On January 4, 2016, the US Food and Drug Administration (FDA) announced a big change for transvaginal mesh. Previously classified as a Class II medical device, the FDA reclassified transvaginal mesh as a Class III device.
This means that the regulatory agency considers mesh to be high-risk.
30 months to reapply for FDA approval
And the FDA didn’t stop there.
They called on all vaginal mesh manufacturers with devices already on the market to reapply for approval.
The FDA gave manufacturers 30 months to submit their premarket approval (PMA) applications.
In these applications, manufacturers must prove that their products are safe for patients, and effectively treat pelvic organ prolapse (POP).
Smooth sailing is a thing of the past
The FDA is tightening the reins on new products, too. In the past, many transvaginal mesh devices received approval via the FDA’s 510(k) process.
Through this process, manufacturer’s only needed to link a new product to an older product that had already won FDA approval; drawing a similarity was, in some ways, the only requirement to get a mesh device onto the market.
For POP only
It’s important to note that the Class III, high-risk ranking applies only to vaginal mesh devices used to treat pelvic organ prolapse (POP). It doesn’t apply to those devices used for hernia repair or to treat stress urinary incontinence (SUI).
Ask your doctor, know all of the risks
Consult with your doctor about all of the options available to treat POP, including those that don’t involve surgery.
ASK A LAWYER
If you’ve received a vaginal mesh implant to treat POP, and you’ve experienced injuries, either physical and/or financial, we encourage you to begin exploring your legal options.
Need a lawyer?
Carey Danis & Lowe can help you. Contact us today about our free case evaluations.
Call us at 800.721.2519. You can also reach us online by completing a confidential personal injury claim form.