September 8, 2020.
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
Today and tomorrow, the Medical Device Advisory Committee will discuss the proposed reclassification of five medical devices. In particular, you will be asked whether the risks are properly identified, and whether the proposed special controls adequately mitigate these risks.
As you know, there have been many concerns expressed in medical journals in recent years about the lack of solid, scientific data for medical devices, especially compared to prescription drugs. Our Center staff have spoken in support and in opposition, and we’ve published articles pointing out the lack of definitive information about safety or effectiveness that are available in PMA and 510(k) applications. Although PMA applications are supported by clinical trials, many fail to include sufficient numbers of people of color and people over 65 to draw conclusions about the benefits of those devices for those important populations.
This meeting is unusual for us, however, because of the lack of information made available to the public prior to this meeting. If the information available to the public is similar to what was made available to members of this committee, as is usually the case for Advisory Committee meetings, we are very concerned that the committee does not have sufficient data necessary to adequately evaluate the most appropriate classification for any of these devices. For example, the executive summaries provided by the FDA give little detail regarding the studies done on these devices. It is impossible to determine if the studies were well designed, implanted poorly, included sufficient numbers of patients, and/or adequately evaluated meaningful clinical endpoints or harms. And, there is no information about whether patients of color were included, patients over 65, or other vulnerable groups.
Although there have been recalls and MAUDE reports, details are often lacking about the latter. Even when details are available, as the FDA mentions in the executive summary of bone growth stimulator, the prevalence of a risk cannot be determined from the reporting system alone, since adverse events are under reported. So even when risks have been identified, the frequency of those adverse events is not established. In summary, the executive summaries do not provide adequate information for ensuring whether safety or effectiveness could be ensured without a PMA for any of these devices. If they are classified as class II, it is unlikely that better data will be forthcoming since our think tank’s published research has found that the 510(k) process almost never requires evidence of safety or effectiveness.1
Today and tomorrow, you are asked to discuss whether the identified risks may be properly mitigated by the proposed special controls. However, the information that FDA provided to the public, which is supposed to be the same information provided to you as committee members, does not describe how frequently the identified adverse events are likely to take place. We respectfully urge you to let the FDA know that Advisory Committee members need more informative scientific evidence of risks and benefits before deciding the classification of a device, and clinical trials are needed if the data are not sufficient to provide information about whether the benefits outweigh the risks.
Further, labeling has been proposed as a special control for many of these devices. For example, one of the proposed additions to labeling is a detailed summary of the clinical testing for the device, as well as the adverse events and complications that occurred with the device. That would provide useful information if the clinical testing is scientifically sound, but only if the label is carefully read. In many cases, patients never see the labeling on devices, especially ones used in surgery. Those that do, may or may not read or understand all the information included in the label, and even if they get a copy of the label, it is almost definitely after the device has been implanted or used in the patient’s body.
Labels should provide clear, unbiased information about the risks and benefits of a medical product, including all devices, but a written label is not sufficient to provide informed consent. The information that the physician provides to the patient will often be the only information that patients rely on, and this information is provided by device sales reps, not just by labels. That is not sufficient as a “special control.”
- Zuckerman D, Brown P, Das A. Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Internal Medicine. 2014 Nov 1;174(11):1781-7.
The devices under discussion for classification were bone growth stimulators, facet screw spinal device systems, intra-abdominal pressure monitoring devices, and intra-compartmental pressure monitors.