In 2011 the U.S. Food and Drug Administration’s Obstetrics and Gynecological Devices Panel recommended that transvaginal mesh products be reclassified from moderate risk to high-risk products. The panel also recommended that transvaginal mesh manufacturers be required to submit premarket approval applications so that the safety and effectiveness of these medical devices could be evaluated before the products were sold.
Now, Almost Three Years Later, the FDA Has Proposed These Changes
The deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health is quoted in the FDA’s April 29, 2014 press release on the matter as saying, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products….”
Is it Too Late?
The FDA allegedly knew of potential complications from transvaginal mesh as early as 2008. In 2011, the agency updated its 2008 public safety communication to emphasize that transvaginal mesh complications were not rare. Now, it is proposing changing the classification of the medical device from a Class II moderate-risk device to a Class III high-risk device. The change may not allow women who have already had transvaginal mesh to treat pelvic organ prolapse to avoid injury.
However, it might not be too late for women who have been hurt by transvaginal mesh in Milwaukee, in Wisconsin, and around the nation to get help. For more information on your rights after a transvaginal mesh complication, please download our free report, Pain, Serious Injuries, and Death: The Frightening Complications of Transvaginal Mesh Implants.