Monday, August 31, 2015

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: or app:, 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.

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!


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