National medical device attorneys, Parker Waichman LLP, just filed a lawsuit on behalf of a Colorado woman who suffered a number of painful injuries, allegedly due to transvaginal mesh manufactured by Johnson & Johnson, Ethicon. The TVT transvaginal mesh device is manufactured by Ethicon, a subsidiary of Johnson & Johnson.
According to the U.S. Food and Drug Administration (FDA), transvaginal mesh implants may expose women to greater risks, compared to non-mesh methods, without offering any additional benefits. The agency has also stated that complications associated with transvaginal mesh are “not rare.” Transvaginal mesh is approved and sold to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Parker Waichman LLP filed a lawsuit alleging that the TVT transvaginal mesh caused the woman significant damage and bodily harm. The suit was filed on November 9th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case 2:12-cv-07553) and is just one of many cases filed into the multidistrict litigation (MDL) known as In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327). Ethicon, Inc., Ethicon, LLC and Johnson & Johnson have been named as defendants.
The lawsuit alleges that transvaginal mesh devices are unsafe, inherently defective, and caused serious injuries to the woman and points out that the devices were approved through the 510(k) process, a streamlined process in which the transvaginal mesh manufacturers only needed to conduct minimal tests before having the device approved. According to the complaint, the woman was implanted with the TVT transvaginal mesh in November 2010.
The mesh allegedly poses unreasonable risks to women because, among other things, the material used is not inert and can react with the tissues in the body. Transvaginal mesh allegedly has a risk of erosion, in which it travels through the body’s tissues. In some cases, the device can become embedded in inappropriate areas and multiple surgeries are required to remove it. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed. The lawsuit alleges that the defendants knew this, yet failed to warn consumers.
Last July, the U.S. Food and Drug Administration (FDA) warned that, contrary to what was initially believed, complications associated with transvaginal mesh are, in fact, “not rare.” The agency also stated that no substantial evidence exists that transvaginal mesh offers significant benefits over non-mesh methods for treating POP and may pose more risks.
The FDA has asked 33 manufacturers, including Johnson & Johnson, to conduct post-market safety studies to assess the risk of transvaginal mesh on organ damage and other health issues. According to an FDA Safety Communication on the matter, the most commonly reported complications associated with transvaginal mesh include: Mesh erosion through the vagina (exposure, extrusion, protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.