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Dental Implants Show Few Complications in FDA Database

Dental Implants have Few Complications in FDA DatabaseIn order to monitor medical devices that are approved for use in patients in the US, the FDA maintains a database of all reports of what it calls “adverse events,” called the Manufacturer and User Facility Device Experience (MAUDE) database. This database is open to the public, and anyone can search it for reports of adverse events.

Utilizing this public resource, researchers looked at reports of dental devices causing “adverse events” in order to determine which dental devices might be dangerous. They found that dental devices were rarely responsible for reported adverse events. Although the dental implant is the most commonly-reported dental device, reports show injuries are rare.

Dental Device Injury Is Rare

In this paper published in the Journal of the American Dental Association, researchers looked at the nearly 2 million adverse events that were reported from 1996 to 2011. Over this fifteen year period, there were about 28,000 reports of adverse events associated with dental devices, about 1.4% of total adverse events reported.

Considering Americans visit a dentist at least 300 million times each year (65% of Americans visit the dentist at least once a year, many twice, and when you add in supplemental visits for treatment, the number is probably much larger), this is really a remarkable safety record for dental devices.

For Dental Implants, Injury Is Rare

Adverse events as recorded in the FDA database can mean any negative outcome, from a device that failed to function to injury to death. When it comes to dental devices, injury is a leading factor associated with reporting, account for more than 17,000 of the reports (62%).

Of the dental devices associated with adverse events, dental implants were the most commonly reported dental device, accounting for nearly 54% of all reports.

Does this mean dental implants commonly lead to injury? No. Researchers looked more in depth at the reasons why dental implant adverse events were reported, and found that more than three-quarters of them (77%) were related to dental implants not integrating into the jaw bone. Adverse event reporting shows that dental implants aren’t really associated with harm, it’s just that they don’t always work. And to have just a few thousand such reports over the 15 years studied here–less than 100 reports a year–shows just how effective dental implants really are.

If concern about the safety of dental implants concerns you, this study shows again how safe this remarkable technology really is.

If you would like to talk to a cosmetic dentist about dental implants in Columbus, OH, please call (614) 848-5001 for an appointment at the Center for Family & Cosmetic Dentistry today.