According to Bloomberg, each year more than 75,000 women undergo transvaginal mesh implants for the treatment of SUI and POP. Since 2008, the U.S. Food & Drug Administration (FDA) has been conducting safety studies of transvaginal mesh products. In a July, 2011 Safety Communication the FDA publicly announced that it had received 2,874 reports of surgical complications in connection with transvaginal mesh products designed by Johnson & Johnson and other medical device companies. These reports were collected during the period of January, 2008 through December, 2010.
These reports were ultimately classified as relating to pelvic organ prolapsed (POP) repairs or stress urinary incontinence (SUI) repairs; 1,503 reports concerned the former and 1,371 reports concerned the latter. Unfortunately, notwithstanding the FDA’s January, 2012 request that transvaginal mesh manufacturers conduct post-market safety studies to further investigate such reports, the agency has previously warned that it is almost impossible to completely remove the meshing device once complications arise—even through multiple surgeries.
There are approximately 600 lawsuits involving Bard Avaulta transvaginal mesh currently pending before U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia. This multidistrict litigation—which was transferred to Judge Goodwin in February, 2012—is scheduled for initial test trials beginning February 3, 2013. The primary complaint at issue is that the transvaginal mesh products used in POP and SUI surgeries have resulted in serious injury, including organ damage. The trial of these initial cases will likely forecast liability issues in similar cases, as well provide insight into potential damage awards.