Physiomesh Surgical Hernia Mesh Lawsuit
Physiomesh Flexible Composite Mesh is a brand of surgical mesh used in hernia repair surgeries. It was one of the best-selling medical device brands used for surgical hernia repair but may have resulted in serious side effects for thousands of recipients.
Thousands of patients whose hernia repair surgeries were performed with Ethicon Physiomesh have filed lawsuits against Ethicon and parent company, Johnson & Johnson, after they experienced serious complications.
Complications of Physiomesh hernia patch failure include:
- Intense pain
- Infection
- Intestinal blockage
- Hernia recurrence
- Adhesion or scar-tissue fusing together
- Bleeding
- Formation of a hole in neighboring tissues or organs
- Mesh migration
- Mesh shrinking
In most cases, complications of hernia mesh implantation will require a hernia repair revision surgery to remove the failed or malfunctioning mesh, repair damage caused by the mesh and stabilize the original hernia.
Physiomesh Hernia Mesh Failure
Surgical mesh is used in the laparoscopic repair and treatment of ventral hernias. It is stitched over the hernia to strengthen abdominal walls so the hernia will not reopen. Some versions of hernia mesh are intended to be implanted laparoscopically, while others require an “open” surgery through a traditional abdominal incision. Ethicon’s Flexible Composix Mesh was available in both forms.
Physiomesh devices are a mesh substance, made from composite material that includes polypropylene which has been shown to break down, leading to hernia recurrence, bacterial infection, and swelling at the surgical site.
The polypropylene used in Ethicon’s Physiomesh is the same material used in the company’s controversial transvaginal mesh, which has also come under fire and been the subject of much legal action. Claims against transvaginal mesh products made of polypropylene include device migration and erosion, puncture and perforation of organs, and excruciating pain and infection.
Medical studies conducted in Germany and Denmark confirmed patients implanted with Ethicon’s Physiomesh stand a higher risk for hernia recurrence and the need for re-operation compared to patients implanted with similar devices made from other materials.
Ethicon Initiated Voluntary Withdrawal of Physiomesh
Though Physiomesh was never subject to FDA recall, Johnson & Johnson’s Ethicon division issued a full market withdrawal in May 2016 of its Physiomesh Flexible Composite Mesh used for laparoscopic surgeries. Plaintiffs allege that Ethicon issued an Urgent Field Safety Notice in countries other than the U.S. advising medical providers about a voluntary recall of Physiomesh. Ethicon did not issue a similar notice in the U.S. and merely removed its product from market.
The voluntary withdrawal of the laparoscopic version came after two studies found higher rates of hernia re-opening when compared to similar products. In 2016, after the number of reports of complications skyrocketed and research indicated that Physiomesh may place patients at higher risk than other mesh patches, Ethicon issued an Urgent Field Safety Notice to hospitals and surgery centers throughout the country alerting medical staff to a problem with many of its hernia mesh products.
The notice withdrew unused products from the market, and invited surgeons to return products to the manufacturer to avoid further problems. Surgeons were advised not to use Physiomesh when repairing hernia recurrence and were given a list of other Ethicon products available for use.
In addition to concerns raised by Physiomesh, other surgical hernia mesh manufacturers have come under similar fire and experts are no longer recommending that mesh be used in hernia repair unless absolutely necessary.
Ethicon Physiomesh Surgical Hernia Mesh Lawsuits
Ethicon and parent company Johnson & Johnson are facing over 3,600 lawsuits for injuries that occurred due to Physiomesh implanted between March 2010 and May 31, 2016. Federal Physiomesh lawsuits have been consolidated into two MDL cases in the United States District Court for the Northern District of Georgia and in the United States District Court for the District of New Hampshire. Past settlements of similar lawsuits against transvaginal or other surgical mesh products show that in some cases, jury awards for compensation have reached into the millions of dollars.
In September 2021, Ethicon agreed to a confidential global settlement to address claims of harm caused by its Physiomesh product. Most recently, in May 2023, Ethicon reached a confidential settlement with plaintiffs in 161 cases in the Northern District of Georgia. While many of the cases against Ethicon have been addressed through this settlement, others continue to be litigated in courts across the country.
People who have experienced serious complications or required revision surgery after receiving Ethicon Physiomesh Flexible Composite Mesh may be eligible for compensation for medical costs, lost wages, pain and suffering or other damages.
*Prior results do not guarantee or predict a similar outcome in any future matter.