DualMesh Lawsuit: Who is the FDA Protecting?

Gore DualMesh label

DualMesh Lawsuit

DualMesh ExposéThe DualMesh lawsuit is against W. L. Gore and Associates, a privately held company with its corporate headquarters in Newark, Delaware. Since 1975, the Gore Medical Products Division has been based out of Flagstaff, Arizona. Gore now has 15 plants in Arizona, nine of which are located in Flagstaff, making Gore the largest employer in Northern Arizona. The DualMesh is made entirely of ePTFE or expanded polytetrafluroethylene, also known as Gore-Tex. Gore knew that hernia meshes made of ePTFE resulted in high rates of infections, adhesions to underlying organs, early mesh failure and hernia recurrence. Despite this knowledge, Gore has marketed ePTFE hernia meshes, such as the DualMesh for approximately two decades! Gore continues to market the DualMesh, even though most surgeons no longer use the product due to the severe complications it can cause. Our hernia mesh attorneys continue to observe severe, chronic, life-threatening infections as a result of the DualMesh. Many DualMesh associated infections have a latent onset of several years. Additionally, many of our clients have required months or even years of IV antibiotic and wound VAC treatment due to chronic DualMesh infections. Research conducted by the Hollis Law Firm has indicated that the ePTFE of the DualMesh degrades in the presence of infection. As the DualMesh degrades, the structure of the ePTFE forms small openings that harbor bacteria and prevent the body’s immune system from fighting the infection. As a result, chronic DualMesh infections are common and typically require numerous additional surgeries to remove the failed mesh and rid the infection.

FDA Clearance of Gore’s DualMesh

Unopened DualMeshGore’s DualMesh was allegedly cleared by the FDA in 1995. However, the FDA does not have a link to the initial 510(k) clearance of Gore’s DualMesh. The FDA also cleared numerous variations of the DualMesh in the decade following initial clearance of the DualMesh. The FDA’s 510(k) clearance program allowed Gore to skip human trials before marketing the DualMesh. Companies that skip PreMarket Approval (PMA) and instead opt for 510(k) clearance are more susceptible to lawsuits, because no human studies are conducted on the device and the FDA doesn’t approve the device as safe, it simply “clears” the product.

Why is it Called DualMesh?

Unlike many hernia meshes, the DualMesh doesn’t contain polypropylene, it is made entirely of ePTFE. So why is it called DualMesh? Because it has dual surfaces; one side of the ePTFE is very smooth and the other side of the ePTFE is rough. The smooth side of the DualMesh is intended to prevent adhesions to underlying organs, such as the bowel. The rough side of the DualMesh is intended to promote incorporation into the abdominal wall. Unfortunately, the rough side of the DualMesh also provides a more suitable surface for bacteria to adhere to and colonize. Once the DualMesh has been colonized by bacteria, the ePTFE begins to degrade. The more the DualMesh degrades, the harder it is to cure the infection.

DualMesh rough ePTFE side
Rough Side of the DualMesh
Smooth side of the DualMesh
Smooth Side of the DualMesh

 

What is PTFE and ePTFE?

PTFE or polytetrafluoroethylene was discovered by DuPont Co. in 1938. PTFE is more commonly known by the brand name Teflon, which is commonly utilized on non-stick cookware. In 1969, W. L. Gore discovered that under the right conditions PTFE could be stretched between 8 and 10 times its normal size, creating expanded PTFE or ePTFE. The new creation was then trademarked under the name Gore-Tex. Expanding PTFE creates small pores throughout the DualMesh, creating an environment ideal of bacteria to adhere and thrive. In fact, the DualMesh is so porous that approximately 70% of the ePTFE is just air. Gore-Tex or ePTFE is most commonly utilized outside of the body as a fabric to create waterproof jackets. However, Gore decided to go a step further and expand its market share by creating a medically implantable device utilizing its proprietary Gore-Tex. ePTFE might make a comfortable jacket, but it doesn’t make for a comfortable life-long hernia mesh implant.

Scientific Articles on Gore’s DualMesh & ePTFE Meshes

Apr 2018: Erosion of Polytetrafluoroethylene (Gore-Tex) Sling Over 20 Years After Placement for Stress Urinary Incontinence.DualMesh Folded in Half

A Gore-tex ePTFE mesh eroded through tissue 21 years after placement.

Dec 2013: An In Vitro Study Assessing the Effect of Mesh Morphology and Suture Fixation on Bacterial Adherence.

Unocated ePTFE mesh was found to have the greatest bacterial adherence compared to any of the other meshes studied. “It was unclear whether the increased filament diameter or the small pore size of DualMesh was accountable for the increased bacterial adherence rather than the ePTFE polymer itself. Taking into account the combined results of this study, it is likely that the increased prostheticload from a reduced pore size and increased mesh thickness had a relatively greater contribution than the ePTFE polymer. In the clinical setting, several studies have shown that ePTFE is more susceptible to infection than other biomaterials, and that when infection occurs, most ePTFE implants will need to be removed. However, once again, it is probably the small pores and increased mesh thickness observed with ePTFE prosthetics that account for these results.”

Sept 2012: Biomechanical and Histological Evaluation of Abdominal Wall Compliance with Intraperitoneal Onlay Mesh Implants in Rabbits: A comparison of Six Different State-of-the-Art Meshes.

The authors found that “significant shrinkage was seen in Gore DualMesh.”

June 2012: Does Expanded Polytetrafluoroethylene Mesh Really Shrink After Laparoscopic Ventral Hernia Repair?

The authors of the study found that the DualMesh Plus (ePTFE) shrunk between 2.6% and 25% in 16 patients implanted with the DualMesh. Seromas were also observed in approximately 8% of patients implanted with the DualMesh.

June 2009: The Problem of Mesh Shrinkage in Laparoscopic Incisional Hernia RepairPackage Cover for DualMesh

A literature search was conducted and found eleven experimental and 3 clinical studies published data referring to shrinkage of intraperitoneally placed meshes. ePTFE meshes, such as the DualMesh were found to shrink up to 51%. The author noted that the surgeon would have to anticipate significant mesh shrinkage in laparoscopic hernia repair. Gore does not warn surgeons that they will experience significant mesh shrinkage with the DualMesh.

Apr 2009: Erosion of a composite PTFE/ePTFE mesh after hiatal hernia repair.

Case report of an 80-year-old women who experienced erosion with an ePTFE hernia mesh. The author concluded that “mesh erosion is a rarely reported complication after hiatal hernia repair, and because many cases will go unreported, their true incidence is unknown. Besides the durability of mesh repair, the ongoing clinical trials investigating laparoscopic correction of hiatal hernias should also focus on the risk of complications associated with the use of prosthetic materials and the mode of fixation.”

Apr 2008: Rejection of Goretex Mesh Used in Prosthetic Cruroplasty: A Case Series.

Three patients underwent hiatal hernia repair utilizing a Gore-Tex (ePTFE) mesh. After 7, 12, and 34 months each of the cases presented with dysphagia. In all three cases initial endoscopy revealed narrowing at the lower end of the esophagus, with inflammatory changes and erosion. In two cases, the mesh was noted to have eroded into the distal esophagus, and in the third case relaparoscopy showed a peri-esophageal collection including the mesh surrounded with fibrosis. The authors concluded that Gore-Tex should be used with great caution in the peri-esophageal region, despite the fact that Gore-Tex (ePTFE) is currently being recommended as one of the choice materials for the prosthetic reconstruction of the hiatus.

June 2007: Management of Infections of Polytetrafluoroethylene-Based Mesh.

The authors conducted a study to determine a protocol for salvaging infected ePTFE mesh after many had advocated a mandatory removal of infected ePTFE mesh. Removal of the infected ePTFE meshes were noted as the cause of high hernia recurrence rates. 22 patients were treated for ePTFE mesh related infections, with an onset between 10 and 480 days. The authors concluded that “infections of ePTFE-based mesh can present in early or delayed fashion. Although mesh with extensive infection could not be salvaged, limited mesh infections could be managed successfully with percutaneous or open drainage and prolonged antibiotic courses.”

June 2007: Comparative Evaluation of Adhesion Formation, Strength of Ingrowth, and Textile Properties of Prosthetic Meshes After Long-Term Intra-Abdominal Implantation in a Rabbit.

The authors of the study found that “prosthetic shrinkage was greatest in the ePTFE (32%) group than in any other group.”

Sept 2006: Prospective Evaluation of Adhesion Formation and Shrinkage of Intra-abdominal Prosthetics in a Rabbit Model.

The authors of the study noted that “laparoscopic ventral hernia repair requires an intraperitoneal prosthetic; however, these materials are not without consequences.” It was found that “Overall prosthetic shrinkage was statistically greater for DualMesh (34.7%) than for the remaining mesh types.”

Apr 2004: Tissue Integration and Biomechanical Behaviour of Contaminated Experimental Polypropylene and expanded Polytetrafluoroethylene Implants.

ePTFE implants infected with S. aureus showed “zones of erosion, disorganized tissue, haemorrhage and necrosis.” Integration with host tissue was also impacted when ePTFE was infected with s. aureus.

May 2000: Ultrastructural Alterations of Polytetrafluoroethylene Prostheses Implanted in Abdominal Wall Provoked by Infection: Clinical and Experimental Study.

Explanted infected ePTFE meshes were compared to explanted non-infected ePTFE meshes. Examination of the explanted infected ePTFE meshes revealed alterations to teh ePTFE structure, such as areas of fragmentation, fracture lines, and detachment of fine layers of ePTFE that harbored numerous Staphylococcus colonies. The contaminated implants were also observed to be arranged more loosely, and on occasion large spaces between fibers gave rise to an unknitted appearance. It was concluded that “irreversible changes to the structure of the prosthesis are produced owing to colonization of the biomaterial by microorganisms, which in most cases necessitates total replacement of the prosthesis.

Jan 1993: Expanded Polytetrafluoroethylene Patch Versus Polypropylene Mesh for the Repair of Contaminated Defects of the Abdominal Wall.

An ePTFE patch was utilized to repair contaminated defects in 21 rats. Wound infection occurred in 16 rats, two of which died due to infection related complications. It was concluded that “expanded PTFE is unsuitable for the reconstruction of contaminated abdominal wall defects.”

DualMesh: Gore Hernia Mesh Lawsuit

Call today to speak to one of our trained hernia mesh team members regarding your potential Gore DualMesh lawsuit. The specific facts of your case will determine if your claim is compensable and to what amount. The Hollis Law Firm represents hernia mesh victims nationwide. All case evaluations and consultations are FREE, CONFIDENTIAL, and carry NO RISK or OBLIGATION. Call 1-800-701-3672 for a Gore DualMesh lawsuit evaluation.

Even though the DualMesh is not made from polypropylene, attorneys nationwide are starting to realize that the DualMesh results in high rates of severe, chronic infections. Check back as this new hernia mesh litigation develops. Visit our general hernia mesh lawsuit page for more information on other danger hernia meshes.

 

Content Created By:

C. Brett Vaughn RN, BSN, JD