ArthroplastyWatch.com three-year follow-up: where do we stand now?

[摘要] In the wake of the Poly Implant Prosthèse breast implant and the metal-on-metal incidents, the inherent flaws of European regulatory systems for medical products and devices have been highlighted once again.1 In lieu of the approximately 70 notifying bodies largely setting their own regulatory standards in the European Union,1 the US has one central regulatory authority to approve medical products and devices.2 According to Samuel et al, between 1982 and 2014, 70 original orthopaedic devices were approved through the US Food and Drug Administration’s (FDA) premarket approval pathway (PMA).3 The PMA, which requires clinical data, is the most rigorous pathway that high-risk medical devices can undergo prior to being introduced on the market. Despite this, of these 70 devices, 12 were subsequently subjected to FDA recalls during their lifespans, and no less than 765 post-market modifications were recorded.3 Twenty-two percent of these post-market modifications either significantly altered components or the device design. Class III devices (which include metal-on-metal hip implants) were intended to undergo PMA. However, because of a legislative loophole, metal-on-metal implants until recently usually only underwent 501(k) clearance, meaning that they did not have to undergo studies showing safety or effectiveness.

[学科分类] 神经科学

[关键词] total hip arthroplasty;Ceramic-on-Ceramic;young patients