Transvaginal & Pelvic Mesh

    4th Circuit Upholds Ethicon Division Win in TVM Appeal

    Transvaginal mesh (TVM) has been under strict scrutiny from the Food and Drug Administration, healthcare providers, and afflicted patients thanks to a growing number of lawsuits in the past few years. The TVM device, used to treat incontinence and prolapsed organs, has caused many women horrible pain and often irreversible injury. Carolyn Lewis is one these women, and her recent appeal was struck down in court this March.

    Ethicon Wins First Federal Transvaginal Mesh Trial

    Unfortunately for one woman, a U.S. appeals court affirmed a Johnson & Johnson win in the first federal trial over TVM injuries, saying that no link appeared between the product itself and her injuries or that a more adequate warning would have caused her physician to insert a different device.

    U.S. District Judge Joseph Goodwin granted Ethicon denied Carolyn Lewis’s failure-to-warn claim in the Southern District of West Virginia back in January 2014, which she appealed in August. The TVM device, which was inserted to treat urinary incontinence, caused her serious pain during intercourse that did not improve even when pieces were removed. The appeals court affirmed the lower court’s decision on account of the lack of expert testimony to back defective device claims.

    Matthew Johnson, the spokesman for Johnson & Johnson’s Ethicon division, told Law360 that the decision was in line with the facts of the case. “While we are always concerned when a patient experiences an adverse medical condition, TVM continues to be a safe and effective option for women suffering from the debilitating effects of stress urinary incontinence,” said Johnson.

    Related: Find Your State’s Deadline to File a Claim

    Transvaginal Mesh Lawsuits Point to Multiple Manufacturers

    TVM is a device used to repair weakened or damaged tissue and is frequently used to treat pelvic organ prolapse and urinary incontinence. The Food and Drug Administration issued a safety communication on the device in February of 2011, stating that complications associated with TVM are not rare. Furthermore, they stated that in the incidence of pelvic organ prolapse, TVM may be no more effective that non-mesh treatments. As a result of countless transvaginal mesh injuries, many women have filed lawsuits against manufacturers, including Boston Scientific, Johnson & Johnson’s Ethicon Division and Bard.

    While problems associated with TVM vary woman to woman, the most common is erosion through the vagina. Multiple surgeries are needed to rectify the problem, and in some instances, it is impossible to remove the mesh in its entirety. Other problems include mesh contraction or shrinking, which can result in vaginal shortening and tightening. Both of these lead to serious pelvic pain, pain during intercourse and scarring.

    Speak With a Professional

    If you or someone you know has transvaginal mesh as a result of urinary incontinence or organ prolapse and has experienced pelvic pain, pain during intercourse or has unsuccessfully tried to have the mesh surgically removed, you may be eligible to file a lawsuit. It’s a good idea to speak with a lawyer who is familiar of mass torts of this nature, as they can help you be successful with your case moving forward. TVM pain is often debilitating and irreversible, and there is no reason not to move forward collecting the damages you deserve.

    Related: 5 Helpful Questions to Ask Your Injury Lawyer

    Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as, Yahoo!, MSN, AOL, Xfinity,, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.

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