As new devices come onto the market, patients and other healthcare decision makers often lack adequate safety information to make the best healthcare decisions. The challenge of developing such information on individual devices is substantial. Sufficient data on adverse events such as device failure can take 5 or even 10 years to accumulate. Yet device manufacturers are under market pressure to revise devices before patents run out, roughly within the same time frame. This results in potentially faulty devices being used in joint replacement, placing patients at risk of serious physical and emotional trauma.
How often do faulty devices end up on the market and subsequent adverse events occur? The extent of this problem is difficult to quantify, given a lack of reliable data. A 2011 New York Times article highlights lags in safety information and problems with reporting. The “precise count of failed implants reported to the FDA is hard to come by because of the agency’s overlapping reporting system” (NYT, 8/22/2011, Hip Implant Complaints Surge, Even as the Dangers Are Studied). “Dr. William Maisel, the chief scientist of the FDA division that oversees medical devices, said he believed that producers would mount rigorous studies and find answers. But he acknowledged that it could take several years.” Some improvements have been made since 2011, but more progress is needed.
“I kind of want to know down the road … my hip is nine years old and I’m starting to have issues with it. What’s in the future? What point do people have to have revisions? What are the risks?”
Although the majority of joint replacement surgery is safe and successful and most implant devices are not recalled, our initial conversations with patients suggest that many are unaware of the risks associated with implantable devices. For easy reference distinguishing among devices for discussion, we classified them into four groups:
- Recalled devices—Devices that cause severe harm to patients and are ultimately recalled
- Potential problems—Other devices that show early evidence of trouble, but have not yet been recalled
- Newbies—New implant devices or existing devices with new components that are too new and unknown to have a safety record
- Safe devices—Devices that have sufficient history to prove safety after accumulating years of safe and effective use
Moreover, most patients are unaware of a potential solution that has been taken up by some (but not all) health systems: system-wide review and selection of implant devices. A system-wide review of the availability or absence of safety information regarding individual devices could result in improved, controlled selection of devices with a track record and limit selection of devices with little or no track record.
What can you do to make a change?
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, we are facilitating a series of one-hour webinars (conference calls) this month to address 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
Patients’ comments during our recent webinar discussions demonstrate their concern about device safety. One woman said, “I kind of want to know down the road … my hip is nine years old and I’m starting to have issues with it. What’s in the future? What point do people have to have revisions? What are the risks?” Patients say they are motivated to be involved as research partners in joint replacement to learn more about it themselves and to help prioritize research questions. “I have a question, too. How long will this new knee last me? Is it 5 years? Is it 10 years?”
Our available webinar sessions filled up quickly and registration is now closed. However, 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 still add yourself to the waiting list to participate in one of the webinar discussions scheduled for February 2016 by clicking here or by emailing Shilpa, our Research Associate, at [email protected] for more information.
We will be holding in-person roundtables in New York, Chicago and Boston during the coming year. If you live in or near one of those cities, we would like to invite you to hear from you. 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.