Medical and Dental Device Safety Urgent Reform (MEDDSURGE)
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Fix FDA regulations for medical devices and dental materials! Unlike for prescription drugs, other medical devices, OTCs, personal care, food, pet, household and yard products, patients are flying blind about dental products containing mercury, and about the harm from other FDA-approved devices such as Essure, Mesh, joints, implants, stents and more. Reactions vary based on gene types that impact methylation, which helps clear heavy metals and toxins that are not natural to the human body. There is NO pretesting recommended to determine if you will have a reaction in advance - as FDA recommends for hair color products - although a one-time test is available.
Mercury has been a scourge on public health for centuries, from Mad Hatters' Disease and the Danbury (Hatmakers) Shakes; to scientists, chemists, and miners; to children via Pink's Disease, which harmed millions of children until mercury was finally removed from teething powders in the early 1950s. Peer reviewed research links autoimmune, neurological and other illnesses with mercury dental amalgam. See James S. Woods et al's four articles 2011-2014 retracting earlier findings of amalgam safety after finding neurobehavioral deficits and kidney damage in boys with a half dozen gene types. See Thomas G. Duplinsky and Domenic V. Cicchetti of Yale School of Medicine's study finding CT dentists have much higher rates of prescription utilization for neuropsychiatric, neurological, cardiovascular and respiratory diseases than carefully matched controls. See UPI's September 2016 release on research finding higher blood levels of mercury in people with eight or more amalgam surfaces from the U.S. NHANES study (each molar can have up to five surfaces).
For dental fillings, there is NO label, warning, or right of written informed consent to patients or parents. FDA warnings for dental amalgam (called silver fillings, but 50% mercury) are required only from manufacturer to dentist, NOT to patients. There is a flawed MedWatch reporting system for dental device reactions with no mention of dental devices being included. Over 1,000 older FDA adverse event reports on dental amalgam were ignored, so patient organizations stopped recommending their use. Dental information does not go into patients' Electronic Medical Records (EHRs), so it is hard for doctors, researchers and Big Data to connect illnesses. Dental insurance does not cover the higher cost of replacing amalgam fillings when medically indicated because of FDA's failure to post its draft 2012 Patient Safety Warning. The Administration must act now.
Patients face years of suffering, high costs, and lost income from needless chronic diseases. The high costs of cheap dentistry are passed on to families, employers, health plans, insurers, and federal and state governments via higher lifelong costs for chronic disease management, medical care, mental health care, prescription drugs, surgery, rehab, PT and OT, and long term care, and for special education, disability, SSI, and unemployment from problems that result.
Enact Medical and Dental Device Safety Urgent Reform (MEDDSURGE)! Reboot FDA Device Regulations for the 21st Century. Refocus Health and Human Services, Centers for Disease Control, Food and Drug Administration, Indian Health Service, Medicaid, Military Health, National Institutes of Health, Surgeon General, US Public Health Service, and Veterans Administration on screening, diagnosis and treatment to prevent, reduce and treat devices illnesses and chronic diseases. This is where we can succeed in helping the most people and realize the greatest benefit. Provide treatment for patients with device illnesses, and hold manufacturers accountable for removal and replacement with biocompatible materials when it harms patient health. Ask the FDA and Surgeon General to take emergency action. Put patient safety first.
For more information, copies of dental, medical and scientific research studies and risk assessments, and how to find a dentist who has additional training and special equipment to remove dental amalgam safely when medically indicated, see www.iaomt.org and https://iaomt.org/safe-removal-amalgam-fillings/. Use of a dental dam and water spray does not protect patients, dentists or staff from mercury vapor entering the lungs via the airway or nose.
In addition, please use the new MedWatcher app to report any adverse events from dental amalgam and other FDA-approved devices. Thousands of patients and many physicians have submitted reports of harm from Essure and Mesh, which has made it easier for their voices to be heard by researchers, regulators, legislators, policymakers and the media. if you have been harmed - or one of your patients has been harmed - by mercury dental amalgam, Essure, Mesh or other dental and medical devices, please download the new MedWatcher app at www.medwatcher.org, select the Device tab, select Dental Amalgam or other product name, and submit your report. Stand up, be counted, help restore your health, and help others. Thank you.
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