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

Abstract

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Earfold: A New Technique for Correction of the Shape of the Antihelix

“…With the updated Earfold implantation procedure, an audit of outcomes in 403 patients showed a lower overall complication rate (9.7%) and lower reoperation rate (4.2%) compared to the rates observed in the pilot study (20.5% and 15.3%, respectively) . Overall, postsurgical safety was improved, evidenced by a greater than twofold decrease in infections, implant extrusion, and reoperations …”

“…Learnings from the pilot study led to modifications of the Earfold implantation technique. These included ensuring that the implant was flush with the cartilage after deployment, specific attention to the orientation of the implant in relation to the planned antihelix, selective use of needle perforation of the cartilage, and use of the introducer dimple to assist with correct positioning . With the updated Earfold implantation procedure, an audit of outcomes in 403 patients showed a lower overall complication rate (9.7%) and lower reoperation rate (4.2%) compared to the rates observed in the pilot study (20.5% and 15.3%, respectively) .…”

“…Based on the pilot study, the Earfold implantation procedure is associated with an overall complication rate that is similar to the rates associated with standard otoplasty using combination techniques (Table ) . An ongoing, long‐term, postmarketing audit has monitored safety outcomes in a series of 403 patients who underwent the procedure in the United Kingdom and Croatia . The overall complication rate in this series, including patients who underwent reoperation, is currently 9.7% after up to 34 months of follow‐up.…”

“…However, it is generally acknowledged that there are challenges with suture‐based techniques. These include difficulties with accurate placement of sutures and the need for more extensive dissection, which can then lead to problems with hematomas or infection (Table ) . The most common complications are recurrence of prominence or problems with asymmetry, both of which may result in a need for reoperation.…”

“…These include difficulties with accurate placement of sutures and the need for more extensive dissection, which can then lead to problems with hematomas or infection (Table I). 5,10,[13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31] The most common complications are recurrence of prominence or problems with asymmetry, both of which may result in a need for reoperation.…”