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What Are The Problems
What Are The Problems With The Transvaginal Mesh?
We believe the surgical mesh is defectively designed and should not remain in the marketplace. This is what occurred with the Mentor OBTape Vaginal Sling, a Transvaginal surgical material which was removed from the marketplace in 2006 because of significant side effects, including erosion, migration and degradation.
The Reasons For The Transvaginal Mesh Problems
Our experts believe that the Transvaginal Mesh is defectively designed because the synthetic mesh may prevent or hinder the free flow of oxygen and nutrients to and through the surrounding tissues.
We also believe that the responsibility for the defect lies with the manufacturers who intentionally bypassed the FDA’s formal pre market safety testing and approval process by applying for and obtaining a clearance or exemption from the otherwise rigorous pre market safety and regulatory testing. The transvaginal mesh manufacturers obtained what is known as a “510K” clearance from the FDA, which allowed them to avoid the standard premarket safety testing and approval of their products. The basis of the 510K clearance is that the manufacturers state in their approval applications that the mesh is “substantially equivalent” to a predicate or prior product.
