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Vaginal Mesh IS Hernia Repair Mesh Re-purposed

A medical device may already have two strikes against it if its method of approval is the FDA's 510 (k) fast-track system

Tuesday, October 15, 2019 - The FDA's fast track medical device approval system is one where all a company has to do to get its medical device approved is to show that it is similar to one already on the market. No consideration is given as to whether the original device has failed and injured people. Hernia repair mesh is a prime example of the system's most basic shortcomings. The now failed and debunked transvaginal surgical mesh was compared to hernia repair mesh such as the Ethicon Physiomesh Composite hernia repair mesh and was approved by the FDA solely for its similarity. Most hernia repair meshes are made by the same company as the transvaginal mesh such as Johnson & Johnson and are simply re-purposed and repackaged for marketing purposes. To understand the future fate of hernia repair mesh one has to look no further than what has happened to transvaginal mesh. Ethicon physiomesh lawsuit lawyers offering a no obligation free consultation to families and individuals harmed from the hernia repair mesh.

Women who have trouble holding their urine, usually after childbirth, have sought answers from doctors who have advised them to have the transvaginal mesh inserted in a simple 45-minute procedure. One vaginal mesh patient told the Netflix documentary movie The Bleeding Edge that she was told: "It is a simple, gold-standard, out-patient surgery, better than sliced bread and its the new thing." The transvaginal mesh, "is a polypropylene resin that is extruded into the fibers and then woven into a mesh, According to Attorney Adam Slater in the documentary. Mr. Slater told cameramen "Johnson & Johnson saw that doctors were starting to take hernia mesh and cut small pieces of it to help support repairs to a woman's weak tissue. Johnson & Johnson ran with the idea and decided to sell hernia repair mesh to support a woman's pelvic floor." Doctors were told that the surgical mesh was easier and more effective than natural tissue and suture pelvic floor repair. "All vaginal mesh devices were cleared through the FDA's 510(k) fast-track system, skirting human testing or human studies."

Dr. David Kessler, FDA Commissioner from 1990 through 1997, told reporters that doctors misunderstood the process the FDA used in approving medical devices because it is "not their area of expertise." Doctors implanting both vaginal and hernia repair mesh were found to think that if the device had been approved by the FDA it had to have been thoroughly tested.

Polypropylene mesh use for pelvic or hernia support becomes absorbed encased in the surrounding tissues, hardens and becomes inflexible, degrades, leaches chemicals into the tissues causing serious infection and pain. Doctors that implanted vaginal and hernia repair mesh were never trained to extract the device and normally will not even attempt the procedure. When a doctor attempts to extract the mesh they may have to remove the underlying organ which could be a section of the intestines or bowels if the device has migrated away from its intended location.

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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.