It has been reported that the medical devices that pose the greatest safety risk to patients, including the metal-on-metal hip implants, are allowed into the marketplace without sufficient evaluation for safety and effectiveness.
According to a recent New England Journal of Medicine article, it was found that previously cleared medical devices, including the metal-on-metal hip implant, were cleared without being fully assessed for safety and effectiveness.
The medical device amendments of 1976 created three classes of devices: Class I included low-risk devices like a toothbrush; Class II devices were of moderate-risk like an infusion pump; and a Class III medical device would be one that would put a patient at high risk, such as the metal-on-metal hip implants.
The Class III devices were designed to undergo rigorous premarket approval (PMA). That would require clinical studies.
According to this report, some of the Class III devices were permitted to receive “substantial equivalence” temporarily, until the FDA down-classified these devices requiring PMA.
Congress had always intended that Class III devices, such as the metal-on-metal implants, undergo PMA before the product would be introduced to the public.
However, as late as Dec. 19, 2012, the FDA had still not completed the transition to PMA for high-risk devices. Currently, 19 types of Class III devices, which include the metal-on-metal hip implants, are permitted to be used on patients through the temporary clearance. In other words, the loophole allows medical device manufacturers to market and sell the devices that are legal without demonstrating safety and effectiveness through clinical studies. Unfortunately, because of this opening, the metal-on-metal hip implants, such as the DePuy ASR XL Acetabular Cup System, received FDA clearance in July 2008 without a clinical study. This medical device has a very high rate of revision surgery at approximately 13 percent, which is more than four times the five-year revision rate for all hip-replacement prostheses combined.
In 2009, DePuy voluntarily recalled the ASR XL in Australia, citing “declining demand” as the reason. Then in 2010, a worldwide recall was announced because of the high revision rate as reported.
Because of the procedural flaw, metal-on-metal hips were cleared, but were never shown to be safe and effective. The clinical trial would have likely identified the high revision rate of the ASR, which became evident nine months later when compared to all other total conventional hip prostheses in the Australian Joint Registry.
Americans are at risk when medical devices are implanted or used that enter the marketplace without clinical data showing whether they are safe and effective. Obviously, implanted body parts, such as a metal-on-metal hip implant, are not easily recalled and replaced.
The Medical Device User Fee and Modernization Act (MDUFMA), passed in 2012, closes the loophole to make it easier for the FDA to reclassify medical devices. The act will reduce the time that it takes the medical device industry to bring safe medical products to the public for safe use.
Kreisman Law Offices has been handling medical negligence matters, medical device defect cases and nursing home abuse matters for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of a medical provider for more than 37 years in and around Chicago, Cook County and its surrounding areas, including Flossmoor, Glenview, Chicago Ridge, Woodridge, Westmont, Willowbrook, Burr Ridge, Brookfield, Elmwood Park, Niles, Bloomingdale, Streamwood, South Barrington, Lake Zurich, Vernon Hills, Libertyville, Gurnee, North Chicago, Crystal Lake, Wauconda, Hawthorne Woods and Lincolnshire, Ill.
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