Published May 13, 2014 by Digital Journal
Carey Danis & Lowe, an experienced law firm representing women in vaginal mesh lawsuits, is pleased to report that the U.S. Food & Drug Administration (FDA) has proposed new regulations to mitigate the risks associated with surgical mesh used in the transvaginal repair of pelvic organ prolapse. According to a press release issued by the agency on April 29, 2014, the FDA has proposed reclassifying vaginal mesh as “high-risk.” The new rule would subject the products to greater regulatory scrutiny, and require manufacturers to submit a premarket approval application to the agency to evaluate safety and effectiveness.
[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm]
According to the FDA, transvaginal mesh products intended to treat pelvic organ prolapse are currently classified as “moderate risk” devices. As such, they are eligible for the agency’s 510(k) clearance process, which doesn’t require a manufacturer to conduct human clinical trials of a product before it is launched on the market. As high-risk devices, surgical mesh used to transvaginally repair prolapse would no longer be eligible for this process. The proposed regulations would also require manufacturers of devices already on the market to conduct safety studies of their products if they intend to continue selling them.
[http://www.federalregister.gov/articles/2014/05/01/2014-09909/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ]
The FDA’s actions follow warnings issued by the agency in October 2008 and July 2011 regarding the risk of serious vaginal mesh complications associated with transvaginal mesh products used to treat pelvic organ prolapse and stress urinary incontinence. In announcing the proposed regulations earlier this week, the FDA said it had since “identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse.”
According to court documents, more than 50,000 transvaginal mesh lawsuits have been filed in the U.S. District Court, Southern District of West Virginia by women who were allegedly injured by these products. The litigations include:
- In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)
- (In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation – MDL No. 2327)
- In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326);
- In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2187)
- In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387)
- In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)
Carey Danis & Lowe is representing alleged victims of transvaginal mesh complications in numerous claims that have been filed in the Southern District of West Virginia, and continues to offer free vaginal mesh lawsuit reviews to women who may have been injured by these devices. Learn more by visitingCarey Danis & Lowe or by calling 1.800.721.2519.
