Transvaginal Mesh Injuires to be Investigated by FDA

The U.S. Food and Drug Administration (FDA) published in July 2011 an update on the safety and effectiveness of using surgical mesh for the transvaginal repair of pelvic organ prolapse (POP).  This update is in response to the FDA receiving an significant increase to the fact that in the last 3 years, the FDA has received over 1,000 adverse event reports about mesh used in transvaginal surgical repair of pelvic organ prolapse and stress urinary incontinence.These reports include problems such as pain, infection, mesh erosion (into vagina, bowel, and bladder), and recurrence of prolapse or incontinence.  There have been several more serious complaints which involved rare but serious intraoperative injuries such as bowel, bladder, or blood vessel perforation. Many of the patients who have filed this complaints report that either medical or surgical attention was required, while others needed to be hospitalized.

 The following the released statement made by the FDA in regards to the increased reports of transvaginal injuries:“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date. And although the exact cause of these adverse events hasn’t been identified, they’re likely to be the result of multiple factors. Further investigation is needed.”

 The release also continues by stating: “The FDA continues to be concerned about this subject and will sponsor a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee. The purpose of the meeting is to discuss the safety and effectiveness of transvaginal placement of mesh for POP and stress urinary incontinence (SUI) procedures.”

 To date, the FDA’s official stance in the matter of what is actually causing the transvaginal mesh repairs to cause injuries is that more investigation is required; while this investigation is ongoing many more patients claiming injury have begun to file transvaginal mesh lawsuits. If you feel that you have been injured in any way because of your transvaginal mesh, consult with your doctor as soon as possible.

References:

fda-reports.com/device/transvaginal-mesh.html

fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm169802.htm