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.
Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices.
Why is a vaginal mesh implant not subject to the highest level of regulatory control?
Are transvaginal mesh implants not approved by the FDA before they are marketed? Imagine permitting a strange object implanted into you or your wife’s or mother’s vaginal/pelvic area before it has been FDA approved?
That sounds like a theme for a science fiction movie.
Why are consumers and patients not aware of the lack of controls and approvals on Class II medical devices? This is front page news. Start tweeting.
It’s aggravating that transvaginal mesh is considered a Class II medical device and in the same class as condoms. Condoms are used externally once for sexual intercourse while transvaginal mesh is implanted surgically under an anesthetic which has its own risks. To recall condoms would be easy and painless but to recall implanted vaginal mesh poses surgical risks; is costly, and the patient may be prone to pain and suffering.
The alleged failures of transvaginal of mesh devices have spawned more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing.
A woman’s body should never be a science experiment.
