Earfold procedure, is it worth it?

Earful implants are a newcomer to the scene in otoplasty. To the best of my knowledge they are currently only licensed in Europe. 
They can effectively correct the ante helical fold. However the majority of patients with prominent ears also have an issue with the conceal bowl which is rotated forward. therefore if you rely on 'earfuls' there is a risk you have the fold over corrected and the bowl ignored. This can lead to a hidden helix.
Earful also have a rask of extrusion through the skin. They are a hard metal implant under a thin skin and perichondral layer on an area subject to pressure during sleeping.
In most cases i still prefer a suture based otoplasty but we can offer 'earful' surgery for those patients who only have a fold issue.

Commentary on: Treatment of Prominent Ears with an Implantable Clip System: A Pilot Study
Charles H. Thorne, MD
Author information ► Article notes ► Copyright and License information ►
Kang and Kerstein have reported on 39 otoplasty patients treated with an ear clip device (earFold implants; earFold, London, United Kingdom) that sets the upper portion of the ear back, creating a more prominent antihelical fold.1 The advantage of utilizing these implants is how quickly they can be inserted. In addition, the implants, being metallic, are presumably stronger than sutures and the recurrence of upper ear prominence, if the implants are left in place permanently, is likely very low. This article raises a number of important questions about the earFold implants, specifically, and about otoplasty, procedures in general.
The authors present these implants as a new treatment for prominent ears. More accurately, the devices are a replacement for one component of an otoplasty procedure, the setback of the upper third of the auricle. The earFold implants do not address the middle or lower third of the ear. I surmise that only a minority of patients could be treated with the implants alone, without addressing conchal excess and lobule prominence by other means. Because these other maneuvers require making an additional incision in the retroauricular sulcus, the less invasive incision required to insert the implants would be less advantageous.
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SUTURE REPLACEMENTS
The earFold implants are best evaluated as replacements for sutures (or the combination of cartilage weakening and sutures) in the creation of an antihelical fold. The authors have demonstrated that the implants are faster to insert than sutures. Although both the implants and sutures can extrude from the ear postotoplasty, an extruded suture is less visible and more easily removed than one of the implants. In addition, sutures may allow for more precision in creating the antihelical fold, because many more sutures than implants can be inserted to create the contour and amount of set-back desired.
One interesting finding of this study was that there was less recurrence the longer the implants were left in place. This suggests that absorbable sutures, such as polydioxanone (PDS) sutures, are probably not appropriate for otoplasty, because they do not maintain their strength as long as the implants (evaluated at 18 months).
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OTHER PURPORTED ADVANTAGES
The authors state that the implants have additional advantages, such as only needing the patient to be under local anesthesia for them to be utilized and their utilization obviating the need for cartilage scoring/weakening. I perform all otoplasties under local anesthesia and never perform any cartilage scoring/weakening, so these purported advantages may not be unique to the earFold implants.
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COMPLICATIONS
The complication rate for otoplasties utilizing the implants (20%) was quite high. The complication rate, however, would probably decrease as surgeons become more familiar with utilizing the implants.
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VISIBILITY
One of the most unsatisfactory qualities of the implants is their high visibility. The authors state that the newer, gold-plated versions are less visible, but it is hard to imagine that a change of color will eliminate the visibility of the implants beneath the thin lateral skin of the ear.
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RELAPSE
The authors state, as mentioned above, that the relapse rate was lower in those patients among whom the implants were left in place for 18 months vs. those who had the implants removed at 12 months. However, the authors did not state exactly how much correction was lost at each time interval. The authors reported the average helix-mastoid (H-M) distance for the group of patients among whom the implants were removed at 18 months, but the question remains, how much relapse did those patients experience vs. the group of patients among whom the implants were left in place permanently?
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OUTCOMES
Kang and Kerstein themselves have commented on the limitations of using H-M distance as an outcome measurement. Otoplasty results are more complex than can be accounted for by this metric alone. I have found that the single most powerful indicator of a good otoplasty result is a straight helical contour when viewed from behind. If that contour is a straight line, as opposed to a “c-shape” (as in a telephone ear, for example), the result will be aesthetically pleasing, even over a range of H-M distances. The problem with setting only the upper third of the ear back, as the implants do, is that a hockey-stick-like contour may be created because of the concha and the lobule not being set back concomitantly and proportionately.
In summary, the authors have published a well-written paper that details a technique for inserting earFold implants and the associated results and complications of their utilization. The authors have not provided enough evidence of the implants’ benefits for this author to switch from employing sutures to employing the earFold implants for otoplasties, but I am open to learning more about these interesting new devices.
Disclosures
Dr Thorne receives royalties from Lippincott Williams & Wilkins (Philadelphia, PA) from textbook sales.
Funding
The author received no financial support for the research, authorship, and publication of this article.
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REFERENCE
1. Kang NV, Kerstein R. Treatment of Prominent Ears with an Implantable Clip System: A Pilot Study. Aesthet Surg J. 2016;363:NP100-NP116. [PMC free article]  [PubMed]