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Hernia Mesh Could Soon Follow Pelvic Mesh And Be Banned In The US

There is little difference between hernia mesh and the transvaginal mesh that has been banned in the US

Monday, May 6, 2019 - Hernia mesh has many similarities to pelvic mesh including in many cases the same manufacturer. It looks as if hernia repair mesh may be going the route of the transvaginal mesh and could eventually be pulled from the market in the US. The reason for the change of heart by the FDA is due to regulators taking a stricter stance on the FDA's 510 (k) fast track medical device approval process, a regulation that failed miserably to keep the faulty and defective transvaginal mesh from the market in the US. The FDA's 510 (k) fast-track process came under fire in the Netflix documentary entitled "The Bleeding Edge" when former FDA commissioner Dr. David Kessler blew the whistle and exposed the process for the flaws therein. The fast track program bypasses the rigors of strict human testing of a medical device in favor of rushing it to market if the manufacturer can prove that the device is substantially similar to one that is already on the market. On the surface the 510 (k) program seems to make sense, however, the regulation fails to account for medical devices that have failed, been recalled, or the subject of patient lawsuits. A medical device like hernia mesh could have and probably did make it to market if it was shown to be similar to the transvaginal mesh that was the subject of thousands of lawsuits and banned from sale in the US.

Due to the high rate of failure, the FDA reclassified the transvaginal mesh as high risk, forcing makers to resubmit their product for additional post-market approval (PMA) testing before being once again approved for sale. According to, the only two companies that continued to sell pelvic mesh devices and had reapplied for FDA approval, Boston Scientific and Coloplast, were both turned down because they failed to demonstrate "reasonable assurance of safety and effectiveness". The companies were forced to immediately stop selling the devices and to recall remaining transvaginal mesh devices. Ethicon Physiomesh lawsuit attorneys for hernia mesh problems pursuing justice on behalf of individuals and families that have been harmed by dangerous drugs and defective medical products specialize in product liability litigation.

In the light of the many failures of hernia mesh, Ethicon's voluntary market withdrawal of Physiomesh citing abnormally high failure rates, as well as the product's similarities to the failed and banned transvaginal mesh device, it seems as if the days are numbered for hernia mesh.

Doctors and experts question the need for hernia mesh given the number and extent of the problems the device has caused. Hernia Mesh is made of component materials, one of which is designed to become absorbed into the surrounding tissue and the other to remain separate yet attached to engender flexibility and to give support to the surgically repaired area. The National Institute of Health has published articles that call into question whether or not polypropylene, the material that makes up the non-absorbable portion of the mesh device, is compatible with human tissue. A large and growing number of hernia mesh patients have reported that the device has migrated away from the spot of the original hernia and has become entangled in the lower intestines or bowels and causes perforations and blockages as well as excruciating pain that requires surgery to remove the device.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. OnderLaw has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. OnderLaw has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.