Innovation of Medical Devices Demonstrates Need for Appropriate Regulation

By Blume Forte Fried Zerres & Molinari on November 1, 2011

The implantation of medical devices can have many health benefits, or, can be detrimental to a patient, and cause injury or death. According to The New England Journal of Medicine (NEJM), this is due to an outdated device-approval system that may not require clinical trials before devices are implanted in patients on a wide scale.

The U.S. Food and Drug Administration’s (FDA) device-approval system of 35 years ago dealt with fewer and simpler devices. Now, even though technological and medical advancements have created more numerous and complex devices, the FDA continues to use the 35-year-old system. The system is not capable of ensuring safety or effectiveness today.

An example of the shortcomings in the antiquated FDA system is the metal-on-metal hip implant design of the DePuy ASR XL Acetabular System, which was cleared through the FDA in a process which only requires that a new medical device be “substantially equivalent” to a previously marketed device; with no need for clinical data necessary. According to a report presented at the British Hip Society Annual Conference, 21 percent of these hip implants failed and had to be replaced after 4 years, and 49 percent had to be replaced after 6 years. The failures were caused by erosion of the metal with subsequent contamination of the bloodstream and surrounding tissues with metallic particles.

The failure of the DePuy hip implant demonstrated the inadequacy of the established FDA medical-device approval system. On July 29, 2011, the Institute of Medicine (IOM) released a report on the clearance process in an FDA-commissioned report. Although the IOM recommended that the old clearance criteria be eliminated, the FDA does not intend to do so. The IOM report has been attacked by the medical device industry, whose goals seem to be significantly geared toward maximization of profit as opposed to device and patient safety.

If you or a loved one has suffered injury or illness as the result of a dangerous or defective product (medical or otherwise), the experienced product liability attorneys in New Jersey at Blume Forte can help determine whether you may have a meritorious claim. To learn more about your legal rights and options, contact us for a no-cost consultation at (973) 635-5400.

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