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| REGULATORY BOARD POSITIONS (OR LACK THEREOF) |
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Food and Drug Administration (FDA) Page
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*NEW* State Dental Licensing Boards Page |
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State Pharmacy Licensing Boards |
Our regulatory boards are paid with taxpayer dollars to protect the public. Why, then, are they looking the other way when there is mountains of convincing research and evidence that paraformaldehyde root canal pastes are dangerous and should not be used. Safer alternatives are available. This topic has fallen off of the radar screens of our regulatory agencies and after decades of side-stepping this issue, it is time to put it to rest. It is NOT ACCEPTABLE for another patient to walk in our shoes.
Put the patient's safety first, not the dentist's wallet and unconventional beliefs!
A search in www.pubmed.com* with any relevant terms, such as "Sargenti endodontic", "Sargenti Paste", "Paraformaldehyde endodontic" will demonstrate this overwhelming INTERNATIONAL mountain of research. Little will be found that supports the use of Sargenti, except proponent articles defending the use of this unaccepted material and technique. No industry accepted scientific data has been collect in support of Sargenti on humans, just proclamations of the thousands of unknowing patients who have had this material used on them and how there are "virtually NO failures". There have been failures, the proponents refuse to accept and own them.
The American Endodontic Society, which includes the President of N2 Products (company sponsoring the FDA activity), claims a Sargenti endodontic clinical trial has been on-going with the FDA. Sargenti dentists, not providing the patient with consent forms and full disclosure of the risks, are using patients as Human Research Subjects. Doctrines such as the Helsinki Act protect humans from being used as unknowing and unwilling guinea pigs.
*Online document service provided by the US National Library of Medicine and the National Institutes of Health
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WHAT ARE (OR AREN'T) OUR REGULATORY BOARDS DOING ABOUT THIS? |
Pointing at each other for accountability! The ADA and AAE point to the FDA. The FDA points to the State Pharmacy Boards. The State Pharmacy Boards point to the State Dental Boards. The State Dental Boards point to the FDA and ADA. NO ONE is accepting responsibility for enforcement of the sale and use of this unapproved and dangerous material. Any action that is taken is only in response to a patient complaint AFTER the damage is done. THIS MUST CHANGE!
The SOS has been in contact with all regulatory boards that are involved with this issue. Unfortunately, for the public, these boards have implemented a reactive form of enforcement. Only when a patient is injured, discovers it is Sargenti, and then reports it, is anything done. Then they only act upon the dentist that is involved with that particular injury. Our regulatory boards must become proactive in their enforcement and stop patients from being harmed instead of waiting until after they are harmed. There is not much that can be done for the injured patient once the damage from Sargenti Paste is done.
In 1996, the FDA confiscated and destroyed Sargenti Paste as toxic waste. They have recently confirmed that their position has not changed. What has changed, is the dysfunction of the FDA and the failure of their mandate to protect the public. On their own website, is a troubling article "A Troubling Trend", about the lack of FDA enforcement of compounded drugs. Sargenti Paste is a compounded drug. Enforcement is lacking.
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Injured 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.