often end up being rejected by the body as the tissues begin to heal around the films.
As the body’s tissues reject the films, this can cause a chronic foreign body reaction. The following complications can result from this dangerous adverse reaction:
- Painful adhesions—scar-like tissue that grows on or around the hernia/patch area
- Severe pain
- Bowel obstruction
- Fluid buildup (seroma)
- Hernia recurrence
- Mesh patch migration, tearing, or shrinking
For many patients who have had the Physiomesh patch inserted during a hernia procedure, they must undergo one or more revision surgeries to have the patch removed and the adhesions repaired. Any adhesions may take months to heal and often cause the patient to experience a great deal of pain.
What Happened During the Physiomesh Hernia Mesh Recall?
In 2010, Johnson & Johnson was granted access to the FDA’s 501(k) approval program which let the manufacturer skip additional testing. The patch was quickly made available for sale and used readily throughout hospitals in the U.S.
Years later, after multiple patients started coming forward reporting negative side effects and complications such as those noted above, the company issued a recall for Ethicon Physiomesh. This was in 2016. The recall was issued due to the risk of hernia recurrence. The company stated that the higher inherent revision/recurrence rates were caused by “product characteristics” as well as operative and patient factors.
Since the recall was issued, Physiomesh was taken off the market. Johnson & Johnson currently has no plans to improve the hernia patch to make it available for sale again, but for hernia patients who have had the mesh surgically inserted, that recall came too late.
How Can a Cincinnati Hernia Mesh Lawyer Help?
If you or a loved one was affected by the above recall and feel that you deserve compensation for injuries or suffering you’ve experienced after having hernia repair surgery that included the Ethicon Physiomesh hernia patch, you should get in touch with the legal team at Bey & Associates, LLC as soon as possible. Our knowledgeable and experienced Cincinnati hernia mesh lawyers know what it takes to get our clients the compensation they’re entitled to.
Johnson & Johnson should not have put Physiomesh on the market knowing that the medical device was made with different components than other types of hernia mesh. They should also not have pushed the product to market without performing adequate clinical trials and testing. When corporations make decisions like these which result in injuries, a recall, and accompanying lawsuits, we define these cases as product liability claims in the legal world.
At Bey & Associates, we understand how to navigate complex product liability claims in Cincinnati and elsewhere in the U.S. We have the resources available to build a strong, compelling case. Contact us to learn more or to receive a zero-obligation consultation.