Dentaltown February 2013 - (Page 26)

second opinion column the Future Dental » PredictingUse and FDAofRegulation Amalgam by Michael D. Fleming, DDS Second opinions are common in health care, whether a doctor is sorting out a difficult case or a patient is not sure what to do next. In the context of our magazine, the first opinion will always belong to the reader. This feature will allow fellow dental professionals to share their opinions on various topics, providing you with a “second opinion.” Perhaps some of these observations will change your mind, while others will solidify your position. In the end, our goal is to create discussion and debate to enrich our profession. – Thomas Giacobbi, DDS, FAGD, Editorial Director, Dentaltown Magazine There is a no greater challenge in dentistry these days than accurately predicting the future of dental amalgam use and FDA regulation. Given the more restrictive trends in federal and international regulatory policy with respect to mercury in general, and dental amalgam mercury in particular, it is very timely to address the current state of amalgam regulation, discuss common misconceptions in the ongoing amalgam safety debate and offer recommendations for future amalgam use. There is considerable confusion among health professionals surrounding the FDA’s role in the regulation of dental amalgam or any other medical device. It is worth mentioning at the outset that the agency does not regulate the actual practice of dentistry or medicine and, while this distinction is not altogether clear at times, the agency is tasked with product regulation only. To review, the FDA regulates medical devices based upon the principle of the “reasonable assurance of safety and effectiveness.” Safety and effectiveness for a particular device are separate and distinct criteria used by the agency in the process of allowing a product or device to enter or remain in the marketplace for its intended use. Medical devices are categorized by means of a classification system that can be generally understood as follows: Class I includes fairly simple products, such as tongue depressors; Class II includes somewhat more important devices, such as most artificial knee joints and dental amalgam; Class III includes devices most important in supporting the life or health of patients, such as heart valves. It is a common misconception regarding device classes that the higher the classification, the greater the device’s potential risks to health. In actuality, medical devices are classified according to their complexity and intended uses, not necessarily any inherent risks to health. Misunderstandings can arise if this distinction is not appreciated. For example, there have been concerted attempts to compel the FDA to up-classify amalgam from its current Class II designation to Class III based in part on the belief there are increased risks to health. Up-classification would then require the agency to automatically restrict its use. In fact, a Class III designation for amalgam would not necessarily achieve that end. However, the up-classification of amalgam to a Class III for whatever reason presents a unique conundrum for manufacturers and regulators. Manufacturers would then be compelled to prove safety by means of the complex and expensive pre-market approval process. Amalgam manufacturers would likely be unwilling or unable to subject their product to such an onerous review given the expense, increasing environmental restrictions on mercury waste, escalating patient health concerns and a general decline in amalgam use worldwide. If amalgam manufacturers chose to opt out of this approval process, they would ultimately be required to cease production and distribution of their amalgam product in the U.S. market. The FDA indicated in the language of the 2009 Amalgam Rule that up-classification of amalgam to Class III was tantamount to a ban and a regulatory action the agency chose not to pursue at that time. The FDA’s current regulatory challenges with respect to dental amalgam use surround matters of safety, not effectiveness. Here again, confusion can abound. It is very common for those on both sides of the amalgam debate to inadvertently, or by design, confuse issues of safety with those of effectiveness. However, clear distinctions between these two criteria need to be maintained whenever the subject of amalgam safety is raised. Typically, such an oversight can make for very tangled continued on page 28 26 FEBRUARY 2013 » dentaltown.com http://www.dentaltown.com

Table of Contents for the Digital Edition of Dentaltown February 2013

Dentaltown.com Highlights
Howard Speaks: The SWOT Analysis
Professional Courtesy: Get Off the Hamster Wheel
Continuing Education Update
Second Opinion: Predicting the Future of Dental Amalgam Use and FDA Regulation
Nuts & Bolts Full Arch Case Dissected… Tips, Tricks & Stuff
Employee Embezzlement, Not Sure Which One
Corporate Profile: GC America
Sleep Dentistry Section
Product Profile: Sleep Optima
Breathe Easy: The Advent of CPAP
ACSDD Consortium
Sleep Apnea
Townie Meeting 2013 Last Call!
Do-it-Yourself Finance, Part III: Debt
The Most Effective Presentation Process Ever
“Patient Friendly Dentistry” to the Rescue
Does Kissing Affect Oral Health?
Can Groundhog Day Make a Difference?
Top 10 Tips to a Successful Practice Start-up
How to Build Up the Perfect Tooth
Why We See Problems with Teeth Whitening: The Science of Whitening Part IV – Whitening Sensitivity Solutions
Continuing Education: Full-Arch Appliance Use for Nighttime Parafunction Management
Ad Index
In This Issue: Implants Are Growing in Popularity
Perio Reports
Continuing Education: A.I.M. for Implant Success
Scaling on Patients with Implants
Dentally Incorrect

Dentaltown February 2013