FDA Advisory Panel Recommends More Transvaginal Mesh Studies And Reclassification
On September 8, 2011, the Obstetrics and Gynecology Devices advisory panel to the U.S. Food and Drug Administration (“FDA”) convened to discuss whether transvaginal mesh products, which are used to repair pelvic organ prolapse, should be reclassified so that medical device manufacturers would be prohibited from utilizing the expedited FDA 510(K) process in order to receive market clearance. Currently, the transvaginal mesh implants are Class II medical devices; a reclassification would require manufacturers to prove the safety and effectiveness of the devices and undergo FDA’s rigorous clinical testing in order to receive market approval. Yesterday, the panel reviewed randomized control trials and studies on the use of transvaginal mesh to repair pelvic organ prolapse. Of the various vaginal mesh complications, they determined that erosion is the most common. Although a formal vote was not taken during yesterday’s meeting, 13 of the 17-member panel informally indicated that a reclassification of the transvaginal mesh devices is appropriate. Additionally, the panel supported the FDA’s plans to require more pre-market approval studies for new transvaginal mesh devices used to repair pelvic organ prolapse. Moreover, the panel called for post-market studies of existing transvaginal mesh products. The panel is meeting again today to continue the review process; it will hear presentations relating to safety issues involved in using transvaginal mesh to treat stress urinary incontinence.
Growing Reports Of Vaginal Mesh Complications Prompted Safety Review Process
Approximately 75,000 women undergo transvaginal mesh procedures to repair pelvic organ prolapse and stress urinary incontinence each year. However, from 2008 to 2010, the FDA received over 1,500 adverse event reports from women who experienced vaginal mesh complications after receiving the transvaginal mesh implants to repair pelvic organ prolapse. In July, the FDA issued a transvaginal mesh warning advising patients and doctors to consider alternative treatments to repair pelvic organ prolapse because of growing reports of vaginal mesh complications. The FDA also stated that they were unable to find any increased benefit to using transvaginal mesh to repair pelvic organ prolapse as opposed to other forms of treatment. At that time, the FDA also announced that it would convene a panel to discuss whether transvaginal mesh devices should be removed from the market. Although consumer groups have requested that the transvaginal mesh devices be recalled because of the serious nature of vaginal mesh complications, the panel is expected to recommend that the FDA reclassify the transvaginal mesh devices as high-risk.
Have You Experienced Vaginal Mesh Complications After Undergoing Treatment To Repair Pelvic Organ Prolapse?
If you or a loved experienced vaginal mesh complications after receiving treatment to repair pelvic organ prolapse, you may be able to file a transvaginal mesh lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.
Contact a transvaginal mesh lawyer at our firm today for a free and confidential lawsuit evaluation. The transvaginal mesh lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our transvaginal mesh lawyers also provide personal attention to guide you through the complex litigation process.