Physiomesh Injury Lawsuits
Manufacturers of a hernia repair mesh medical device known as Physiomesh pulled the products from production amid allegations the devices may cause severe side effects and require surgical revisions.
Johnson & Johnson’s Ethicon unit has refused to call the 2016 action a “recall,” insisting they merely initiated a “voluntary withdrawal” of the product. Whatever they want to call it, the bottom line is that Phyisomesh, which first received clearance for distribution in October 2014, was halted after unpublished data from Europe revealed a stark discrepancy between the surgical revision rates for Physiomesh, compared to others on the market.
Failure rates for Physiomesh patients were much higher.
Perhaps unsurprisingly, the company blames patients and doctors for the reported complications. In one statement, company officials say higher revision rates were a “multifactorial issue.” However, our Boston Physiomesh injury lawyers know there are a growing number of Physiomesh injury lawsuits, both in Massachusetts and around the country, that allege defective design and failure to warn – both of which fall on Ethicon’s shoulders.
Ethicon is the same company that for years has been battling injury lawsuits for the failures of its transvaginal mesh products. The transvaginal mesh products are made from polypropylene – which is the same material used to make the Physiomesh Open, used for hernia repair.Approval of Physiomesh by Ethicon
Like so many other medical devices that have received approval from the U.S. Food & Drug Administration, Physiomesh was fast-tracked through the FDA 510(k) approval process.
Normally, any medical product would need to endure a battery of rigorous tests and research before it would be allowed to be distributed on the public market. However, the FDA 501(k) program allows new medical products that are “substantially similar” to ones already existing to bypass this process. In this case, Ethicon submitted that Physiomesh was substantially similar to another of its hernia patches, Proceed.
Ethicon first received approval for Physiomesh in 2010, and then for its modified version in 2014. It should be noted that at the time, the FDA was clear to point out that approval through the 510(k) process didn’t mean the product was in compliance with any federal laws or regulations.What is Physiomesh?
Physiomesh is a product that is made with a substance called polypropylene. That’s the base layer, and it’s the same material the company uses for its bladder slings and transvaginal mesh.
It should be noted that Ethicon is a defendant in thousands of lawsuits for its bladder slings and transvaginal mesh, with plaintiffs asserting the product was defectively designed and the company failed to warn them of the severity of risk they were undertaking by having the device surgically implanted in their body.
Physiomesh also has a film coating on each side that is absorbable and composed of various compounds, which is intended to help reduce the risk of destruction to human tissue – which polypropylene is known to do.
The product was designed to repair hernias, which can occur spontaneously or after some type of surgery or injury. They can range from tiny to very large. In some cases, hernias can be repaired using muscle flaps. However, when the damage affects a larger area, some type of mesh is typically used.
Medscape reports more than 1 million abdominal wall hernia repairs are conducted every year in the U.S. Approximately 150,000 of those are for the purpose of correcting earlier surgeries.Defective Design of Physiomesh
It has been alleged in litigation that Ethicon knew its Physiomesh product was defectively designed and perilous to patients since it was first made. That’s because the coating on both sides of the mesh is supposed to keep the bowel from coming in contact with polypropylene, which is known to adhere quickly to human tissue. If this happens and the product sticks to the bowel, this can cause serious injuries to the patient.
However, when the polypropylene is not exposed, the mesh is not going to properly adhere to the abdominal wall, which essentially leaves it floating in the abdominal cavity. This can have serious side effects too, and often requires surgical revision.
If you have suffered complications as a result of hernia mesh surgery or needed to undergo revision surgery, our experienced attorneys will analyze your case and help you determine the best course of action for your circumstances.