Jersey City, NJ (PRWEB) April 29, 2014
The JTB Law Group, LLC filed another lawsuit alleging that the pelvic mesh used in women’s bodies is dangerously unsafe. (Docket 2:14-cv-15430 Southern District of West Virginia Federal Court - MDL No. 2187). The lawsuit comes as the FDA issued a proposal to address the risks associated with surgical mesh for trans-vaginal repair of pelvic organ prolapse (“POP”)(http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm).
According to the the U.S. Food and Drug Administration, the health risks associated with surgical mesh used for trans-vaginal repair of pelvic organ prolapse warrant reclassifying surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III). This would require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate the products safety and effectiveness.
Consumer Rights Advocate and Attorney Jason T. Brown heralded the FDA’s action as a step in the right direction. “There are thousands of women who allege in their TVM lawsuits that they have suffered life altering events from these products and the FDA should vigilantly look into the safety of any trans-vaginal mesh that are in the stream of commerce and women’s bodies,” Brown stated. The lawsuits allege that the TVM failure rate is high resulting in a large volume of TVT and TVM revision surgery and some reconstructive surgery due to the possibility of erosion of the vaginal walls.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
Attorney Zijian “Coco” Guan, also of The JTB Law Group commented, “The FDA definitely needs to address this, there’s just too many women out there who are alleging the same injuries in their TVM lawsuits. For it to go unchecked would create an injustice.”
The lawyers at the JTB Law Group, LLC has been at the forefront of women’s health litigation for almost a decade speaking with thousands of women who have alleged injuries such as Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Stroke, Heart Attack, Sagittal Venous Thrombosis (SVT) and death from Yaz, Yasmin, BeYaz, Ocella, Gianvi,(MDL 2100 - Southern District of Illinois) and Nuvaring(MDL 1964 - Missouri): . The firm is also investigating alleged bladder cancer from Actos (MDL No. 2299 - Louisiana), uncontrolled bleeding allegedly from Pradaxa (MDL 2385 - Illinois), and the potential link between SSRI drugs like Celexa, Prozac, Lexapro, Topamax, Zoloft and birth defects (MDL 2342- Pennsylvania).
About the Firm – The JTB Law Group, LLC represents clients nationwide in Class Actions, Mass Torts and Catastrophic Injuries. Jason T. Brown the senior litigator, was recognized by The National Trial Lawyers as a Top 100 Trial Lawyer and by NAOPIA as a Top 10 Lawyer.