Composite Hernia Mesh Recall

Published On: March 22, 2017

As many as 40% of hernia repair procedures between 2010-16 used a composite meshes, that are now failing on patients.

Are you or a loved one living every day in pain suffering from blockage, adhesions, and infections that may be caused by your hernia mesh?  If you had a hernia mesh implanted subsequent to 2010, you may be eligible to seek compensation. 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. 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.

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.

As a result of the lack of proper testing and trials, it has been medically proven the barrier film is unreasonably dangerous. We have confirmation that at least one clinical trial was terminated (with the Ethicon Physiomesh product) due to concerns from increased adverse events. The body naturally begins the healing process 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.  Unable to either fully accept or reject the barrier results in scar plate bridging between the mesh pores. causing even greater damage to the patient’s body and necessitates additional corrective surgery.

Patients are at risk with these failing devices and deserve fair medical justice.
Please call The Law Offices of Lucas|Magazine today for a free consultation.