Charite artifical disc, SB Charite artificial disc surgery

Two years ago I faced death imposed on me by Johnson & Johnson's corporate greed My SB Charite artificial spinal disc experience. You are not gonna believe this happens in America. The Charite Artificial Disc Clinical Trial and subsequent Charite disc implants are a tragedy for so many patients. 1. Due to degenerative disc disease I had no spinal disc at L4/L5. In 2001, based on Johnson & Johnson’s representations of the SB Charite artificial disc’s 20-year history of safety and efficacy throughout the world, I was convinced to enter a clinical trial to bring this metal and plastic spinal disc to the United States. I was told that all complications from the disc have been recognized and mitigated throughout its successful global history. 2. My Charite disc had a catastrophic failure and migrated anteriorly out of my spine - smashing my Vena Cava, Illiac Artery, Renal Artery, and my entire Lumbar Plexus nervous system. The disabilities I am left with have profoundly changed my life. 3. My research has uncovered that J&J and the manufacturer of the SB Charite noticed the discs migrating out of European patients since 1987 leading to catastrophic failure. By 1997/98, 100% of the discs coming off the assembly line were being coated with a porous coating that bonds the metal endplates to vertebral bone and prevents migration, 100% of the time, 100% effective. According to published studies by J&J’s lead surgical investigator, Dr. Paul McAfee, there has never been a reported case of a coated disc that migrated out. 4. Yet, in 2001, 3 years after they were coating all the discs worldwide, the U.S. clinical trial started using an old-generation uncoated disc design, even though J&J knew these old uncoated discs were prone to a higher rate of migration, higher devastating disabilities and higher mortality rate. 5. Seems odd – doesn’t it? How could Johnson & Johnson, their doctors and surgeons do this to patients? Why would they not be criminally liable for hiding knowledge that could have protected patients’ lives and why would they use an old generation of the device that they knew was prone to a higher risk of device failure? Corporate greed. A clever scheme to manipulate the FDA and the Fast Track approval process to gain a competitive edge over two other manufacturers. J&J engaged in this appalling behavior to beat their competition to market in the United States. 6. During its review of the SB Charite Disc clinical trial, the FDA asked J&J: "If you have been using coated discs throughout the world and are planning to use coated discs in the United States, why did you use uncoated discs in these U.S. patients?". THe question went unanswered. In fact, immediately after the two year clinical trial, Johnson & Johnson switched the SB Charite disc device specifications on file with the FDA to coated discs. Even though J&J always knew that the coated discs were safer, they never mentioned any such thing to me or any other patients. I had never heard of this debate. J&J knew that patients would never enter a clinical trial if they were told that the disc they were going to receive was an old generation device design that was prone to a higher risk of catastrophic failure and they had corrected the problem with a newer version of the disc that was only available outside the U.S. They implanted an uncoated disc in my spine years after they had recognized and corrected the problem. Mine migrated out anteriorly. A catastrophic failure. It never should have happened. More on J&J's criminally negligent behavior that almost killed me... I started researching how and why my disc slipped out; an event that changed my life forever. The gross negligence that I uncovered as I spoke to Dr. Paul McAfee - J&J’s lead investigative surgeon for this Charite disc - is startling! Upon looking at my X-rays during my emergency visit to Dr. McAfee to try to save my own life, he and his team actually told me and my mom “Oh, you must have gotten one of the uncoated discs. The coated discs don’t migrate out.” Startled, I asked what they were talking about. They went on to tell me that the disc migration problem had been solved by using a coating on all the discs worldwide (outside the U.S.) years before mine was implanted. Dr. McAfee even went on to tell me that before they ever inserted the first disc into a patient in the U.S. clinical trial, he was fighting with J&J to use the coated discs to help protect the patients lives. “Ultimately, the decision was made to start the U.S. clinical trial with uncoated discs.” My SB Charite artificial disc migrated out anteriorly. The damage done to my nervous system, lumbar plexus nerves, Vena Cave, Illiac and Renal arteries, makes each day of my life very difficult to manage. The original inventors/manufacturers of the SB Charite disc introduced the device throughout the world (Europe and Asia) in 1987. The disc was sold to me based on the "20 year history" of this device throughout the world with the understanding that the device is well established, studied, and that any device failures have been overcome and all risks have been mitigated. Indeed they had. It seems that in the early 1990's, the manufacturer noticed a high rate of catastrophic failure by device migration as a mode of failure. To correct the problem, they started coating the discs with a "porous ingrowth coating" to promote bonding of the metal to bone interface of the device. This proved so successful, that by 1998 the manufacturer started coating 100% of the discs throughout the world with this coating to stop migrations. As a matter of fact, the original manufacturer went so far as to tradename the proprietary coating process in 1997. There has never been a documented case of a device migration of a coated disc. It is 100% effective. My disc was put in me in 2001. They used an old-generation uncoated disc. Even though device migration was halted throughout the world by coating the discs, and there was a 3 year track history for this, J&J started the U.S. clinical trial with uncoated discs. They never told me this critical information. This was withheld from me. How could this happen you ask? How/why would a big pharma company withhold information that they know can protect patients lives? I have received a number of answers. None of them acceptable. The prevailing answer was given to me by the lead investigative surgeon for J&J who oversaw the 14 clinical trial study sites - Dr. Paul McAfee: "I had been fighting with J&J since before we ever put the first disc in a U.S. patient to use coated discs. Ultimately, the decision was made that the majority of the data from Europe was garnered from uncoated discs, and we wanted the U.S. data set to be statistically comparable to the majority of the European data." The truth is that J&J used the fast-track FDA approval process to start the US trial with uncoated discs in humans, while they ran a simultaneous baboon study for 18 months to prove the biocompatibility of the coated discs. So, rather than delay the human studies for 18 months and start the study with coated discs, which they knew could help protect lives, they went ahead and manipulated the FDA by using the fast-track approval process which allowed them to do the simultaneous primate study rather than waiting for the results of the primate survey. They used the FDA fast-track approval process, not in the spirit of fast-track, but instead purely for corporate greed designed to beat two competing artificial disc manufacturers to U.S. market entry (Spine Solutions and Medtronic). This move was worth hundreds of millions of dollars to J&J, even though it put clinical trial patients at undue harm. In my estimation, gross negligence. More research I have done has uncovered that this is standard operating procedure for Big Pharma. Tthe FDA has put the corporate greed of this powerful lobby above patient welfare. Many Big Pharma companies, introducing devices and drugs to the U.S. have found they can manipulate the FDA and its fast-track process to get products to market in a shorter period of time. This is hugely beneficial both in terms of a competitive advantage as well as for the extra hundreds of millions of dollars of extra profits that Big Pharma can accumulate simply by getting a product to market fast. BIG PHARMA PUTS CORPORATE GREED ABOVE PATIENT WELFARE – Three Big Pharma companies are competing to be first to market in the U.S. with their medical device – one has the opportunity to manipulate the FDA approval process to beat their competitors to market, but it means holding back critical medical observational information and using an old-generation device design - putting the lives of the patients and a higher risk of catastrophic device failure – the cost of getting a new medical device to market: if they kill, disable a few patients but can beat their competitors to market and gross hundreds of millions of dollars? well that’s a no-brainer isn’t it? – just figure that into the cost of getting a device to market expenses………. I was patient #19 for the Charite disc in the United States clinical trial. I had that catastrophic failure. My God has quite a sense of humor – Mr. Funny ha-ha! As if implanting an uncoated disc in me were not enough, when mine migrated out and I was facing “imminent death” that required immediate emergency surgical intervention, J&J left me to die and told me they could not provide me any referral or suggestions on what to do. For real – when I had my first Xray showing that the disc was migrating out and my life was in danger, I frantically started calling J&J’s clinical trial hotline for what I should do. You see, I could not find a surgeon with the experience revising a catastrophic failure of this experimental device. After hours and hours on the phone with many many people throughout J&J, I finally got a final phone call from the head of J&J’s “business affairs” who told me that they would not be able to help me since the two year clinical trial was over. They left me to die. Can this happen in America? After exhausting research, I found that there are only 4 surgeons in the world (one in the Netherlands, one in Paris, one in Texas, one in Maryland – I managed to reach them all), that had ever attempted to do this kind of revision surgery. I was standing on death’s door………. On a personal note…. The days surrounding my Charite Disc catastrophic failure are insane. What do you do when you have only days to live? You have to get on a plane in 48-hours to prepare for emergency surgery? Using your last 48-hours, how do you prepare your home, friends and family to go on without regret and with minimal pain after your death? How do you reassure them that you are prepared and OK to die? That your life was perfect just how it was? How do you say goodbye to your loved ones when your surgeon informs you that you only have a 20% chance of surviving the surgery you are about to undergo… That your death is imminent without the surgery, so you have to at least try. As the only child of a single mom, how do you look in your mother’s eyes? How do you say goodbye? What words do you use to say goodbye from your hospital gurney before they sweep you into surgery? How do you deal with the nightmares of her sitting alone in the hospital waiting room while you are in O.R.? The single mom that wanted more than anything at that moment to give her life for you – to change places with you…. How? Her only son is more likely to die over the next few hours than not, and she sits in horror and shock in the waiting room alone. What happened to me is really a big deal. How do you deal with the anger and emotions when you find out that this never should have happened; when you learn that for years every one of these devices being put in patients worldwide outside of the U.S. were a newer, safer design than the old design that the company put in you. How did I get through this? How did I navigate to save my life? What lessons did I learn? And, how do I live everyday now? Overcoming an event like this and going forward with the Hope of a new and better tomorrow can be hard. Read my Thank You note to all those who prayed and supported me and my mom through this. I will write a book about it if it will help even one other person to overcome obstacles. Manipulating the FDA fast-track approval process, putting corporate greed above patient welfare is standard-operating procedure for Big Pharma. Big Pharma, today, is still getting away with this, killing and maiming unsuspecting patients everyday. It may happen to someone you love. And the FDA lacks oversight and regulation. This is march on Washington time! This is lobby your Congressmen time! This is Congressional Investigation time for both the FDA and Big Pharma! There are so many things that J&J did, and continue to do, as they compete for U.S. market entry and victimize patients. After months of research, there are even more things that I have uncovered that J&J did to their Charite disc patients. Here is a partial list of J&J’s negligence and criminal behavior that continues to effect so many patients CLICK HERE.	(Front and Back incisions) For details of J&J's reckless negligence as they continue to risk patients lives as they have brought the SB Charite Disc to market in the US. How Big Pharma manipulates the complacent FDA (the FDA provides no regulation or oversight of Big Pharma during the Bush administration) CLICK HERE Here is what other Charite victims go through trying to get through each day...CLICK HERE (above) This is when the nightmare started. Notice the uncoated SB Charite artificial disc slipping out of the front of my spine Here is one of my lived nightmares.... When I was rushed in for emergency surgery, the surgeon's attempted to diagnose the extent of the damage being caused by the migrated disc by performing a diagnostic Venogram. As I lay on the cold metal operating table in the O.R. the day before the surgery, I soon felt myself laying in a massive pool of warm liquid, growing deeper by the minute, with a surgeon clearly concerned and getting more and more frantic as the minutes ticked by. (I was awake for the procedure). I started to splash the liquid with my hand and looked up at the surgeon, "is this what I think it is? my blood?". He was a little preoccupied and nodded. Later I found out why... Surgeon's Report. Diagnostic Venogram: Preoperative diagnosis: Status post L4/L5 disk replacement...which is migrating forward and might be even crushing on the vessels. Report: Using Seldinger technique, the right common femoral vein was canalized and 6-French sheath was inserted. To note, it was concerning to me that the left renal vein had a very huge clot that was going south towards L4/L5... I could not reflux in to the left common iliac vein. Now attempted using Seldinger to get the left common femoral vein off 10-20 times I could not get the vein... After multiple attempts to get the common femoral vein on the left without success, at this point I decided to go ahead and proceed with doing an up-and-over sheath to see if I could hook the left common iliac vein from the right. Now, using a RIM and hook catheter, I attempted to do left common iliac selection without any success. At this point, I felt there were only two options, either the patient was completely occluded, and that is why there is no reflux from the vena cava from previous clot and that would explain the collateralization here, which I saw from the left renal vein going down toward L4/L5, or the patient has a double Vena Cava. (which I do not) ...................................... Following all the diagnostics, I had a double (anterior and posterior) surgical approach 360-degree spinal fusion at L4/L5 after they successfully removed my SB Charite disc. (above) This is my spine today. Notice my IVC filter umbrella that I maintain to prevent me from stroking out from blood clots in the future. .......................... Comment: as appauling as is what Johnson & Johnson and LINK Spine (the original manufacturer of the SB Charite) did by implanting an uncoated disc in me; I thank God everyday for the brilliant life-saving skills of Dr. Sam Saiedy (VAscular Surgeon) and Dr. Paul McAfee (Spine Surgeon). These are two of the most talented surgeons in their practice in the world and I owe my life to them. Thank you to the teams of doctors who saved my life - Darren

Two years ago I faced death imposed on me by Johnson & Johnson's corporate greed

My SB Charite artificial spinal disc experience. You are not gonna believe this happens in America. The Charite Artificial Disc Clinical Trial and subsequent Charite disc implants are a tragedy for so many patients.

1. Due to degenerative disc disease I had no spinal disc at L4/L5. In 2001, based on Johnson & Johnson’s representations of the SB Charite artificial disc’s 20-year history of safety and efficacy throughout the world, I was convinced to enter a clinical trial to bring this metal and plastic spinal disc to the United States. I was told that all complications from the disc have been recognized and mitigated throughout its successful global history.
2. My Charite disc had a catastrophic failure and migrated anteriorly out of my spine - smashing my Vena Cava, Illiac Artery, Renal Artery, and my entire Lumbar Plexus nervous system. The disabilities I am left with have profoundly changed my life.
3. My research has uncovered that J&J and the manufacturer of the SB Charite noticed the discs migrating out of European patients since 1987 leading to catastrophic failure. By 1997/98, 100% of the discs coming off the assembly line were being coated with a porous coating that bonds the metal endplates to vertebral bone and prevents migration, 100% of the time, 100% effective. According to published studies by J&J’s lead surgical investigator, Dr. Paul McAfee, there has never been a reported case of a coated disc that migrated out.
4. Yet, in 2001, 3 years after they were coating all the discs worldwide, the U.S. clinical trial started using an old-generation uncoated disc design, even though J&J knew these old uncoated discs were prone to a higher rate of migration, higher devastating disabilities and higher mortality rate.
5. Seems odd – doesn’t it? How could Johnson & Johnson, their doctors and surgeons do this to patients? Why would they not be criminally liable for hiding knowledge that could have protected patients’ lives and why would they use an old generation of the device that they knew was prone to a higher risk of device failure?
Corporate greed. A clever scheme to manipulate the FDA and the Fast Track approval process to gain a competitive edge over two other manufacturers. J&J engaged in this appalling behavior to beat their competition to market in the United States.
6. During its review of the SB Charite Disc clinical trial, the FDA asked J&J: "If you have been using coated discs throughout the world and are planning to use coated discs in the United States, why did you use uncoated discs in these U.S. patients?". THe question went unanswered. In fact, immediately after the two year clinical trial, Johnson & Johnson switched the SB Charite disc device specifications on file with the FDA to coated discs.

Even though J&J always knew that the coated discs were safer, they never mentioned any such thing to me or any other patients. I had never heard of this debate. J&J knew that patients would never enter a clinical trial if they were told that the disc they were going to receive was an old generation device design that was prone to a higher risk of catastrophic failure and they had corrected the problem with a newer version of the disc that was only available outside the U.S.

They implanted an uncoated disc in my spine years after they had recognized and corrected the problem. Mine migrated out anteriorly. A catastrophic failure. It never should have happened.

More on J&J's criminally negligent behavior that almost killed me...
I started researching how and why my disc slipped out; an event that changed my life forever. The gross negligence that I uncovered as I spoke to Dr. Paul McAfee - J&J’s lead investigative surgeon for this Charite disc - is startling!

Upon looking at my X-rays during my emergency visit to Dr. McAfee to try to save my own life, he and his team actually told me and my mom “Oh, you must have gotten one of the uncoated discs. The coated discs don’t migrate out.” Startled, I asked what they were talking about. They went on to tell me that the disc migration problem had been solved by using a coating on all the discs worldwide (outside the U.S.) years before mine was implanted. Dr. McAfee even went on to tell me that before they ever inserted the first disc into a patient in the U.S. clinical trial, he was fighting with J&J to use the coated discs to help protect the patients lives. “Ultimately, the decision was made to start the U.S. clinical trial with uncoated discs.”

My SB Charite artificial disc migrated out anteriorly. The damage done to my nervous system, lumbar plexus nerves, Vena Cave, Illiac and Renal arteries, makes each day of my life very difficult to manage.

The original inventors/manufacturers of the SB Charite disc introduced the device throughout the world (Europe and Asia) in 1987. The disc was sold to me based on the "20 year history" of this device throughout the world with the understanding that the device is well established, studied, and that any device failures have been overcome and all risks have been mitigated. Indeed they had. It seems that in the early 1990's, the manufacturer noticed a high rate of catastrophic failure by device migration as a mode of failure. To correct the problem, they started coating the discs with a "porous ingrowth coating" to promote bonding of the metal to bone interface of the device. This proved so successful, that by 1998 the manufacturer started coating 100% of the discs throughout the world with this coating to stop migrations. As a matter of fact, the original manufacturer went so far as to tradename the proprietary coating process in 1997. There has never been a documented case of a device migration of a coated disc. It is 100% effective. My disc was put in me in 2001. They used an old-generation uncoated disc. Even though device migration was halted throughout the world by coating the discs, and there was a 3 year track history for this, J&J started the U.S. clinical trial with uncoated discs. They never told me this critical information. This was withheld from me.

How could this happen you ask? How/why would a big pharma company withhold information that they know can protect patients lives?

I have received a number of answers. None of them acceptable. The prevailing answer was given to me by the lead investigative surgeon for J&J who oversaw the 14 clinical trial study sites - Dr. Paul McAfee: "I had been fighting with J&J since before we ever put the first disc in a U.S. patient to use coated discs. Ultimately, the decision was made that the majority of the data from Europe was garnered from uncoated discs, and we wanted the U.S. data set to be statistically comparable to the majority of the European data." The truth is that J&J used the fast-track FDA approval process to start the US trial with uncoated discs in humans, while they ran a simultaneous baboon study for 18 months to prove the biocompatibility of the coated discs. So, rather than delay the human studies for 18 months and start the study with coated discs, which they knew could help protect lives, they went ahead and manipulated the FDA by using the fast-track approval process which allowed them to do the simultaneous primate study rather than waiting for the results of the primate survey.

They used the FDA fast-track approval process, not in the spirit of fast-track, but instead purely for corporate greed designed to beat two competing artificial disc manufacturers to U.S. market entry (Spine Solutions and Medtronic). This move was worth hundreds of millions of dollars to J&J, even though it put clinical trial patients at undue harm. In my estimation, gross negligence.

More research I have done has uncovered that this is standard operating procedure for Big Pharma. Tthe FDA has put the corporate greed of this powerful lobby above patient welfare. Many Big Pharma companies, introducing devices and drugs to the U.S. have found they can manipulate the FDA and its fast-track process to get products to market in a shorter period of time. This is hugely beneficial both in terms of a competitive advantage as well as for the extra hundreds of millions of dollars of extra profits that Big Pharma can accumulate simply by getting a product to market fast.

BIG PHARMA PUTS CORPORATE GREED ABOVE PATIENT WELFARE –
Three Big Pharma companies are competing to be first to market in the U.S. with their medical device – one has the opportunity to manipulate the FDA approval process to beat their competitors to market, but it means holding back critical medical observational information and using an old-generation device design - putting the lives of the patients and a higher risk of catastrophic device failure – the cost of getting a new medical device to market: if they kill, disable a few patients but can beat their competitors to market and gross hundreds of millions of dollars? well that’s a no-brainer isn’t it? – just figure that into the cost of getting a device to market expenses……….

I was patient #19 for the Charite disc in the United States clinical trial. I had that catastrophic failure.
My God has quite a sense of humor – Mr. Funny ha-ha!

As if implanting an uncoated disc in me were not enough, when mine migrated out and I was facing “imminent death” that required immediate emergency surgical intervention, J&J left me to die and told me they could not provide me any referral or suggestions on what to do.

For real – when I had my first Xray showing that the disc was migrating out and my life was in danger, I frantically started calling J&J’s clinical trial hotline for what I should do. You see, I could not find a surgeon with the experience revising a catastrophic failure of this experimental device. After hours and hours on the phone with many many people throughout J&J, I finally got a final phone call from the head of J&J’s “business affairs” who told me that they would not be able to help me since the two year clinical trial was over.

They left me to die.
Can this happen in America?

After exhausting research, I found that there are only 4 surgeons in the world (one in the Netherlands, one in Paris, one in Texas, one in Maryland – I managed to reach them all), that had ever attempted to do this kind of revision surgery. I was standing on death’s door……….

On a personal note….
The days surrounding my Charite Disc catastrophic failure are insane. What do you do when you have only days to live? You have to get on a plane in 48-hours to prepare for emergency surgery? Using your last 48-hours, how do you prepare your home, friends and family to go on without regret and with minimal pain after your death? How do you reassure them that you are prepared and OK to die? That your life was perfect just how it was? How do you say goodbye to your loved ones when your surgeon informs you that you only have a 20% chance of surviving the surgery you are about to undergo… That your death is imminent without the surgery, so you have to at least try. As the only child of a single mom, how do you look in your mother’s eyes? How do you say goodbye? What words do you use to say goodbye from your hospital gurney before they sweep you into surgery? How do you deal with the nightmares of her sitting alone in the hospital waiting room while you are in O.R.? The single mom that wanted more than anything at that moment to give her life for you – to change places with you…. How? Her only son is more likely to die over the next few hours than not, and she sits in horror and shock in the waiting room alone.

What happened to me is really a big deal. How do you deal with the anger and emotions when you find out that this never should have happened; when you learn that for years every one of these devices being put in patients worldwide outside of the U.S. were a newer, safer design than the old design that the company put in you. How did I get through this? How did I navigate to save my life? What lessons did I learn? And, how do I live everyday now? Overcoming an event like this and going forward with the Hope of a new and better tomorrow can be hard.

Read my Thank You note to all those who prayed and supported me and my mom through this. I will write a book about it if it will help even one other person to overcome obstacles.

Manipulating the FDA fast-track approval process, putting corporate greed above patient welfare is standard-operating procedure for Big Pharma. Big Pharma, today, is still getting away with this, killing and maiming unsuspecting patients everyday. It may happen to someone you love. And the FDA lacks oversight and regulation.

This is march on Washington time! This is lobby your Congressmen time! This is Congressional Investigation time for both the FDA and Big Pharma! There are so many things that J&J did, and continue to do, as they compete for U.S. market entry and victimize patients. After months of research, there are even more things that I have uncovered that J&J did to their Charite disc patients. Here is a partial list of J&J’s negligence and criminal behavior that continues to effect so many patients CLICK HERE.

(Front and Back incisions)

For details of J&J's reckless negligence as they continue to risk patients lives as they have brought the SB Charite Disc to market in the US. How Big Pharma manipulates the complacent FDA (the FDA provides no regulation or oversight of Big Pharma during the Bush administration) CLICK HERE

Here is what other Charite victims go through trying to get through each day...CLICK HERE

migrate

(above) This is when the nightmare started. Notice the uncoated SB Charite artificial disc slipping out of the front of my spine

Here is one of my lived nightmares....

When I was rushed in for emergency surgery, the surgeon's attempted to diagnose the extent of the damage being caused by the migrated disc by performing a diagnostic Venogram. As I lay on the cold metal operating table in the O.R. the day before the surgery, I soon felt myself laying in a massive pool of warm liquid, growing deeper by the minute, with a surgeon clearly concerned and getting more and more frantic as the minutes ticked by. (I was awake for the procedure). I started to splash the liquid with my hand and looked up at the surgeon, "is this what I think it is? my blood?". He was a little preoccupied and nodded. Later I found out why...

Surgeon's Report. Diagnostic Venogram:

Preoperative diagnosis: Status post L4/L5 disk replacement...which is migrating forward and might be even crushing on the vessels.

Report: Using Seldinger technique, the right common femoral vein was canalized and 6-French sheath was inserted. To note, it was concerning to me that the left renal vein had a very huge clot that was going south towards L4/L5... I could not reflux in to the left common iliac vein. Now attempted using Seldinger to get the left common femoral vein off 10-20 times I could not get the vein... After multiple attempts to get the common femoral vein on the left without success, at this point I decided to go ahead and proceed with doing an up-and-over sheath to see if I could hook the left common iliac vein from the right. Now, using a RIM and hook catheter, I attempted to do left common iliac selection without any success. At this point, I felt there were only two options, either the patient was completely occluded, and that is why there is no reflux from the vena cava from previous clot and that would explain the collateralization here, which I saw from the left renal vein going down toward L4/L5, or the patient has a double Vena Cava. (which I do not)

......................................

Following all the diagnostics, I had a double (anterior and posterior) surgical approach 360-degree spinal fusion at L4/L5 after they successfully removed my SB Charite disc.

now

(above) This is my spine today. Notice my IVC filter umbrella that I maintain to prevent me from stroking out from blood clots in the future.

..........................

Comment: as appauling as is what Johnson & Johnson and LINK Spine (the original manufacturer of the SB Charite) did by implanting an uncoated disc in me; I thank God everyday for the brilliant life-saving skills of Dr. Sam Saiedy (VAscular Surgeon) and Dr. Paul McAfee (Spine Surgeon). These are two of the most talented surgeons in their practice in the world and I owe my life to them.

Thank you to the teams of doctors who saved my life

- Darren