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Investigations

Clinical Trials Revealed that Ethicon’s Physiomesh Caused an Unacceptably High Number of Reoccurrences

A clinical trial (terminated in early 2014 due to safety concerns) found that Ethicon’s Physiomesh, had unacceptably high rates of reoccurrence and postoperative complications. The FDA cleared Physiomesh for marketing in 2010 under its 510(k) “substantially equivalent” approval mechanism. Under the 510(k) process manufacturers are permitted to market medical devices so long as they show they are substantially equivalent to another medical device that is already on the market. FDA 510(k) clearance does not require manufacturers of medical devices to perform clinical trials to determine the safety and efficacy of a new medical device before they are released onto the market. Thus, no clinical trials had been performed on the Physiomesh device when it was released in 2010. The clinical trial on this device did not come until four years later.

In 2014 the Polish Hernia Study Group sponsored a clinical study intended to compare two different fixation techniques for hernia mesh in laparoscopic ventral repairs. The researchers compared the Physiomesh/Securestrap and Ventralight ST/SorbaFix mesh products with respect to pain. It was a single-center, prospective randomized study, a study protocol which is at the top of the hierarchy of evidence paradigm. The study was intended to include 50 patients per group with interim analysis for safety after 25 patients. The safety parameters included the number of recurrences and postoperative complications. However, at the interim analysis the study was abruptly terminated because of safety concerns. The researchers observed a 20% recurrence rate with the Physiomesh group in the first 6 months. They also found a significantly higher pain rate for the Physiomesh group at the 3-month point. Although the study could not be completed because of these safety concerns, the researchers concluded that these interim findings confirmed the superiority of elastic mesh, which was found to be safer and more efficacious for laparoscopic ventral hernia repairs. Despite being aware of these severe adverse events associated with the Physiomesh product in 2014, Ethicon waited until May 2016 before withdrawing the product from the market.

Physiomesh implants are made up of three materials. The core is prolene polypropylene mesh with 3mm pores and a polydioxanone film on top. This film is supposed to act as a gluing agent between the mesh and monocryl film, which is the top layer of the mesh. This design is unique in that it consists of polypropylene sandwiched between layers of thick polymer films. The outer layer of film prevents adequate tissue ingrowth with the mesh allowing it to move, migrate or ball-up. Additionally, the large pore, small filaments design makes this mesh too weak causing it to rupture and for the hernia to reoccur. These design flaws are consistent with the severe adverse events that were observed in the clinical trials. Studies have also shown that these films can act as absorbable barriers that provide an adequate environment for bacterial adherence, niche formation and biofilm development due to the large surface area provided by the barrier sheet. As a result, a large surface area is prone to the colonization of bacteria that can lead to persistent infection. Many of these complications cause patients debilitating pain and often lead to subsequent surgeries.

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