Letter: Neurosurgical Educational Societies Need to Be More Involved in Surgical Education and Certification for Sacroiliac Joint Surgery

To the Editor: Approximately 60 000 minimally invasive sacroiliac joint (SIJ) fusion surgeries have been performed in the United States over the past decade, with approximately 10 000 currently being performed annually.1 Neurosurgeons comprise a significant number of the surgeons preforming these surgeries. The primary cause for the dramatic increases in the numbers of SIJ fusions stems from one company in 2008 requesting a 510 (k) designation for their device to fuse the SIJ from the Federal Drug Administration (FDA). This company saw a need, created a device, and hoped that this FDA designation would provide for them the Blue Ocean financial win fall that startup companies dream about.2 They were not the only ones looking for the end of the rainbow because today more than 24 other companies, mostly startups, have jumped on board this 510 (k) SIJ fusion machine hoping for the same outcome.3,4 The sum result is that all these companies, each with their FDA 510 (k) device(s) averaging $10 000 per case according to my own extensive interactions with this industry, in order for a profit to be made need both patients and the surgeons to implant their device(s) into them. Suddenly, surgery on the SIJ has become one of the most hotly competitive markets in spine surgery. This has been a nightmare for the industry as both the patients and the surgeons have not been formally educated on the dysfunctional chronically painful SIJ or on surgery for it. All the treatments for this condition have long been handled by the pain doctors and chiropractors, both who understand the pain this joint can cause and their subsequent creation of the endless “revolving door” of temporarily successful injections and manipulations.5,6 With the surgery industry now desperately and urgently searching for patients and surgeons to offer a definitive treatment for this chronic pain and to sell their devices, the neurosurgeons have been aggressively solicited to help them out. And that they have. Historically, before 2008, you would be hard pressed to produce evidence of even one neurosurgeon diagnosing SIJ pain let alone operating on it. It is of interest that the orthopedic surgeons, who have dabbled as individuals in surgery for this joint for almost a century, as a collective group, have wanted nothing to do with the joint either until after that 2008 FDA 510 (k) designation.7,8 Formal education on the surgical treatment for the chronically painful dysfunctional SIJ is currently nonexistent in medical schools, surgical residency programs, spine fellowships, and all the major surgical education societies to include CNS, AANS, NASS, and the AAOS.1,8 Thus industry, who manufactures the devices used in their procedures, has become, by default, the primary educator for the surgeons, both orthopedic and neurosurgery, who are preforming today's SIJ fusion surgeries on these tens of thousands of patients. This should be alarming to patients, surgeons, and anyone involved in surgical patient care for the SIJ. This is not a benign situation because significant complications are occurring to thousands of patients having these fusions within this circumstantial American capitalistic health care format. These complications include death, paralysis, lasting morbidity, severe hemorrhage, with most of the severe cases requiring one or more reoperations. Over 1100 cases of severe injury secondary to SIJ fixation surgeries using the 510 (k) devices over a 10-year period have been reported on the government's Manufacturer and User Facility Device Experience data base.1,9 Over 50% of causes for patient injury were due to operator error with over 90% requiring reoperation. Follow-up was lost in well over 50% of cases. Unfortunately, because these devices are FDA 510 (k) designated, reporting is voluntary, so there is potential for significant under reporting, and there is no meaningful follow-up by anybody or any organization of true importance.10 Both neurosurgeons and orthopedic surgeons are responsible for all these complications. This situation raises some serious liability issues for surgeons, the SIJ fusion device industry, and surgeon educational societies. CNS was not part of the litigation, unlike NASS and the AAOS, in the early 1990s with the pedicle screw complications and the total lack of surgeon education at that time for their use in patients. It took class action legal steps from more than 3000 injured patients to finally bring the pedicle screw into focus for the national surgical teaching societies. Unfortunately, there are some similarities with what occurred then with pedicle screws and what is happening now with SIJ fusions and their associated 510 (k) devices. Now is the time that neurosurgical organizations such as CNS and all the others formally pull the painful, dysfunctional SIJ into their folds and properly educate neurosurgeons how to fully care for these patients from start to finish to include proper rehabilitation and follow-up. CNS has an obligation to its members to keep them up to date on what is a complete, up to date, surgical education and to give them the sanctioned certifications they need to protect themselves and their patients.