Surgical Mesh Injuries Highlight Flawed FDA Approval Process

In a bold move January 4th, the Food and Drug Administration (FDA) ordered manufacturers of surgical mesh to conduct studies on the risks associated with the popular medical devices.
In 2002, transvaginal mesh was approved to treat pelvic organ prolapse. Each year, more than 100,000 women receive implants of transvaginal surgical mesh.
This new order by the FDA comes after patients have been complaining for years of serious injuries linked to the surgical mesh. Patients who have been injured have experienced bleeding, pelvic pain, infections, urinary tract injuries, bladder perforation, pain during sexual intercourse, and projection of the mesh through the vaginal tissue.
An estimated 1,000 adverse events involving transvaginal mesh were reported between 2005 and 2007. That number grew to more than 3,000 between the years 2008 and 2010, including seven deaths, prompting the FDA to require additional studies.
Surgical mesh was approved by the FDA under its 510(k) review process. Based on 510(k), a medical device that is classified as either a moderate- or low-risk device and that is substantially equivalent to another device already on the market can be cleared for sale on the market.
A medical device that has been cleared under 510(k) does not have to undergo additional studies, unless ordered by the FDA. At this point, all the medical device manufacturer needs to worry about is reporting serious injuries or malfunctions linked to the device to the FDA within 30 working days of the manufacturer becoming aware of the injury.
The FDA’s order is too little too late. Under 510(k), the FDA rushes its approval process, putting patients at risk of experiencing serious, sometimes fatal injuries. Only after these dangerous injuries come to light does the FDA require more in-depth studies.
If you or a loved one suffered an injury from a transvaginal surgical mesh implant, call experienced defective medical device attorney Kay L. Van Wey today at (214) 329-1350 or (800) 489-5082. You may be entitled to compensation for your injuries.