Many friends have been harmed from FDA approved medical and dental
devices. The regulations are nearly four decades out of date.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.
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.
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.