Physiomesh, a hernia mesh device made by Johnson & Johnson and its subsidiary, Ethicon, was approved by the FDA in a 510(k) process, which allows the company to fast-track the product onto the market without adequately testing the product for safety and efficacy, according to The Ring of Fire Network.
Many lawsuits have been filed alleging failed Physiomesh devices are connected to serious injuries. Claims have been filed by a Florida woman who says she suffered excruciating pain as a result of the mesh, a Canadian woman who describes her pain as if her “insides are going to explode,” and a Louisiana woman who had revision surgery in attempt to remedy her agony. All allege Physiomesh is the problem.
This particular type of hernia repair mesh has been linked to dangerous infections, perforation of organs, inflammation, allergic reactions and nerve damage. Physiomesh allegedly is also responsible for the deaths of three patients. Agonizing pain is a commonly reported side effect, leading Ethicon to withdraw the product from the market in June of 2016.
Information has surfaced, however, that the Physiomesh hernia mesh device used the controversial 510(k) process to gain approval by the FDA, which allows a medical product to bypass safety testing as long as the product is “substantially similar” to an already existing product.
“The FDA’s 510(k) process is more like a loophole for device manufacturers instead of a protection mechanism for patients,” says one Florida attorney. “What we’ve seen in the mesh litigation for years is that a mesh manufacturer can generate numerous different experimental mesh designs through that process, and the end result is damage to thousands of patients.”
In May of last year, Ethicon issued an urgent Field Safety Notice warning that the Physiomesh device seemed to have a higher rate of failure than other similar products.