Transvaginal Mesh Lawsuits Allege Lack of Clinical Trials
UPDATED: June 19, 2018
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Transvaginal mesh lawsuits filed throughout the country have a common thread - the allegation that manufacturers failed to conduct meaningful clinical trials. New results from an independent clinical trial provide meaningful information that consumer need before trying a product, so lack of meaningful trials can ahve serious consequences for consumers.
Clinical Trial Halted Due to High Vaginal Mesh Injuries
In August 2010, the Journal of Obstetrics and Gynecology published an article entitled "Vaginal Mesh for Prolapse, a Randomized Controlled Trial." The trial itself was conducted in Washington DC and used 65 women, 32 of whom had undergone a medical surgical procedure with the mesh. However, it had to be halted shortly after it had begun because 15.6% of the participating women experienced vaginal mesh erosion issues within three months. Interestingly, there was no significant base line distinction with respect to demographics, menopausal status or race. It was just random.
The reality is that so many other women have had vaginal mesh in them for much longer than three months. Transvaginal mesh injury lawyers say that it is simply mind boggling to think about how many women have been affected. They say that many of these surgical mesh lawsuits will allege that manufacturers were negligent for their failure to warn and/or take their products off of the market. So far, none of the products have been recalled and what's worse is that women continue to have these procedures done because they simply haven't been adequately warned by manufacturers.
It's a situation that many experts call unethical, tragic and perhaps unnecessary. In fact, the lead author of this article, Dr. Cheryl B. Iglesia, the Director of the Female Public Medicine and Reconstructive Surgery at the Washington Hospital Center, stated that patients would have been better off with the traditional treatment - which are currently available and do not use artificial products - as opposed to vaginal mesh which has caused such tragic complications as early as three months and resulted in thousands of complaints.
FDA Received Thousands of Vaginal Mesh Complaints
On October 20, 2008, the U.S. Food & Drug Administration (FDA) alerted doctors that it had received thousands of reports of serious transvaginal mesh injuries over the past four years and that they should look into why these might be occurring. Those injury reports were associated with at least nine different transvaginal mesh manufacturers.
Unfortunately, none of those manufacturers seem to have have stepped up to the plate and warned consumers about the serious transvaginal side effects and risks being associated with these products. In fact, most point the finger at the FDA for approving the product or saying that something else must have gone wrong in the process such as surgeons botching the procedure.