A recent meeting of the American Urological Association ("AUA") included extensive debate by surgeons and experts about the risks and benefits of transvaginal mesh slings which have been widely used in recent years for the treatment of stress urinary incontinence in women.  The longstanding, official position espoused by the AUA is that the synthetic mesh devices are important treatment options for women affected by urinary stress incontinence, a condition that leads to bladder leakage in women due to pressure from... Read More

In the wake of mounting lawsuits against manufacturers of transvaginal mesh devices implanted in women to treat a litany of internal conditions, the U.S. Food and Drug Administration ("FDA") is now moving to heighten the risk label associated with transvaginal mesh specifically used to treat pelvic organ prolapse ("POP").  The risk label for mesh devices used to treat POP will be heightened from "low" to "intermediate." If the new standard is adopted after a mandatory 90-day public comment period, manufacturers of... Read More

Coloplast, Inc. may be considering settling a number of transvaginal mesh lawsuits against it for $16 million, Bloomberg reports.  If Coloplast A/S, one of the smaller manufacturers of mesh devices, proceeds with the settlements, legal experts predict an impending global settlement of similar lawsuits against other mesh manufacturers. Coloplast A/S, a Danish medical device company, has reportedly agreed to pay $16 million to settle various lawsuits covering approximately 400 women who sued for injuries caused by the company’s transvaginal mesh device,... Read More

Thousands of lawsuits have been filed by women across the country who underwent transvaginal mesh surgeries to repair pelvic organ prolapse and stress urinary incontinence following serious injuries from the procedures.   The lawsuits allege that various manufacturers failed to safely design and test the vaginal mesh devices and did not adequately warn women about the risks of injury. The complainants have alleged serious injuries resulting from implantation including chronic pain, organ perforation, infection, and device erosion. The transvaginal mesh multi-district... Read More