Urogynecologists Welcome Transvaginal Mesh Reclassification While Lawsuit Filings Mount

April 18, 2016 – – TheProductLawyers.com reports on the reaction of urogynecology experts to the reclassification of transvaginal mesh devices on January 4. According to Contemporary OB/GYN, many experts in the field welcomed the FDA’s change. Dr. John O. DeLancey stated in the article, “ Thirty years ago, when the original regulations were developed, saying something was substantially similar to existing products was something that surgeons welcomed and that allowed rapid progress. However, new complex surgical technologies have unique risks and change rapidly, and it is time to make sure that there are adequate safety and efficacy data before approving new techniques, devices, and products. It is what the public expects from the FDA and what all of us would want for our own health care.”

The reclassification of transvaginal mesh followed the reports of over 1,000 adverse events related to the device. The mesh, typically made of synthetic polypropylene, was approved by the FDA in 1996 for use in stress urinary incontinence procedures. In such cases, the mesh is used to support the urethra to prevent urinary leakage. It was also approved later in 2002 for treatment of pelvic organ prolapse in which it is used to support bulging organs. Companies that manufacture the mesh include Johnson & Johnson, C.R. Bard, Coloplast Corp, Cook Medical and Boston Scientific.

Reported adverse events have involved a variety of issues including bleeding, recurrent prolapse or incontinence, need for corrective surgery, organ perforation, urinary tract infections, severe pelvic or vaginal pain, vaginal scarring, inability to engage in sexual intercouse, infection, erosion of mesh through the vagina, fistulas, vaginal shrinkage and nerve damage.

Several thousand lawsuits concerning mesh have already been brought to court and more are expected to accumulate. Meanwhile, attorneys at Banville Law are working to make sure that those who believe they have suffered adverse side effects as a result of a transvaginal mesh implant are given the important opportunity to explore their legal rights fully. Qualifying individuals may be entitled to legal action and financial compensation. Banville Law is currently offering free case evaluations for those parties.

To learn more about transvaginal mesh, or to ask questions, contact Banville Law by calling (877) 671-6480.

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