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/

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).

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."...

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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