Congress needs to turn its attention to medical device safety

This article was originally published by STAT (www.statnews.com) on December 21, 2016:

With the landmark 21st Century Cures Act now signed into law, Congress needs to turn its attention to another pressing health issue: the safety — or lack thereof — of medical devices.

Thousands of medical devices are on the market today, with a steady stream of new ones coming along. They include spinal and breast implants, pacemakers, TENS devices for pain, transvaginal mesh slings, tubal occlusion sterilization coils, dental amalgam, prosthetic joints, and more.

The Food and Drug Administration puts medical devices into three categories. Class I devices are simple and have little potential to cause harm, such as bandages. Class II devices are more complicated and present a greater risk or harm. These include motorized wheelchairs and simple implants such as radio frequency identification chips; they are often approved with special guidelines for control. Class III devices help support or sustain life or present a potentially significant risk of injury. Examples include pacemakers, artificial heart valves, and joint replacements.

For all the good that medical devices do, they can also cause harm. I know this because my health was almost irreparably harmed by the mercury-based dental amalgam used over my lifetime to fill cavities — it turns out that genetic susceptibility is a factor. I have friends, relatives, and colleagues who have endured cancers and autoimmune diseases, allergies, rashes, pain, memory loss, and incredible emotional strain from problems caused by various medical devices.

Click here to read the complete article. 
https://www.statnews.com/2016/12/21/medical-devices-safety-congress/

Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE)

Please sign this Petition to Congress & Administration: Medical & Dental Device Safety Urgent Reform (MEDDSURGE)

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The regulations are nearly four decades out of date.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. 

Put patient safety first.

SIGN THE MEDDSURGE PETITION HERE

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.