Transvaginal mesh devices, also known as TVM mesh or TVT slings, are used to treat and control Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). Both are medical conditions typical for women that have had children. They involve the weakening of muscles associated with internal organs that begin to descend around the areas of the uterus and bladder.
A TVT sling was designed as a more minimally invasive surgery to address urine leakage in women suffering from SUI. TVM mesh is most commonly associated with treatment of POP. Surgical mesh is inserted through a small incision and deployed within the body using a surgical scope procedure.
Hundreds of women have reported pain and complications after transvaginal mesh has protruded through the vaginal wall, urethra, and bladder. The injuries can be profound, physically and emotionally. There are reports of complications ranging from infections, bleeding, and painful intercourse with their partners, to serious urinary complications and extensive invasive damage to the vaginal or urinary organ tissues.
If your Surgical Mesh implant has caused you unusual pain, discomfort or injury, call Perdue Kidd & Vickery at (877-833-7475) and speak to a lawyer that can advise you on your legal rights and help you receive the compensation you deserve.
For many women, a transvaginal mesh lawsuit has ensued. The US Food and Drug Administration (FDA) allowed manufacturers of new products similar to those already on the market to dispense with the need for pre-market clinical testing. This "fast-tracking" process allowed TVM and TVT onto the market without understanding the full range of complications they could cause. As the reports of severe injuries grow, the liability of the companies to women who received these products are better understood, even without FDA action.
In February 2012, hundreds of TVT and TVM lawsuits from around the nation have been further consolidated into an MDL proceeding. The US Judicial Panel on Multidistrict Litigation (JPML) established three new multidistrict litigation cases: American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326) and Ethicon, Inc./Johnson & Johnson (MDL No. 2327). These join the previously established Bard Avaulta MDL formed in October 2010.
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These MDLs will be centralized before Chief Judge Joseph R. Goodwin in the US District Court for the Southern District of West Virginia. Judge Goodwin has been described as being familiar with the issues surrounding transvaginal sling and TVM mesh products.
Meanwhile, the Federal Drug Administration may finally be catching up with the public health risks caused by these products. The FDA recently suggested a change in policy that may re-classify the class of products to now require pre-market clinical testing. The field is also finally recognizing that TVM mesh and TVT sling may not be the most advisable way to surgically treat SUI and POP.
All pelvic mesh products reached the marketplace through the FDA's so-called "fast-track" process. Women who had these products implanted could never have known that the manufacturers were able to bypass any human testing for risk by claiming that all the mesh products were based upon a previously approved product. Women were entitled to trust companies like J&J, Bard, AMS, and Boston Scientific to assure these products were safe. The horrible injuries women have suffered prove this use of mesh was not safe.
The legal rights of women who underwent transvaginal mesh surgeries continues to strengthen as more is learned about how these companies got these products to market. For example, women who received J&J's Ethicon mesh have now learned that the pelvic mesh product was placed on the market place and sold for three years without any approval whatsoever from the FDA. Other manufacturers also relied on the 510(k) process at the FDA to fast-track these products to market. The actions of these manufacturers continuously evidence their preference for profit over safety. Women who underwent transvaginal mesh surgeries are only now learning of the companies' rush to get pelvic mesh onto the market and into women's bodies without any testing of its risks. Sadly, women were left to pay the price for the pelvic mesh manufacturer's gamble. Perdue Kidd and Vickery is filing lawsuits and prosecuting claims nationwide for women injured by pelvic mesh from all manufacturer's and under all brand names.
J&J Marketed Vaginal Mesh Implant Without U.S. Approval - Click Here for more information
In July of last year, the FDA said it had received some 2,874 reports of TVM and TVT complication in the two years between 2008 and 2010 - Link to FDA Public Health Notification. Erosion of the vaginal mesh and protrusion through the vaginal wall were commonly reported. These injuries can be devastating to a woman and her marriage. Given the numbers of women who received these products and the vast number of complications being reported, anyone who has undergone pelvic surgery and received one of the products should immediately learn their legal rights.
Perdue Kidd & Vickery is actively involved representing women across the United States who seek to bring lawsuits related to pelvic mesh, TVT and TVM. Please feel free to contact us about your rights.
Recent News
9/8/11-FDA advisers urge closer scrutiny of pelvic mesh click here to read more.
9/8/11-FDA Panel Calls for Surgical Mesh Studies, click here to read more.
