This news release announces the first two implantations of Bodycad’s Unicompartmental Knee System, knee replacement devices manufactured for individual patients using 3D printing technology and Bodycad’s “proprietary methods.”
Despite claims throughout that the 3D printed devices result in “a better fit” and “the potential for improved clinical results,” the company offers no data or evidence and does not reference any studies measuring the effectiveness of the devices.
The device has received clearance from the FDA in a letter stating the device is “substantially equivalent” to existing devices already in use. It should give readers pause that neither the news release or FDA letter indicate that any studies on patient outcomes were completed or even required. We offer a primer that describes the weak regulations governing approval of medical devices like this one.
The news release neglected to mention that one of the surgeons quoted received more than $90,000 in payments from two manufacturers of joint replacement devices during 2016.
Many people receiving knee replacements (or knee arthroplasty) are elderly and with our aging population, it’s expected the numbers of these procedures will keep growing. Estimates on the number of knee replacements performed each year in the US vary, but are projected to reach 3.4 million by 2030.
Devices manufactured specifically for individuals to replicate their existing knee joint could potentially improve clinical outcomes but studies of this device are still needed to show its benefit.
There is no mention of cost for the device itself or for the implantation surgery. The news release says manufacture is rapid, but gives no indication as to the actual time it takes, nor are the device’s component materials mentioned, so no estimation of materials costs can be made.
The cost for 3D printed knee replacements are undoubtedly higher than traditional replacements.
The news release states that a personalized knee joint would fit better and therefore provide better results. However, there is no data supporting how much better the device fits, how closely existing knee replacement devices do fit, nor is there any mention of how patients lives improved after receiving the implants. Did they have less pain? Increased mobility? Some measurement is needed here.
The news release does not mention any potential harms from knee replacement surgery in general or for the 3-D printed knee replacement specifically. There are risks associated with new medical devices and the risks increase when the device has not been tested.
The release doesn’t include any evidence. There are testimonials from two surgeons who implanted the two devices and a statement by Jean Robichaud, president of Bodycad, who said “These recent procedures reinforce a growing body of evidence that demonstrates the benefit of personalized restorations.” But no reference is provided for that evidence.
There is no disease mongering. A percentage of the aging population and some athletes will require knee replacement surgery.
While no funding sources are mentioned, it is obvious from the news release that Bodycad is the funding source of their device. There is also an obvious conflict of interest because the company wants to sell their product and the company controls the U.S. patent. But this is expected from a news release from a company touting its own product.
At least one of the surgeons quoted in the release has received funding from manufacturers of joint replacement devices. Dr. Brain Hamlin received $$87,737 from Smith & Nephew in 2016 and $8,127 from Depuy Orthopaedics, also in 2016, according to Open Payments, a federal transparency program.
These conflicts should have been included in the release.
While the news release does compare the 3-D printed device to conventional devices suggesting that personalized devices are better, there are no data showing that this is the case.
The whole point of the news release is to say that Bodycad can make personalized knee replacements and it has implanted two of them and it worked. By mentioning that the devices were cleared for use in the U.S. and Europe the company makes it clear they are available. It’s unknown, though, how many surgeons have been trained in the use of the devices.
The news release doesn’t establish novelty. In fact, it implies that other companies are making personalized knee replacement devices, but that theirs is better. The news release states, “The efficient, rapid, and highly automated process is the only one of its kind in the world that is impeccably integrated between software and modern manufacturing such as 3D printing.”
Companies have been developing customized joint replacement devices for about 25 years. Last year, a company called ConforMIS released results from its prospective study of 62 patients that received either its customized knee replacement product or a conventional device.
The release’s use of the word “revolutionary” is unjustified because 1) customized knee replacement devices are not unique to this company and 2) the release provided no evidence of its benefits.