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Press Release

FDA Clearance Process Misses Defective Medical Devices Report Finds

A recent study found the FDA's medical device approval process flawed and recommended that it be replaced with a process that could better protect patient health.
June 01, 2012 /24-7PressRelease/ -- An investigation of the FDA medical device approval process found four high-profile defective medical devices were released to market with little or no testing.
ProPublica's investigation found defective medical devices like the DePue ASR hip implant, transvaginal mesh, heart rings and defibrillator lead wires all were placed in patients without clinical data to support their effectiveness or safety.
The metal-on-metal ASR hip implant deteriorated, leaving metal fragments in the body and causing tissue to decay. The transvaginal mesh failed and poke through the walls of the vagina causing extreme pain.
The heart ring manufacturer began using them in patients with no FDA clearance or approval, and the defibrillator lead wires' insulation failed and could short out; 20 deaths have been attributed to the issue.
Section 510(k) Process
The investigation used information from the Government Accountability Office (GAO) and the Institute of Medicine, both of which had examined medical devices that made it to market via the FDA's 510(k) clearance process.
The 510(k) process was designed to allow the FDA to clear a product for market that has "substantial equivalence to previously cleared devices." This means a new medical device can be used on patients without a clinical study or any specific evaluation of its performance.
ProPublica found that during a four-year period, 75 percent of recalled high-risk devices had been approved by the the 510(k) clearance process or had been exempt from review altogether.
The prognosis for patients is not hopeful, as they also cite a 2011 FDA study that notes "adverse event" reports for medical devices have risen 15 percent per year for the last ten years.
The GAO report found that even after a recall, many of the medical devices remained unaccounted for, including devices implanted in patients.
Broken and Cannot be Fixed
Last year the Institute of Medicine (IOM) reviewed the clearance process for medical devices and called for the 510(k) process to be eliminated altogether because it could not guarantee safe devices.
According to the IOM study, "The 510(k) process has become a major component of medical-device regulation in the United States. Thousands of devices are cleared via the 510(k) process each year--about one-third of devices entering the market."
They concluded that 501(k) process should "be replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle."
Given the constant increase in adverse events for patients in the last decade and the presence of numerous defective medical devices, it appears that the FDA needs to improve its supervision of the medical device marketplace.
Article provided by Novak Pavlik Deliberato LLP
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