Due to Numerous Injuries, FDA Proposes Reclassifying Vaginal Mesh Devices from Class 2 to Class 3
Based on a number of risks associated with the transvaginal mesh devices including infection, vaginal bleeding, damage to connective tissues, nerves, and blood vessels, on May 1, 2014, the FDA proposed reclassification of mesh devices from Class 2 to the more rigorous Class 3 status.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse [POP] and is now proposing to address those risks for more safe and effective products,” said William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a statement. “If these proposals are finalized, we will require manufacturers to provide pre-market clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” Previously the manufacturers avoided rigorous investigation by using the 510 k procedures. In a scathing review of these devices the FDA said, “The published literature reveals that, although transvaginal POP repair with mesh often restores anatomy, it has not been shown to improve clinical benefit over traditional non-mesh repair and, given the risks associated with mesh, the probable benefits from use of the device do not outweigh the probable risks.”
Sadly, tens of thousands of women have already learned this lesson.
In 2011, the FDA issued a safety communication warning serious complications for the mesh devices used for POP are not rare. In 2012, the FDA ordered post-market surveillance studies to address safety and effectiveness concerns regarding the transvaginal surgical mesh devices. Many believe if the mesh manufacturers were not able to use the 510 k process this disaster would not have happened.
Vaginal Mesh Trial History
Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced. In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries. Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.
In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product. Gross had 18 surgeries. The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.
On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages. The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective. Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries. In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected. Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.
On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).
On April 4, 2014, a Dallas jury found for the plaintiff Linda Batiste and ordered Johnson & Johnson to pay $1.2 million for its defective design of the Ethicon TVT-O pelvic mesh.
On September 29, 2014 the consolidated Boston Scientific mesh trial are scheduled to commence in the Southern District of Florida.
If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.