Transvaginal mesh and condoms – FDA Class II
Your doctor will or has already implanted transvaginal mesh into your pelvic vaginal area. It is a medical device and has the same FDA classification as a condom.
Based on an increase of adverse event reports submitted to the FDA, evaluation of 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 FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.
Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.
Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices -- the same as implantable transvaginal mesh.
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