How The FDA Is Working To Improve Safety And Effectiveness Of Transvaginal Mesh As Lawsuit Numbers Climb

April 22, 2016 – – TheProductLawyers.com reports on ways in which the FDA has stated they are addressing issues associated with transvaginal mesh. The FDA stated in an update that in order to take care of increased reports of serious side effects, they are taking specific actions to deal with the issues. According to the statement, the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee convened on Sept. 8 and 9 of 2011 to discuss and make recommendations about the safety and effectiveness of mesh for stress urinary incontinence. In addition, they stated that the FDA planned to explore solutions and answer questions about mesh as well as continuing to monitor adverse events and assess data as it becomes available.

As the FDA continues to look into transvaginal mesh, many women have claimed that the devices cause serious, life-altering side effects. Among the issues cited by women are bleeding, inability to engage in sexual intercourse, urinary tract infections, fistulas, organ perforation, mesh erosion, recurrent prolapse or incontinence, severe vaginal or pelvic pain, need for revision surgery, nerve damage, vaginal scarring, emotional problems and vaginal shrinkage. These side effects have not only been reported to the FDA but have resulted in over 70,000 lawsuits across the U.S. The lawsuits have been filed against manufacturers including C.R. Bard, Coloplast Corp, Cook Medical, Johnson & Johnson and Boston Scientific alleging that, despite knowing about the risk of serious side effects, the companies continued to push them to market.

The devices were approved in 1996 for stress urinary incontinence procedures and again in 2002 for pelvic organ prolapse. The mesh, which is usually made of synthetic polypropylene, is used to support the urethra to prevent urine leakage in patients with stress urinary incontinence and used to support bulging organs in cases of pelvic organ prolapse.

Attorneys at Banville Law are currently 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 now 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
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