More than 6,000 federal lawsuits have been filed against manufacturers of pelvic mesh products. Those cases have been consolidated in a multidistrict litigation venued in West Virginia. The defective medical device that is the subject of the lawsuits is a pelvic mesh most commonly used after a pelvic organ prolapse to repair weakened muscles in the pelvic area.
The Food and Drug Administration (FDA) issued warnings of multiple complications associated with the mesh, including erosion, shifting and infections. Many lawsuits claim that the mesh manufacturers failed to disclose potential risks and further allege inadequate testing and deceptive marketing of the mesh products.
The FDA approved pelvic mesh to repair pelvic organ prolapse in 2002. At that time, pelvic mesh products were believed to be an improvement over surgery that used sutures and the patient’s own tissue. Because similar mesh products were already in use for other procedures, pelvic mesh products received “fast-track” approval by the FDA. With this type of approval, the FDA did not require the type of testing that is required for new products.
In 2008, the FDA issued a public notice stating that problems with pelvic mesh products were “rare.” In July 2011, the FDA reversed its opinion and estimated that problems occurred in 10 percent of women within a year following surgery.
Last year, the FDA ordered pelvic mesh manufacturers to study and track the rates of complications associated with their products. While some companies have elected to conduct the ordered studies, other manufacturers have stopped producing certain products.
In July, a jury in California awarded $5.5 million to a woman who had filed suit against C.R. Bard, finding that her injuries were caused by the defective medical device. Five “bellwether” federal cases against Bard are scheduled to begin in June 2013. Trials against American Medical Systems, Boston Scientific and Ethicon–a subsidiary of Johnson & Johnson–are scheduled over the next year.
For more information, contact the Ohio transvaginal surgical mesh attorneys at Clark, Perdue & List.
Source: ABC News, “Thousands of women sue over surgical mesh,” Associated Press, Kate Brumack, February 8, 2013.