Vaginal Mesh Class Action Suit Might Be Australia's Largest in History

Australia’s Herald Sun is reporting that up to 20,000 women could possibly join the nation’s largest class action lawsuit ever, which was filed over a transvaginal surgical mesh alleged to have caused severe side effects. The suit was filed against the local unit of U.S. pharmaceutical giant Johnson & Johnson Medical, the mesh’s distributor.

This Australian class action suit comes on the heels of announcements the FDA has made in the U.S. regarding transvaginal mesh products and their adverse side effects.

Transvaginal mesh products are most commonly used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Prolapse describes any condition where organs slip or fall out of place after tissue holding the organs becomes weak. Uterine prolapse in women typically occurs after pregnancy or delivery. Stress urinary incontinence develops when the weakened pelvic muscles that support the bladder do not work properly, causing women to lose urinary control. More than one pregnancy or vaginal delivery may cause SUI.

The severe side effects thousands of women reportedly suffered due to these products include organ perforation and erosion, infections, unusual bleeding, urinary issues, and discomfort during sex. Potential damages awarded from the Australia class action suit would cover the “huge losses” these women have suffered, including “pain and suffering, care and assistance, medical expenses, and economic loss,” an attorney in Australia told the Herald Sun. The date of the suit’s first hearing should be announced in the next month.

This Australian class action suit comes on the heels of announcements the FDA has made in the U.S. regarding transvaginal mesh products and their adverse side effects. The FDA’s October 2008, Public Health Warning cited over 1,000 reports from nine surgical mesh makers of complications associated with the device’s use in treating POP and SUI. A July, 2011, update of this report revised the FDA’s previous announcement, saying the serious complications associated with transvaginal mesh in the repair of POP are not rare and are an “area of continuing serious concern.” Since the FDA’s initial warning, almost 3,000 additional reports of transvaginal mesh complications in relation to the treatment of POP and SUI were reported.

There are six active MDLs in the U.S. for pelvic mesh devices, the most recent consolidated in August, 2012, involving Coloplast Corp. Five other companies—C.R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp, Mentor Corp., and Johnson & Johnson subsidiary Ethicon, Inc.—are also facing multidistrict litigation for alleged injuries suffered by patients.