Washington, DCIt's been a little more than two months since the US Food and Drug Administration (FDA) mandated that manufacturers of artificial hip replacements conduct post-marketing studies in the wake of Hip & Knee Replacement Implant Failure. Various complaints include dislocation, fluid buildup, soft tissue damage and even squeaking joints that have become cause for embarrassment for some.
This all comes amidst the alignment of several factors that appear to have the makings for a pending perfect storm of US health care.
First, the US population is aging—and the largest segment is beginning to move into retirement and in need of joint augmentation to maintain the kind of active lifestyle that proved foreign to their own parents just a generation ago. Those baby boomers lining up for new hips and knees represent a huge market, estimated to grow into the billions of dollars annually in just a few short years.
To meet the demand, manufacturers are rushing new products onto the market with minimal testing. That's because current FDA regulations allow them to: any manufacturer proposing to introduce a product to market that is substantially similar to products already approved can benefit from reduced scrutiny. It's essentially a fast track to the market—and any manufacturer that puts a new face on an existing hip or knee replacement device (such as the introduction of metal-on-metal hips) can escape the long years of clinical trials usually required of new products presenting a sufficiently unique design.
In other words, the quality and reliability of implants appear to be going the way of modern appliances that don't have a fraction of the lasting power of a previous generation. And yet demand is steadily increasing.
An increasing demand, combined with more frequent incidents of Hip & Knee Replacement Implant Failure and the resulting need for revision surgery will put huge pressure on an already overtaxed US healthcare system. With preventable revision surgeries billed to Medicaid, Medicare or private HMO plans, advocates fear an upward pressure on health insurance rates and taxes to keep Medicare and Medicaid going, at a time when Americans—and the overall economy—can least afford them.
Little wonder so many Americans are embroiled in a Hip Replacement Lawsuit. They may have little choice, after having to face the financial and sometimes career-killing costs associated with revision surgery when an implant fails.
The FDA's request to manufacturers for post-market analysis of their products appears to have come too late for hundreds, if not thousands of hip and knee replacement patients—who probably wish such post-market testing might actually have been required prior to the approval of the problematic devices.
But therein lay the cracks in the veneer of the FDA. The agency's rules allow for a holiday from clinical trials for medical devices of similar design to existing devices. And yet the FDA appears to have limited authority. Dr. William H. Maisel, deputy director for science at the FDA Center for Devices and Radiological Health, noted in comments published in The New York Times May 11 that the order to hip replacement manufacturers represents the broadest use of the FDA's current authority to mandate post-market studies.
One break in the storm clouds is the fact that would-be patients, together with their doctors, are becoming more aware of problematic devices prior to initial surgery and are voicing their concerns—either through words or actions, such as choosing an alternative implant that has proven more reliable. Word is getting out, and sales of metal-on-metal implants have fallen. Those patients who have been negatively impacted by a defective hip or knee replacement have sought the services of a Hip Replacement Lawyer.
The fact remains, however, that the largest single demographic of the US population will be faced with the potential of a Hip and Knee Replacement Implant Failure at a time when the FDA has few tools in its toolkit to fix the problem. The agency can perhaps predict the perfect storm, but can do little to stop it…
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