Thursday, July 30, 2015

MEDDSURGE: Is Your Medical/Dental Device "Right for You?"

Medical and Dental Device Safety Urgent Regulatory Reform
MEDDSURGE: Top Priority for FDA Reform
Is Your Medical/Dental Device “Right for You”? Keep Pace with Science, Reduce Harm, Lower Costs
 For All Medical and Dental Devices, Congress should require:
·         Written information for patients on what materials devices contain, like for Rx & OTC.
·         One-time pretest to determine which devices are “right for you” in advance.
·         Immediate full implementation of the new system of Universal Device Indicators (UDIs).
·         Redirect device tax to Medical & Dental Device Illness Compensation (MEDDIC) Fund, and end federal preemption so ill and injured patients can seek redress in the courts.

Additionally for Dental Materials:
·         Written informed consent for dental fillings.
·         Medical records to include dental devices, fillings and materials information to allow physicians, epidemiologists and Big Data to assess the potential for health impacts.
·         FDA MedWatch Form 3500B to include a section tailored for dental fillings and devices.
·         Order HHS to release FDA January 2012 Safety Communication on Dental Amalgam.

Thousands of Patients Are Harmed by Medical and Dental Devices:
·         According to MedWatch & DENS, over 1,000 complaints have been filed on dental amalgam. Over 100,000 people have sought volunteer counseling from DAMS to find dentists qualified and able to work with patients ill from dental mercury toxicity.
·         FDA’s MAUDE shows thousands of women have filed complaints for medical devices such as Essure contraceptive coils, vaginal mesh, morcellators, and breast implants.
·         FDA’s MAUDE shows thousands of men and women have filed complaints for cardiac devices, implants, joints, stents, etc. If they are “right for you” is learned after the fact.

We Need Precision Medical and Dental Devices
MEDDSURGE Can Improve Health, Reduce Diseases and Lower Healthcare Costs By:

·         People react differently to foods, prescription drugs, and medical devices and materials.
·         Medical and dental devices provide 24/7/365 exposure to sources of inflammation.
·         Inflammation is at the root of many chronic diseases, from autoimmune to neurological.
·         Ensuring devices are ‘right for us’ will lower chronic disease rates and health care costs.
·         Tailoring medical devices selected for treatment to the characteristics of patients.
·         Conducting clinical trials run as “basket studies” by major genetic variants to determine which device materials are safer for which patients, and which should not be used.
·         Making sure any device used is “right for you” before it is installed.
·         Enabling patients to be reimbursed for uncovered medical, dental and supportive treatments by a Medical & Dental Device Illness Compensation (MEDDIC) Fund, and for patients to recover lost income and care expenses when needed.

Sign MEDDSURGE Petition here.


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