Wednesday, February 13, 2013

FDA Expected To Announce Stricter Metal-on-Metal Implant Standards

Tomorrow the FDA is expected to announce that it will finally tighten regulations on makers of metal-on-metal hip implant products. Previously, manufacturers like DePuy (a Johnson & Johnson company) were permitted to put their products on the market based on their products’ similarity to a previously-approved hip device already on the market (510(k) clearance). Even now, the decision to actually require manufacturers to conduct clinical trials and produce data supporting their product’s safety and effectiveness will not take effect immediately, and may still be modified or opposed by industry lobbyists. Whether this tightening of regulations is successful, for patients who have already suffered the consequences of having an all-metal implant, the move is too little, too late.

For thousands of US patients who received one of the defective metal-on-metal hip replacement devices, it may come as a shock to find out that companies were not previously required to provide clinical evidence for the safety of their products. The vast majority of those who received metal-on-metal devices now face a lifetime of complications, ranging from localized tissue damage or death, to pseudo-tumors, to permanent bone damage, pain, immobility, and disability. Almost all metal-on-metal hip implant patients have either undergone, or are preparing to undergo, at least one, if not multiple, painful and costly revision surgeries.

This extremely delayed action by the FDA is intended to close a loophole in the federal law initially regulating medical devices. The Medical Device Amendments of 1976 allowed differing requirements for different types of medical devices, according to their perceived risk. At the time, there were already all-metal hip implants on the market, so the “temporary” solution was to classify hip implant products as “moderate risk” devices, which allowed them to enter the market under the 510(k) clearance. The FDA began working on a system to classify the hip implant devices, but nothing was ever completed. In other words, corporations were allowed to put devices on the market without performing clinical trials and without proving the safety and efficiency of their individual products for 36 years. According to Daniel Nigh, attorney with Levin Papantonio: “In the 1970’s and 80’s, manufacturers of metal-on-metal hip implants knew of the risks posed by metal ions; however, despite this knowledge, at the turn of the century they were still blindly manufacturing metal-on-metal hip devices in order to aggressively upsell their products and attempt to make a higher profit.”
 
TIMELINE OF SIGNIFICANT EVENTS
Late 2009/early 2010: The majority of orthopedic surgeons realize metal-on-metal is bad and begin to phase out use of metal-on-metal hip implant products

May 9, 2011: FDA issued orders for post-market studies of metal-on-metal hip implant devices

June 27/28, 2012: FDA panel convenes to discuss risks/benefits of metal-on-metal hip implants and conclude that metal-on-metal implants have no benefit, but have the risk of releasing high levels of metal ions

January, 2013: FDA announces plans to tighten regulations on all metal-on-metal hip implants
Alisha Mims is a Content Management Specialist for Levin, Papantonio law firm, a writer, and contributor to Ring of Fire

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