Over the past several years, the U.S. Food & Drug Administration (FDA) has received thousands of reports of adverse health complications associated with transvaginal mesh devices. These products are surgically implanted to strengthen a woman’s vaginal tissue which has become weakened due to pregnancy, menopause, or hysterectomy. The vaginal wall is usually a sturdy muscle that can support other organs in the abdomen, but when it becomes weakened, it can no longer carry this weight. The medical name for this condition is pelvic organ prolapse (POP), and at least 100,000 women have transvaginal mesh devices implanted each year to correct it.
Between 2005 and 2007, problems with vaginal mesh began to be routinely reported around the country. In 2008, the FDA sent a letter to doctors who were performing the surgery warning that there were numerous reports of complications, and that they should inform their patients about the risks associated with the devices. Yet even after the FDA issued its warning letter, the number of complaints associated with transvaginal mesh implants continued to rise dramatically.
Hundreds of women around the country have taken a stand by filing lawsuits against the manufacturers of transvaginal mesh devices. These claims have a two-fold purpose. First and foremost, they allow women the opportunity to receive much-deserved compensation for their financial losses, as well as physical and emotional suffering. Additionally, the filing of transvaginal mesh lawsuits may also cause manufacturers of the devices or the FDA to pull the products off the market, thereby preventing other women from undergoing the same suffering caused by the patches.
Commonly reported transvaginal mesh side effects include:
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skin breakage
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device protrusion
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contraction of the mesh that leads to vaginal shrinkage
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erosion of the vaginal epithelium
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return of pelvic organ prolapse despite implantation
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urinary incontinence
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serious infections
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bleeding
A study published in the May 2011 edition of the New England Journal of Medicine reveals the negative side effects associated with transvaginal mesh devices. The research measured the effectiveness of surgical mesh compared to that of colporrhaphy, the traditional method of stitching connective tissue in the vaginal wall back together. The study found that transvaginal mesh had a significantly higher risk of injury, including:
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7x greater risk of bladder perforation than colporrhaphy
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Nearly 2x the risk of urinary incontinence (loss of bladder control)
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3.2% of women required follow-up surgery to correct exposure problems
Transvaginal mesh products and manufacturers include:
Johnson & Johnson
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Ethicon TVT
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Gynecare TVT
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Gynemesh PS
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Prolene Polypropylene Mesh Patch
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Secur
Bard
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Avaulta Plus™ BioSynthetic Support System
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Avaulta Solo™ Synthetic Support System
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Faslata® Allograft
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Pelvicol® Tissue
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PelviSoft® Biomesh
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Pelvitex™ Polypropylene Mesh
American Medical Systems or AMS
Boston Scientific
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Advantage™ Sling System
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Obtryx® Curved Single
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Obtryx® Mesh Sling
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Prefyx Mid U™ Mesh Sling System
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Prefyx PPS™ System
Nearly all of the manufacturers listed above have already been named in litigation surrounding the defective nature of these devices, and the injuries to those who have been implanted with them. Federal transvaginal mesh cases have been consolidated into four multidistrict litigations (MDL) based on the manufacturer they’re filed against. Transvaginal mesh MDL pretrial proceedings are currently in full swing under Chief Judge Joseph R. Goodwin, United States District Court, WV. As of June 2012, the number of suits filed against each manufacturer continues to increase rapidly:
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335 cases filed against AMS
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268 cases filed against Johnson & Johnson’s Ethicon division
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205 cases filed against Boston Scientific
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649 cases filed against C. R. Bard
Women who suffered injuries after undergoing surgery with a transvaginal mesh device may have legal recourse. In July 2011, the FDA issued a warning stating that patients implanted with surgical mesh may be at a greater risk of developing complications than women pursuing other treatment options. Due to the fact that manufacturers of transvaginal mesh products failed to warn the public about this risk, women suffering from mesh-related complications may be able to file a transvaginal mesh lawsuit seeking compensation for medical bills, pain and suffering, and other damages.
Michael E. Schmidt is recognized as one of Americaʼs most passionate, accomplished and skilled trial lawyers. His law firm, Schmidt & Clark, LLP is currently accepting transvaginal mesh lawsuits in all 50 states. To learn more about this topic, please visit his website: http://www.transvaginalmeshlawsuit.com
