Harford, P.C. has been retained by a New York client injured by a Johnson & Johnson Ethicon Physiomesh medical device. The Physiomesh product is manufactured from polypropylene and intended for ventral hernia repair. It has been developed and marketed in the United States by Ethicon, a subsidiary of Johnson & Johnson.
The device was originally approved on April 9, 2010, using the FDA 510(k) approval program. This allowed the mesh device on the market without rigorous safety studies, because it was purportedly “similar” to another mesh product “Proceed” which was also manufactured by Ethicon.
Unfortunately, shortly after its release into the United States market, studies began to reveal multiple dangers associated with the mesh product. A pair of registries in Germany and Denmark showed a distinctive discrepancy between the Physiomesh flexible composite and other meshes in the registries after laparoscopic ventral hernia repair. Because the Physiomesh product is made of polypropylene, the mesh material can actually break down after surgical installation. This can cause the hernia to reoccur, bacterial swelling, or severe swelling at the surgery site.
Another study released in 2014 found significantly more pain associated with the Physiomesh product after 3 months. The study concluded the mesh had dense adhesions, especially to the intestines, and poor incorporation into the abdominal wall.
In May 2016, Ethicon issued a market withdrawal of the device and instructed surgeons to no longer use Physiomesh, yet Ethicon denies the mesh was “recalled.” There are now multiple consolidated litigations involving patients injured by the Physiomesh product, including an MDL in the Northern District of Georgia and an MCL in New Jersey.
Harford, P.C. currently represents individuals harmed by the Physiomesh medical device. If you or someone you know has been injured by a Physiomesh product, please contact Scott A. Harford immediately at Harford, P.C. You can directly reach him at (212) 390-8983.
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