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Fast-Tracked Medical Device Review Will Take Two Years

Posted by Jane Akre
Friday, September 25, 2009 9:24 AM EST
Category: Major Medical
Tags: Medical Devices, Federal Preemption, Medtronic, Zimmer Holdings, Truth in Medicine, Ethicon, Synthetic Surgical Mesh

Synthetic surgical mesh is just one of many medical devices that are allowed in the market under a fast-track 510 (k) process. The Institute of Medicine will examine the process to see if it is allowing unsafe devices on the market.

Many Unsafe Devices Approved For Marketing Not Safety

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IMAGE SOURCE: Surgical mesh, Nylon 66 top left, IVS top right, Soarc bottom left, TVT bottom right/ Int. Urogynecol. J. 2003, Web image

It’s not happening fast enough for patients who have been hurt by defective medical devices they say should never have been approved.

A federal study will take the next two years to look at a Food and Drug Administration (FDA) program, known as – 510 (k), which fast- tracks medical devices into the marketplace without pre-market approval for safety.

Under 510 (k), the manufacturer must submit to the FDA’s Center for Devices and Radiological Health (CDRH) which is responsible for overseeing medical devices, that it’s device is “substantially equivalent” to a device already on the market, known as a "predicate" device.

But the Government Accountability Office (GAO) finds that more than have of the devices fast-tracked have not been similar to their predicate device, either because of new technology or a new use.

Besides bandages and wheelchairs, 510 (k) devices can include pacemakers, heart valves, and synthetic surgical mesh.

And 30 years ago, the FDA allowed some Class III devices, the most dangerous, to be grandfathered into the 510 (k) process, including a heart defibrillator, dialysis catheters, spinal screws, hit joints, and a heart pump.

3,600 products apply for the 510(k) designation every year. About 90 percent are granted, according to an investigative series by IB News "Suffering in Silence" on synthetic surgical mesh, approved under 510(k).

Patients who have received the synthetic mesh for hernia repair and urinary incontinence and their doctors, are now finding that the complication rate may be as high as 30 percent with side effects that include bowel obstruction and performation, sepsis, and death.

Ready in 2011

The $1.3 million study of the 510 (k) process by the Institute of Medicine (part of the National Academies) was mandated by a law two years ago. The FDA says the review will not be complete until March 2011.

The Institute of Medicine (IOM) will look at how the premarket notification program operates. Meanwhile, the CDRH will convene its own internal working group on the 510 (k) process.

Truth in Medicine, a nonprofit patient advocacy group, was formed from thousands of patients who complain synthetic surgical mesh has ruined their lives. Founder, Lana Keeton, tells IB News, two years is too late.

“Thousands and thousands will be injured before they complete the review process,” she says. "Congress needs to stop reacting and start acting.”

The Project on Government Oversight also believes there needs to be more of a sense of urgency.

The Obama Administration has been responsible for a recent shake-up at the Center for Devices and Radiological Health. Last January, a number of whistleblowers went to the incoming administration to express concern that their warnings about fast-tracked approvals were not being heard.

Since then, the head of the device unit, Dr. Daniel Schultz has resigned. #


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