NCHR Testimony on Classification of Spinal Sphere Devices

My name is Dr. Anna Mazzucco, and I thank you for the opportunity to speak today on behalf of the National Research Center for Women and Families.   After completing my Ph.D. at Harvard Medical School, I conducted research at the National Institutes of Health.  Those are the perspectives I bring today.

Our nonprofit organization conducts research, analyzes data in the research literature, and then explains the evidence of risks and benefits to policymakers and consumers.  Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the resources that the FDA needs to do its job.  Our organization does not accept funding from medical device companies, and therefore I have no conflicts of interest.

Under consideration today is the classification of spinal sphere devices.  We support FDA in considering a Class III designation for these devices.  The FDA report details 21 adverse events.  These include some extremely serious complications, such as paralysis below the waist, difficulty walking, numbness and loss of sensation.  Other reports are of chronic pain, device subsidence or migration from its original site, and there were even reports of implants breaking during insertion.  These are significant injuries with potentially debilitating consequences.

As you know, the FDA’s voluntary reporting system captures just the tip of the iceberg for adverse events.  Patients and their families are often unaware that this reporting system even exists, and even when they know about it, people in chronic pain, and those caring for them, often do not fill out these reports.

Problems with these devices also resulted in 16 revision surgeries.  I’m sure we all agree that spinal surgery has significant risks, lengthy recovery times, and serious potential complications.  Patients who receive these implants rely on them to aid in the healing process, as stated in their indication for use, not to cause another surgery.  Furthermore, spinal spheres can be made from a metal alloy of cobalt-chromium-molybdenum.  Higher levels of cobalt and chromium have been found in the serum of patients who receive implants made from these materials.

Several studies have also linked use of cobalt and chromium in hip and knee implants to leukemia, kidney and prostate cancer.

Therefore, we strongly support FDA in its assessment that these significant safety concerns warrant a Class III designation, which is consistent with current regulation of these devices for non-fusion purposes.

Regulatory decisions are based on weighing the risks and benefits for patients and consumers.  As the FDA has stated, no evidence has been presented that demonstrates the effectiveness of spinal sphere devices specifically for fusion procedures, which is the indication for use being considered today.   Keeping this device at Class III and requiring that new devices go through the pre-market approval process will ensure that safety and effectiveness are demonstrated before these are sold for patients.  The PMA process also requires pre-market inspections, which will help make sure that these implants are manufactured correctly – and hopefully less likely to break during surgery, for example.

There is also controversy about the potential overtreatment with spinal fusion devices, raising questions of whether most patients benefit from these surgeries.  Holding these implants to the higher standards of the PMA will help to reassure patients that these devices are proven to be beneficial.  We hope you will agree with the FDA that these are high-risk, life-sustaining devices that need to be tested in clinical trials to be sure that they are safe and effective.