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After nearly 200,000 women nationwide filed vaginal mesh lawsuits in recent years, over painful and debilitating injuries associated with the use of pelvic repair products, new research suggests that many of those problems could have been avoided with stronger regulatory oversight.
Researchers from Oxford University in the U.K. published a study in the medical journal The BMJ Open on December 6, indicating that dozens of transvaginal mesh products were approved with little to no research to establish that they were safe or effective, suggesting that regulatory failures are partially to blame for vaginal mesh problems and injuries experienced by women.
The study looked at data on 61 devices approved through the FDA’s controversial 510(k) “fast-track” approval program, which only requires that manufacturers show that proposed devices are “substantially equivalent” to previously approved products. The researchers found that all of the devices received approval by tracing their lineage back to only two devices; the Ethicon Mersilene Mesh, approved in 1985, and the Boston Scientific ProteGen Sling, approved in 1996.
However, the researchers note that the devices that claimed to be equivalent to those two mesh often used new technology, materials and designs that should have raised red flags among regulators.
The researchers found no clinical trials evidence for any of the 61 devices when they were approved which showed that they worked or that they were even safe. The study also found that in 119 cases where the FDA later called for clinical trials, 66% of the manufacturers ceased marketing the device and 22% changed the indication of the device instead of subjecting the device to intense scientific study.
Out of all of those cases, only seven studies even went as far as recruiting participants, and none have actually reported their outcomes.
“Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years,” the researchers concluded. “Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.”
Vaginal Mesh Litigation
In recent years, Ethicon, C.R. Bard, Boston Scientific and other manufacturers of transvaginal mesh products have faced massive numbers of product liability lawsuits, each raising similar concerns that the devices were introduced without adequate research or warnings. Design defects associated with surgical mesh have been linked to severe complications among women, including infections, erosion of the mesh into the vagina and organ perforation.
The litigation over vaginal mesh products has been one of the largest mass torts in recent years, with the number of cases beginning to increase rapidly after July 2011, when the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010.
After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.
In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women. Since then, a number of manufacturers have decided to stop making the devices to avoid the need to spend money studying the safety of products they have sold for years.
Following several years of litigation, various different manufacturers have reached vaginal mesh settlements to resolve groups of claims involving problems with products manufactured by Endo’s AMS, C.R. Bard, Boston Scientific, Ethicon and others.