Better Regulations Should Accompany Investment in Artificial Joints

Better Regulations Should Accompany Investment in Artificial Joints

One orthopedic company projects $41.8 billion in revenue by 2016, an annual growth rate of 7.8%. This is typical of the industry, which sees profit margins of 35% per year. That’s a lot of money, and investors know it. Why is there so much growth in joint replacements?

The answer is simple: more demand. The increase is attributed to three factors. One, people in wealthy countries are aging. As of now, one American in thirty has an artificial joint, twice the ratio from ten years ago. Two, improvements in artificial joint technology has made it possible for people who in the past would have had to live with reduced mobility to live active lifestyles. Three, Americans have gained weight; obesity stresses joints, necessitating replacement procedures.

Aside from obesity, how can is any of this a problem? Shouldn’t we be happy people can live longer, active lives? Of course we should, but there’s a snag: new artificial joints are often sent to the market without sufficient clinical testing, and those joints end up injuring recipients. This is the lesson from the DePuy hip recall. DePuy Orthopaedic’s ASR XL Acetabular System and ASR Hip Resurfacing System both fail in up to 49% of recipients after only six years. These recipients must undergo risky revision procedures and treatment for poisoning by toxic metal ions.

DePuy was able to sell such a remarkably poor product by using the U.S. Food and Drug Administration’s “510(k) preapproval process,” which allows companies to avoid subjecting their products to clinical trials by claiming their products are “substantially equivalent” to those already on the market. In this way, DePuy managed to convince regulators that its ASR series hip implants were somehow substantially equivalent to other hip replacements even though they used new metal-on-metal designs.

Since we know artificial joint manufacturers want that 35% profit margin, we can expect that they will all use the 510(k) process as often as possible. The result will be more questionable orthopedic devices and more injured recipients. If you’ve been injured by a recalled DePuy hip replacement implant and you are interested in compensation, contact the Rottenstein Law Group for a free consultation.