Recent safety problems with artificial knees and hips highlight the need for more patient involvement in research
Over the past few years, well-publicized implant device recalls underscore the importance of this issue. Zimmer recalled components of its NexGen® Complete Knee Solution and other products in 2010 and 2012. In the 2010 DePuy hip replacement recall, Johnson & Johnson recalled its Articular Surface Replacement (A.S.R.) device at a cost of billions to the company and substantial pain and suffering by patients. A New York Times story about the DePuy case highlights risks faced by patients and stakeholders:
Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients.
That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the A.S.R., that process unfolded with devastating results.
“You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic. (NYT, 12/16/2010, The Implants Loophole)
What can you do?
The device selection process was identified by CreakyJoints and our partners as an area that is under-studied. Patients are interested in the selection of devices, but they must be further involved before research is conducted. To that end, you are encouraged to sign up for a one-hour webinar (conference call) to be held in February that covers the following topics:
- Patient Experience—Discussion of patient experience and knowledge regarding joint replacement implant devices (artificial knees and hips)
- Research Involvement—Discussion of how patients can be involved in all phases of research
If you are age 18 or older, live in the U.S. and have had or are thinking about having knee or hip joint replacement surgery, you may be interested in our upcoming webinar discussions scheduled for February 2016. You can register here or email Shilpa, our new Research Associate, at [email protected] for more information.
You can participate at home by phone, computer or both. Participating in this patient-led project can lead to changes in the way care is delivered. For example, through your involvement, you may contribute to improvements in the safety of joint replacement and implant devices. Or you may help initiate improvements in the way your individual care is delivered, like making joint replacement follow-up at home possible.
This project is funded through a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award (2228-GHLF).
Looking for more ways to get involved in research? Check out www.ArthritisPower.org.
Dr. Thomas Concannon is Senior Policy Researcher at the RAND Corporation, Assistant Professor of Medicine at Tufts University School of Medicine and Associate Director of Comparative Effectiveness Research (CER) Programs at the Tufts Clinical and Translational Science Institute. His research is focused on patient care in emergency, acute and post-acute settings using administrative claims, survey, and other types of data. Dr. Concannon has been active for over 20 years in efforts to engage patients, consumers, communities, and other stakeholders in healthcare research.