text_1: Bodycad Announces First Use of Its Unicompartmental Knee System in Patients
text_2: 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.