No would-be patient undergoes surgery needlessly. Pain and lack of mobility from a failing natural joint prompts most patients and their doctors to consider artificial joints as a means to regain mobility, mitigate pain and resume an active lifestyle.For some, however the potential for early failure and revision surgery – which is often more complicated and complex than the initial procedure – may prompt many to reconsider initial surgery in the first place, and stick with what they have as long as possible.
To be sure, the majority of patients who receive artificial hips experience a successful outcome. However a growing number of patients – especially those who accept newer designs and updates such as metal-on-metal hip implants – experience early failure. Metallosis (which is the term used to describe metal ions entering the bloodstream), inflammation of surrounding tissue from the shedding of minute metal fragments, and other forms of mechanical failure of the joint translates, for a growing number of patients, into a negative experience far removed from the expectation of a 10-to-20 year useable lifespan for the hip implant (the average is 15 years).
It all combines to turn patients into plaintiffs filing a defective hip implant lawsuit.
Baby Boomers – more active than previous generations – are not only a force demographically, but are also unwilling to while away their retirement years in a rocking chair. This has challenged device manufacturers to come up with a more robust design capable of withstanding the rigors of a more active lifestyle.
Heritage designs for hip implants were primarily fashioned from ceramic. Then the idea for metal-on-metal came along. Metal – sturdy and strong – was thought to be the pathway to a stronger hip implant that would last longer than more traditional implants, and provide better service.
However, a study published in journal BMJ in 2011 suggested that newer designs were at best, no better than older designs fashioned from more traditional materials. What’s more, new designs were becoming besieged with adverse events and failures unforeseen.
That’s because they were not thoroughly tested in the same rigorous fashion as a new medical device. Decades ago now, the FDA brought in the 510(k) Clearance, which allowed for abbreviated testing for existing medical devices submitted with design updates. In other words, hip implants have been around for some time. Adding metal to the devices, for example, would translate as a design update to an existing device already on the market, previously approved and performing well.
That allows the manufacturer to skip the normally years-long clinical trial that involves a group of volunteer subjects ‘trying out’ the new device. With the 510(k) Clearance, there is no clinical trial involved. To wit, the trial is carried over to the general public, which unwittingly accepts a heavily marketed updated design as new and improved, when the opposite is often true.
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Health and regulatory advocates have been calling for some time for the FDA 510(k) Clearance to be abolished, or revised in order to prevent what has become a parade of defective hip implants and other medical devices from reaching the general population. However, given overtures continuing to pour from the Trump Administration – which has yet to nominate an FDA Director – FDA regulatory authority may be further curbed, instead of strengthened.
The result could achieve an even faster pathway to markets for promising drugs and medical devices and make them available to patients sooner. The downside is the role the general public will play as unwitting participants in real-world clinical trials for heretofore untested design updates.