Vaginal Mesh

Oklahoma Law Injury Blog

FDA Recommends Vaginal Mesh Devices Be Classified as High Risk

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.  Continue reading

FDA Warns of Serious Complications Associated with Vaginal Mesh

Noble McIntyre on July 28, 2011

Only July 13, the U.S. Food and Drug Administration (FDA) issued a safety communication warning health care providers and patients about vaginal mesh complications. 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. Continue reading

© 2019 McIntyre Law, P.C. All Rights Reserved