Once hailed as a breakthrough for women suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI), transvaginal mesh (TVM) implants have been linked to numerous painful and irreversible complications. Because these medical devices have not only failed to correct patients’ medical conditions but they also have further damaged the women’s bodies, victims are seeking legal justice and compensation.
Transvaginal Mesh Complications
Transvaginal mesh complications have been widely reported to range from new urinary incontinence to such debilitating effects as erosion of the implant into surrounding organs and exposure of the mesh through the vagina. These surgeries also can result in pelvic bleeding, painful sexual intercourse for both partners, and bladder perforation.
Unfortunately, even corrective procedures, known as revision surgeries, cannot always reverse the damage done by TVM implants. In fact, in 2008, the U.S. Food and Drug Administration (FDA) issued a public warning about such complications and announced it would study 15 years of scientific data.
FDA Warning On Transvaginal Mesh
Three years later, the agency updated its safety communication, calling the use of TVM in surgeries to treat POP “an area of continuing serious concern.”
The FDA emphasized that the complications are not rare and that there is no evidence that TVM produces better results than older methods of treating SUI and POP.
The July 2011 update also stated that health-care providers must “watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.”
One common method for placing TVM in a woman’s body comes with higher risk of bladder perforation. With a tension-free vaginal tape (TVT) sling, the doctor must blindly pass a large needle through abdominal cavity to insert the mesh tape.
Types of Transvaginal Mesh Lawsuits
Defective and painful TVM products are, unfortunately, widespread. Consequently, so are the related lawsuits. More than 600 Bard-Avaulta cases, including those for Bard’s Avaulta Transvaginal Patch, have been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia. (The MDL allows the discovery to be expedited by eliminating duplication, but each plaintiff still receives her own trial.) Judge Joseph R. Goodwin, who is presiding over the MDL, set the first trial date for Feb. 5, 2013.
Lawsuits against three other TVM manufacturers — Johnson & Johnson, American Medical Systems and Boston Scientific — also have been consolidated in a separate, smaller MDL that will be heard by Judge Goodwin.
Many of the mesh slings were approved based on a mesh product from Boston Scientific that was voluntarily recalled in 1999. Because it had been previously approved by the U.S. Food and Drug Administration (FDA) and not recalled by the agency, other manufacturers were allowed to use the faulty design in their own products. This process, known as 510(k) clearance, has facilitated devastating results for thousands of women.
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