What Is A Gore DualMesh?
Injured By A Gore DualMesh Product?
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What is gore dualmesh
Gore DualMesh is a surgical mesh that, like similar products, is designed to be implanted into a patient’s body to reinforce weak or damaged tissue, most frequently in the case of hernias but also in other instances where soft tissue requires repair. According to Gore, what sets DualMesh apart from other surgical mesh products is its two-sided design, with one side preventing tissue attachment while the other side supports tissue ingrowth and incorporation.
Gore, the same company that brought us Gore-Tex—the water-resistant materials frequently used in hiking boots and other outdoor gear—heralds its DualMesh Biomaterial as “the first dual-surface material that encourages host tissue ingrowth while minimizing tissue attachment.” It is used to repair hernias and other soft tissue damage, as well as in fascial reconstruction, temporary bridging TRAM flap procedures, and chest wall reconstruction.
Gore DualMesh Plus
In addition to DualMesh, Gore offers DualMesh Plus, which contains silver carbonate and chlorhexidine diacetate, purportedly for additional antimicrobial protection, which Gore markets as helping to stave off post-surgery infections for up to ten days. However, as noted by the author of Laparoscopic Hernia Surgery: An Operative Guide, “Long-term data on the benefits of impregnating these substances [silver and chlorhexidine] into the product [DualMesh] are difficult to document due to the low rate of infection that is associated with laparoscopic hernioplasty.” In other words, the inclusion of these antimicrobial elements is largely a solution in search of a problem, the efficacy of which cannot even be adequately determined.
Gore DualMesh Composition
Gore DualMesh is constructed of expanded polytetrafluoroethylene (ePTFE), which Gore claims is one of the most inert and biocompatible polymers available. As a result, according to Gore, “there has never been a confirmed allergic reaction to a GORE ePTFE product.” Gore DualMesh is designed to work best, of course, with Gore-Tex Sutures for “optimized soft tissue approximation.”
ePTFE—the material Gore uses in its DualMesh products—is just one substance used to make surgical mesh. Other makers of surgical mesh manufacture their products from composite materials or from a collagen matrix. Manufacturers using a composite substance include C.R. Bard (Composix, Composix EX), Genzyme (Sepramesh), and Brennen (Glucamesh, Glucatex 3D). Surgical meshes utilizing a collagen matrix are produced by manufacturers such as Cook Surgical (Surgisis ES, Surgisis Gold), Organogenesis (FortaPerm, FortaGen), and Lifecell (Alloderm). Each of these products is associated with its own potential risks and benefits, so if you require a surgical mesh implant, it is important to educate yourself as much as possible and to discuss all of your potential options with your healthcare professional.
Meet the new Gore DualMesh, same as the old mesh
In order to expedite government approval of new medical devices and to bypass certain premarketing requirements, medical device makers often will argue to the U.S. Food and Drug Administration (FDA) that a new device is, in fact, “substantially equivalent” to one or several FDA-approved devices already on the market. Gore has used this approach with several iterations of its DualMesh products.
However, one would be excused for not knowing this from medical device makers’ multi-million-dollar ad campaigns, which are intent on selling consumers on the “revolutionary” and “new” aspects of each device they roll out.
What are the risks and potential side effects of gore dualmesh?
Unfortunately, for all of GORE’s claims about the revolutionary nature of DUALMESH, it appears to expose patients to many of the same risks and potential complications as other surgical mesh products.
Going back over a decade, the United States Food and Drug Administration (FDA) has been receiving reports from patients complaining about side effects they attribute to their surgically installed GORE DUALMESH. These patients’ symptoms have included serious infections, obstruction of the bowels, severe abdominal pain, and inflammation. In some cases, patients reported these symptoms as having been so intense as to require hospitalization.
According to the FDA, the most common complications and side effects following surgical hernia repair using mesh include:
What do patients who have had gore dualmesh surgically installed have to say to the fda?
Here, in his/her own words, is one anonymous patient’s experience with GORE DUALMESH, which the patient reported to the FDA:
“I am a patient that had a hernia repair surgery that was repaired with [GORE DUALMESH] in 2006. Since this surgery, I have been hospitalized once for an infection, and have had a buildup of inflammation, for which I had to have a small tube inserted in the section where the hernia was repaired, and I also often have severe abdominal pain, which has caused me to constantly be off work. 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.”
• Patient complaint over GORE DUALMESH filed with FDA 7/10/2007
• Source: US FDA
• Source: US FDA
• Source: GoreMedical.com
• Source: Laparoscopic Hernia Surgery: An Operative Guide
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Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.
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