David vs Goliath, Round 2
A consumer version of FDA, you were WRONG! Tells how the FDA is Stifling Innovation
and Hurting Patients
Dr. Robert W. Christensen,
David vs Goliath, Round 2
Tells how the FDA is Stifling Innovation and Hurting Patients
Printed in the United States of America
All rights reserved. No part of this book may be reproduced,
In any form, without the expressed written permission of
TMJ Implants, Inc. P.O. Box 0443, Arvada, CO 80001
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Design and Photography by Michelle Pesce
“To Know Him and Make Him Known “
“ Dr. Christensen, this is Dr. Susan Runner, of the FDA’s Center for Devices and Radiologic Health, letting you know you need not come to next week’s Panel Hearing, because your PMA application for TMJ implants will not be approved. What are you going to do, Dr. Christensen?”
In writing this book I wanted to take the reader back to the biblical tale of a young shepherd boy who was called by God to do great fetes and to eventually be king of Israel and even be in the linage of Jesus Christ. At one point God himself says of David, that he is a man after God’s own heart (I Samuel 13:14).
But let’ take a moment to set the stage. Saul is king of Israel, but has come under the condemnation of God himself. God told the prophet Samuel to go to King Saul and tell him he has done foolishly and now God will raise up a man after his own heart to be the new king.
Saul had all of the capability to be a good king, but he relied on his own strength and his own direction instead of relying on a merciful God. In our strength we will fail, but if we combine our God-given talents to do what the Lord commands we will be victorious.
Saul went into battles with the enemy in his own strength and not always in Gods’ strength and command. Saul did a number of things which greatly displeased God. He had been told by the prophet Samuel, that he would be replaced by a king, but whom? It was when King Saul was being tormented and couldn’t sleep that the young shepherd boy, the son of Jesse, would be brought to the king to play music on a harp so the king might be able to get some sleep. Young David became the king’s armor bearer and a little time later when the Israelites were in a fierce battle with their sworn enemy, the Philistines, the situation came to a real head.
A 10-14 foot giant was in the army of the Philistines. His name was Goliath. The Philistines were heavily armored and appeared way superior to what weapons the Israel army had. Actually they were without spears, but when God has a plan, and some person is called by God to stand for a cause, with God’s help, he will win.
Goliath of Gath was well armored, with a helmet of brass, a coat of mail and greaves of brass upon his legs. He also had a spear which was like a weaver’s beam and the head weighed 600 shekels of iron. In other words he was fully armored. The children of Israel were losing the battle and the two armies were a distance apart scorning one another. It was at this very instance that God brought forth the young man whom He had anointed to be the next king of Israel and who had found favor in the tormented king Saul’s life., The appointment as king had not been revealed except unto David and Samuel.
David’s father called David from the fields where he was tending the flock of sheep and asked him to go to see how his brothers were faring in the battle with the Philistines and to bring them some loaves of bread and some cheeses. David was obedient and left for the battlefield at that moment. When he arrived, the older brothers scorned young David’s being present and voiced the sentiment that he should be home tending the herd. But, you see, God had a different plan. Goliath taunted the army of Israel and said to them, choose you a man who will come down and meet with me. Goliath went on to say, if he is able to beat me, then we will be your servants, but if I win, then you will be our servants. When Saul and his army heard these words they were sore afraid. David was the youngest of Jesse’s eight sons.
As David was talking with his brothers and some of other soldiers in Saul’s army, the giant Goliath arrived. David heard the giant speak out the threatening words so David asked, what would King Saul give to the man that would fight this Philistine? They let him know that the king would supply that person riches and give him the hand of the king’s daughter, and would make his father’s house free in Israel. Then David asked a very insightful question. Who is this uncircumcised Philistine that he should defy the armies of the living God?
David asked his brothers, Is there not a cause? When King Saul heard of the words of David he sent for him and David said, Let no man’s heart fail because of him; thy servant will go and fight with this Philistine. The king said to David, how can you go fight with this man of war. You are but a youth. But David recounted the time when he was feeding his father’s sheep and a lion and a bear attacked him. He went on to tell the King, that he slew the lion and the bear, and this uncircumcised Philistine shall be as one of them. Saul told David to go and take on this Goliath.
King Saul attempted to get David to take his heavy armor and sword and to go into battle, but then David said I cannot go in this armor because I have not proved it. So with his staff in his hand, he gathered 5 stones from the brook, put them in a shepherd’s bag, grabbed his sling shot and drew near to the giant.
When the Philistine giant looked up and saw David, he disdained him and thought, Who is this ruddy faced youth? and said to David, Am I a dog that you come against me with staves? And the Philistine cursed David by his gods. Then the Philistine giant said, I will give thy flesh to the fowls of the air and the beasts of the field.
Then David said to the Philistine, You come to me with a sword and with a spear and a shield; but I come to thee in the name of the Lord of hosts, the God of the armies of Israel, whom you have defied. David, then said, This day will the Lord deliver you into my hand; and I will smite thee, and take thine head from thee.
Because David knew his own God, and the fact that he was in covenant with God, he would be able to do what God had put in his heart to do. Also, another important point is the fact that God has shown David what He could accomplish when attacked by another enemy, the lion and the bear. This is the most important lesson for us to learn when having to fight an enemy that is larger than we are and appears to be better resourced or able. That did not stop David, because he knew the covenant he had with the Creator of the universe, and which David correctly proclaimed. “Who is this uncircumcised Philistine?” That was the statement and knowledge and proclamation which made this victory possible.
It was back in Abraham’s time when God told Abraham He was making a covenant with Abraham and all of his descendants. Basically, they would be His people, a chosen Nation, the apple of God’s eye. But God told Abraham, there is one thing you must do to confirm this covenant, and that is to circumcise the foreskins of all of your males, young and old. He also let Abraham and others know that if this wasn’t done to a given person, they would not be under the covenant. This was the “blood flow” that is needed to confirm a God type of covenant.
David well understood that very point and because of that he was able to say to the Philistine giant that you worship pagan gods and are not circumcised as a token of the God-Abraham covenant, so basically you have no power over the armies of the living God. Therefore, I am proclaiming, David said, that I will not only win against you, but will take off your head and actually parade it before the people of Israel. That’s of course what happened. One stone catapulted out of David’s sling penetrated the forehead of this massive giant, and killed him.
This is quite a story, but brings forth the character and boldness of a person who is being led to help make some changes in our culture and certainly in this case, in our FDA regulatory process for devices and drugs. It is a story of one man’s courage, like that of Erin Brockovich, was not afraid of being ridiculed for doing what he felt was right.
You might be asking, what is this book all about and why did Dr. Christensen call it by this name? A very fair question and by the time you have read this short book, I suspect you will see exactly why I chose that title.
I want you to remember this statement made to Dr. Bob in April-May of 1999.
“ Dr. Christensen, this is Dr. Susan Runner, of the FDA’s Center for Devices and Radiologic Health, and you need not come to next week’s Panel Hearing, because your PMA application for TMJ implants will not be approved. What are you going to do, Dr. Christensen?”
After being initially shocked, my courteous reply was, that I wanted a night to consider her request.
Folks. This is an attack muck like David was confronted with by the uncircumcised Philistine. This book will tell the story of much of my professional life as an oral and maxillofacial surgeon, and why I was put in this spot, and what I did about it. I believe many of you will find this story quite interesting as a middle aged surgeon takes on the FDA, and wins. It should give you much hope for the battles and struggles which you may have encountered thus far along life’s path, or which you will encounter as you attempt to walk out the path God has set you on.
My beginning starts in my birth at Montefiore Hospital in the Bronx, NY was on April 6, 1925. My mother, Eva Sutherland Hart, lived in Lawton, Oklahoma and was at this time attending Columbia University, Teachers College where she graduated and then married a New York City dentist named, Dr. Charles J. Brophy in about 1921.
Over the next 6 years, my parents had three children. My older brother, Charles, was born in August 1923 and my younger sister, Shirley, was born in in February of 1927. To Mother and Dad, this must have seemed like a dream come true, but then in August of 1927, Dad got acute septicemia from a boil on his face and promptly died, leaving mother with 3 small children and very little money.
Mother then moved to Oklahoma for a few months with the children, to be with her mother and her stepdad, and then on a few months later to be with her grandfather, Fred Sutherland. This was in the latter part of 1927 to the early months of 1928. In the Nation at that time there was much turmoil about to develop in the October 1929 Stock Market crash, which of course affected the election between Hoover and Roosevelt. It brought in the Great Depression.
For mother and her small family, being able to live in Granddad’s home was a real blessing, but then in 1931 my granddad had a ruptured appendix and he died, leaving Mom stranded again. So this story can get to the main portion, I will only mention a few key moments in our lives through the 1930s.
It was about the time of my Grandfather’s death that Mother had met a young man whom she later married, thus our names changed, as did hers, from Brophy to Christensen. It was in school at about the 3rd grade that I just got in my spirit that I should go into dentistry. I really believe God placed that thought in my mind so that He could lead me down the path I was eventually to take, and one in which my Father, Charles, and his brother Fred had taken.
The Depression years were certainly difficult for most of the families of America. It was certainly no different for the new Christensen family. My stepfather, Lee, was a hard worker and a self-made man. His earlier apprenticeship was with his uncle Louie in Green Bay, Wisconsin where he grew up, and was in the building construction area. He later, after moving to the San Diego region, decided to specialize in termite extermination phase of the construction industry, as there seemed to be an opening in that area, since new home construction was slow.
As I grew up, I too, was being mentored in all types of building and construction, along with my brother, Charles. Shirley, my younger sister was being taught all of the home economics tasks, as well as helping us construct a small building or whatever.
Being this was in the years of the depression, Dad-Lee, was attempting to spread out his areas of occupation to include the area of cattle ranching. Property prices were low so it was possible to buy 160 acres of prime mountain property in the back mountain regions of San Diego County (Julian) for often as low as a total price of $5000, with just a handshake and payment over a number of years.
Because of Lee’s entrepreneural spirit, it taught us many things too, but mainly how to fence pastures, build homes or barns and milk cows, brand cows, dehorn cows and cut calves.
During those same years we lived during the school year in San Diego, proper, but then in the summer months we would be on the ranch in Julian which had become some 500 acres and kept Chuck and me very busy tending some 50-60 head of whiteface, better known as Herefords. We attended schools in San Diego and all graduated from Hoover High School in San Diego, and Chuck and I received our letters in football.
WWII came along just as my brother was graduating from Hoover High School. I would graduate in February 1993. My sister, Shirley, would graduate about 18 months after me. Both Chuck and I would go into the Service to serve our country. Chuck went into the Army to service as an enlisted man in the European Theater whereas, I was more fortunate to be able to serve in the Navy and was able to get in the College program, first as an enlisted man and then later as a midshipman. I had a short stent as a Navy corpsman stationed at a Navy Hospital in Corona, California. In any case when the War ended both Chuck and I were discharged from active service. We both continued our education, me in dentistry and he in civil engineering.
My next few years was spent in graduating from dental school and then going through an oral surgery training program at the Los Angeles County General Hospital. After that, I was called back into active service in the U.S. Navy Reserve as an oral surgeon, during the Korean War. I was finally discharged from active service 2 years later. It was then when I was free to start my own private oral and maxillofacial surgery practice in Pasadena, California.
After leaving the Navy this second time, I had gained a good deal of practical experience as I headed the oral surgery department at the U.S. Marine Corps Recruit Depot in San Diego, where all incoming Marine recruits would go through their initial Boot Camp experience. It was my duty to be sure any of the 18,000 recruits who came through the program every 13 weeks, were fit from an oral surgical point of view for combat in Korea. It was a real challenge, but one I was happy to tackle and accomplish.
Now, starting my own surgery practice in Pasadena would open up all sorts of challenges and opportunities. First, I would now be involved in some more serious trauma surgeries and would at times be required to figure out some different, and at times novel, ways to accomplish some surgery.
In those years I applied to and was accepted on at least a half dozen hospital staffs in the Southern California area as a consulting or staff oral surgeon. This would allow me to perform surgery in these various hospitals and to receive calls to be on call for various trauma surgeries which might come through their Emergency Rooms. I would be meeting and at times performing surgeries with various other surgeons on the staffs and also of varying specialties. Sometimes on very complicated facial and skeletal reconstructive surgeries I would be teamed up with a general surgeon, orthopedic, or an ear, nose and throat surgeon.
All of this added to my experience and increased the respect that these surgeons and other medical professionals would have for my ability. I was during those years that I was given the opportunity to care for patients who might have a variety of facial deformities, tumors or traumatic problems. I enjoyed this more challenging aspect to an ever enlarging scope of practice in which my specialty was operating.
Sometimes there would be little consensus as to the best way to treat a certain surgical problem, thus for the innovative surgeon, there were many opportunities to bring forth either some variation of an older surgical technique, or occasionally a whole new approach to some surgical problem. It is this arena that my life was leading me and I guess I had no idea at that moment what a path the Lord was leading me on.
In those early years I found myself performing many surgeries of the “jaw joint” which is more properly called the temporomandibular joint. We have a joint on one side of the head just in front of the ear and another on the opposite side. It consists of a socket, somewhat like the hip joint, and a ball which is the most superior and posterior portion of the lower jaw known as the mandible. Between those two bony surfaces is a fibrous disc which is a separating medium between two bone surfaces.
A number of different things can happen to this temporomandibular joint that can offer the patient so involved, with some very serious and painful consequences. One of the entities I was being faced with had to do with trauma to the face where the lower jaw might be fractured, or frequently just the ball portion of the TM joint, either unilaterally or bilaterally. Back in my training at the Los Angeles County General Hospital, the usual treatment for that type of jaw fracture was to immobilize the lower jaw to the maxilla, or upper jaw by wiring the jaws together in occlusion, thus preventing any motion until the bone fracture(s) had time to heal.
Another entity or pathology we were beginning to see was some arthritic problem going on within the temporomandibular joint. In these years in which I had just started my private practice there was no excellent treatment for the malady. There was even less understanding about what was going on within the joint and certainly no agreement as to what should be done.
I began to develop the philosophy in regards to the treatment of the fractures of this bone(s), that what we call an open reduction should be done with some form of immobilization of the fragments. This was not the norm for the oral surgical practices, but certainly was a more accepted type of treatment in the orthopedic surgeon’s practice when other bones were involved.
In reference to the fractured neck of the condyle, or ball, of this joint, instead of allowing the fractured portions to just be floating in their incorrect positions, I preferred to do an open surgery, locate the fragments, re-align them in their more normal position and the fix the fragments in their correct position with a bone plate or some other mode of fixation. Certainly there was more surgical risk, but I felt the end result was more predictable and favorable.
When I started my private practice in Pasadena that opinion of mine was not the overall consensus. But because of treating so many of these fractures by an open reduction type of surgery, I got more comfortable and certainly more proficient in this type of surgery and this allowed me to begin to look at the other arthritic TMJs in a different way, and that becomes the genesis for this book.
Without getting necessarily into the intricacies of the various surgical techniques, let me just state there were no surgical treatment modalities, for the temporomandibular joint, which had a significant rate of success going out over 5 years post-surgically. There were few studies accomplished on any surgical treatments prior to 1960 which gave much confidence that they were successful over a long period. There certainly were little or no long term studies with any of these surgical techniques.
The techniques available were the following and many of them had been accomplished by the author:
The earlier surgeries which were available and which I was involved in fell into one or more of the following categories:
Many of these treatment modalities have persisted over all of these ensuing years, but most with very limited success or outright failure.
In the orthopedic realm there was a bit more hope for success. Let us now consider some of the options which were available in those years.
In my early years of practice as an oral and maxillofacial surgeon, I became very interested in surgery of the temporomandibular joint. That led to my seeking information from my orthopedic friends as to what they were doing to improve the joints which they would be operating. Early on I purchased a book by Dr. Otto Aufranc, titled Arthroplasty of the Hip which dealt with Dr. Smith-Peterson’s work with the mold arthroplasty of the hip. Dr. Smith-Peterson was a Norwegian orthopedic surgeon who was born in 1886 and died in 1953. His major pioneering effort was in the 1930-1940 period.
Dr. Otto Aufranc was Professor of Orthopedic Surgery at Massachusetts General Hospital and Harvard University School of Medicine. Dr. Smith-Peterson was the innovator of the hemi-arthroplasty implant for hip reconstructive surgery known as the mold arthroplasty of the hip. Dr. Smith-Peterson developed a hemispherical, acetabular-shaped implant to be placed within the hip joint in cases of early joint degeneration. He started with this project in 1925 by using glass as the material of choice for those first implants. He soon found those would fracture so went to a variety of materials until about 1938 when he learned of the Vitallium Cobalt-chrome metal, as a casting which he then used for these implants.
The original implants were placed in the freshened acetabular cup of the natural iliac bone. It was allowed to be unattached and thus was able to rotate or move as the head of the femur was taken through its normal rotation. This technique had a lot of success and some failures. This implant was state of art until the more radical total hip joint implant was developed.
Others came along like Dr. Marshall Urist who felt the hemispheric implant should be solidly fixed to the acetabular portion of the ilium, and thus had three small foot-like retaining spikes on the proximal surface which allowed for fixation of the implant to the iliac bone thus immobilizing the implant.
Dr. Urist became chairman of the Orthopedic Surgery Department at the UCLA Medical School in 1969 and later became an adjunct professor until the time of his death, in Los Angeles in 2001, at 86 years of age. He had been born in Chicago in 1914 and graduated in medicine at Johns-Hopkins University in 1941. He placed some of the earliest total joint implants in the United States and wrote several books and about 400 scientific articles on orthopedic surgery. He trained hundreds of surgeons and became most well -known for his research on the value of bone morphogenetic protein (BMP), in the restoration of normal bone within tissue and joints. His legacy, like those pioneers before him, is well established.
A Dr. Stephen S. Hudack, a New York orthopedic surgeon began experimenting with total hip replacement as early as 1939. It was at New York Orthopedic Hospital in 1948 that he began replacing the hip joint with the total hip replacement (THR) with some success.
The previously popular forms of hip surgery for degenerative disease were the interpositional arthroplasty, where skin, muscle or tendon tissues were placed within the joint to prevent the bone surfaces from contacting each other, and the excisional arthroplasty, where the surface of bone was removed allowing for scar tissue to resurface the bone in hopes of reducing the pain.
There certainly were other forms of arthroplasty developed over the years, such as:
Most of these earlier types of hip or knee arthroplasty have been replaced by either the total joint reconstructive surgery or in some cases a more minimal resurfacing type of implant reconstructive surgery, getting totally away from the use of autogenous materials.
Many of the earlier implants used for joint replacement of the hip and knee were passed through the FDA regulatory process as pre-amendment, grandfathered devices with little if any further testing. The written articles attesting to the effectiveness of the implants was considered sufficient for the approval of them by the FDA.
It is at this point, much of my story begins. As stated earlier, the need for a better solution to surgical improvement of the failing or missing temporomandibular joint was apparent to all who would look, yet many professionals didn’t look. They forgot to find out exactly what the pathology was in these joints and they were afraid to step out and be criticized by their colleagues and look for a better way. The pressure was too great for conformity, and for anyone who dared to take that step, the attacks would be great. Again, this was reminding me of the calling and the courage required by the young shepherd boy in Israel who dared to confront the giant of the Philistines. Now, let’s look at the next decade.
It was in these years that my experience in the practice of oral and maxillofacial surgery was such that I had weathered some earlier battles, seen much success and recognized the particular need of each patient.
To give you an idea of one battle I had fought earlier mostly against my specialty colleagues when I was taken to task for performing tracheostomies on a number of my trauma patients when such a technique was medically necessary and life -saving. You would have thought that was a no brainer, but when asked by St Luke hospital administrative staff, about the medical liability for oral and maxillofacial surgeons performing these procedures, the competitive, local oral surgeons who might wished to discredit me, raised all sorts of questions, thus forcing me to justify my ability, training and actions. I finally won the battle, but it certainly wasn’t a fun situations. Other battles over time developed about my developing or performing some major jaw corrective surgery, but like the earlier one mentioned, I always won the battle.
My surgical films on all of these type surgeries were not only well documenting the experience and ability I was fortunate to possess, but these films were shown at the American Dental Association’s Annual Conventions around the Nation and most were requested for the library at the U.S. Naval Medical Center in Bethesda, MD, and were used for teaching of their residents. I found myself presenting lectures on oral and maxillofacial surgery subject at about 10-15 annual meetings of the American Dental Association and had been placed on their surgical film review panel, which gave me the opportunity of reviewing many films on new and innovative procedures.
It was during the late 1950s that I began exploring new ways to implant metal teeth in the human jaw bone as a separate, or individual implant to replace the natural tooth which had been previously extracted. Over the next half dozen years I innovated some 3 different and novel methods of replacing a natural tooth. This pioneering effort was way ahead of its time and for which I received three distinct U.S. Patents for dental implants. These were the very first individual dental implants in the United states and possibly even the world.
Simultaneously, with my innovative effort to develop the first dental implant, another very interesting thing was occurring.
This next part of this chapter deals with my innovation of an implant to reconstruct the temporomandibular joint. It truly starts in the late 1950s and more specifically in 1960. As a successful oral and maxillofacial surgeon practicing alone in Pasadena California, I was being asked to treat many difficult and complex patient issues. For some of the problems, there had been no effective treatment and I was attempting to think out of the box to be helpful to those patients.
One area of surgical treatment in which there was no consensus and certainly no satisfactory treatment modality, had to do with the surgical TMJ problem. The problem could manifest itself in a host of ways from fractures of the joint all the way to agenesis or even tumors of the particular structures. But the most frequent was degenerative joint disease, just like we see in the hip and knee.
I had examined many patients, during my training at the Los Angeles County General Hospital, who had suffered trauma to the mandible and who then suffered fractures of the condylar neck, unilaterally or bilaterally. The usual treatment being recommended at that institution was the closed reduction with immobilization of the mandible, in occlusion, to allow the fractured condylar portions to heal in whatever position they found themselves in after the trauma As I started my own specialty practice, after the Korean War period, I began to see a pretty significant number of similar patients. I wasn’t comfortable with not attempting to do what we now call an open reduction and skeletal fixation of the fragments.
As time went on I found I had a great deal of success.
Was it a more risky procedure than the closed reduction? Yes, definitely. But I really did master that operation and in the next 8- 10 years I had probably operated some 75-100 such patients with measurable success.
With this background, it is easier to see why I began to operate on the degenerated TMJ, that didn’t have any fractures, but was deteriorating much like the degenerated hip or knee joint. The problem was there was no excellent surgical technique that gave any long term good results. We might do a disc removal procedure, but overtime that would cause more serious problems within the joint. Or, we might do what is called plication of the disc. In that instance, the displaced and somewhat degenerated disc was placed back over the condylar head, in hopes that it would stay in that position, and secondly that it wouldn’t repeat the dislocation or just plain wear out.
There were other procedures, and to be truthful the success rate was usually less than 30% in the first 5 years. Not a compelling reason for doing that procedure. Now came 1960 and Sister Lucille. Here was a young Catholic nun in her mid thirties, who has had a prior discectomy seven years earlier, followed by a high condylectomy some 3-4 years later. Her condyle is now anchored (ankylosed) to the skull base with almost no jaw function.
Now what, Lord? “Physician, do no harm.” And yet both of the procedures accomplished on this young sister were accomplished by a very knowledgeable surgeon, who happened to be an orthopedic surgeon in the Central Valley of California. Was he negligent? No. He was doing the only treatment considered effective at that period of time. But how could I help this young Sister have proper, pain free joint function?
This was the challenge I was faced with that winter day in 1960. Was I capable of improving the situation? I certainly had been recommended very highly by the surgeons at St. Luke Hospital as well as Huntington Memorial Hospital. But, would that be good enough? I certainly could operate on Sister L and get an immediate relief from pain and a greater amount of jaw function, but I could not guarantee that this good effect would last more than a few weeks to a few months. The problem which would occur after any surgery, normally accepted at that time by the medical community, would be that the bones would grow together and she would be worse off after another surgery than if we had performed no surgery at all. Only God could really make a difference. Either He would miraculously heal Sister L, or He would show me how to operate on her TMJ and make it well.
In 1960, as I was driving from Pasadena toward Santa Barbara, God placed an idea in my head which was so simple, so perfect and so just as easily condemned by the naysayers. He showed me that I could take the ten human skulls which I possessed and could fabricate a metal, S shaped implant to cover the bone at the base of the skull, which was the superior joint surface, and the one the degenerating condyle would normally attempt to attach to. Wow!
So, it was December 1960 when I began to work on my new project. It meant I would need to place all ten of my skulls on a laboratory table, unhinge the lower jaw (mandible) and make wax patterns to duplicate the base of the skull in the area of the TMJ. It would need to extend laterally over the rim of the zygomatic process and have 3-5 holes placed for the screws which would be required to hold the implant in place.
This was getting exciting, but could I pull it all together? If when I got the first wax patterns developed, what metal should I use to cast the final implants? What made me think that I could make any of the ten implants which I would fashion fit Sister Lucille’s skull base accurately enough? That was the biggest challenge. If, at surgery, I had her left TMJ fully exposed, and the new implant didn’t fit, what then? I would be no better than the earlier surgeon and she would have trusted me and we both failed.
Well it took me the next couple of months to fashion 15 implants for Sister’s left TMJ. I then had to do some corrective bone surgery to go with the implant, if I was going to give Sister a chance for proper jaw function. I decided to do all of this surgery on a skull, including the bone corrective surgery which would have the effect of lengthening that part of her left mandible and putting the articular portion back into the cup configuration of thebe required to hold the implant in place.
This was getting exciting, but could I pull it all together? If when I got the first wax patterns developed, what metal should I use to cast the final implants? What made me think that I could make any of the ten implants which I would fashion fit Sister Lucille’s skull base accurately enough? That was the biggest challenge. If, at surgery, I had her left TMJ fully exposed, and the new implant didn’t fit, what then? I would be no better that the earlier surgeon and she would have trusted me and we both failed.
Well it took me the next couple of months to fashion 15 implants for Sister’s left TMJ. I then had to do some corrective bone surgery to go with the implant, if I was going to give Sister a chance for proper jaw function. I decided to do all of this surgery on a skull, including the bone corrective surgery which would have the effect of lengthening that part of her left mandible and putting the articular portion back into the cup configuration of the new TMJ implant. It was all getting more complicated, but exciting.
Dr. Bob Christensen (circa 1960)
I decided with Sister’s permission, to make a surgical film of the entire surgery. I had fully explained the surgery to Sister Lucille and she and I explained it to the Mother Superior of her order of Dominican Sisters. We were now just three days before the surgery, when I made a costly mistake. There was an excellent general dentist, whose office was near mine, that I made the mistake of telling him about what I was contemplating. He taught at USC and of course had many colleagues there. It turns out they were having an office party that very evening, and my friend Dr. Ray Contino let his comrades know about what Dr. Christensen was doing the next Tuesday on a young Catholic nun named Sister Lucille. There was a couple there that probably was not too friendly with anything I might be doing. Thus, on Monday early afternoon, one of those darling doctors took it upon himself to phone the sister administrator of St Luke Hospital to ask “if they allowed experimental surgery to be done in their hospital?”
The custard hit the fan. Sister had been admitted in the hospital and was awaiting surgery at 7:30 AM on Tuesday. She was unaware of what had transpired over the weekend and on Monday noon. Now, sister administrator found herself in a pickle. After all, Dr. Christensen had been on staff for about 8 years, had taken his rotation as head of the OMS department of the surgical staff, and was very well respected for doing a great deal of excellent surgery, and sometimes on the sisters, at no charge of course, but even the Catholic priest at the hospital.
She had to call me and explain I would not be allowed to do that “experimental” surgery in St. Luke Hospital and especially on a Catholic nun. That last part added by me. Won’t the devil attempt to stop God’s plan at every turn? After all it was God who showed me how we might effectively treat this type of problem. And now what? Only God could have orchestrated the next words out of my mouth. I said calmly to Sister, “I would like to go before the Executive Committee.” It just happens that they were meeting that very night. Well, PTL. So they listened to me as I explained what I have just written, and long story short, they allowed me to operate Sister Lucille the next morning, and all went perfectly. The implant fit well and then it was secured with four screws. My assisting surgeon, Dr. Douglas Donath, and I accomplished the other bone corrective surgery and the patient was returned first to ICU then to her room on the surgery floor of St Luke’s Hospital of Pasadena, California where the first Christensen TMJ arthroplasty was accomplished this week in 1961. That was a momentous moment for future TMJ sufferers.
Over the next 15 years I had the opportunity of operating on hundreds of patients with a variety of TMJ problems. The surgery was proving to be more successful than I might have first imagined. I was on about 17 major hospital staffs in the greater Los Angeles area and in 1964 we put on a teaching symposium on TMJ arthroplasty at Hollywood Presbyterian Hospital where I performed a live surgery which was televised to about 200 surgeons from across America who were present for the symposium. That TV program on TV 13 in Los Angeles brought a lot of attention to the work that I was doing and was featured as a news story in a number of papers across America.
TV Channel13 in Los Angeles recorded the live surgery and it was shown a couple weeks later on a prime time, one hour program called, “Surgery 64”. It was seen by likely hundreds of thousands in the Southern California region. The patients continued to be referred to me from across the country and many of them had severely arthritic TMJs to where they had not had any jaw function or mobility for over 20 years. The successes were phenomenal and I give all of the glory to God. It was God who showed me very simply how to correct these problems.
There were always the naysayers somewhere in the crowd of professional people, but the successes were so spectacular anybody really reviewing them couldn’t help be impressed.
I started a company called Implants Inc. back in the 1960s but I was just too far ahead of the curve. The professionals just never caught on. The public was much more attuned to why this technique would work, but the profession was cautious. Another medical device company. Howmedica licensed and sold the implants which I had innovated in 1960
I was given a number of honorary positions:
Honorary member, Hollywood Academy of Medicine
President, Southern California Association of Oral Surgeons
Assistant Clinical Professor, Department of Head and Neck Surgery, Medical School, University of California, Irvine
Consulting Staff Member of St Josephs Hospital in North Hollywood, California
The TMJ Partial Joint Implant
Following the attacks which occurred from the moment of my operating on Sister Lucille’s temporomandibular joint over the following ten years, there were always those naysayers who would inform their colleagues and their patients that this hemi-arthroplasty surgical technique was harmful and was a failure and I was a charlatan. It was a very interesting time, but one in which I was resolved to help TMJ surgical patients and to bring forth the teaching of this useful technique. That was a bit of a balancing act, especially during those first four years when the Professor of Oral and Maxillofacial surgery at the local dental school and University hospital was doing all he could to prevent any patient from reaching me and going forth with the surgery to implant these devices. At one of his talks before a surgery meeting in Hawaii, he made the statement that I was the “laughing stock” of the nation. That was not only very hard to take, personally, but just as hard to overcome.
Because of those attacks, I wanted to be sure that I preserved in surgical film and in hospital records and in my office charts a meticulous account of what was being accomplished in placing these implants in many types of hurting patients. I frequently said that I would be the first to report if these implants were not all they should be, if and when I ever saw that they were not accomplishing the pain relief and effectiveness we were proposing.
I was amazed at how well these patients were doing, month after month and year after year I was seeing such a remarkably effective treatment coming forth. I was seeing no risk or harmful effect by my placing these devices. I was being very careful confirming by history, examination and by radiographic means, what type of joint problem each patient had and then to be sure I documented my rationale for treating surgically this patient in this manner.
I would select various different hospitals to operate these patients and I believe at the end of about 10-15 years, I had been the first to operate the patients with surgical temporomandibular joint disease, by this surgical technique, in some 17 different hospitals in the Southern California area. I was offered and became an Assistant Clinical Professor of Surgery, Head and Neck Surgery Department of the Medical School of the University of California, Irvine. This afforded me an opportunity of teaching this type of surgery to the 4th and 5th year surgery residents in that department over about a 7 year period.
So, all in all, the success rate of placing both the Partial TMJ implant as a hemi-arthroplasty, or the placement of the Total TMJ implants for total joint reconstruction were imminently successful. Another interesting factor that shows the success of these implants is that I, nor my company, TMJ Implants, Inc. ever lost a professional liability suit or action in any court, in the combined 60 years of his being involved in the field of TMJ reconstructive surgery. In today’s litigious society, it is a record to be proud of. (Reposition later)
(From Larry Pilot’s “Stifling Medical Device Innovation” Article)