Hernias are a common issue for many people that require surgery as a treatment for pain and other symptoms. Hernias occur when a tissue or an organ squeezes through a perforation or hole in the surrounding muscle or connective tissue. Hernias can occur throughout the body but commonly occur in the abdomen.
Hernia mesh can be implanted through non-invasive laparoscopy or open surgery. Mesh is used to repair the hernia tissue making it stronger, which in turn helps reduce the rate of recurring hernias. Hernia mesh can minimize the amount of time in surgery and shorten recovery time following surgery.
Some patients who elected to have a hernia mesh implant to treat a hernia experienced heightened pain leading to infections, adhesions or even additional surgeries to repair the mesh. The U.S. Food and Drug Administration (FDA) has received reports of complications following hernia mesh surgical implants including: pain, infection, hernia recurrence, adhesion, intestine obstruction, mesh migration and recurrence of a hernia requiring additional surgery.
Ethicon, Inc., a subsidiary of Johnson & Johnson, manufactured and sold Physiomesh which received FDA 510(k) clearance in April 2010, meaning it did not require FDA review or clinical trials to evaluate its safety before being placed on the market. Physiomesh was launched on the market in October 2010.
Johnson & Johnson recalled its Ethicon Physiomesh product in May 2016 after the company reviewed unpublished studies that found an increased rate of failure of physiomesh compared to similar mesh products in the market. Johnson & Johnson voluntarily recalled Physiomesh and sent letters to health care providers stating that they had, “…not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market.”
Atrium C-QUR Hernia Mesh
Atrium Medical Corporation's C-QUR hernia mesh product was cleared by the FDA 510(k) in March 2006 and recalled in 2013. There has been an influx in hospitals and surgeons no longer using these products because there has been an elevation in cases involving infections, allergic reactions and bowel obstructions.
Covidien Parietex Mesh
Covidien also known as Medtronic started making the Parietex Mesh in 1999. Medtronic claimed that the Parietex Mesh was better than any polypropylene alternatives because of the special polyester that was used to make the mesh.
In 2017, researchers put their claims to the test, and placed a polypropylene mesh and a parietex mesh in rats and examined them. The researchers found that the Parietex was more difficult to use in some cases. The FDA has not recalled Medtronic products yet, however, they are aware of the complications that are arising.
C.R. Bard Hernia Mesh
C.R. Bard is the manufacturer of numerous hernia mesh products. The Bard hernia mesh products include SepraMesh, Ventralex, Bard 3D Max, Kugel, Kugel Composix Mesh, PerFix Plug, Ventrio, Ventrio ST, Composix E/X Mesh, Visilex, Spermatix and Marlex.
Bard meshes are made of a material called Marlex HGX-030-01. The manufacturer of this material gave this material an “MSDS” warning on the product which states that products made of this polypropylene material was not meant for permanent use. The manufacturer warned against using the product for treatments such as hernia mesh implants. This material can degrade and break off inside the body resulting in injuries and complications.
Wagstaff Law Firm is investigating potential claims of patients who suffered serious complications after undergoing hernia repair surgery that involved mesh implants from several manufacturers. Please contact us by using the online form or by calling our office at 303-376-6360 so that we may better evaluate your claim.
If you or a loved one has suffered any health damage due to complications after undergoing hernia mesh surgery, we recommend that you discuss your situation in a free, initial consultation with a national mass tort injury attorney at the firm at your earliest opportunity.