FDA Reclassifies Transvaginal Mesh As ‘High Risk’ While Lawsuit Numbers Grow

April 07, 2016 – – TheProductLawyers.com reports on a recent article by Common Health indicating that the FDA has reclassified transvaginal mesh devices as “high risk.” The FDA issued two orders that would place new requirements on the device “to address safety concerns, including severe pelvic pain and organ perforation, through rigorous PMA pathway to demonstrate safety and effectiveness.”

According to the FDA, mesh has been used in surgeries since the 1950s, originally being used to treat hernias. Then, in the 1970s, the device was used by gynecologists for abdominal repair to treat pelvic organ prolapse. In the 1990s, doctors began using the device transvaginally for treatment of pelvic organ prolapse. The device is also used to treat patients with stress urinary incontinence.

The device has been at the center of thousands of lawsuits that have been filed by women claiming that they suffered adverse side effects following their procedures. Plaintiffs have alleged that these side effects include bleeding, infection, recurrent incontinence or prolapse, severe pelvic or vaginal pain, organ perforation, vaginal shrinkage, mesh erosion through the vagina, and neuro-muscular problems. The women also allege that companies who manufacture the device such as Johnson & Johnson, C.R. Bard, Boston Scientific and Coloplast Corp have not adequately warned consumers about the alleged dangers of the device.

As these cases are only expected to increase in number, 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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Banville Law
877-671-6480
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New York, NY 10023

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