A recent federal review is not happening fast enough for patients who have been hurt by defective medical devices in Florida and throughout the nation that reports say should never have been put on the market.
A federal study will take the next two years to look at a FDA program that provides an easy fast-tracked method for medical device makers to get their product into the marketplace. The process is known as – 510 (k), and it amounts to an exchange of paperwork seeking approval from the Center for Devices and Radiological Health to market the device.
Note – the device makers claim that the catheter or defibrillator is “substantially equivalent” to another device already on the market. Unfortunately many of these devices are implanted inside patients, some permanently, and they have not undergone pre-market approval for safety.
Besides bandages and wheelchairs, 510 (k) devices can include pacemakers, heart valves, and synthetic surgical mesh.
3,600 products apply for the 510(k) designation every year. About 90 percent are given the okay.
The $1.3 million review by the Institute of Medicine (part of the National Academies) is better late than never. However, for those who have been harmed by medical devices that were never reviewed for safety, waiting another two years for it to be complete, slated for March 2011, opens the door to more abuse of the system.
A Truth in Medicine founder and patient advocate who is suing Ethicon over its synthetic surgical mesh which remains implanted in her, says two years is too late.
“Thousands and thousands will be injured before they complete the review process,” says Miami-based patient advocate. She and thousands who have contacted her Web site, say they never should have been implanted with synthetic surgical mesh for hernia repair and urinary incontinence. Many say their lives have been ruined because the mesh migrates, perforates organs, and is difficult if not impossible to remove.
You guessed it – the mesh was approved for sale through the 510 (k) process.
The Project on Government Oversight also believes there needs to be more of a sense of urgency.
You may recall that in January, a few whistleblowers with the FDA, spoke out to the incoming Obama administration that, which oversees medical devices, is more responsive to big business manufacturers than the public.
Since then, the head of the device unit has resigned.