The FDA issued two final orders to vaginal mesh manufacturers and notified the public that the agency is strengthening the medical data requirements for surgical mesh.
Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.
The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
As a Texas Vaginal Mesh attorney, and Dallas medical doctor, we are reporting this important potential transvaginal mesh settlement breakthrough. According to sources, C.R. Bard Inc., and other makers of vaginal-mesh implants, are in advanced talks to settle thousands of vaginal mesh product liability lawsuits.
Bard, Endo Health Solutions Inc. the parent of AMS, Boston Scientific Corp., Coloplast and Cook Medical Inc. manufacturers making vaginal mesh devices to treat pelvic organ prolapse (POP) and treat stress urinary incontinence (SUI) in talks about settling all suits.
Johnson & Johnson, which also faces suits over the vaginal mesh devices, isn’t involved in the talks.
Transvaginal mesh injury lawsuits are consolidated and coordinated in 6 individual multidistrict litigations (MDLs) established in the federal court system. These injury claims against vaginal mesh manufacturers have now become the largest pending litigation in the U.S.
There are more than 30,000 complaints filed in U.S. District Courts over injuries with transvaginal mesh and bladder sling products. These medical devices have been used for treatment of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).
Bard agreed to pay an undisclosed sum to resolve Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems. Virgil’s case had been set for a Sept. 23 trial in state court in Atlantic City.
According to the filings, the 56-year-old woman said she needed three surgeries to address urinary problems created by the insert.
As previously noted, in the first Bard Avaulta bellwether trial, the jury awarded $2 million to a woman who claimed that Bard failed to warn of defects in its product that caused her mesh side effects. The settlement ended the second trial, brought by a North Carolina woman, Wanda Queen. A third bellwether case goes to trial on October 8 and a fourth on November 4.
Over 20,000 Trans Vaginal Mesh Lawsuits Pending
Plaintiff Suffered Serious Injuries
Bard Avaulta mesh is used for transvaginal surgical repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). Thousands of women have claimed that Avaulta plastic mesh have caused them to suffer serious and catatrophic injuries when the mesh may eroded through the vagina.