In light of the recent U.S. Food and Drug Administration warnings about vaginal mesh and potential problems associated with other medical devices, the approval process has come under scrutiny.

Currently, the FDA 501 (k) approval process clears newly developed or manufactured medical devices with little testing, as long as the device is similar to another medical device already on the market, known as predicate devices. Bloomberg reports that the 501 (k) process clears close to 90 percent of all medical device applications.

However, if the predicate device is ever recalled or pulled from market due to safety concerns, the similar products given approval through the 501 (k) process are still available. The predicate device for several vaginal mesh products, Boston Scientific’s ProteGen mesh was pulled less than a year after it was approved. ProteGen mesh was used as a predicate device for Johnson & Johnson’s Gynecare TVT, which in turn was used as a predicate device for other vaginal mesh 501(k) approval applications.

These medical devices are still available on the market, even though the original device has been shown to be unsafe for consumers.

As advocates for consumer safety, LegalView urges the revamp of an outdated approval process to better serve the consumers the FDA aims to protect.

For more information about vaginal mesh lawsuits or other medical devices that have been approved via the 501(k) process with the predicate later recalled, please visit LegalView.com.

Tags: Depuy Hip Replacement, FDA, Vaginal Mesh

This entry was posted on Thursday, January 12th, 2012 at 7:02 pm and is filed under Medical Devices, Medical Malpractice, Personal Injury, Vaginal Mesh. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.