FDA May Tag Surgical Mesh for Organ Prolapse as High Risk
In a report issued Wednesday, the U.S. Food and Drug Administration indicated that the agency might classify as high risk surgical mesh devices used to treat organ prolapse, report news sources.
The report stated that the devices, which are transvaginally implanted, do not lead to better outcome and may expose patients to greater risk than traditional non-mesh procedure. The devices are currently classified as moderate risk. The FDA’s outside advisers are slated to look into the issue next week.
Patient advocates are calling for a recall of the surgical mesh devices, and the U.S. Institute of Medicine noted flaws with surgical mesh in it’s criticism of an FDA’s fast-track approval process that cleared the devices. That process, called 510(k), is currently under review by the FDA.
The FDA received 1,503 reports from January 2008 to December 2010 related to issues connected to the use of surgical mesh for treatment of pelvic organ prolapse. According to the agency, the surgical mesh devices were used in 75,000 transvaginal procedures in 2010.
As a Los Angeles personal injury attorney, patient safety is something I am very aware of. I hope that everyone impacted by complications stemming from the use of surgical mesh is receiving the proper care and support they deserve. Because of my experience as a product liability lawyer, I know that people often rely on medical devices to help stay healthy. I encourage anyone who suspects they might be experiencing adverse effects from a medical device to contact their physician right away.