Many friends have been harmed from FDA approved medical and dental
devices.
The regulations are nearly four decades out of date. Fix them now.
The regulations are nearly four decades out of date. Fix them now.
Fix FDA regulations for medical devices and dental materials! Unlike for prescription drugs,
OTCs, personal care and food products, there is NO information required to go to the
patient or parent about materials they contain. Patients can experience harm from devices
ranging from dental amalgam fillings to Essure, Mesh, joints, implants, stents and more.
Reactions vary based on gene types that impact how well we clear materials that are not
natural to the human body. There is NO pretesting to determine if you will have a reaction in
advance as is recommended for hair color (although a one-time test is available). Peer
reviewed research links autoimmune, neurological and other illnesses with devices.
patient or parent about materials they contain. Patients can experience harm from devices
ranging from dental amalgam fillings to Essure, Mesh, joints, implants, stents and more.
Reactions vary based on gene types that impact how well we clear materials that are not
natural to the human body. There is NO pretesting to determine if you will have a reaction in
advance as is recommended for hair color (although a one-time test is available). Peer
reviewed research links autoimmune, neurological and other illnesses with devices.
For dental fillings, there is NO right of written informed consent. 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, and dental information does not go into patients' Electronic Medical Records so
it is hard for doctors to connect illnesses. Dental insurance does not cover the higher cost of
replacing amalgam fillings when medically indicated. Patients face high costs and lost income.
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, and dental information does not go into patients' Electronic Medical Records so
it is hard for doctors to connect illnesses. Dental insurance does not cover the higher cost of
replacing amalgam fillings when medically indicated. Patients face high costs and lost income.
Enact Medical and Dental Device Safety Urgent Reform (MEDDSURGE)!
Refocus CDC and National Institutes of Health (NIH) funding on Chronic Diseases. Provide
treatment for patients with device illnesses. Ask Surgeon General to take emergency action.
Put patient safety first.
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