FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (Draft Jan 2012)

FDA Amalgam Safety Proposal

In January 2012, the FDA prepared a “Safety Communication” that recommended reducing the use of mercury amalgam in the general population, and avoiding it in susceptible subpopulations:

• pregnant and nursing women
• children under six years of age
• people with allergy to mercury or other components
• people with neurological disease
• people with renal disease

It also recognized the risk of occupational exposure for dental personnel.

The recommendations were never made public, and in January 2015, the FDA issued another statement saying that amalgam was unequivocally safe for everyone. Somehow, somewhere in the reaches of government and the Health and Human Services Administration, this amendment to the FDA rule was killed.

Here is the full text of the original, 2012 proposed rule:

FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (“Silver Fillings”)

HHS has not allowed FDA to release this safety warning. The most vulnerable continue to be harmed by a hidden river of mercury poisoning installed without our knowledge or consent.

Please sign the Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE).

RECOMMENDATIONS FOR ACTION May 2015 - HELP THE TOXIC SUBSTANCE ABUSED FOR HEALTH, LOWER COSTS

1. Patient Labeling of All Installed Medical and Dental Devices

2. Funding Recovery Services for Device Related Illnesses

3. Develop Comprehensive Plan for Patient/Worker Protection, Reform

4. Urgent FDA Safety Reform of Installed  Devices, Surgeon General Report
OUTLINE OF COMPREHENSIVE PLAN for Patient Protection and Reform

a)      Patient Protection

i)   Follow the lead of four states and add consumer labels with warnings to the product to discourage its use by those for whom it may be harmful and written consent; the FDA has indicated state consumer laws do not violate preemption.[1]

ii)   Fund and require Medicaid to pay for alternate filling materials, as Pennsylvania does, so people can chose what is best for their children’s and their own health needs.

iii)   Require dental plans to be cost neutral on fillings, and accountable to medical necessity and patient protection laws, and require them to use of biocompatible dental materials.

iv)    Encourage integrated health and dental insurance plans to ensure oral care supports physical and cognitive health, and reduce costly externalities down the road.

v)   Require and expedite inclusion of dental materials and records in electronic medical records for review and analysis by physicians, ACOs, health insurers, HiWay, MA Health Policy Commission.

b)      Research

i)        Set up a surveillance system and reporting system as there is none functioning at the federal or state level, and include as a priority for the Health Prevention Trust Fund.

ii)       Hold hearings and survey the public as to prevalence of people who had health impacts, survey biologic dental practices and functional medicine practices to quantify numbers served with dental mercury toxicity and assess training and capacity building needs, and conduct a learning tour to get their input on steps to expand training and capacity.

iii)     Include dental insurance data in the all-claims database and analyze connections between oral health, dental materials, chronic diseases, and health and long-term care costs.

iv)     Require organ donor programs operating in Massachusetts, and all autopsies performed with state funds, to measure bioburden of mercury in the brain, heart, kidneys and liver of its donors and report to state and federal authorities, along with proximate cause of death.

c)       Systems Reform and Building Capacity

i)        Update dental and medical practice and insurance standards to confidentially screen people for genetic glitches, and for toxic burden; and/or require biocompatibility tests for dental materials.

ii)       Tax dental amalgam to equalize the costs with alternative filling materials, and neutralize the bias of dental insurance plans that base what they will pay on amalgam fillings cost.

iii)     Reboot community hospitals that have overcapacity for acute care needs as centers for the training and practice of biologic dentistry, train all dentists in mercury safe removal protocols and special safety equipment. Explore launch of a state university Biologic Dental School.

iv)     Design a new a Mass Save Health program, similar to Mass Save, helping screen people for toxins in their bodies and homes, and fund treatment and remediation, as win-win.

d)      Occupational and Environmental Risks

i)        Require dentists and staff who work chairside be tested periodically for mercury exposure. Because standard blood and urine tests only measure circulating mercury, more sensitive tests are required to rule out false negatives for non-excretors.

ii)       Require dentists and staff get special training and equipment to protect patients, staff and dentists from mercury vapor during installation, polishing and amalgam removal.

iii)     Test mercury levels in all dental offices and dental schools, and inspect all dental offices and dental schools for proper use and functioning of amalgam separators.

iv)     Require removal of amalgam from all bodies before cremation, and require installation of adequate scrubbers on crematoria, to protect people from exposure via air, water and fish.

4. Ask Delegation for Urgent FDA Safety Reform of Installed Dental and Medical Devices
5. Petition for Surgeon General Report on Dental Amalgam and Mercury Health Risks

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[1] http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/UCM174024.pdf pp. 71-72.

Audio: Rob Moir's Environmental Dialogues with Laura Henze Russell

Audio: Moir's Environmental Dialogues

Listen to Dr. Rob Moir and Laura Henze Russell discuss mercury poisoning and safer alternatives in dentistry.

March 20,2014 Episode  - Dental Assistant Karen Palmer of Bethlehem, PA talks about her occupational mercury poisoning.

March 6, 2014 Episode - Laura Henze Russell talks about the Campaign for Good Health, Call for a Surgeon General's Report, and IAOMT Lawsuit Against the FDA and HHS.

November 29, 2012 Episode - Laura Henze Russell talks about the upcoming Sharon, MA Town Warrant Articles.

Hidden River Health Challenge on YouTube - Watch Us!

Hidden River Health Challenge on YouTube - Watch Us!

March 2014 Resolution for Surgeon General Report to Sharon Finance Committee for May Town Meeting, and IAOMT Lawsuit vs. FDA in a Nutshell (14 min)


December 2012 Articles at Sharon Town Meeting to Learn About, Share and Act on Health Risks of Mercury Dental Amalgam for Genetically Susceptible Children and Adults (14 min)

November 2012 Cable TV Show FYI with Colleen Tuck

October 2012 Presentation to Board of Selectmen on Articles for Town Meeting Dec 2012

Oct. 2012 Presentation to Sharon Finance Committee on Articles for Town Meeting Dec. 2012

July 2012 Presentation to Sharon Board of Health on Health Risks for Dental Mercury Amalgam for Genetically Susceptible Children and Adults