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 versus similar products. The product is used in the laparoscopic repair and treatment of ventral hernias. Hernia mesh patches are 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
Issues with Physiomesh grew so common and severe, 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 from the market unused products, and invited surgeons to return products to the manufacturer to avoid further problems. Surgeons were also encouraged not to use Physiomesh when repairing hernia recurrence and were given a list of other Ethicon products available for use.
Complications, Pain, and Suffering Caused by Ethicon’s Physiomesh
Patients who experience a problem with the Ethicon Physiomesh are likely to experience any of the following health issues:
- 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
Ethicon Physiomesh Lawsuits
Several patients implanted laparoscopically between March 1, 2010 and May 31, 2016 with Ethicon’s Physiomesh have already taken legal action against the manufacturers of the device.
One Florida woman filed a lawsuit against Johnson & Johnson and Ethicon, alleging her mesh device blocked her intestines and caused her chronic pain. An Illinois man filed a similar lawsuit alleging his device caused an infection to develop, which led to two abscesses and a fistula.
Investigation into mesh devices continues and more lawsuits are expected in the coming months. Anyone implanted with a Physiomesh device or unsure how his or her hernia was treated is encouraged to follow-up with their doctor or contact a legal professional for more information. Additional information about physiomesh lawsuits can be found here: https://www.drugdangers.com/physiomesh/lawsuit
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
