The The Business of Fusing the Sacroiliac Joint and the danger it poses to patients

In 2007 there were no companies promoting surgery for chronic pain from the sacroiliac joint (SIJ), in 2008 there was one, and as 2019 gets going there are 24.  It would seem to the casual reader that this must be a new area of study in surgical medicine, but that couldn’t be farther from the truth.  The first scientific study discussing successful surgeries for chronic pain from this joint appeared almost a century ago in what was then and still is today a very prestigious international surgical journal.  Since that time hundreds of articles on this subject have been accepted and published in dozens of respected journals worldwide.  In actuality though little has changed in the basics of this surgical procedure over the past 50 years with the current surgeries mimicking a procedure that pre-dated the creation of the Federal Drug Administration (FDA) in 1976.  Through the years Industry showed no great desire to be involved with the fusing of this joint, as no definitive standards were in place from the medical community to make this happen.  It was in the year 2008 that all that changed with now an industrial frenzy to be part of the sacroiliac joint fusion surgery paradigm change.   What exactly has changed?

 

Before this “gold rush” mentality currently underway, several dedicated orthopedic spine surgeons, each working independently, had been creating novel ways to surgically treat those people suffering with chronic unrelenting sacroiliac joint pain that was unresponsive to seemingly endless bouts of conservative treatments.  They were using methods that approached the joint from primarily posterior directions as the attempts using straight lateral approaches, invented by orthopedic trauma surgeons prior to 1976 using two screws to put the joint back together after being violently torn apart, had failed miserably to achieve success in relieving the resulting chronic pain from these traumatized joints.  These few surgeons working on new and exciting procedures to create real fusions and pain relief were accompanied by an equal number of industrial companies assisting in developing their procedures.  Although these surgeries were proving to be very successful and good results were being published, there was a major roadblock to contend with before further development could be possible.  This formidable obstruction was the Federal Drug Administration (FDA). In order for a new device or instrumentation system using any of these novel and most often posterior approaches to be approved by the FDA it had to go through a “pre-market approval” process. This meant these Industries had to invest a minimum of 70 million dollars to make this happen.  So, what was it that was holding them back as there was definitely the need, and the surgeons they were working with were having significant success with the patients they were treating?

 

The primary reason Industry did not want to move forward on this was because the medical educational system in America was not jumping on board.  In fact, not only were they not getting involved in this chronic sacroiliac joint pain problem, they were going out of their way to avoid it.  Why would Industry want to spend millions to enter a surgical treatment program that is not being taught in medical schools, in orthopedic and neurosurgical residency programs, or in spinal surgery fellowships. There also were and still are no questions concerning surgery for chronic pain from the sacroiliac joint and their associated complications on board examinations for orthopedic surgeons or neurosurgeons.  The absence of education and oversight by America’s prestigious surgical educational societies and examination boards, despite existing knowledge about chronic and disabling pain from this joint and thousands of successful surgeries for it, makes one think there is more to this than meets the eye.  The truth is that the current financial stimulus for all decisions about what is being taught to surgeons revolves around what is currently most profitable for both Industry and the mega educational surgical teaching societies.  Since surgery for the lumbar spine is now a multibillion, if not trillion, dollar industry, and Industry now as a result of this owns the very souls of the surgeons both running the teaching societies and being responsible for the educational content, why add a small fry like the sacroiliac joint to muck everything up.  Since this type of fusion surgery is still only a multimillion-dollar industry, such a move might decrease the lucrative flow of spine money by sharing it with the less lucrative sacroiliac joint surgeries. With this model in place it would seem that further progress on surgical fusion for the sacroiliac joint should be all locked up and not able to move forward.

 

Why then are 24 companies now furiously jumping into the arena of fusing this joint?  There are several reasons.  In 2008 an entrepreneurial orthopedic surgeon with a device originally developed for ankle surgery applied for and received a 510 (k) designation from the FDA to use his device for lateral minimally invasive sacroiliac surgery for arthritis.  He was able to do this by convincing the FDA that by inserting his devices (triangular rods) across the sacroiliac joint to stabilize it, he was simply mimicking the age-old trauma surgery method of putting screws across the joint to stabilize it after it had been pulled apart.  A few years later his sacroiliac joint fusion company became a multimillion-dollar enterprise.  For him the beauty of this designation meant not spending millions on clinical trials and having to prove safety for the patients having these procedures, because it presumes that similar devices were in use prior to the creation of the FDA in 1976.  These predicates as they are called were, according to the FDA logic, already tested by years of use.  The truth is that these trauma screws worked very well to accomplish joint stability, but they did not work well for removing or relieving chronic sacroiliac joint pain or fusing this joint together.  Due to the millions of dollars put forth by this new sacroiliac joint fusion company to promote its device a few very noteworthy effects occurred.  The first was that more and more surgeons and patients became aware of pain from the sacroiliac joint and its severe and disabling consequences, and secondly other companies, primarily startup companies, wanted to get in on the action.  With all these new companies now pushing their devices (averaging $10,000 apiece) Becker’s Spine Review a year ago estimated that by 2020, now just months away, 50,000 of these surgeries will be performed annually in the United States. If you multiply that number by 10,000 you can appreciate why Industry is now wanting to be involved.

 

This all seems like the perfect American business model and a sure method for success.  It is, for Industry, but, other than creating much needed awareness and achieving at least a 75% success rate in relieving disabling pain, it is not so subtly negatively affecting a significant number of patients themselves. For these patients a significant part of the formula for their success is not only missing but purposely being kept out of the picture.

 

Let’s consider some sobering facts about what the individual patient faces who has sacroiliac joint pain that has been refractory to conservative treatment.  The first choice they have is to stay in the continuous “revolving-door” of manipulation, injections, and exercise that, for some, could last a life-time.  If they look instead for a surgical solution their first obstacle is where to look.  Those clinicians providing their conservative care have no clue who to refer them to as surgeons aren’t being taught about this and aren’t soliciting these kinds of patients like they do for torn ACLs, shoulder impingement syndromes or verified herniated lumbar discs.  Having had no formal training for this condition surgeons are really the most unqualified professionals to be seeing a patient with chronic disabling refractive sacroiliac joint pain.  They have not been formally taught to diagnose it, to treat this condition conservatively, to properly select the right patient for surgery, what surgery to perform on a patient with unique pathology or anatomical challenges, how to diagnose and treat complications from these surgeries, or how to properly rehabilitate someone having had a sacroiliac joint fusion surgery.  In an environment where tens of thousands of these surgeries are performed annually with published complication rates between 1-17% for the most commonly utilized procedure, which includes severe hemorrhage, paralysis, and morbidities, this is not only concerning but frightening.  What is more frightening is that the surgeons and the Industry are not being held accountable by any institutional or federal organizations for poor results or complications.

 

Who then is teaching all the surgeons performing these thousands of sacroiliac joint fusions each year?  The quick answer is Industry.  It’s not the North American Spine Society (NASS).  It’s not the American Association of Orthopedic Surgeons (AAOS). It’s not any of the neurosurgical societies.  It’s no one but Industry.  It’s true that surgeons are teaching other surgeons, however those teaching surgeons were taught by the Industrial company manufacturing the device that’s being inserted. Many of the teaching surgeons have a financial stake in the device they are both encouraging other surgeons to use and teaching them how to put in.  It is a very one-sided situation that favors the company or the entrepreneurial surgeons over what is best for the patient.  What is not being taught is how to deal with the complications that do occur and alternative methods or techniques to salvage a procedure gone wrong. Adding to the precarious situation patients are in is that, when complications occur, no one of authority is watching and looking out for the patient’s best interest.

 

I have been running a blog for the past year that advocates for those people with chronic unrelenting sacroiliac joint pain (sijointpaingone.com), and the stories I have received from such people all over the world (England, Wales, Australia, New Zealand, Taiwan, South Africa, all over the United States, and many others) relate the struggles and frustrations they are experiencing due to the lack of dissemination of a century of published information about the sacroiliac joint, the severe disabling pain it can cause, and their inability to find surgeons who understand this joint and can reliably perform at least one of the many techniques that exist to fuse this joint.  Now that I am retired I have been steering all those patients to the few surgeons that do understand this problem and are trying to do something about it.

 

What I do not want to do here is to suggest that the Industry behind all this is evil. Industry is just doing what it is designed to do, create things and make money.  It is those surgeons within the medical system itself from entrepreneurs to those responsible for creating the educational models for other surgeons who are responsible.  My personal belief is that this “lock down” on pushing the sacroiliac joint forward revolves around greed with little concern for the people out there suffering with unrelenting chronic sacroiliac joint pain as well as those having complications from or failures of these surgeries.

 

There are several ways to begin fixing this very broken system.  Repairing all faults in the system starts with those in positions of power and resources to admit that a problem exists.  Right now, many of these individuals are treating surgery on the painful sacroiliac joint like those who are benefiting from not wanting to address climate change.  These highly educated and powerful surgeons have the authority to educate surgeons to:

  1. Learn how to diagnose a painful sacroiliac joint.
  2. recognize the various anatomic anomalies possible surrounding this joint.
  3. know the methods of conservative therapy for this condition.
  4. Understand how to select the right patient for a specific sacroiliac joint approach and procedure.
  5. Differentiate between the different kinds of approaches and surgeries available for patients and when to use a specific procedure.
  6. Learn how to identify and treat the complications that do occur from these surgeries.
  7. consider various salvage procedures that can be performed if any one fails.
  8. Understand how to go about rehabilitating any sacroiliac joint fusion patient despite the type of surgery they had performed.
  9. Contribute to the knowledge base for surgery on this joint.

 

This education is currently not publicly available except in one textbook and hundreds of journal publications.  Otherwise it remains in the minds of a few hundred surgeons who have taken the time to read that which is available and self-learn what has worked and what hasn’t by listening to and compiling data from their own patients.  Before all this can be taught to surgeons in an organized way, it must be assimilated into a core teaching model independent from Industry and entrepreneurial surgeons.  Disseminating these educational principles alone will not solve all the problems in our system without also contributing to our scant knowledge base with vigorous research efforts that expand our understanding of surgery for the chronically painful sacroiliac joint.  Also, surgeons need to be held accountable for the known complications that occur with these tens of thousands of surgeries they currently perform through board examinations and proper hospital accreditation measures.

 

Unless these changes come from the top down, they will come from the bottom up.  Surgery for the sacroiliac joint is much like the introduction of the pedicle screw for spine surgery in the early 1990s.  At first those at the top ignored it, or profited by it, until the lack of accountability became a hugh problem for thousands of patients.  We do have a mechanism in our democratic capitalistic system that will look out for the individual patient when all other responsible parties do not.  Let’s hope that those in charge at the top get involved before the lawyers understand what is happening.

 

Bruce E Dall, MD

sijointpaingone.com

January 2019

 

Leave a Reply: