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The regulations are nearly four decades out of date.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.

From MetroWest Daily News July 14, 2015

• Russell: Congress can do more to fight ‘hidden health risks'

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   By Laura Henze Russell
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  Guest Columnist

  Posted Jul. 14, 2015 at 3:52 PM 
  
  
  

  The 21st Century Cures bill, passed the U.S. House of Representatives on July 10th, would provide $8.75 billion in funding over five years to the National Institutes of Health (NIH), and $550 million in additional funds for the Food and Drug Administration (FDA) to speed discovery and approval of drugs and devices. It needs a little tweaking by the Senate as it takes up its own biomedical innovation bill to accomplish the ultimate objective of curing the most Americans at the least possible cost. This can enable us to begin to pay down the national debt, and finance efforts on more complex health problems.

  We would do well to focus attention on the common causes of chronic diseases, and the hidden health epidemics that are endemic to our time. These include Lyme and various tick-borne coinfections, mold that is hidden and off the radar screen, and surprisingly, medical and dental devices that are not pre-tested for biocompatibility in individual patients to ensure the materials are “right for you.”

  An increasing number of medical and dental professionals, ill and recovering patients, medical researchers, and public health professionals now consider these hidden health risks as a major driver of chronic diseases that impact Americans across the age spectrum, as transmission of microorganisms, heavy metals and the like can occur through direct exposure, and prenatally and via breast feeding. Device illnesses for people with genetic susceptibilities include such common FDA approved products as artificial joints, cardiac devices, dental amalgam, Essure contraceptive coils, implants, mesh, and stents. I have personal experience with one of these products, and friends with all of them.

  With the progress of Precision Medicine in recent years, clinicians are discovering the varied causes behind a range of chronic disease diagnoses. These conditions are legion, and include ADHD, allergies, arthritis and Alzheimer’s; chronic fatigue, diabetes, fibromyalgia, and heart disease; gastrointestinal problems, fungal and yeast infections, skin irritation and rashes; Multiple Sclerosis, Parkinson’s, peripheral neuropathy and tremor; and behavioral, cognitive, memory, mobility, mood and mental status challenges. Surprisingly, good clinicians using the principles of functional medicine are able to properly diagnose and “reverse engineer” some of these diseases, when the specific genetic susceptibilities and toxic inflammatory triggers are revealed by genetic and toxic screening.

  It is time for the nation’s health system to catch up. With 21st Century Cures and other bills concerning FDA medical device regulations and taxes in Congress, we have a chance to reboot the system in several ways. There is broad bipartisan and public support from America’s families, who serve as patients, parents, caregivers, relatives and friends to people with a growing number of such health challenges, which tend to multiply as they mature and age.

  It is important to do 21st Century Cures and Device legislation right. Here are some Big Ideas.

   1) Focus attention on common causes of chronic diseases: bad combinations of gene types and toxins outside and within the body, including medical and dental devices. These diseases need remediation and reverse engineering, not lifelong medication. Prompt diagnosis and proper treatment can forestall a future of costly prescriptions for symptom control, joint replacement surgeries, mobility aids, memory care, etc.
  

  • 2) Rebalance federal health priorities, research, surveillance and spending so it focuses on the biggest, most prevalent, easiest-to-resolve health burdens of chronic inflammatory autoimmune and neurological diseases impacting the body and brain. Focus on common, everyday health risks - especially for those with common genetic variants in their methylation and immune pathways - such as mercury, Lyme and co-infections, and mold. These are endemic, and the hidden epidemics of our time.

    3) Medical and Dental Device Safety Urgent Reform (MEDDSURGE) as regulations years out of date and UDIs alone do not go far enough. Patients must get labels, written informed consent for dental fillings, prior biocompatibility screening to determine if a device is "right for you" before installation, entry of all device information into EMRs (not just dental records) seen by one's doctor and big data, and a revised MedWatch Form 3500 with a new section specifically designed for dental device adverse reactions.

    4) Redirect Medical Device Tax to a Victims Medical and Dental Device Illness Compensation (MEDDIC) Fund. Many patients wind up with harm after the fact as we still prescribe devices based on averages rather than individual tolerance vs. toxicity pre-testing. Somebody has to pay for remediation, treatment, recovery, lost income, and high uncovered medical, dental and care expenses patients have incurred.

    While we are promoting 21st Century Cures, it would be wise to end 19th Century dentistry. Nobody is filing patents to perfect amalgam anymore - not even the ADA - only to mitigate its harm. And stop open season on women and men via reproductive system, heart, joint and other implants that are not well tolerated by those with methylation and immune variations. Test for tolerance or toxicity first.

    Call your Representative and thank them for their vote, and Senators Ed Markey and Elizabeth Warren at 202-224-2742 and 202-224-4543, respectively, and ask them to Rebalance Attention to Chronic Diseases and Medical Device Safety, Focus on the Common Causes and Hidden Health Risks for Chronic Diseases, and Reform FDA Regulations for Precision Devices and Safety via MEDDSURGE and the MEDDIC Fund.

    Restore, safeguard and protect the health of Americans for the health and well-being of us all.

    Laura Henze Russell is the Principal of Precision Research & Communications: Precision Health. She was an invitee at the White House Champions of Change Precision Medicine Event July 8th, and also attended the NIH Precision Medicine Advisory Committee Work Group on Patient Engagement and Health Equity July 1-2, 2015. Her summaries of these events are athttps://storify.com/LauraHRussell/nih-precision-medicine-patient-engagement-health-e andhttps://storify.com/LauraHRussell/white-house-champions-of-change-precision-medicine.