The FDA and Transvaginal Mesh Approval
The Food and Drug Administration (FDA), the regulatory agency charged with overseeing the safety of medical devices, has known about the potential for risks involved with transvaginal mesh for sixteen years. On November 15, 1996, the FDA gave the green light to Boston Scientific to market ProteGen, the first transvaginal surgical mesh implant or sling, which has been used to treat women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). ProteGen and other surgical pelvic mesh products have been associated with a high rate of complications and failures requiring additional surgeries for removal of the product.
The original FDA clearance was given through the 510(k) process, which allows devices onto the market without a substantial amount of testing. The 510(k) process is the same one that gave clearance to defective hip prosthetics to enter the market. Congress has been pushing the agency for an overhaul of 510(k). The manufacturer needs only to argue that the device is similar enough to a previous device, called a predicate. Yet if the predicate gets recalled, that recall may have no effect on the second, third, or other following generations of the device. Boston Scientific had only conducted a 3-month rat study and cited predicates such as hernia slings and fabric used for cardiac surgery.
Just one and a half years later, in June 1998, the FDA inspected a Boston Scientific manufacturing plant and found problems with the device were worse than reported. The FDA “learned that the number of events being reported is approximately two-thirds of the complaints being made to the firm,” as stated in The Star Ledger. [http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implantsside2.html] Nevertheless, the FDA stated in its inspection report three months later that Boston Scientific was “not involved in any activities at the present time that could be considered to be a recall.” Also in 1998, Johnson & Johnson gained clearance through the 510(k) route for Gynecare TVT using Boston Scientific’s ProteGen as a predicate.
In January 1999, Boston Scientific recalled ProteGen, but the recall does not affect Johnson & Johnson’s Gynecare TVT nor any following devices based on either of these products. In 2003, Boston Scientific settled 738 lawsuits over its transvaginal mesh.
The FDA received more than 1,000 reports from 2005 to 2007 from nine different manufacturers regarding pain, infection, erosion of vaginal tissue, urinary problems, instances of bowel, bladder, and blood vessel perforation, and recurrence of POP and SUI, the very problems transvaginal mesh was supposed to treat. Yet, the FDA waited until October 2008 to issue a Public Health Notification warning about these complications, but stating that they are rare.
Over the next two years, FDA received 2,874 additional reports regarding these complications. Additional complaints include painful sexual intercourse, organ perforation, emotional problems, vaginal scarring and shrinkage, and neuromuscular difficulties. The FDA estimates that 300,000 women had received transvaginal mesh implants by 2010.
In 2011, the FDA updated its previous 2008 Public Health Notification to acknowledge that complications associated with transvaginal mesh are, in fact, not rare as it had previously announced. In September, an FDA advisory panel recommended that vaginal mesh implants should be reclassified from moderate-risk to high-risk, which would force manufacturers to conduct studies based on human testing. In January 2012, FDA ordered 33 manufacturers, including Johnson & Johnson and C.R. Bard, to conduct three-year studies. Also by January 2012, manufacturers faced more than 650 lawsuits. In February, the U.S. Judicial Panel consolidated three multi-district litigation cases into one. Lawsuits filed against Johnson & Johnson’s Ethicon Inc., American Medical Systems, and Boston Scientific are to be heard before U.S. District Chief Judge Joseph R. Goodwin in the Southern District of West Virginia.