News tagged with 'Surgical Mesh'

Two years after the Riegel decision by the U.S. Supreme Court, patients injured by medical devices still have no recourse in the court to hold the device maker accountable. The Riegel decision applies to medical devices that undergo FDA approval, many do not.

A review of the process that fast-tracks medical devices into the marketplace without a safety review will be undertaken by the Institute of Medicine. The review will take two years, long overdue say patients hurt by devices that have been fast-tracked.

Amber Suriani liked what she heard. Turning 40 and suffering the inconvenience of a light case of urinary incontinence, she liked hearing there was a quick fix – a sling would be placed under her urethra and she would be back to practicing karate the same week. Instead she's filing suit.

Lana Keeton's near death experience with synthetic surgical mesh has transformed her into a powerful online patient advocate.  With a chorus of others, Truth in Medicine is working to urge Congress to remove the medical device from the market. Already the group has generated an FDA notice warning of 1,000 adverse events and 10 deaths due to mesh.

The FDA is holding an urgent meeting to try and fix the medical device crisis that is putting millions of Americans in danger of defibrillators, hip joints, and spinal screws, among others. Both FDA insiders and a GAO report called for immediate attention and confirmed many devices are marketed without rigorous premarket approval.  Ironically, consumers lost their right to hold device makers accountable under the Riegel decision by the U.S. Supreme Court.

If you assumed that a medical device that's implanted to help hold up internal organs passed some safety review by the FDA, you'd be wrong.  Synthetic surgical mesh was approved for marketing only. Some in the medical profession suspect there's a problem - some women and men know there is.  

While the complication rate is said to be one in a million, a growing voice of patients claim that the medical device - synthetic surgical mesh - used to treat incontinence and hernias, is not staying put but is migrating, wrapping around organs, requiring repeated surgeries, and in some cases killing patients. They want it off the market. 

The Medical Device Safety Act introduced into Congress, would allow consumers to hold manufacturers of defective medical devices accountable, even if the device has been approved by the FDA. 

Vaginal mesh surgery sounded like a good idea to correct urinary incontinence that comes from childbirth, but so far there are at least 32 lawsuits filed against Mentor's ObTape and more are in the pipeline. The FDA reports 1,000 adverse reports from manufacturers concerning complications.