Quality Deficiencies of Sterile Packaged Dental Implants 

How Much Safety can FDA Clearance or the Newly Implemented MDR in Europe Guarantee?

When dentists began using dental implants in the late 80s, no implant was launched on the market without comprehensive studies and pre-launch tests in renowned dental centers, normally linked to universities of high international prestige. With an increasing number of dental implant manufacturers and suppliers, dental professionals can choose from a variety of implant types with different geometries, surface treatments, and core materials. However, can dentists blindly trust the quality of these implants?

In 2019, the FDA released two decades of previously unpublished data containing millions of malfunctions by medical devices, including 2.1 million reports of failed dental implants. This amounts to more than 100,000 reports in 2018 alone – most of them related to a lack of osseointegration.

Opinion article by Dr. Joao Pimenta, Dr. Dirk Duddeck, published in:  JDODT 4-2020

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