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

Plastic and Reconstructive Surgery. Global Open
Norbert V KangWalid Sabbagh

Abstract

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. 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. 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. 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...Continue Reading

References

Feb 5, 2000·British Journal of Plastic Surgery·S L Jeffery
Nov 17, 2001·Plastic and Reconstructive Surgery·N HorlockD T Gault
Oct 19, 2006·Journal of Plastic, Reconstructive & Aesthetic Surgery : JPRAS·A MandalK J Stewart
May 19, 2010·Archives of Facial Plastic Surgery·Christoph Schlegel-WagnerThomas Linder
Nov 11, 2011·Journal of Plastic, Reconstructive & Aesthetic Surgery : JPRAS·Manish Sinha, Bruce Richard
Apr 29, 2015·Plastic and Reconstructive Surgery·Sammy SinnoCharles H Thorne
Dec 18, 2015·Aesthetic Surgery Journal·Norbert V Kang, Ryan L Kerstein

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Citations

Aug 3, 2020·Plastic and Reconstructive Surgery·Nadim JoukhadarMichael Bezuhly
Apr 17, 2018·The Laryngoscope·Norbert V KangMichael Silberberg

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Software Mentioned

Earfold

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