DID YOU HAVE PROBLEMS FOLLOWING ETHICON PHYSIOMESH HERNIA REPAIR?
Physiomesh is a sterile, low profile, flexible composite mesh designed to repair hernias and other deficiencies. Polypropylene is the same material that Ethicon makes their transvaginal mesh and bladder slings from, except that it contains an absorbable film coating on each side which is composed of slightly different compounds.
In May 2016, Ethicon announced that it was withdrawing its Physiomesh Flexible Composite Mesh after an analysis of unpublished data found higher than average recurrence and reoperation rates following laparoscopic ventral hernia repair with the products. According to the withdrawal notice notice:
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors. Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”
This action affects the following product codes: PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R and PHY3050R.
HOW FDA 510(k) APPROVAL WORKS
Physiomesh entered the U.S. market via the FDA’s 510(k) approval process, which allows clearance of devices that are ‘substantially equivalent’ in safety and effectiveness to other products that are already on the market. In requesting approval, Ethicon said Physiomesh was similar to its Proceed hernia mesh. However, the company withdrew the Proceed mesh in 2006 over concerns the product could increase the risk of adhesions and bowel fistulas. Proceed was later returned to market.
WHAT IS A HERNIA?
A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or weak spot in the surrounding muscle or connective tissue. Hernias occur most often at the abdominal wall. In some cases, hernias are visible as an external bulge, particularly when straining or bearing down.
- Hernia Recurrence Symptoms
- Palpable mass / bulge
- Difficulty urinating
- Unable to pass gas
- Excessive sweating
DO I HAVE A PHYSIOMESH LAWSUIT?
The Defective Medical Device Group at our law firm is an experienced team of lawyers that focus on the representation of plaintiffs in physiomesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases. Call 800-550-0000 today.
Free Confidential Case Evaluation: Again, if you were injured by an Ethicon Physiomesh composite mesh hernia patch, you should contact our law firm immediately. You may be eligible for compensation by filing a suit and our lawyers can help.