Amalgam Concerns Flood Patient Info Docket
Patients and consumers worried about dental amalgam’s mercury content and its risks have taken on a campaign to urge FDA action by submitting almost 200 comments to an agency docket seeking input on Patient Preference Information related to medical device regulatory decisions. As of 6/14, 94% of comments submitted have been related to dental amalgam and its risks. Based on a review by FDA Webview, the vast majority of amalgam-related comments raised concern with:
- amalgam’s toxic mercury content
- the risk to vulnerable populations
- the risks of mercury exposure when there are mercury-free filling materials available
- non-minimally-invasive procedures
- a lack of direct-to-patient information
- negative environmental impacts
Patient input and involvement is a growing area at CDRH. As part of its recent device user fee reauthorization, FDA committed to better engage with patients to understand and consider their experience and perspectives on medical device clinical studies, benefit-risk assessments, and postmarket surveillance.
Based on its ongoing research, CDRH has assembled a listing of identified patient preference-sensitive areas. In the dental devices area, the Center found procedure duration, convenience, durability, and pain as patient-preference areas. Consumers for Dental Choice national counsel Charles G. Brown noticed that the listing failed to recognize any of the pressing concerns that the group hears about amalgam (like mercury exposure and risks to vulnerable populations), and so the comment campaign began. Brown contacted his followers and provided details on how to submit amalgam-related comments to the agency docket. “We must seize this opportunity to urge FDA to respond to its real customers: the patients who are calling on FDA to protect them from a primitive 19th century mercury product that has no place in the human body,” he said in an email.
Brown told FDA Webview that FDA is behind the times. “It has been a year since the European Union imposed a virtual ban (the exception is extremely limited) in all its 28 Member nations on amalgam use in children under 15, pregnant women, and breastfeeding women, a limitation that appears to be working seamlessly,” he told us. “On this side of the pond, by contrast, FDA’s 2009 rule concedes that FDA does not know if amalgam is safe for children under six and for pregnant women – yet FDA green-lights its use in children: with no disclosure to parents about the mercury, no warnings to parents, and no limits on number of fillings, which could include mercury in every single tooth if the dentist is so inclined.”
Brown said that in the past decade, “America’s middle class has virtually escaped to mercury-free dentistry, where amalgam plays no role whatsoever, and concomitantly most dentists in private clinics no longer do amalgam. In America today, if you choose your dentist, you likely get mercury-free dentistry... while if a third-party chooses your dentist, you probably don’t. While even lower-income nations, such as Mauritius and Vietnam and Indonesia, have ended amalgam use for children, FDA allows pediatric dentists to use all they want to, and to conceal the mercury from the parents... With public comments focused almost entirely on amalgam, it’s clear the Center on Devices needs to act, such as assembling its scientists like the European Union did (seven years ago, by the way).”
Asked to comment of other countries banning mercury-containing dental amalgam, FDA spokeswoman Alison Hunt pointed to a 2009 final rule that addressed such comments seeking a ban. “FDA has concluded that there is sufficient information from which to establish special controls that, along with the general controls of the act, will provide reasonable assurance of the safety and effectiveness of the device,” the rule said. “Specifically, FDA has determined that the risks to health presented by dental amalgam can be addressed through the general controls of the act in conjunction with the recommendations in the special controls guidance document. Because of this determination, FDA disagrees with comments suggesting that the device should be banned.”
FDA spokeswoman Stephanie Caccomo separately told FDA Webview that CDRH is planning a November advisory committee meeting to discuss metal implants and the potential risk for certain patients to have hypersensitivity or exaggerated immune and inflammatory reactions to these metals. “We’ve been exploring the link between immune and inflammatory markers and symptoms such as pain, headaches and fatigue in patients who have these devices implanted,” an FDA notice in March said. An agenda is not yet available, and there are no specifics on whether amalgam will be discussed.