FDA,Warns,Use,Non-Mesh,procedu health FDA Warns to Use Non-Mesh procedures over TVM
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The United States Food and Drug Administration (FDA) hasrecently finished a review of the reports submitted by patients and providersand the most current scientific literature concerning transvaginal meshsurgery. Upon finishing this review theFDA has concluded that there is no evidence that supports the use oftransvaginal mesh in transvaginal organ prolapse surgery over traditionalnon-mesh repairs. This is mainly due tothe potential for increased complications for undergoing repair procedures. The FDA has stated inits most recent alert concerning TVM that Serious complications associatedwith surgical mesh for POP procedures and stress urinary incontinence (SUI) arenot rare." The FDA continues on by saying, "Furthermore, it is notclear that transvaginal POP repair with mesh is more effective than traditionalnon-mesh repair in all patients with POP and it may expose patients to greaterrisk." In its review of the thousands of transvaginal mesh casesfrom 1996 to 2010, the FDA found that patients who have transvaginal pelvicorgan prolapse repair with mesh are exposed to additional risks compared withthose who have repair with stitches alone. According to the results of the review the FDA found that, while oftencorrecting any anatomy problems, the evidence showed that there was no greaterclinical benefit of TVM over non-meshsurgery. In 2010 alone there were at least 100,000 pelvic organ prolapserepairs using surgical mesh, almost 75,000 of these repairs were transvaginal,according to the FDA. The FDA tellsdoctors that they should be able to recognize that many of their pelvic organprolapse cases can be treated without the use of mesh. The FDA also issued awarning to doctors that mesh implants are permanent, and that any repairs madein the future may be difficult, and would put their patients at further riskfor additional complications and surgeries. Mesh that is placed abdominally, or used to treat SUI are not covered inthe 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 September2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering therecommendation that urogynecologic surgical mesh used for transvaginal repairof pelvic organ prolapse (POP) be reclassified from Class II to Class III. The research ontransvaginal mesh and to find out if it is clinically better over non-meshsurgery is still ongoing by the FDA. Please consult your doctor as soon as possible if you believe that yourtransvaginal mesh has caused you harm.
FDA,Warns,Use,Non-Mesh,procedu