NCHR Testimony at 2016 FDA Meeting on the Classification of Urogynecologic Surgical Mesh Instrumentation and Automated, Blood Cell and Plasma Separators

FDA Advisory Committee Meeting on Reclassification of Urogynecologic Surgical Mesh Instrumentation and Classification of Separator, automated, blood cell and plasma, therapeutic

Thank you for the opportunity to speak today. My name is Dr. Laura Gottschalk. I received my Ph.D. from Johns Hopkins School of Medicine and am currently a senior fellow at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers, and policy makers. We do not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.

Our research center is very interested in the quality of medical care, and one of the first steps towards ensuring the safety of medical devices is correct classification. We agree with the FDA’s recommendation to reclassify the urogynecologic surgical mesh instrumentation from class I to class II. We previously supported the upclassification of this instrumentation in a public comment to the FDA in July 2014.

Currently, surgical mesh instrumentation is listed as a class I device. Class I devices are subject only to general controls.  They do not need to submit data to the FDA to ensure that the device is appropriately designed or manufactured.  As a result, medical device reports have cited injuries associated with the instrumentation such as organ perforation, blood loss, hemorrhaging, and numerous instances of the devices breaking and leaving fragments in patients. Clearly, class I controls are insufficient for properly regulating this type of device. Therefore, we strongly support the upclassification to class II with special controls. We specifically support the special controls suggested by the FDA, which are clear improvements to ensuring the safety and efficacy of the instrumentation.

We also agree with the FDA suggestion that “bench and/or cadaver testing can help ensure that surgical mesh instrumentation is appropriately designed and limits damage to blood vessels, nerves, connective tissue, and other structures.” Testing the accuracy of this instrumentation is especially important because the operation to insert surgical mesh is performed ‘‘blind.’’ Since the surgeon cannot directly see where he or she is placing the mesh, the precision of the instrument to correctly position the mesh is paramount. The suggested upclassification and special controls of the mesh instrumentation would be a step in the right direction for the safety of all patients who undergo this surgical procedure.

We would also like to voice our support for improving the regulation of the centrifuge-type therapeutic apheresis device, product LKN. As the executive summary describes, there have been a number of injuries, as well as some deaths, associated with the malfunction of centrifuge apheresis devices as listed in the MAUDE database. The classification of these devices should accurately reflect the danger that they could pose to patients due to malfunction or misuse.   In our view, since patients died when this device malfunctioned, it should be considered a Class III device.  If the FDA decides to instead designate it a class II device with special controls specific to the adverse events that are unique to centrifuge apheresis devices, the FDA needs to go the extra mile to make sure those controls are sufficient. We agree with the special controls suggested by the FDA to test the biocompatibility and performance as well as improve the labeling of the centrifuge devices. These special controls directly address problems that have been, or could possibly be, experienced while using the instruments. Additionally, the suggested control of clinical performance testing would provide the FDA with valuable information pertaining to the performance and adverse events of the devices in a clinical setting. This information would strengthen the FDA’s ability to properly regulate the devices in the future as well as provide better information to clinicians and patients on the operability of these life-saving devices.

In conclusion, there are a number of devices currently on the market that pose safety risks to the public because they were inappropriately designated Class I.  The upclassification of the surgical mesh instrumentation from class I to class II as well as the new classification of centrifuge apheresis devices as class II are both moves towards increasing patient safety. The special controls suggested by the FDA should be carefully evaluated to determine if they are adequate to protect patients from undue harm.