The Atrium C-QUR patch and Ethicon PHYSIOMESH patch have shown evidence of failure, thereby requiring additional surgical procedures for intervention/correction of the recurrence.
Hernia mesh devices were placed on the market despite inadequate testing, trials and proper warning of concerns from physicians. We have confirmation that at least one clinical trial was terminated (with the Ethicon Physiomesh product) due to concerns from increased adverse events. In May of 2016, Ethicon issued an “URGENT FIELD SAFETY NOTICE” alerting surgeons that they are voluntarily recalling the patch. It has been substantiated that manufacturers were aware the patches caused increased adverse effects, yet trained their sales force to blame surgical teams rather than accept the product’s fault.
Subsequent effects are caused by problematic design. Hernia mesh devices are made of synthetic polypyrene. “Composite meshes” are just like synthetic, yet they have a barrier coating on the mesh. This coating can be referred to as a “prosthesis” or “film.” Both manufacturers presented their enhanced barrier coating on the composite mesh products to help reduce the risk of adhesions. The use of the barrier film was never adequately studied in clinical trials. Under a 510(k) PMA submission process the mesh devices were placed on the market.
Hernia mesh procedures can be done laparoscopically or by open surgical operations. Surgical practices overall have seen a reduced amount of complications as well as recovery time from laparoscopic procedures. Yet when these mesh devices are laparoscopically embedded, they cause a greater risk for adhesions. During the procedure, the mesh often comes in contact with internal organs. When this happens, disastrous results occur due to the inability to properly integrate within the patient’s body.
As a result of the lack of proper testing and trials, it has been medically proven the barrier film is unreasonably dangerous. The body begins the natural healing process immediately after any surgical procedure. Anywhere from one to several months post-surgery, the barrier layer was to be absorbed by the patient’s body. Unable to penetrate the “barrier film” during the healing process, foreign body reaction naturally occurs to try and reject the mesh. The body’s inability to either fully accept or reject the barrier results in scar plate bridging between the mesh pores. This consequently results in even greater damage to the patient’s body and necessitates additional corrective surgery.