In its review of the thousands of transvaginal mesh cases from 1996 to 2010, the FDA found that patients who have transvaginal pelvic organ prolapse repair with mesh are exposed to additional risks compared with those who have repair with stitches alone.
The United States Food and Drug Administration (FDA) has recently finished a review of the reports submitted by patients and providers and the most current scientific literature concerning transvaginal mesh surgery. Upon finishing this review the FDA has concluded that there is no evidence that supports the use of transvaginal mesh in transvaginal organ prolapse surgery over traditional non-mesh repairs. This is mainly due to the potential for increased complications for undergoing repair procedures.
The FDA has stated in its most recent alert concerning TVM that “Serious complications associated with surgical mesh for POP procedures and stress urinary incontinence (SUI) are not rare." The FDA continues on by saying, "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."
In its review of the thousands of transvaginal mesh cases from 1996 to 2010, the FDA found that patients who have transvaginal pelvic organ prolapse repair with mesh are exposed to additional risks compared with those who have repair with stitches alone. According to the results of the review the FDA found that, while often correcting any anatomy problems, the evidence showed that there was no greater clinical benefit of TVM over non-mesh surgery. In 2010 alone there were at least 100,000 pelvic organ prolapse repairs using surgical mesh, almost 75,000 of these repairs were transvaginal, according to the FDA. The FDA tells doctors that they should be able to recognize that many of their pelvic organ prolapse cases can be treated without the use of mesh. The FDA also issued a warning to doctors that mesh implants are permanent, and that any repairs made in the future may be difficult, and would put their patients at further risk for additional complications and surgeries. Mesh that is placed abdominally, or used to treat SUI are not covered in the current FDA warning.
There has been, however a recent update on this issue: “Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.”
The research on transvaginal mesh and to find out if it is clinically better over non-mesh surgery is still ongoing by the FDA. Please consult your doctor as soon as possible if you believe that your transvaginal mesh has caused you harm.
Hip Fractures Common in Women with Prolapse
Doctors point out the need for regular physical evaluation in women, specifically to find out about their pelvic muscle strength and bone density. They need it more when they age 50 and over.
Pelvic Examination: Enough to Diagnose Presence of Prolapse?
You should know that there are series of tests that your doctor will perform to diagnose prolapse, and the first thing that you should be prepared about is the over-all assessment of your pelvic organs.
Sling Attachment during Prolapse Repair: Important?
Patients with pelvic organ prolapse opt for vaginal mesh implantation not only because it immediately puts an end to the embarrassing symptoms they acquire from pelvic organ prolapse, but most importantly because doctors recommend its use.
