Metal Hip Replacement Lawsuit News Update
FDA’s “Tougher Regulations” On All-Metal Hips Come 20 Years Too Late For Thousands Injured by Metal-on-Metal Hip Implants
Ennis & Ennis, P.A. Continues to Offer Free Nationwide Confidential Hip Replacement Lawsuit Consultations to Patients with Hip Implants that have suffered severe hip replacement side effects like metallosis or have needed a revision due to a hip defect or hip failure.
- Ennis & Ennis, P.A.
01/21/2013 - Many medical devices such as the metal-on-metal (MOM) hip implants are approved by the FDA by methods that fail to even consider the safety and/or effectiveness of the product. This pathway, called the 510 (K) process simply evaluates whether the product is “substantially equivalent to previously cleared devices. These previously cleared devices may never have been tested and assessed for safety or effectiveness and some may no longer even be in use because of poor clinical performance.
A brief history helps understand the approval process. The Medical Device Amendments of 1976 outlined three classes of devices according to risks. Class I and Class II devices were low risks item such as toothbrushes and infusion pumps, which did not require extensive testing and clinical data. Accordingly, they were allowed to undergo review to determine if they were “substantially equivalent” to devices already on the market. Class III devices were high-risk devices and those awaiting proper classification such as MOM hips implants. These devices were meant to undergo the more rigorous premarket approval (PMA), which requires testing and clinical data. Unfortunately these class III devices were temporarily allowed to receive review for substantial equivalence until the FDA down-classified these devices or promulgated regulations requiring PMA.
Congress always intended class III devices to undergo PMA, so in1990, it directed the FDA to establish a schedule to finish the transition to PMAs for all devices that were to remain in class III. Outrageously, over 20 years later, as of 2013, the FDA still had not completed this transition to PMA for high-risks devices. Over the years, the FDA started to classify the implants but never completed them. Implant companies also strongly lobbied the agency to classify the all-metal hips as only moderate-risk products. Accordingly, manufacturers of MOM implants used this loophole to obtain clearance and market their products without ever demonstrating their product’s safety and effectiveness through clinical studies, but instead simply claiming “substantial equivalence.”
After an estimated 500,000 patients have received MOM implants which have shown record high failure rates, the FDA is FINALLY proposing that makers of hips with all-metal components, must prove the devices are safe and effective before they obtain approval for new all-metal designs or continue selling existing ones. The NY Times reports this action comes amid one of the biggest device-related failure in decades. Dr. William H. Maisel, deputy director for science at the FDA told The New York Times the agency’s proposal would require makers of all-metal hips to produce clinical data to justify their use because of the “large number of patients who received these products and the numbers of adverse events associated with them.”
Thousands of patients have been forced to undergo painful and expensive operations to replace the defective devices. Additionally, the MOM implants often release tiny particles of metallic debris when the joints move which has caused severe tissue and bone damage in thousands of patients as well as neurological problems, leaving them disabled. The damage is so pervasive that for the first time, the FDA will recommend that patients, who are experiencing pain or other symptoms, indicating device failure, undergo routine testing to detect levels of metallic ions in their blood.
If you or a loved one have been injured as a result of a defective metal on metal hip replacement implant you may be entitled to compensation. Our experienced Hip Replacement Lawsuit Attorneys are here to answer any questions you may have about a hip replacement lawsuit or a possible hip replacement class action lawsuit. Fill out the free hip replacement lawsuit case evalution form on this page or contact our Hip Replacement Recall Lawsuit Lawyers directly by calling toll-free: 1.800.856.6405.