Posted to MediaSyndicate.com (Apr 16, 2009 - 08:22 AM) : The FDA is failing in its mandate to protect the American public from a rogue group of dentists who are using formaldehyde in root canals.


Since the 1960's, the FDA has been aware of a rogue group of dentists (members of the American Endodontic Society (AES)) and their use of an unapproved root canal filling material which contains formaldehyde, Sargenti Paste (aka N2, N2 Universal, RC2B, RC2W, One Step Endodontic White, as well as many others). In 1993, Sargenti Paste was denied approval by the FDA for failure to prove safety and efficacy. This group of mainly general dentists uses testimonials in lieu of science to justify their use of this material. Most conceal it from their patients before the procedure and even after a patient is injured. The American Association of Endodontics (AAE) has a very strong position paper against its use as it is considered below the standard of care (http://www.aae.org/NR/rdonlyres/14F3726F-DA2D-4155-97E9-D0201E690B17/0/paraformaldehydefillingmaterials.pdf). The AAE is the only American Dental Association accredited and recognized endodontic specialty board in the US. The American Endodontic Society (AES) is not recognized or accredited by any mainstream US dental agency.

The AES claims virtually no failures with this material, yet, they specifically state that their membership case submittals are not to include "gross overfills" (a condition where the material is extruded out the bottom of the tooth into surrounding tissue) and allow only a maximum of 5 failures to be submitted out of 130 patient cases.

Every single accredited dental school in the US not only does not teach the Sargenti technique, they teach NOT to use it as it is dangerous, toxic, and below the standard of care. This has been taught since the 1970s.

For decades, the FDA has been notified of the continued manufacturing and sale of this unapproved material by compounding pharmacies (who sell in bulk across state lines) but, since the early 1990's, has done nothing to enforce their own laws regarding it. They have been notified of false claims of FDA approval by the proponents, including a claim in 2003 that the material had passed "Phase III (final testing)". The FDA has told Sargenti proponents that this material is not approved and has sent letters stating such. Yet, to this day, members of the American Endodontic Society along with the President of N2 Products, the company pursuing FDA approval, continue to falsely tout some form of FDA approval and nothing is done to stop them or alert the public otherwise. The FDA is aware that many patients have been seriously and permanently injured. They are aware that dentists frequently conceal their Sargenti Paste usage and therefore the vast majorities of injuries go unreported. Injuries can range from chronic sinus infections to life altering permanent numbness and/or burning nerve pain to the most severe - anaphylactic shock and chronic bone infections that have destroyed jaw bones requiring surgeries to rebuild and repair. These bone infections are often unstoppable.

The Sargenti Opposition Society was founded in 2008 by two patients severely and permanently injured from Sargenti Paste root canals. Neither of these patients was told the true case of their problems and, as a result, valuable recovery was lost forever. The founders met each other as they were surfing the internet looking to diagnose themselves since they could not rely upon their own dentists to help them. These patients were told by nearly every other dental/medical professional, as well as malpractice attorneys and state dental board attorneys, that they were unaware that this material was still in use. One surgeon argued that it was not used in the US, only third world countries. This lack of knowledge by our medical profession contributes to the severity and permanency of the patient's damage since they do not know to look for formaldehyde as a source of the patient’s problem and often do not know how to treat them. Immediate removal of the material and/or tooth is warranted when persistent pain and/or numbness is reported by the patient.

The story of Sargenti Paste is well known by our state dental regulators who, rather than actively enforcing the standard of care, wait for an injured patient to show up and then address that dentist's use on that patient. It does nothing to help the next patient who sits in that same dental chair. By the time a patient knows to file a report with their state dental board, the damage is likely permanent with no chance of recovery. Reactive enforcement is not what the taxpayers expect from our tax-payer funded regulators.

All dental patients should know that this situation exists so that they are able to protect themselves from these dentists who feel that they know better than mainstream dentistry and who impose their unconventional beliefs on their patients without their knowledge or consent. There is no place for formaldehyde in dentistry as safer and more effective materials have been successfully used for decades by the vast majority of the US dental community.

More information on Sargenti Paste can be found at the following websites -

http://www.worstrootcanalever.com

www.dentalwatch.org/questionable/sargenti/overview.html (an excellent article on the history of this material)