FDA gets mouthful on mercury dental fillings after requesting public comment on device regulation

Over 90% of the public comments sent to FDA in response to its request for public comments on patient preferences in medical devices address FDA’s failed policy on dental amalgam, the 19th -century filling material which is 50% mercury.

On May 2, FDA’s Center for Devices and Radiological Health invited patient comment on patient preferences in medical devices [1], because patients “bring their own experiences to bear in helping inform the agency’s evaluation of medical devices over the total product lifecycle”; the Center adds that patient input is “important to consider during the FDA’s decision-making....” [2]

The resulting comments were virtually all about dental amalgam – and critical of FDA’s current policy.

What patients prefer is not to have a 19th century mercury device implanted in their bodies,” said Charles G. Brown, executive director of Consumers for Dental Choice.  “With so many superior mercury-free alternatives available today, patients do not want to take that risk – especially with their children.

As comments [3] to FDA show, patients are concerned about:

  • amalgam’s toxic mercury content,
  • the lack of evidence that amalgam is safe for children and other vulnerable populations,
  • the unacceptable risk  of mercury exposure when there are mercury-free filling materials available,
  • how unlike alternatives, amalgam cannot be placed in a minimally-invasive manner,
  • the absence of any direct-to-patient information from amalgam manufacturers, and 
  • how amalgam use conflicts with important patient values, such as protecting the environment

The European Union virtually banned dental amalgam for use in children under 15 and for pregnant and breastfeeding women in its 28 Member States in 2018. [4]   FDA concedes that amalgam has not been proven safe in these populations, [5] but neither prohibits, nor limits, nor warns about, nor even orders disclosure of the mercury to parents:  

“Patients appreciate this opportunity to be heard by FDA,” says Brown.  “Now they want to see FDA act on these patient preferences by taking steps to protect the public – especially children – from this outdated mercury device.” 


[1] FDA, FDA In Brief: FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical deviceshttps://www.fda.gov/news-events/fda-brief/fda-brief-fda-advances-science-patient-input-seeking-specific-feedback-patient-preferences-may

[2] FDA, Patient Preference-Sensitive Areas: Using Patient Preference Information in Medical Device Evaluationhttps://www.fda.gov/about-fda/cdrh-patient-engagement/patient-preference-sensitive-areas-using-patient-preference-information-medical-device-evaluation

[3] Comments can be found at https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&dct=PS&D=FDA-2019-N-1619 ;  comments can be submitted at https://www.regulations.gov/comment?D=FDA-2019-N-1619-0001

[4] Regulation of the European Parliament and of the Council on Mercury, and Repealing Regulation (EC) No 1102/2008 (17 May 2017), p. 25, http://data.consilium.europa.eu/doc/document/PE-4-2017-REV-1/en/pdf 

[5] In its 2009 regulation (never amended since), FDA says: 

“The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor.  Very limited to no clinical information is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed.”

Federal Register / Vol. 74, No. 148 /pp. 38706-07 (2009), http://www.gpo.gov/fdsys/pkg/FR-2009-08-04/pdf/E9-18447.pdf


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