Transvaginal mesh manufacturers continue to face an increasing amount of litigation over the reported defects of their product. The device, distributed by companies such as Johnson and Johnson, Boston Scientific, Endo Pharmaceuticals Holdings, C.R. Bard and more, is allegedly causing painful medical complications. According to Bloomberg news, there are over 650 lawsuits claiming that the implant has caused serious side effects. The controversy has brought attention to certain U.S. Food and Drug Administration (FDA) procedures that approved these devices for human use without a substantial amount of clinical testing.
Transvaginal mesh implants are used to treat conditions such as Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). SUI is uncontrolled urine leakage during physical activity, while POP is a condition in which pelvic organs bulge into the vagina due to weakened tissues surrounding the organs. The mesh is implanted to strengthen surrounding walls and tissues, preventing further deterioration.
On July 13, 2011, the FDA made a statement about surgical mesh used to treat POP and SUI. The agency updated its previous Public Health Notification from 2008, stating that, contrary to the previous announcement, the complications from this device are not rare. The update went on to say that the mesh might have no benefit over traditional procedures, and may even be more dangerous in some respects. According to the reports received, common complaints included pain, bleeding, mesh erosion through the vagina, organ perforation, urinary problems, pain during sexual intercourse and more.
The transvaginal mesh cases shed light on the 510(k) process, a simplified approval procedure mostly intended to be a “fast track” route for low-risk devices. Through 510(k), a device can be allowed onto the market with little to no clinical testing so long as it is similar enough to a previous device, known as a predicate. In 1996, Boston Scientific gained clearance for the first transvaginal mesh, ProteGen, by citing hernia slings and fabric used during cardiac surgery. The company had also relied on a 90 day rat study to support the product. Other manufacturers, including Johnson & Johnson, American Medical Systems and Covidien Plc, won approval for similar devices by citing ProteGen as a predicate. What’s disconcerting however, is the fact that Boston Scientific issued a recall of ProteGen in January 1999. Yet, the products based on the recalled device were unaffected, and their use continued.
The DePuy ASR XL Hip Replacement System, recalled in 2010, was also approved through 510(k).
Last September, an FDA advisory group recommended that meshes used to treat POP be re-categorized from moderate-risk to high-risk, which would force manufacturers to conduct clinical studies. In January, the FDA ordered 33 transvaginal mesh manufacturers to conduct 3-year studies to more accurately assess the safety profile of the device.
Now, the transvaginal mesh industry is under more pressure as lawsuits continue to mount. As of January, more than 650 mesh suits have been filed, according to Bloomberg News. Allegations involve claims such as fraudulent misrepresentation, strict liability, breach of implied and express warranties, negligence and fraudulent concealment. Last month, the U.S. Judicial Panel moved to consolidate three multidistrict litigation (MDL) cases into one. The suit, involving J&J’s Ethicon Inc., American Medical Systems and Boston Scientific, will take place before U.S. District Chief Judge Joseph R. Goodwin in the Southern District of West Virginia.