FDA Considers Requiring More Studies of Transvaginal Mesh
On January 4, 2012, the FDA announced that it is considering changing the classification of transvaginal mesh from a Class II to Class III medical device.
What is the difference between Class II and Class III?
A Class III device requires "an independent assessment of safety and effectiveness during a premarket review." Basically, a Class III drug goes through rigorous trials before it is approved by the FDA for use. A Class II device, on the other hand, may be exempt from this kind of testing or premarket review.
How did transvaginal mesh get approved by the FDA in the first place?
For most Class II devices, they are not required to go through premarket review because of the FDA's 510(k) submission process. This process allows drug companies to get their devices approved by the FDA by claiming that they are "substantially equivalent" to a device that has already been approved. 168 transvaginal mesh devices on the market became FDA approved through this process.
Was there any kind of testing of transvaginal mesh?
There were lab studies and animal studies that drug companies submitted to the FDA. There were no human studies.
If transvaginal mesh is reclassified from a Class II to Class III device, companies that make these devices will be required to go through postmarket surveillance studies. According to FDA policy, this process can take up to three years. It could have a very significant impact on some of the ongoing lawsuits brought by women and their spouses who have been injured by transvaginal mesh.
What is transvaginal mesh?
Transvaginal is mesh that is used in the vagina for certain surgeries to treat one of the following conditions:
- Pelvic Organ Prolapse (POP). For more information on POP, click http://www.the-recall-lawyers.com/2011/09/fda-to-hold-transvaginal-mesh.html#more
- Sudden Urinary Incontinence (SUI). This is a condition that occurs when a woman is unable to prevent urine from leaking from her urethra. There are many known causes, the most common of which is pregnancy. Multiple pregnancies may cause this condition to become permanent.
Continue reading "FDA Considers Requiring More Studies of Transvaginal Mesh" »