According to the letter, Ethicon has requested that it receive 120 days to cease sales of these products so it can inform customers and give medical providers an appropriate amount of time to decide on alternative treatment options for their patients. The company has also pledged to “discontinue or revise, as appropriate, all marketing materials during this time.” The FDA has yet to respond to the request, according to the letter.
The FDA first alerted the public to complications associated with mesh products used in the surgical treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in 2008. After issuing this initial health notification, the agency reported that the number of adverse events associated with transvaginal meshes continued to increase. In July 2011, the FDA issued an update to reflect that, contrary to its initial announcement, transvaginal mesh complications associated with the surgical repair of POP are not rare. Patients undergoing the surgical placement of the mesh through the vagina in the treatment of POP may be exposed to a greater risk than those undergoing other surgical options, according to the FDA. Pain, infection, mesh erosion, urinary problems and recurrence of prolapse are among the problems reportedly associated with the product.
The Gynecare products, as well as a number of other vaginal mesh systems, have become the center of pending litigation on behalf of women who claim they suffered serious complications following implantation. In Feb. 2012, it was reported that the U.S. Judicial Panel on Multidistrict Litigation ruled that three pending and separate MDL actions against Ethicon, Boston Scientific and American Medical Systems be heard in the U.S. District Court for the Southern District of West Virginia before the Honorable Judge Joseph R. Goodwin, who was already overseeing the MDL against C.R. Bard. To guide the plaintiff’s side of this litigation, a single Plaintiffs’ Steering Committee (PSC) was created to coordinate across MDL lines in the four separate vaginal mesh MDLs.
Michael Goetz, a leading attorney in Morgan and Morgan’s mass tort and class action department, is among the small number of attorneys honorably named to the PSC. As the litigation moves forward, Mr. Goetz and his fellow medical device attorneys at the firm are accepting new claims from women who suffered side effects after implantation with a vaginal mesh. If you or a loved one suffered from mesh erosion or other complications following surgery, visit ForThePeople.com today for a free evaluation of your claim.
About Morgan & Morgan
Morgan & Morgan is one of the largest plaintiff’s law firms in the country with multiple office locations throughout Florida and the Southeast. The firm handles auto accident cases, personal injury cases, and medical malpractice cases, as well as claims against drug and medical device manufacturers. Visit Morgan and Morgan online at http://www.forthepeople.com/ for a free case evaluation and information about your legal rights.
Morgan & Morgan
Michael Goetz
877-667-4265
pressrelease@lawyercentral.com
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