17 May 2014

FDA Calls for More Stringent Regulations Surrounding Pelvic Mesh

The US Food and Drug Administration (FDA) is calling for stricter safety regulations governing pelvic mesh implants, which are commonly used to perform surgical repairs for conditions such as pelvic organ prolapse.

Under the new FDA proposal that was issued earlier this week, pelvic mesh implants would be classified as a high risk medical implantation device. This would require manufacturers to subject their pelvic mesh implants to pre-sale testing and analysis in order to offer up proof that the devices are actually safe and effective.

Over the course of the next 90 days, the FDA will be accepting commentary on their plan to re-classify pelvic mesh as high risk.

Currently, the FDA has classified pelvic mesh implants as a moderate risk medical device, which means this exempts the implants from the testing that’s required for more high risk devices.

If the FDA proposal is approved and pelvic mesh devices are re-classified as a high risk device, then the implant manufacturers would need to subject their devices to clinical analysis. This clinical data would need to be submitted to the FDA for review prior to receiving approval.

Pelvic mesh implants — also called bladder mesh or transvaginal mesh for the way the implants are inserted through an incision in the vagina — have been in use since the 1990s. It wasn’t until 2011 that the FDA concluded that women were dramatically more likely to suffer complications from the pelvic mesh implants. A number of patient case studies were compared and it was revealed that those who opted for the implant (instead of the traditional remedy involving sutures) had a one in ten chance of suffering a condition called mesh erosion within one year. These women had a 50% chance of requiring one or more follow-up surgery to remove the pelvic mesh implant and/or to correct the damage caused by the device.

Pelvic mesh implants were originally marketed as an easier, safer alternative to traditional pelvic organ prolapse surgery. But the FDA’s findings have revealed that the exact opposite is true, according to the FDA Device Center’s chief scientist, William Maisel, who added, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.”

Pelvic mesh originally received a fast track approval from the FDA, as manufacturers indicated that it was extremely similar to the mesh devices used to repair hernias.

This latest FDA proposal comes on the heel of several multi-million dollar lawsuits that have been filed against pelvic mesh manufacturers. Over 22,000 women have filed mesh lawsuits against Johnson & Johnson alone, after they reportedly suffered serious complications following implantation, including infection, internal bleeding, erosion of nearby soft tissue structures and chronic pain, among other symptoms.

Attorneys for the women who have filed suit argue that Johnson & Johnson knew about the dangers of its mesh products, but failed to issue cautions to the public.


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