According to an FDA Executive Summary report released Wednesday, August 31, on the FDA website, the agency said, “Because of the outstanding safety and effectiveness concerns for mesh products indicated for vaginal POP repair and an inability to adequately address these concerns via the 510(k) pathway, the FDA believes that 510(k) premarket notification is no longer an appropriate premarket pathway for devices indicated for vaginal POP repair. Therefore the FDA believes that reclassification of these devices to Class III and evaluation via the PMA process is warranted.”
The report says the rate and severity of mesh-specific adverse events such as pain, immobility, infection, mesh erosion, a return of incontinence and prolapse following vaginal POP repair “calls into question the safety of these devices.”
Under the proposal, synthetic surgical mesh would be reclassified as a high risk or Class III device to repair pelvic organ prolapse. The FDA report does not suggest a Class III designation for mesh designed to treat incontinence.
That designation would require manufacturers to independently demonstrate the safety and effectiveness of mesh by submitting it for premarket approval including clinical trials, scientific studies, and post-approval studies to obtain long-term data. Annual reporting and label changes could be required.
Presently, surgical plastic mesh is a Class II device (moderate risk) and is allowed to be marketed under the 510 (k) process as manufacturers claim it is “substantially equivalent” to a product already on the market bypassing safety and efficacy assurances.
"For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option," says Wanda Moebius, spokeswoman for AdvaMed, a Washington trade group told the Wall Street Journal.
This is just the latest demand for a change to the approval procedure for plastic mesh.
A July 13, FDA safety notification warned the public and medical professionals that mesh did not have any benefit over a non-mesh procedure but did have a considerable downside of risk. Just last week on Thursday, August 25, the consumer advocacy group, Public Citizen, filed a petition with the FDA calling for a recall of all non-absorbable synthetic mesh because of the high complication rate and, in many cases, the requirement for multiple surgeries.
An expert FDA medical device panel will be convened September 8 & 9 to consider the mesh reclassification. The Food and Drug Administration (FDA) is soliciting comments on the streamlined 510 (k) process that evaluates products and clears them for market.
In July an Institute of Medicine panel report said the fast-track 510 (k) process is “fatally flawed” and needs to be replaced.
According to Bloomberg, 85 surgical mesh products were cleared to treat pelvic organ prolapse from 1992 to 2010. About 75,000 pelvic surgeries were performed with the synthetic mesh last year, according to the FDA. The FDA staff said they have “not seen conclusive evidence” of improved clinical outcomes with the devices.
If the change is adopted it could take several years to be completed and could be phased in granting makers a grace period to comply with the more stringent rules. #