Johnson & Johnson and its Ethicon division are facing thousands of hernia lawsuits for injuries caused by its Physiomesh Flexible Composite Mesh.
Physiomesh Hernia Lawsuit
Johnson & Johnson’s Ethicon division issued a full withdrawal in May 2016 concerning its Physiomesh Flexible Composite Mesh. The voluntary withdrawal came after two studies found higher rates of hernia re-opening when compared to similar products.
Thousands of patients whose hernia repair surgeries were performed with Ethicon Physiomesh have filed lawsuits against 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
Physiomesh Failure
Surgical mesh is used in the laparoscopic repair and treatment of ventral hernias and is stitched . over the hernia to strengthen abdominal walls so the hernia will not reopen. Unfortunately, Ethicon’s Physiomesh devices are made from composite material that includes polypropylene. This material has been shown to break down, leading to hernia recurrence, bacterial infection, and swelling at the surgical site.
In most cases, patients need follow-up surgeries to repair the problem. 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 patient implanted with similar devices made from other materials.
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.
Ethicon’s Voluntary Withdrawal of Its Physiomesh
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.
Ethicon Physiomesh Lawsuits
Ethicon and parent company, Johnson & Johnson are facing thousands of 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. Bellwether trials are expected to begin in September of 2019.
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. Patients who were injured by Physiomesh hernia repair surgery may be eligible for compensation for medical costs, lost wages, pain and suffering or other damages.
People who have experienced serious complications after receiving Ethicon Physiomesh Flexible Composite Mesh should seek advice from an attorney.
Ethicon’s voluntary withdrawal applies to the following Ethicon products:
1) Laparoscopic Hernia Pack
ELH5 PHY1515Q
2) Laparoscopic Hernia Pack
ELH10 PHY1515Q
3) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY0715R
Rectangle 7.5cm x 15cm
4) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1015V
Oval 10cm x 15cm
5) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1515Q
Square 15cm x 15cm
6) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1520R
Rectangle 15cm x 20cm
7) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1520V
Oval 15cm x 20 cm
8) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY2025V
Oval 20cm x 25cm
9) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY2030R
Rectangle 20cm x 30cm
10) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY2535V
Oval 25cm x 35cm
11) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY3035R
Rectangle 30cm x 35cm
12) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY3050R
Rectangle 30cm x 50cm
Sources:
Hernia Surgical Mesh Implants, Food and Drug Administration (2/2018)
J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh, Mass Device (6/2016)
