More than a million Americans pursue surgical repair of their hernia each year. But, many have found that the relief they sought ends up causing them more harm than good. They suffer damage from the very device (Physiomesh hernia mesh) which their doctor used to repair their hernia.
Have you had a hernia repair operation, and the doctors used Physiomesh hernia mesh? You could be in danger.
What is Physiomesh?
Hernias often occur in the abdominal wall when tissue, part of the intestine, or an organ pushes through a weak spot in the surrounding muscles. The main danger of a hernia occurs when it blocks the blood supply to a part of the body causing strangulation.
For decades doctors have used hernia mesh, a loosely woven flexible mesh made of synthetic fibers, to help repair hernias. The hernia mesh acts as a patch or plug for the hole in the muscle instead of stitching.
The FDA approved Physiomesh Flexible Composite Mesh, made by Ethicon a subsidiary of Johnson & Johnson, in 2010. Physiomesh is intended for use in laparoscopic hernia surgery. Ethicon received FDA approval through a special method known as 510(k) process. This process allowed Ethicon to gain approval without providing extensive safety or efficacy testing usually required for new products. The company only had to show that Physiomesh was “substantially equivalent” to similar products Ethicon manufactured and had already tested.
Physiomesh Side Effects and Complications
Within a few months of Physiomesh being on the market, the FDA began receiving many reports of complications with the hernia mesh. Over the next several years, the FDA continued to receive thousands of reports of the product’s failure. Many studies also showed Physiomesh caused the various harmful side effects in patients. Common problems reported include:
- Swelling and redness
- Internal scar tissue
- Mesh migration
- Mesh shrinkage
- Mesh distortion
- Organ damage
- Nerve damage
- A recurring hernia
- Required revision surgery
- Seromas (fluid build-up)
Because of all the reported complications, Ethicon withdrew Physiomesh from the market in 2016.
Even though Ethicon has taken Physiomesh off the market, thousands have suffered because of the product’s defects. Many have filed lawsuits against the manufacturer. They claim Ethicon knew about the defects of Physiomesh but failed to provide adequate warnings to doctors and patients. Some plaintiffs also claim Ethicon failed to adequately test the product before putting it on the market. If found liable, Ethicon could be made to pay compensation.
Have you had hernia surgery using Physiomesh and suffered complications? You could be eligible for compensation. You could receive compensation for:
- Past and future medical expenses
- Past and future loss of wages
- Pain and suffering
Contact our experienced attorneys for a free evaluation to see if we can help you get the compensation you deserve.