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Gore-Tex Hernia Mesh Lawsuit

More than a million hernia repairs are performed every year in the United States alone. Since the 1980s, the use of medical devices called surgical mesh in hernia repairs has risen drastically. The U.S. Food and Drug Administration (FDA)1estimates that more than 90 percent of certain types of hernia repairs use mesh.

While the use of hernia mesh may cause a reduction in recurrence, the devices have also been plagued by defects and higher-than-expected side effects. One of the hernia mesh devices that has been linked to high infection rates and other problems is the Gore-Tex hernia mesh.

Hundreds of adverse reports have been reported to the FDA, and now victims are starting to explore their legal options and hernia mesh lawsuits.


Gore-Tex Hernia Mesh Recall

Due to serious complications like organ damage and infection, thousands of people have filed lawsuits against the makers of hernia mesh products. This has resulted in a surgical mesh class action lawsuit. Hundreds of lawsuits are currently pending in federal courts related to Atrium C-QUR Mesh and Ethicon Physiomesh devices. Many of these hernia mesh lawsuits have been settled for $70,000 on average per case.

Plaintiffs in these hernia mesh lawsuits have claimed that the manufacturers have made defective products, failed to test the hernia mesh adequately, failed to warn the public of serious risks, concealed dangers from the public, and negligently designed and marketed the products.

So far, millions of dollars in settlements have been paid out to plaintiffs who filed lawsuits against manufacturers. For example, C.R. Bard agreed to pay $184 million to settle claims over its Kugel surgical mesh in 2011.8

Lawsuits against Gore Medical over its Gore-Tex hernia mesh devices have also started popping up. In one reported lawsuit, a patient allegedly suffered severe complications following implantation with Gore-Tex DualMesh PLUS Biomaterial. The patient ultimately died following several surgeries.

Any patients who have suffered from unexpected and severe complications related to Gore-Tex hernia mesh should contact a qualified attorney immediately.


What is Hernia Mesh?

A hernia is a condition in which an organ or tissue squeezes through a weak spot in the wall of the muscle surrounding the area. It most commonly happens in the belly and groin area.

Until about three decades ago, hernias were typically repaired by a surgeon who cut an incision in the abdomen, pulled the tissue together, and sewed the hole shut with dissolving sutures.

More recently, hernia repairs have been done with something called surgical mesh. Instead of pulling the tissue and sewing it together, surgeons now place a mesh over the hole or weak spot. Surgical mesh is usually made from synthetic materials that are either absorbable or nonabsorbable — or a combination.

By reinforcing the area of a hernia instead of squeezing the tissue together, surgical mesh should reduce the recurrence rate of hernias. As time goes by, the hernia mesh will degrade or lose its effectiveness. The idea is that new tissue will have grown over the repair site by then.


Types of Hernia Mesh

Hernia meshes come in all different types of sizes and materials. The designs often differ to optimize the repair of specific hernias. One mesh might be used for an inguinal hernia and another might be used for a ventral hernia.

Manufacturers of Hernia Mesh

  • Atrium Medical
  • C.R. Bard
  • B. Braun
  • Cook Medical
  • Ethicon
  • Gore Medical
  • LifeCell
  • Medtronic
  • TELA Bio

Companies making hernia mesh devices often manufacture several different models. Ethicon, a subsidiary of Johnson & Johnson, makes a hernia mesh called “Physiomesh.” Here is a video explaining the defects with Physiomesh - Physiomesh defect explainer (video).


Gore-Tex Hernia Mesh Info

W.L. Gore & Associates was founded in 1958 and has grown into one of the largest privately held companies in the country. The company focuses on making products from a waterproof and breathable material known as Gore-Tex.

Gore expanded to include a division called Gore Medical2 that makes various medical devices using Gore-Tex, such as vascular grafts, endovascular and interventional devices, sutures, and more.

The FDA first approved3 the Gore-Tex DualMesh in the 1990s under the 510(k) approval process.4 Devices approved under the process only need to show that it is “substantially equivalent” to a device already on the market.

Since then, several iterations of the Gore-Tex DualMesh have been approved. The device generally uses an ePTFE mesh with a coating. Gore currently makes the Gore DualMesh Biomaterial and Gore DualMesh Biomaterial PLUS.


Patients Report Problems with Gore-Tex Hernia Mesh

Hernia mesh devices like Gore-Tex have been used for decades. With an increase in use, more and more people have reported adverse effects associated with the products. Patients or physicians often report adverse events to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database.

Here are some of the most common reported complications:

  • Infection
  • Hernia recurrence
  • Bowel obstruction
  • Severe abdominal pain
  • Adhesion
  • Hospitalization

In one report5, a patient developed an infection following implantation with a Gore-Tex hernia repair mesh in 2006.

“I am now experiencing a great deal of pain from this hernia repair surgery. I am asking that an investigation be conducted on this product. I have spoken with several other persons that are experiencing the same symptoms as mine.”

In the follow-up report, the patient reported having more episodes of infection, constant pain, and obstruction of the bowel.

Another report6 from 2016 said that a patient suffered an infection that resulted in emergency surgery and a loss of colon after being implanted with a Gore-Tex surgical mesh in 2013 for abdominal hernia repair.

Studies have also noted an increase in possible infections in those implanted with Gore-Tex mesh. A retrospective review7 published in The American Journal of Surgery in 2013 found an uptick in infection rates. “The risk of mesh infection with the use of goretex was found to be higher than with the use of nongoretex mesh,” the authors concluded.


References
  1. FDA. "Hernia Surgical Mesh Implants", U.S. Department of Health and Human Services, https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm. Accessed April 24, 2018.
  2. Gore Medical. "About Us", Gore Medical, https://www.goremedical.com/about-us. Accessed April 24, 2018.
  3. FDA. "510(k) Premarket Notification ", U.S. Department of Health and Human Services, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K926565. Accessed April 24, 2018.
  4. FDA. "Premarket Notification 510(k) ", U.S. Department of Health and Human Services, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Accessed April 24, 2018.
  5. FDA. "MAUDE Adverse Event Report: GORETEX MESH DUAL MESH GORE TEX NONE", U.S. Department of Health and Human Services, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=879511. Accessed April 24, 2018.
  6. FDA. "MAUDE Adverse Event Report: W.L. GORE AND ASSOCIATES, INC. GORE-TEX HERNIA MESH MESH, SURGICAL, POLYMERIC", U.S. Department of Health and Human Services, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6676709&pc=FTL. Accessed April 24, 2018.
  7. Rodger H. Brown, M.D., Anuradha Subramanian, M.D., Cindy S. Hwang, M.D., Shirong Chang, M.D., Samir S. Awad, M.D."Comparison of infectious complications with synthetic mesh in ventral hernia repair", The American Journal of Surgery, https://www.americanjournalofsurgery.com/article/S0002-9610(12)00466-7/abstract. Accessed April 24, 2018.
  8. Amy S. "Hernia Mesh Patch Recall - FDA Warns of Death and Serious Healt...", Topix, http://www.topix.com/forum/news/prweb/TE4DF83JKBNACOFNO#c10. Accessed April 24, 2018.
  9. Bibeka Shrestha. "Bard Offers $184M To Settle Hernia Patch Suits", Law 360, https://www.law360.com/articles/255403/bard-offers-184m-to-settle-hernia-patch-suits. Accessed April 24, 2018.
  10. FDA. "MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES, INC. GORE DUALEMESH PLUS BIOMATERIAL SURGICAL MESH", U.S. Department of Health and Human Services, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036762. Accessed April 24, 2018.