Sargenti Opposition Society
WHAT YOUR DENTIST MAY NOT TELL YOU
but you need to know before your next root canal
FDA MedWatch LinkInjured patients should file an adverse event report with the FDA. Absent reports from the public, the FDA will not realize the extent of the dangers of Sargent Paste. Click here to file report. Also ask your doctor to file a report on your behalf. Since reports are voluntary over 90% of adverse events go unreported.
 

FOR LEGAL CONSIDERATIONS, THE NAMES OF THE OFFENDING DENTISTS HAVE BEEN REDACTED.   
NAMES OF TREATING DOCTORS HAVE BEEN REDACTED OUT OF RESPECT.  THEY PLAYED NO PART IN THE PATIENT'S RESULTING HEALTH CONDITION.


December 21, 2005

Dr. S.M. Mahan, DMD, President
Alabama Board of Dental Examiners
5346 Stadium Trace Pkwy, Ste. 112
Hoover, AL   35244

Dr. S.M. Mahan,

With this letter, I am submitting a formal complaint against the dental practice of  A and B,  Madison, Alabama 35758 and the dentists operating in that practice.  These dentists are A, B and C.  With this information, I have summarized the events that have resulted in possible permanent injury to my inferior alveolar nerve during a root canal procedure where the non-FDA approved Sargenti RC-2B endodontic paste was used and overfilled into my nerve channel.

On Friday October 7, 2005 I went to the A and B dental practice (Madison, AL)  with a toothache on #18.  As expected, a root canal was needed. Dr. C performed the procedure.  The following x-rays were taken – Figure 1 - Full mouth, Figure 2 – Tooth 18 before the root canal and Figure 3 – Tooth #18 after the root canal. 

a
Figure 1  - Full mouth x-ray prior to root canal

 

Figure 2 – X-ray of #18 pre-treatment.  This x-ray was not provided to me when I requested copies of my record.  I later sent a letter specifically asking for this missing x-ray and never received a response.  I expect this x-ray to be provided to me as it is the one that was used to determine the length of the canal to be drilled.  I would like to evaluate the quality of this x-ray in performing that measurement.

 

 a
Figure 3 – Tooth #18 post procedure

I had not viewed the Figure 3 xray until much later but, as you can see, the x-ray is sufficient to show that an overfill occurred but insufficient to show the full extent.  A repeat x-ray should have been taken and evaluated.  I additionally should have been notified of the situation and immediate corrective action initiated by Dr. C.

By Monday, October 10, I was still experiencing numbness (and pain) in my lower left lip and left chin.  I went in to see Dr. C again.  No additional x-rays were taken and she reported that the problem was parasesia from the novacaine injection.  She indicated that she wanted to see me monthly and that, if not resolved in 4 months, she would refer me to a neurologist.  She was aware that I was researching the possible causes on the internet and suggested that I not read the internet. Later that week and after much additional internet research, I asked to see one of the other dentists. Dr. B was the only one available.  I made an appointment for October 13 but overslept and cancelled the appointment.  I was told that Dr. B would not be available until the following week. 

By Friday, October 14, I was experiencing extreme pain in my lip and chin.  I called the office after hours and left a message for Dr. C to call me.  She did.  At this point she mentioned a referral to an oral surgeon but “she already knew what they would say”.  I told her that the numbness in my chin had changed to pain and I thought that this was a sign that the nerve was waking up.  I asked for pain medications to get thru the weekend and I would see how I was on Monday.  I expressed a concern over what I was reading on the internet and was told that it could not be the root canal procedure.  The problem that I was experiencing, according to Dr. C, was a result of the injection.  Throughout that following weekend, I took Darvocet and Ibuprofen regularly and was able to control the pain. 

On Monday, October 17, A and B office called me to see how I was doing.  I indicated that the problem still existed and they made an appointment for me to see Dr. B on Tuesday, October 18.  After missing a dose of Ibuprofen, the pain returned full force.  When I went to the Oct 18 B appointment, the x-ray shown in Figure 4 was taken. 


Figure 4 – Dr. B Visit X-ray

After viewing this x-ray, Dr. B again indicated that the problem was from the injection and made no mention of the gross overfill that is evident on the x-ray.  This fact is documented in my patient record.  I specifically asked him about the possibility of the root canal being the problem, since I had been reading that on the internet and I didn’t want to put a crown on and later find out that it should have been corrected before then.  He told me that it could not possibly be the root canal because after all they had removed all of the root.   However, when asked about the discomfort I was having in the tooth, he indicated that it could be cracked.  As you can see from Figure 4, a gross overfill is clearly visible on the x-ray.  The x-ray was not shown to me, the overfill was not mentioned and a problematic root canal issue was dismissed.  I think you will agree that there was an issue with honesty from Dr. B and an attempt to cover up the real source of the problem ensued.

Conflicted over what I was being told vs. what I was reading on the internet, I decided that either something was amiss or they were lacking what seemed to me to be basic root canal knowledge.  I made an appointment with an endodontist for a second opinion.  The Endodontist, Dr. T1 took an x-ray (see Figure 5) and immediately told me that I had an overfill and referred me to an Oral Surgeon, Dr. T2.  T2 worked me in that day since I indicated that I was in extreme pain.  After reviewing the endodontic x-ray, he expressed concern that the filling material was possibly injected into my nerve channel.  He prescribed a course of steroids.  I continued to take Ibuprofen and Darvocet to control the pain.  I continue, to this date, to use those medications, as well as Elavil, in an effort to deal with the pain.

 

Figure 5 – Endodontist [Dr. T1] X-ray

On Thursday, October 20, I called A and B office asking for a copy of my records and indicated that I had gone for a second opinion.  That same day Dr. A called me.  I immediately told him that I knew the problem was not from the injection as I was told by Dr. B and Dr. C  and that I was very unhappy with the follow up care that I had received.  It was obvious to me that they had not been honest.  He asked that I come in the following day.  I agreed.

On Friday, Oct 21 I went to see Dr. A.  Although I didn’t know him, his behavior seemed to be over the top.  He made comments like “You are the number one thing on my mind”, “I’ve lost sleep” and “I feel responsible”.  I allowed him to grind the tooth down so that it didn’t hit the top tooth and replace the temporary filling with more permanent.  Curious about his behavior, I went back to the internet and researched litigation related to root canals.  I found a lawsuit where a dentist was sued for failure to detect, failure to inform and failure to refer.  I thought that this must be what he is concerned about.

I continued to see Dr. T2 and continued to have the same pain and numbness.  During the next few days Dr. A called me and my gut feeling was that he was acting obsessive and wanted to be in control.  I eventually asked Dr. T2 to talk to him as I didn’t want to have to deal with dueling opinions.  This problem was clearly beyond a general dentistry problem and I was looking to Dr. T2 to provide guidance on how to deal with this situation, not Dr. A.

When Dr. A spoke to Dr. T2, Dr. A asked him to call a dentist in Pennsylvania who “had experience with this type of problem”.  That dentist was Alvin Arzt, secretary/treasurer of the American Endodontic Society.  Arzt told Dr. T2 that the material would be absorbed by my body within 2-3 months and recommended a shot of Decadron into the general vicinity of the overfill. Dr. T2 asked me to research the request and call him in a day or two with a decision on what I wanted to do.  It didnt take long to realize that Alvin Arzt was associated with Sargenti paste.

The following day, I decided to call Dr. A to find out what the material was that was in my mouth, although I already knew.  I wanted confirmation. The conversation went like this –

Me:  So, what is this material that is in my mouth?
Dr. A:  Its standard endodontic filling material.
Me:  What is it?
Dr. A: Its what I have in my office.  It contains zinc oxide.
Me:  What is the brand name?
Dr. A: I don’t know, its what I have in my office.  (NOTE:  HE OWNS THE PRACTICE!!)
Me:  Is it Sargenti?
Dr. A: Sargenti isn’t a filling material, it’s a man.
Me:  OK, IS IT SARGENTI N2?  …at this point I was quite angry…
Dr. A: It’s a similar compound.
Me:  DOES IT CONTAIN FORMALDEHYDE?
Dr. A: Yes, it’s a similar compound.

Dr. A then went into a discussion defending the use of what he acknowledged was a “controversial” material; told me that no other endodontic materials were approved by the FDA and Sargenti was the only one that was close.  I later learned, through conversations with the FDA, that this is not true.  Gutta Percha is approved as a dental device.  Sargenti was classified as a drug due to its advertised “cleansing” properties and was thus required to go thru the more stringent drug approval process. Dr. A went into a discussion about “time is of the essence” for this decadron shot.  He told me that he himself had a root canal in his mouth with this material as did many of his patients.  I asked if he had an overfill into his nerve channel?  Of course, he doesn’t.  He proceeded to tell me that chemo patients put more toxic materials into their system than this paste.  I believe that I said to him that chemo patients know what they are putting into their body, unlike me.  At this point I was quite inflamed and it was very clear toDr. A that I was not a candidate for his snow job.   I had done my homework.  I later learned that after this conversation, Dr. A turned my “case” over to his insurance company.  He stopped calling me but still contacted Dr. T2.  At this point, it became very clear to me that Sargenti paste was the real reason for Dr. A’s suspicious behavior.  I wasn’t happy with what I had found out and was quite alarmed by what I was reading on the internet.

I reported the materials information to Dr. T2 who, like everyone else he contacted for guidance, was surprised, as they didn’t think Sargenti paste was used anymore.  At this point, the plan changed from waiting it out to getting it out.    The issue of the decadron shot was dropped.  Dr. A and Arzt’s inputs were clouded with suspicion and doubt and I no longer wanted or needed their input.  I was fully aware of what was going on and the cover up that they attempted to pull off.  I also went back and re-reviewed my records and saw that RC2B was noted as the material used.  I apparently overlooked it when I first looked through my chart when I was less educated about the subject.  I had shown the x-rays to Dr. T2 but did not show him the patient record so he was also not aware and actually assumed the material was standard endodontic cement.

I continued to research the issues related to the material – including finding the American Association of Endodontics position paper on paraformaldehyde fillers, calling the American Dental Association to find out that they and the Council on Dental Therapeutics either do not recommend it or have taken a neutral position.  Additionally, I called the FDA and was told that no activity had occurred since the 1993 attempt by Arzt to get the material approved.  In that 1993 attempt, the FDA rejected the drug approval for numerous reasons including a finding that their study was skewed to the “good” cases.  As I learned from the American Endodontic Society’s web page, gross overfills are not to be submitted as part of their study, confirmation that they continue to pursue a study that will never meet the FDA criteria.  The FDA has allowed for an open field study using this material as long as the practitioners are participants in the study to get the material approved.  Don’t patients have to agree to be included in clinical studies?

I continued to experience numbness and pain in my lip and chin, with the only change being a decrease in pain due to steroids.  Once off the steroids, the pain started to return to its intolerable level.  I often referred to the pain, predominately on my lip, as “my invisible raging fever blister”.   Because of the issues with long term steroid use, Dr. T2 prescribed Elavil as an alternative for pain control.  This medication does appear to reduce the pain but not eliminate it.

On December 14, I had nerve decompression surgery and the material was removed from my nerve channel.  As reported by the Oral Surgeon performing this surgery, Dr. T3, the material was sprayed throughout the nerve channel and had killed the tissue that it came in contact with.  He removed the associated scar tissue.   There were also pieces of the material that were stuck to the jawbone.  Dr.T3 removed that material [scraped] the bone.  Pathology results are pending.  He noted that there was also damage to the nerve itself. He additionally removed the #18 tooth because, as he indicated, teeth are porous and over time, the material can seep into the surrounding tissue and also kill it.  Post surgery, the numbness and pain continues and, as explained to me, could take up to two years to resolve or never resolve, resulting in permanent nerve damage.

I have also learned that Drs. A and B have been using this material for over 20 years, without their patient’s knowledge or consent.  Dr. A told Dr. T2 that long ago he had used the standard gutta percha material and had problems with it so he went searching for an alternative.  I find that to be an unacceptable excuse as the vast majority of dental practioners have used gutta percha successfully for many decades.  Neither myself, nor any other of their patients that I know, were asked for informed consent.  I believe this to be a serious situation as their patients are obviously being used as unknowing and unwilling guinea pigs in a study that they know nothing about.  I can’t help but wonder how many patient records were submitted to the American Endodontic Society without appropriate written permission (another complaint by the FDA), a possible violation of the Hippocratic oath.

As you can imagine, I find this to be inexcusable, clearly below the standard of care and potentially criminal.  The material is being purchased from a compounding pharmacy in California, a violation of FDA rules that the material must be compounded intra-state.    It is not okay with me for a medical professional to decide for me to put non-approved, controversial toxic study material in my mouth without my knowledge or consent.  I can’t help but believe that the rest of his patients would agree but they haven’t been given the chance, yet. 

I think that the Alabama Board of Dental Examiners needs to investigate these dentists who are clearly operating below the standard of care and risking the health of their patients.  There are well-documented cases where, within 1 year of the procedure, infections ensued, jawbones were destroyed, and cancer became a part of their life.  I can provide you with names and contact information for patients that have required extensive reconstructive surgery to repair the damage.  I can also provide you points of contact from A and B’s patient population where problems continued after the root canal, in one case, causing the loss of the tooth.  I can only imagine the response that would ensue when the information is made available to their entire patient population.  It is obvious that Dr. A knew he was in the wrong otherwise, when asked, he would have been forthcoming with the brand name of “Sargenti RC2B”.   The true integrity of a person becomes apparent when they are faced with addressing their own mistakes.  Dr. B lied and attempted a cover up which, in my opinion, is a serious ethical breach and one that cannot be ignored.   At a minimum, Dr C.  was negligent in her care.  It is not obvious to me whether or not she participated in the cover up or was simply negligent.  However, I am fully aware that the dental school from which she graduated in 2000, Boston University, teaches their students that Sargenti is not to be used as it is below the standard of care.

Your prompt and serious attention to this situation is appreciated.  Please contact me if you need additional information.  I have attempted to keep this brief.  I look forward to hearing from you regarding the Board’s plan to address this situation.  As I’m sure you can understand, I plan to take legal action as well as addressing this issue in the “court of public opinion”.  I cannot sit back and let this careless and wreckless behavior go unchecked.

Sincerely yours,

 

 

Lorrie Hellier

cc:  Office of the Attorney General
Alabama State House
11 South Union Street, Third Floor
Montgomery, AL 36130

Attachments: 

  1. American Association of Endodontic Position Paper on the use of Paraformaldehyde filling materials
  2. American Endodontic Society (AES) “study club” membership requirements.  The AES is a group of dental practitioners whose whole purpose is to advocate for the use of Sargenti root canal method and materials.  It is not recognized by the American Dental Association.  Their name is extremely misleading.

 

 

 


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