Noble McIntyre on September 1, 2011
On August 31st, the Food and Drug Administration (FDA) released a report recommending that transvaginal mesh devices that are used to address pelvic organ prolapse and incontinence fail to lead to outcomes better than non-mesh repair and should be reclassified as posing a high risk to patients. Currently, the products are classified as moderate risk, with various patient advocates demanding a recall. The FDA’s outside advisers responded by stating that they will examine the issue next week.
Previously, the FDA issued a safety communication on July 13th warning health care providers and consumers about vaginal mesh complications. In that safety communication, the FDA also warned that transvaginal repair with mesh may not be more effective than traditional non-mesh repair and may actually expose patients to a greater risk.
Transvaginal mesh devices were approved through a process called 510(k) that is used to evaluate products similar to those that have already been cleared and are under agency review. In July, the U.S. Institute of Medicine found flaws with surgical mesh and urged the FDA to abandon the 510(k) process and require makers to prove that the product is safe and effective on its own merits. As of now, the FDA is seeking comment on that recommendation.
The FDA has received 1,503 reports of complications associated with vaginal mesh from January 2008 to December 2010 when used for pelvic organ prolapse. Last year, the devices were used in 75,000 transvaginal surgeries.
Getting a change from moderate risk to high risk could be a lengthy process. A change in risk classification may take several years to complete and the agency may consider a grace period in which it allows makers of the product to submit date to comply with a more stringent review. Also, the agency may require companies to conduct post market studies that could be used to support future submissions that will comply with the new process.
To learn more, please visit our page designed to give you more information about vaginal mesh and its complications. If you have had a transvaginal mesh implant, you may be eligible to participate in a lawsuit. Please contact an experienced products liability attorney at McIntyre Law for a free consultation by either filling out our contact form or by calling us toll free at (877) 917-5250.