Nearly 1,300 Physiomesh lawsuits are currently pending against Johnson & Johnson subsidiary Ethicon in federal court. As of July 19, 2018, court dockets from the U.S. District Court of the Northern District of Georgia, where the litigation has been consolidated for pre-trial proceedings, show a total of 1,287 claims against the company. Plaintiffs allege that Ethicon released a defective product, the Physiomesh hernia mesh patch, onto the market without proper warnings.
Over 1,200 Physiomesh Lawsuits Pending In Federal Court
In their lawsuits, plaintiffs call Physiomesh “unreasonably dangerous,” noting the mesh patch’s use of polypropylene, a plastic that many experts believe should never be implanted in the human body. Ethicon is also presently facing thousands of product liability lawsuits filed over its transvaginal mesh patch products, which are also made from polypropylene.
Plaintiffs Say Physiomesh Problems Lie In Defective Design
Digging down into the mesh’s design, plaintiffs note five lawyers of coating that surround the polypropylene patchwork that serves as the patch’s foundation.
Ethicon intended the 5-layer design to decrease the risk for adhesion, a serious complication in which scar tissue develops around the mesh and sticks to surrounding internal organs.
In reality, plaintiffs claim, Physiomesh’s multi-layer design did the exact opposite. The patch’s five layers, the lawsuits contend, actually inhibit the process of absorption, leading to dramatic inflammatory responses in the body. The human body reacts to Physiomesh as an invasive foreign object, plaintiffs say.
Like an implant being rejected by its host, over 1,200 injured patients claim that Physiomesh triggered debilitating immune system responses in their bodies, leading to chronic pain, rampant infections, life-threatening fistulas and invasive corrective procedures.
Ethicon “Withdrew” Mesh Patch From Global Market In 2016
Finally, in May 2016, Ethicon withdrew its Physiomesh Flexible Composite Mesh from the global market. Warning practicing physicians across the globe in an Urgent Safety Field Notice, Ethicon told surgeons to stop using the Physiomesh product model immediately.
Independent Studies Find Increased Risk Of Recurrence, Re-Operation
Two independent analyses, Ethicon wrote, had linked the product to an increased risk of hernia recurrence and re-operation. Compared to competitor products, patients who had been implanted with Physiomesh were far more likely to require invasive and costly revision procedures.
The product withdrawal was limited only to products in Ethicon’s Physiomesh Composite Mesh line. Additional products branded with the Physiomesh name, including the Physiomesh Open Flexible Composite Mesh, have not been withdrawn from the market.
It’s extremely important to note that Physiomesh has not been recalled. It was withdrawn, voluntarily, from the market. The withdrawal process requires fewer safety notifications than would a full recall.
Ethicon Provides Vague Explanation For Physiomesh Failures
Ethicon has not provided an explanation for the increased risks of recurrence and re-operation to which Physiomesh has been linked. In its Urgent Field Safety Notice, the company attempts to portray Physiomesh failures as a “multifactorial” problem, citing potential issues with product design, operative characteristics and patient factors.
The company says that, without a full understanding of the problem, a voluntary market withdrawal was the only viable option.
As we’ve seen, thousands of patients have their own theory to explain the extraordinary harm they say Physiomesh has caused: defective design.