Earfold Implantable Clip System for Correction of Prominent Ears: Analysis of Safety in 403 Patients

Background: The Earfold system, a new treatment for the correction of prominent ears, consists of 3 components: the Earfold implant, the Earfold introducer, and the Prefold positioner. Methods: This is an interim report based on an ongoing analysis of safety in a series of patients treated for prominent ears with the Earfold implant between February 2013 and September 2014. Safety was assessed based on adverse event reports and the need for implant revision; follow-up is ongoing. Results: Seven surgeons used 1,200 Earfold implants to treat 403 patients (ages, 7–70 years; 63% male); the time since the initial implant procedure now ranges from 30 to 48 months. To date, 145 patients (36%) have returned for a follow-up visit (mean, 7.7 months [range, 1–34 months]). Adverse events requiring intervention have affected 39 of 403 (9.7%) patients; these include implant revisions (n = 17 [4.2%], most often due to implant visibility), skin erosion over the implant (n = 15 [3.7%]), and infection (n = 7 [1.7%]). Bleeding, recurrence of prominence, hematoma, deformity, or adverse scarring did not occur. Conclusions: This interim analysis has shown that Earfold prominent ear correction system is associated with relatively few adverse events that require intervention; a small number of patients experienced infection, implant extrusion, or implant visibility that required revision. Most adverse events were related to either patient selection or technical errors at implantation. It is expected that with continued use of Earfold by surgeons experienced in otoplasty, the adverse event incidence will decrease. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Published online 12 January 2018. Received for publication June 8, 2017; accepted November 8, 2017. The opinions expressed in this article are those of the authors. The authors received no honoraria or other form of financial support related to the development of this article. Allergan plc, Dublin, Ireland funded editorial support for this article. Data collection and writing of the article were performed by the principal author with the assistance of his co-authors and without funding support. The decision to submit the article rests with the authors. Disclosure: Editorial support for this article was provided by Peloton Advantage, Parsippany, N.J., and was funded by Allergan plc, Dublin, Ireland. Norbert V. Kang is the inventor of the Earfold implant used for this investigation. He was formerly the chairman and chief technical officer for the company [Northwood Medical Innovations (NMI) Ltd] that supplied the Earfold implant. NMI Ltd has now been acquired by Allergan. None of the other authors listed have any conflicts of interest. The Article Processing Charge was paid for by Allergan plc, Dublin, Ireland. Supplemental digital content is available for this article.Clickable URL citations appear in the text. Norbert V. Kang, FRCS (Plast), Royal Free Hospital NHS Trust, Pond Street, London NW3 2QG, United Kingdom, E-mail: norbertkang@gmail.com Copyright © 2018 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons. All rights reserved.

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