The first of some 20,000 lawsuits brought over vaginal mesh device products is scheduled to go to trial.
The case is one of many pending in a multidistrict litigation (MDL) before United States District Judge Joseph Goodwin in Charleston, West Virginia. This first trial is scheduled to begin next week, according to the Daily Report.
Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. Vaginal mesh devices are supposed to help correct these conditions by providing additional strength to the pelvic walls.
The vaginal mesh devices were approved through a U.S. Food and Drug Administration fast-track process known as the 510(k). Under the 510(k), a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for transvaginal mesh and other controversial devices, the process has drawn increasing criticism.
Thousands of women were recipients of transvaginal mesh devices and, now, the devices have come under intense scrutiny as many women who were implanted with these devices are reporting complications allegedly related to their defects. The FDA reports that the most common complications associated with transvaginal mesh surgery may include:
- Mesh erosion through the vagina (exposure, extrusion, or protrusion)
- Dyspareunia (pain during sexual intercourse)
- Organ perforation
A July 13, 2011 FDA safety alert indicated that complications associated with vaginal mesh implants are “not rare” and that use of these devices may be more harmful when compared to alternative methods for treating POP. The FDA also asked 33 manufacturers to conduct post-market safety studies to investigate the health effects of vaginal mesh, including on organ damages, according to Bloomberg News.
This first case involves a woman who underwent POP surgery in 2009 and was implanted with vaginal mesh manufactured by C.R. Bard. She began suffering from an array of adverse reactions including bleeding and pain during sex and bladder spasms; she underwent two surgeries to remove the vaginal mesh, according to the Daily Report.
Meanwhile, Goodwin, who has had the Bard cases since 2010 was given four more MDLs in 2012 against Johnson & Johnson’s Ethicon Inc. unit; American Medical Systems Inc.; and Boston Scientific Corp. Last August, Goodwin received a group of cases against Coloplast Corp. and received more cases against Cook Medical Inc. on June 11, the Daily Report indicated. A status conference on all of the litigation is scheduled for August 1. There are also thousands of cases pending in state courts nationwide; two have led to jury verdicts during the past year.