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/

Breaking News: Genetic Health Risks of Dental Mercury

Dental Group Defends Mercury Fillings Amid Mounting Evidence of Risks

Greg Gordon, McClatchy January 5, 2016 

HIGHLIGHTS

Researchers: Brain effects threaten up to 4 in 10 people with certain genetic traits

Food and Drug Administration defends safety of mercury dental products

Thirteen years after issue arose, EPA yet to order controls on dental mercury discharges

EXCERPT

"THE ADA OWES NO LEGAL DUTY OF CARE TO PROTECT THE PUBLIC FROM ALLEGEDLY DANGEROUS PRODUCTS USED BY DENTISTS. THE ADA DID NOT MANUFACTURE, DESIGN, SUPPLY OR INSTALL THE MERCURY-CONTAINING AMALGAMS. ... DISSEMINATION OF INFORMATION RELATED TO THE PRACTICE OF DENTISTRY DOES NOT CREATE A DUTY OF CARE TO PROTECT THE PUBLIC FROM POTENTIAL INJURY."American Dental Association response to a patient lawsuit

Read more here: http://www.mcclatchydc.com/news/nation-world/national/article53118775.html#storylink=cpy

Read more here: Dental Group Defends Mercury Fillings Amid Mounting Evidence of Health Risks

Tests Suggest Mercury in Air at Some Dental Clinics 

Greg Gordon, McClatchy DC, January 5, 2016

Highlights

Firm finds soaring mercury levels in visits to dental offices

Dental workers among those sickened by toxin

‘There are kids running around everywhere. . . . It’s nuts’

Read more here: Tests Suggest Mercury in Air at Some Dental Clinics

Presentation to FDA Panel: "Precision Device" Framework for FDA: Is Essure Medical Device "Right for You?"

Here are the six slides I presented at the FDA Ob/Gyn Panel on Essure Sept. 24, 2015.

The testimony is on pages 173-175 of the FDA Hearing Transcript here. They asked a question about biocompatibility testing after my presentation.

Got Health Problems from Mercury Fillings or Other Medical Devices? Report them on MedWatcher App

Got health problems from mercury fillings or other medical devices? Report them to FDA on MedWatcher website: www.medwatcher.org or app: www.medwatcher.org/mobile. Register, select medical device, select dental amalgam. It is quick and easy. Be counted!

Health Conditions Related to Mercury Toxicity

The International Academy of Oral Medicine and Toxicology (IAOMT)’s 2013 Position Statement, which includes references to extensive research from hundreds of studies and sources, states: “The mercury in dental mercury amalgam fillings can exacerbate and contribute to all of the conditions stated below, as well as a myriad of other health problems.”

o Allergies	o Hearing loss
o Alzheimer’s disease	o Immunodeficiency
o Amyotrophic Lateral Sclerosis	o Kidney disease
o Antibiotic resistance	o Micromercurialism
o Autism Spectrum Disorders	o Multiple sclerosis
o Autoimmune disorders	o Oral lichen planus
o Cardiovascular problems	o Parkinson’s disease
o Chronic Fatigue Syndrome	o Periodontal disease
o Complaints of unclear causation	o Reproductive dysfunction
o Erethism (added by author)	o Chronic mercury poisoning

Source: International Academy of Oral Medicine and Toxicology (IAOMT,) Position Statement against Dental Mercury Amalgam Fillings for Medical and Dental Practitioners, Dental Students, and Patients.

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Epidemico's Medwatcher app helps patients report harm from dental and medical devices. It is a tool for quick action. Here is a case study:

"Epidemico and representatives from a patient group, Essure Problems, co-authored a publication describing the use of Facebook outreach and the MedWatcher app to encourage adverse event reporting to the US FDA for Essure, a hysteroscopic sterilization device. Over 1,300 valid reports were received through the app over approximately 19 months... A report took on average 11 minutes to submit, compared to 40 minutes estimated for the traditional FDA MedWatch form."  

Source: Epidemico blog, "Increasing Patient Engagement in Pharmacovigilance," 8/11/15

Background: Before 1993, 900 reports of harm from dental amalgam were filed with FDA under the old DENS system. DENS was replaced with MedWatch in 1993, using Form 3500, a lengthy and cumbersome form that did not mention dental materials, and requested information not available such as model and serial number. Few took the time to report. We have filed a Freedom of Information Act request to get the count for 1993-2004. 

A shorter patient version was developed a few years ago, Form 3500B, but it still did not mention dental materials, and still asked for model and serial number. About 100 Medwatch forms were filed 2004-2015, which can be accessed through the FDA's online MAUDE system. Coding issues make it possible to locate only a dozen using dental amalgam as the product name. FDA staff did a search to locate about 100 total during the past ten years.

Epidemico developed the new MedWatcher portal and app that makes reporting adverse events much quicker and easier. Register online or via mobile, select the category of medical devices, and select the product of dental amalgam.  Fill out the screens that follow, they are simply worded.  If you are not sure, put N/A. Be succinct; give highlights. If you have any questions, email. Thank you!

FDA Regulatory "Oversight" of Dental Amalgam - A Timeline -

FDA Regulatory "Oversight" of Dental Amalgam
- Timeline -

2011-2019: Eight Years of  Denial and Delay

• 2011-2014: James S. Woods et. al. publish four retractions of their findings of amalgam safety in children, finding neurobehavioral deficits in boys with four gene types.
• 2011: At FDA regional public hearings around the country, many dental professionals and patients testified of harm and many diseases caused by mercury in dental amalgam. 
• 2012: HHS quashed a planned FDA Safety Communication in an election year. The FDA called for reducing the use of amalgam, recognizing the risk of occupational exposure for dental personnel, and avoiding its use in susceptible sub-populations: Pregnant and nursing women; Parents and guardians of infants and children under age 6; People with mercury allergy or sensitivity; People with neurological disease; and People with kidney disease.[1] 
• 2014: FDA and HHS were sued for failure to respond to multiple petitions for reconsideration.
• 2015: FDA response to lawsuit is to take no action. McClatchy DC, Medscape and MD+DI Device Talk all report on HHS cover-up. FDA and HHS are sued for third time.

2006-2010: Five Years of Wrong Action

•       2006: FDA issued a White Paper concluding dental amalgam was safe. However, the FDA’s Dental Products Panel rejected the FDA’s position 13-7. The FDA did not act.
•       2008: a number of organizations and plaintiffs sued the FDA for its failure to classify amalgam. The FDA settled the lawsuit, published a website warning, and agreed to issue a final rule within a year. FDA Commissioner Hamburg came in after a six year board seat on dental products distributor Henry Schein; the website warning was removed. 

Federal judge Ellen Huvelle told the FDA that, "the probability of harm is enormous," and called the agency's 32-year foot-dragging, "government at its worst."[2]

• 2009: FDA classified dental amalgam as Class II, with warning labels only to dentists.
• 2010: After strong objections, FDA reconvened a Dental Products Panel. FDA did not take a vote. Dentists, patients and an expert risk assessment testified of risk and harm.

1976-2005: Thirty Years of Inaction

• 1976: Congress passed legislation to add medical, dental and radiological devices to the Food and Drug Administration (FDA).  Certain materials were ‘grandfathered’ as generally recognized as safe (GRAS) initially, including cigarettes, asbestos, and dental amalgam, but were to be reviewed and classified. The FDA declined to classify dental amalgam for three decades. The FDA also declined to exempt it from classification.
• 1987: FDA developed a new definition for an element to add to the periodic table, “dental mercury.” The FDA ruled “dental mercury” to be Class I – generally recognized as safe.
• 2002: FDA announced a proposal to reclassify dental amalgam as Class II with special controls related to dentists. Then it was put on the back burner again.

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[1] http://iaomt.org/wp-content/uploads/FDA-2012-safety-communication-mercury.pdf

[2] http://mpp.cclearn.org/wp-content/uploads/2008/08/transcript051508momsvfda.pdf

FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (Draft Jan 2012)

FDA Amalgam Safety Proposal

In January 2012, the FDA prepared a “Safety Communication” that recommended reducing the use of mercury amalgam in the general population, and avoiding it in susceptible subpopulations:

• pregnant and nursing women
• children under six years of age
• people with allergy to mercury or other components
• people with neurological disease
• people with renal disease

It also recognized the risk of occupational exposure for dental personnel.

The recommendations were never made public, and in January 2015, the FDA issued another statement saying that amalgam was unequivocally safe for everyone. Somehow, somewhere in the reaches of government and the Health and Human Services Administration, this amendment to the FDA rule was killed.

Here is the full text of the original, 2012 proposed rule:

FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (“Silver Fillings”)

HHS has not allowed FDA to release this safety warning. The most vulnerable continue to be harmed by a hidden river of mercury poisoning installed without our knowledge or consent.

Please sign the Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE).

MD+DI DeviceTalk: Lawsuit Tells How Politics Trump FDA's 'Gold Standard' on Mercury Fillings

MD+DI: Lawsuit Tells How Politics Trump FDA’s “Gold Standard”

Jim Dickinson August 3, 2015

FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam.

..."Copiously documented with legal, regulatory, and scientific exhibits, the 28-page Washington complaint supplements a 16-month-old lawsuit that FDA has been trying to ignore from the International Academy of Oral and Medical Toxicology and other mercury-opposed plaintiffs who, on other fronts, are winning as the archaic amalgam market in U.S. dentistry dwindles in favor of non-mercury composite resin alternatives.

The darkest tarnish on FDA’s illusory gold glitter could be the new complaint’s discovery that after the agency in 2012 dutifully sent to its political bosses at HHS a scientifically-based final decision restricting mercury amalgam’s use in dentistry, FDA mysteriously reversed course.

That final decision remained a secret, internal document until by a process unexplained in the complaint, it came into the hands of the plaintiffs’ lawyers, enabling them to compare what FDA had decided to tell the world about amalgam and what it was diverted from above to say instead. It did this last January in deceptive responses to three petitions from plaintiffs for a ban on amalgam."...

Medscape: Did HHS Cancel Proposed FDA Limits on Mercury Fillings?

Robert Lowes  July 29, 2015

"In January 2012, the US Food and Drug Administration (FDA) appeared ready to prohibit the use of mercury-based dental fillings, or dental amalgam, in pregnant women, nursing mothers, children aged less than 6 years, and other groups considered sensitive to the metal's neurotoxic vapors.

The agency also was ready to advise dentists that "alternative materials would best be offered as the first line of restorative care minimizing the use of dental amalgam," according to a draft FDA safety communication dated "January XX, 2012."

The proposed FDA guidance, stemming more from cautious uncertainty than clear evidence on dental amalgam's effects on health, would have represented a sea change in the government's regulation of the controversial filling material.

However, as part of the US Department of Health & Human Services (HHS), the FDA needed a green light from higher-ups to issue this guidance. The green light never came.

"We were unable to obtain clearance from HHS," an FDA official told an attorney in February 2012 in a lawsuit seeking to either ban or limit the use of dental amalgam. "We are still working on securing that clearance. When or even if it will happen I cannot say."...

Breaking News: Four Stories on HHS Cover-Up of FDA Safety Warning on Dental Amalgam

Health officials kill proposal to curb mercury dental fillings
Greg Gordon, McClatchy DC, July 21, 2015

Proposed warnings have been kept secret more than three years
Safety communication could have affected millions of patients
Scientist says one in 10 with mercury fillings could be very ill

Six lives upended by mercury-filled teeth
Greg Gordon, McClatchy DC, July 21, 2015

Dental patients describe battles with mercury
Combing the Internet to find a cause
‘The brain fog in my head lifted’

Things to know about mercury fillings
Greg Gordon, McClatchy DC, July 21, 2015

A risk assessment said 122 million Americans exposed to unsafe mercury levels
Scientist says he can trace sources of mercury in hair, blood and urine
Worried about your mercury fillings? Don’t detox until they’re gone

Mercury-free dentists shoot back at national association
Greg Gordon, McClatchy DC, July 21, 2015

20 Hard Questions to FDA Science Forum on Storify

20 Hard Questions to FDA Science Forum 2015 (Click here) 

Will FDA throw medical device illness patients a lifesaver, or continue to see, hear and speak no evil of dental and medical devices that - due to genetic variability in methylation, immunity, and detoxification pathways - are not "Right for Us?" We need #RightToKnow and #WrittenInformedConsent for everything installed in our bodies. We need all installed device #UDIs in #EMRs - not just in dental records, not seen by our doctors or #BigData. 

It is time to recognize and respect #GeneticRights, and put patients' health first through #PrecisionDevices. We do not control our DNA, so we need strict controls and prior biocompatibility screening for all dental and medical device materials before they are installed. This is basic science and safety to protect children and adults as genetically unique snowflakes. 

ATLANTA WSB-TV2 INVESTIGATES: Are Fillings in Your Mouth Toxic?

Here is a jaw dropper from Atlanta WSB-TV2 on May 18, 2015

Atlanta WSB-TV2 Investigates: Are Fillings in Your Mouth Toxic?
">WATCH THIS SHORT VIDEO NOW


Atlanta WSB-TV2 Investigates: Are Fillings in Your Mouth Toxic?

Call for Surgeon General Report on Dental Amalgam and Mercury Health Risks - A Rachel Carson/Deborah Sampson/Norma Rockwell Moment

Genome, Toxome, Deviceome: Ultimate Selfies for Health

My comment on the CDC Blog Post, The Ultimate Selfie.

The CDC cautions against overreliance on the genome and the dangers of the "narcissome."  Instead, it should accelerate equal attention to the toxome, the exposome, the dentalome, the deviceome.

Among the early adopters of genomics are those whom mainstream top line medicine failed for years, who got sick and tired of living with inexplicable chronic diseases, and doing the best they could with "medication management" and "chronic disease management." They are discovering new learning, medical practitioners, avenues and approaches to explore, and groups to seek out peers and share experiences, initially in person and increasingly online.

We learn that looking at both sides of the equation, genetics and toxicology together, are the keys to chronic diseases, and that one can remediate bad combinations and restore healthy functioning of the body and brain.  We learn that functional medicine physicians can be more helpful than specialists for various conditions because they see they body as a whole, an integrated symphony and set of systems.  We learn that the lack of attention to biocompatibility in the human body is a  gaping whole in medical practice and regulation of installed devices, as is lack of an integrated approach to body, brain, dental and mental health.

We are working to update regulations that are nearly 50 years out of date in which patients get no labels, no written informed consent, no prior biocompatibility screening for the individual before installation of permanent medical and dental devices (while it is recommended for temporary hair color products), no entry and updating of information on our installed devices such as we get for prescription drugs and OTCs at every doctor visit.

There is a Rosetta Stone of sorts, it is to follow basic engineering principles in the body. If genetic glitches impacts one's ability to methylate and clear everyday toxins, we must be vigilant in screening them and clearing them for health. These can be biotoxins like Lyme throughout its lifecycle and coinfections, chemotoxins, metallotoxins like mercury from fillings and fish, mycotoxins like mold, etc.

Health is a powerful motivator, and reward.  As important as genomics is toxicology. As important as Precision Medicine is Precision Devices, to ensure they are right for us. This is where the easy, quick wins and big payoffs for reducing chronic disease rates begins.

RECOMMENDATIONS FOR ACTION May 2015 - HELP THE TOXIC SUBSTANCE ABUSED FOR HEALTH, LOWER COSTS

1. Patient Labeling of All Installed Medical and Dental Devices

2. Funding Recovery Services for Device Related Illnesses

3. Develop Comprehensive Plan for Patient/Worker Protection, Reform

4. Urgent FDA Safety Reform of Installed  Devices, Surgeon General Report
OUTLINE OF COMPREHENSIVE PLAN for Patient Protection and Reform

a)      Patient Protection

i)   Follow the lead of four states and add consumer labels with warnings to the product to discourage its use by those for whom it may be harmful and written consent; the FDA has indicated state consumer laws do not violate preemption.[1]

ii)   Fund and require Medicaid to pay for alternate filling materials, as Pennsylvania does, so people can chose what is best for their children’s and their own health needs.

iii)   Require dental plans to be cost neutral on fillings, and accountable to medical necessity and patient protection laws, and require them to use of biocompatible dental materials.

iv)    Encourage integrated health and dental insurance plans to ensure oral care supports physical and cognitive health, and reduce costly externalities down the road.

v)   Require and expedite inclusion of dental materials and records in electronic medical records for review and analysis by physicians, ACOs, health insurers, HiWay, MA Health Policy Commission.

b)      Research

i)        Set up a surveillance system and reporting system as there is none functioning at the federal or state level, and include as a priority for the Health Prevention Trust Fund.

ii)       Hold hearings and survey the public as to prevalence of people who had health impacts, survey biologic dental practices and functional medicine practices to quantify numbers served with dental mercury toxicity and assess training and capacity building needs, and conduct a learning tour to get their input on steps to expand training and capacity.

iii)     Include dental insurance data in the all-claims database and analyze connections between oral health, dental materials, chronic diseases, and health and long-term care costs.

iv)     Require organ donor programs operating in Massachusetts, and all autopsies performed with state funds, to measure bioburden of mercury in the brain, heart, kidneys and liver of its donors and report to state and federal authorities, along with proximate cause of death.

c)       Systems Reform and Building Capacity

i)        Update dental and medical practice and insurance standards to confidentially screen people for genetic glitches, and for toxic burden; and/or require biocompatibility tests for dental materials.

ii)       Tax dental amalgam to equalize the costs with alternative filling materials, and neutralize the bias of dental insurance plans that base what they will pay on amalgam fillings cost.

iii)     Reboot community hospitals that have overcapacity for acute care needs as centers for the training and practice of biologic dentistry, train all dentists in mercury safe removal protocols and special safety equipment. Explore launch of a state university Biologic Dental School.

iv)     Design a new a Mass Save Health program, similar to Mass Save, helping screen people for toxins in their bodies and homes, and fund treatment and remediation, as win-win.

d)      Occupational and Environmental Risks

i)        Require dentists and staff who work chairside be tested periodically for mercury exposure. Because standard blood and urine tests only measure circulating mercury, more sensitive tests are required to rule out false negatives for non-excretors.

ii)       Require dentists and staff get special training and equipment to protect patients, staff and dentists from mercury vapor during installation, polishing and amalgam removal.

iii)     Test mercury levels in all dental offices and dental schools, and inspect all dental offices and dental schools for proper use and functioning of amalgam separators.

iv)     Require removal of amalgam from all bodies before cremation, and require installation of adequate scrubbers on crematoria, to protect people from exposure via air, water and fish.

4. Ask Delegation for Urgent FDA Safety Reform of Installed Dental and Medical Devices
5. Petition for Surgeon General Report on Dental Amalgam and Mercury Health Risks

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[1] http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/UCM174024.pdf pp. 71-72.

European Committee Recommends Amalgam Alternatives for Certain Patients

From DrBicuspid, European Committee Recommends Amalgam Alternatives for Certain Patients.  Sanity prevails in Europe. Madness continues in the United States... FDA Fiddles while Rome heals...

May 26, 2015 -- "In a final opinion on dental amalgam, a European Commission scientific committee concluded that alternative materials to dental amalgam should be the first choice for certain restorations, such as those in pregnant patients and primary teeth.

The updated opinion by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) updates the committee's previous one published in 2008. It assessed the safety and effectiveness of dental amalgam and possible alternatives, such as resin-based composites, glass ionomer cements, ceramics, and gold alloys, by evaluating the scientific evidence on the potential association of amalgam and its alternatives with allergies, neurological disorders, or other adverse health effects.

This opinion contrasts with the January 2015 U.S. Food and Drug Administration (FDA) update of its consumer advisory on dental amalgam, which did not change the agency's position on amalgam fillings and concluded that such fillings are safe for adults and children ages 6 and older.

Individual patient characteristics

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) of the European Commission wrote that, while "current evidence does not preclude the use of either amalgam or alternative materials in restorative treatment," individual patient characteristics should determine the material used in treatment.

The following patient characteristics should be considered:

• Primary or permanent teeth
• Pregnancy
• The presence of allergies to mercury or other components of restorative materials
• The presence of impaired renal clearance

“Alternative materials have now been in clinical use for well over thirty years. ... Existing clinical experience has revealed little evidence of clinically significant adverse events.”

— Scientific Committee on Emerging and Newly Identified Health Risks, European Commission

"Alternative materials have now been in clinical use for well over thirty years, initially in anterior teeth and more recently also for restorations in posterior teeth," the committee wrote. "Existing clinical experience has revealed little evidence of clinically significant adverse events." It noted that the composition of available materials has changed substantially in recent years because of "improved polymerization processes and particular improvement in the adhesive systems and the filler parts." Among the benefits, the committee wrote, is that there is "no evidence that infants or children are at risk of adverse effects arising from the use of alternatives to dental amalgam."

There is a trend toward minimal interventional, adhesive techniques in dentistry, which are "based on adhesion to tooth structure by chemical interaction, and/or micromechanical retention," according to the opinion. At the same time, the committee noted, the quality and durability of alternative materials have improved.

As a general principle, the committee recommended that the relative risks and benefits of any dental treatment should be explained to patients to help them make informed decisions. Also, manufacturers should provide better information concerning the relative risks of dental restorative materials, it added.

An effective material

Dental amalgam is "an effective restorative material for the general population" and has "long been considered the material of choice," the committee noted in its executive summary noted. However, the drawbacks of dental amalgam are well-known, including the exposure to mercury and that it is neither tooth-colored nor can it adhere to remaining tooth tissues. The use of amalgam has been decreasing in recent years, and the alternative tooth-colored filling materials are increasingly used in Europe.

The committee, however, concluded that already-in-place dental amalgam is not considered a health risk for the general population and should not be removed as a preventive measure.

Future research

In the opinion, the committee wrote further research is needed relating to the "evaluation of the potential neurotoxicity of mercury from dental amalgam and the effect of genetic polymorphisms on mercury toxicity." It also recommended that more research be conducted in the development of new alternative materials with a "high degree of biocompatibility" and to expand knowledge of the toxicity profile of alternative dental restorative materials.

More publicly available research data are also needed, and it would be "beneficial for the community in general to be better informed of the recognized benefits and risks," the committee noted.

The opinion corresponds with the intentions of the 2013 Minamata Convention on Mercury to reduce mercury and the general aim to reduce mercury use in the European Union, according to a press release by the European Commission."

Related Reading

Amalgam tops composite or glass ionomer restorations in new study, March 31, 2015

FDA: No change of position on dental amalgam, January 30, 2015

EPA proposes rule requiring dentists to install amalgam separators, September 25, 2014

UNEP, IADR, WHO hash out dental amalgam's future, January 28, 2013

UN mulls global amalgam restrictions, May 24, 2010

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