NICE Standards, Orthopedic Device Manufacturers

As technology advances our standards for efficiency, performance and safety are increased. These improvements are sometimes brought about by the natural evolution of the particular industry itself, the development of industry standards or the imputation of government requirements. Often, though, the change is influenced through lawsuits filed against manufacturers; sadly only after people are injured.

A good example of this kind of technological progression and accompanying increased regulatory standards can be found in the automobile industry. Once it was discovered that manufacturers were making safety decisions based upon economics rather than strictly consumer safety (resulting in disasters like Ford’s Pinto explosions), the government stepped in and compelled some amount of safety oversight. New safety standards set by government caused cars to become safer while improved technology helped them perform better for longer periods of time. As such, the expectations of the American people were raised.

A similar historical lens might be applied to hip implants. As a whole, hip implant products are getting better as time marches on. The National Institute for Health and Care Excellence, (NICE) has recently issued new guidance revising the standards for implant hips from a 1% revision rate (the amount of hips that fail and have to be revised) per year to 0.5% per year. After NICE’s assessment group analyzed data from the National Joint Registry, they estimated that the 10-year revision of total hip replacements (THRs) was far more improved than 10% at 10 years and that the highest estimated revision rates of THRs was fewer than 5% at 10 years. This is great news for people who require hip implants due to a variety of joint and trauma related conditions. The new standard demonstrates how far the technology of hip replacement has come.

However, even with technological progress, there are some outliers who do not meet the current standards set by their peers. These outliers can lead to terrible medical situations for patients who require a THR. Recalls like the Ford Pinto disaster, or more recently, Toyota’s problem of “unintended acceleration” remind us that oversight is important. Unfortunately, the implant hip industry also seems to have a few of these outliers who cannot meet or even come close to even the old standards set forth by NICE. These companies have certainly fallen far short of the increased new standards.

Some of the most prominent outliers are the DePuy ASR and the Stryker Rejuvenate and ABG II hip implants. While NICE has increased its standards for the longevity and functionality of implanted hips, these implants seem to fall woefully short with a DePuy ASR revision rate at 8% (49% over the course of 6 years) and Stryker with a suspected revision rate of 12.5% (or 50% after 4 years). That is a revision rate eight times higher than the previous NICE standard for DePuy and twelve times higher for Stryker. If one applies the recently issued NICE standard the DePuy revision rate is sixteen times higher and for Stryker it is twenty-five times higher. As such, these hips are no longer considered acceptable for use in some UK hospitals, nor are any other hips which do not meet the improved NICE standard. Though it is good news that these implanted hips are not being used anymore, they have already done significant damage to people around the world. When industry and regulatory standards increase with as time progresses, it is inexcusable to produce a product that falls shockingly short of these standards.