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Transvaginal Mesh Risks, Exposed
It seems that there are no more untold secrets about surgical mesh products. Its nature, causes and effects have already been dissected. But not much was verified regarding the side effects that these products might cause to the patient as time goes by. A growing number of adverse event reports attributed to the use of the product surfaced. There have been a lot of declarations regarding surgical mesh products but it may be summed up to one and that is vaginal mesh causes inconvenient health issues.Presently, many complications were connected with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh treatment for POP and SUI safety and efficacy issues remain unsettled since it is still subject to re-evaluation by the FDA. This medical procedure has been in existence for a long time. In July 2011, a number of ill effects were massively reported associating transvaginal mesh to many side effects. The FDA then issued a warning to inform doctors as well as the patients of the potential complications of surgical mesh products. Moreover, the FDA asked health care professionals to consider other treatments for POP and SUI aside from transvaginal mesh implant.
Recent data shows that a lot of potential complications are linked with transvaginal mesh implants. This includes bleeding, vaginal pain, vaginal erosion, infection, shrinkage and pain during sex. The risks and benefits of surgical mesh products were discussed by the advisory panel of the FDA in September 2011.
Recently, the FDA announced that based on assessment of medical device reports submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, surgical mesh was reclassified from Class II to Class III. This reclassification warrants that surgical mesh device is now classified as high risk. Manufacturers of Class III devices may be required by the FDA to perform randomized controlled trials, scientific studies and post approval studies to demonstrate safety and efficacy in order to qualify for market approval. But class II products do not require such a strict procedure in order to qualify for market approval.
The FDA did not categorically confirm and it was not yet categorically established by evidence that there is a causal connection between transvaginal mesh implant and the reported adverse events. However, the growing number of reported adverse events and the rising number of transvaginal mesh lawsuit shows that transvaginal mesh implant may possibly cause serious danger.
URL References:
http://www.womenhealthzone.com/womens-health/what-is-the-transvaginal-mesh/
http://www.medpagetoday.com/OBGYN/GeneralOBGYN/27530
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
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