The Long-term Results of Earfold Implantable Clip for the Correction of Protruding Ears: A Plastic Surgeon's Experience with an Initial 19 Cases

Abstract

Objectives:

This article reports the long-term results of the minimally invasive Earfold™ device.

Methods:

Between May 2017 and January 2021, 19 patients (7 men and 12 women) received an Earfold™ implant. Fifteen patients had bilateral implants placed, and among them, 2 received 2 implants per ear. In 4 cases, placement was limited to one ear. In one patient, a concurrent earlobe correction was performed.

Results:

Of the 22 patients assessed with Prefold™, 19 chose for this option instead of surgical otoplasty, 2 chose not to undergo any surgery, and one was not found fit for the procedure by the surgeon. Six patients suffered from a complication and had their implants removed. One additional patient requested to have his implants removed as well.

Conclusions:

The Earfold™ implant is a promising, minimally invasive alternative for standard otoplasty treatment. Nevertheless, in our series, a notable high complication rate was observed, often necessitating implant removal, particularly in the long term. Despite recognizing a learning curve, the surgeon in this study chose to discontinue the use of Earfold™ implants.

Introduction

Protruding ears occur in about 5% of the Caucasian population¹⁾ and frequently arise as a result of an underdeveloped antihelical fold and conchal fossa hypertrophy²⁾. Aesthetic plastic surgery for this indication is widely accepted, even in children, as it improves social anxiety and self-confidence^3,4).

Traditionally, the surgical approach is based on the anatomical characteristics of the protruding ears and can be achieved in a cartilage-sparing (i.e. suturing) or cartilage-sculpting (i.e. incision or scoring) manner, or a combination of both⁵⁾. The antihelical fold is generally corrected by using sutures or cartilage scoring⁶⁾, whereas excision or plication of cartilage and concha-mastoid sutures can be applied to correct an enlarged conchal bowl⁷⁾.

Although patients generally report high levels of satisfaction and enhanced health-related quality of life, notable complications can arise with standard otoplasty^5,8,9). Anterior scoring techniques are more and more abandoned by plastic surgeons, as complication and recurrence rates were higher, in addition to less satisfactory aesthetic outcomes, when compared to conventional otoplasty¹⁰⁾. Efforts to lower complication rates, expedite recovery, and streamline surgical procedures have led to the description of minimally invasive otoplasty techniques^11-15).

A recent minimally invasive method for antihelical fold correction has been introduced, involving a subcutaneously placed clip implant on the anterior side of the ear. This Earfold™ (Allergan plc, Dublin, Ireland) implant system, invented by Norbert Kang with the publication of initial safety data in 2016, is constructed from a nickel-titanium alloy (nitinol) coated with a thin gold layer to diminish implant visibility¹³⁾. Upon release, the Earfold™ grips auricular cartilage, reshaping the antihelical fold addressing ear protrusion.

The Earfold™ could be a valuable alternative to traditional otoplasty due to its suggested benefits such as short procedure time, outpatient surgery, expedited recovery time resulting in shorter work absence, the elimination of postoperative bandages, and lower recurrence rates^13,16). Furthermore, the outcome of this surgery is highly predictable as patients and surgeons are able to predetermine implant positions and effects using Prefold™ (Allergan plc, Dublin, Ireland) positioners, which have identical properties as the Earfold™ implant except for the tines before surgery¹³⁾.

This publication reports initial results and long-term observations of this new implant performed by a single plastic surgeon.

Methods

A retrospective review of all patients who underwent Earfold™ implant placement by a single plastic surgeon between May 2017 and January 2021 was conducted. Beforehand, the surgeon underwent official Earfold™ training before proceeding to use the implant independently. Demographics, clinical outcomes, complications, and follow-up data were gathered from written patient records.

Patient selection

Patients who consulted with protruding ears with an absence or poor definition of the antihelical fold were presented with the option of the Earfold™ technique. If patients consulted for correction of protruding ears without getting Earfold™ implants, they were excluded from this study. Using the Prefold™ positioners during preoperative assessment, the effectiveness and patient expectations were determined. If the patient and surgeon were unable to achieve a satisfactory enhancement through Prefold™, alternative corrective options for protruding ears could then be presented to the patient. In order to be able to compare effectiveness of Prefold™ and Earfold™, photographs were taken preoperatively (without and with Prefold™ clips) and postoperatively at the time of the first follow-up; however, these were not systematically acquired (Figure 1).

Figure 1.

(a) Initial situation before surgery, (b) preoperative assessment using Prefold^TM, (c) 6 weeks after Earfold^TM implant placement.

Surgical technique

Patients who decided to receive the Earfold™ implants underwent surgery under local anaesthesia in an outpatient setting. Every procedure was conducted in the following steps.

• Prefold™ were placed on the auricle to create an aesthetically pleasing antihelical fold, and its edges were marked on the skin.

• Broad disinfection of the ear using Hibidil 0.05% and placement of surgical drapes.

• Local infiltration and hydrodissection of subperichondrial pocket with xylocaine 1% with adrenaline.

• Small anterior incision on the anterior inner side of the helix.

• Sharp dissection in the subperichondrial plane unto the antihelix.

• Insertion of the Earfold™ introducer into the subperichondrial pocket.

• Verifying alignment of the introducer with the marked area.

• Device deployment and appliance of firm pressure to reach cartilage gripping.

• Slow removal of the introducer while maintaining firm pressure to the implant.

• Gradual release of ear so that the clip could curl and create the antihelical fold.

• Monofilament 6/0 sutures.

• Closure with interrupted Ethilon 6/0 sutures and paper sutures.

• Pressure bandage for 2 hours postoperatively.

Postoperative advice and follow-up

Patients who underwent Earfold™ treatment were discharged on the same day of the surgery and did not need to wear a head bandage at home. For 3 to 4 weeks following the procedure, patients were advised to avoid contact sports and swimming to prevent accidental contact with the healing ears. Additionally, to prevent infection, cell phone usage, earplugs, helmets, and earrings in contact with the treated ears were not recommended, or, if necessary, to be used with extreme caution, keeping them away from the incision sites, until the wounds were fully healed. Patients were allowed to shower immediately after the procedure. To reduce the risk of dislodging the implants in the first few weeks after the procedure, patients were recommended to avoid sleeping on their sides. Every patient was seen at a routine follow-up appointment at 1 week and again at 6 weeks postoperatively and was advised to return in case of concerns about the outcome of treatment.

Results

Patients' demographics and follow-up

Nineteen patients (7 men and 12 women) were treated using Earfold™ between May 2017 and January 2021. Patients' ages ranged from 9 to 84 years, with a median of 24 years. The study included 16 adults (aged ≥16 years) and 3 children (aged 9 to 14 years). Only one patient was an active smoker at the time of treatment or any time after. Median follow-up time was 6 months (range 6 weeks to 69 months) with a return for follow-up rate of 73.7% (n = 14). Ten patients had a follow-up time of at least 3 months. A total of 38 implants were placed to treat 34 ears, on average 2 implants per patient. Four patients received unilateral placement of 1 implant. Two cases were treated with 2 implants per ear.

Of twenty-two patients preoperatively assessed using Prefold™, one was advised not to undergo the Earfold™ procedure because of a deep conchal fossa and received a standard otoplasty using the Mustardé technique, and 2 declined treatment without opting for a standard surgical alternative.

Side effects

Commonly reported side effects encompassed ear pain, swelling, and bruising. Surgical discomfort typically diminished within 24-48 hours, necessitating only basic pain relief such as acetaminophen or ibuprofen. Every patient experienced some degree of swelling or bruising shortly after treatment which resolved within 7 days postoperatively for all individuals. None of the patients were asked to wear a head bandage after discharge, and the majority of patients resumed work or school activities within a week.

Complications

Six patients (2 children and 4 adults), approximately 31.6% of the sample, experienced 1 complication related to 1 of their implants.

Two adults suffered from erosion of an implant through the overlying skin; each case involved a single implant (Figure 2). These extrusions occurred at 22 and 69 months after the initial implant insertion. Both patients were advised to have the implants removed to reduce the risk of infection, and one received an antibacterial ointment.

Figure 2.

Two cases of the Earfold^TM implant in which erosion through the overlying skin occurred.

Hematoma occurred in 2 patients (14 and 16 years of age) and required an evacuation of a blood clot without implant removal.

Infection affected 1 implant of an adult patient. This case was treated with oral antibiotics and antibacterial ointment. However, it was decided to remove the implants bilaterally once the infection was resolved.

Furthermore, one patient suffered a traumatic injury affecting the auricle, which exposed 1 of 2 implants on that side one year after initial placement (Figure 3). Hereupon, an infection occurred, which was treated with oral antibiotics and took several months to resolve. Another year later, it was decided to remove the implants on the affected side.

Figure 3.

Earfold^TM implant exposure following traumatic auricular injury.

Among our participants, no hypertrophic scarring or “Spock-ear” formation was reported.

Revision and removal

Prominent implants were reported in 7 patients. We encountered 2 cases of implant extrusion, both of which had implant prominence on the contralateral side. A high reticulated hyaluronic acid filler was injected to conceal the implants in 6 cases, one of these cases required multiple injections at different appointments to completely cover up the implants.

In 3 cases, additional otoplasty was conducted to reach an optimal aesthetic outcome. One adult and one child had a unilateral upper pole prominence which was then corrected, one adult had a deep conchal fossa which was resected.

When we collected our data for this retrospective study, a total of 10 implants (26.3%) were removed from 6 patients: 5 cases in which a complication occurred and 1 case where the implants were prominently visible. The interval between initial implant placement and removal ranged from 4 months to 69 months (median 37.5 months).

Discussion

Given the relatively small sample of patients, we recognize that this report presumably represents an early insight into the results of this new procedure. Nevertheless, considering the scarcity of independent reports on the outcomes of Earfold™ implants^16,17), it is important to contribute a more comprehensive picture of the long-term results of this technique to fellow plastic and aesthetic surgeons who might consider using the device.

Although we can acknowledge Earfold™ being a quick and minimally invasive procedure, the overall complication rate in our study was relatively high at 47.3% of patients and the reoperation rate at 42.1% compared to previous Earfold™ studies (Table 1)^13,16-18). However, the follow-up time in our study was longer than in most other studies and might therefore suggest more complications in the long term, which is demonstrated by 5 of the 6 implant removals that took place at least 23 months after initial placement. Schuster¹⁷⁾ and Honeyman et al.¹⁶⁾ previously stated the Earfold™ technique requires a different learning curve and set of technical skills, even for experienced otoplasty surgeons, and we concur. Executing more procedures may lower the complication rate as the study from Kang et al.¹⁸⁾ suggests with its larger sample. In spite of that, the author decided not to continue placing these implants as of February 2021, as complication rates were noticeably higher than with standard otoplasty and outweighed the advantages. Before this date, only 2 patients had their implants removed. Four more cases required or requested removal at a later point in time.

Table 1.

Summary of Earfold^TM Complications and Follow-Up Time in Different Case Series.

Series	Number of patients	Haematoma and/or bleeding (%)	Infection (%)	Implant extrusion (%)	Keloid and hypertrophic scars (%)	Recurrence of prominence (%)	Reoperation to correct a problem (%)	Overall complication rate* ≤6 months (%)	Overall complication rate* >6 months (%)	Follow-up time (months), mean (range)
Current study	19	10.5	10.5	15.8	0.0	0.0	42.1	15.8	47.3	14.4 (1-69)
Honeyman et al.16) (2020)	36	0.0	0.0	8.3	0.0	0.0	22.2	8.3	22.2	4.8 (1-13.3)
Kang et al.18)(2018)	403	0.0	1.7	3.7	0.0	0.0	4.2		9.7	7.7(1-34)
Schuster17) (2018)	19	0.0	21.0	10.5	0.0	0.0	26.3		42.1	6(1-15)
Kang and Kerstein13) (2016)	39	0.0	5.1	12.8	5.1	0.0	15.4	10.3	20.5	17(3-47)

*all patients who reported a complication and/or needed revision surgery.

As opposed to other series, we encountered 2 cases of haematoma formation in younger individuals (14 and 16 years of age), following the procedure without apparent cause. Perhaps perforating branches of the auricular branch of the posterior auricular artery of these patients were damaged during the dissection of the auricle or placement of the clips. Prominent implants were seen in 36.8% (n = 7) of cases. Visibility of the implant's edges could be reduced by hyaluronic acid filler injections in most cases. Two cases who did not receive filler injections for the visible clip also experienced unilateral implant extrusion after more than 1 year (22 and 69 months). This reinforces the belief that there might be a connection between implant prominence and skin erosion over the implant^13,17). According to these authors, to reduce implant prominence and extrusion, the Earfold™ clip should be aligned perfectly with the cartilage during insertion. Neglecting to ensure the clips are flush with the cartilage can result in increased visibility and skin erosion. The objective is to make sure no edges can be palpated intraoperatively, or the implant should be removed and replaced with a new one¹⁸⁾. With this knowledge, it should be feasible to further diminish the erosion rate through increased experience and training in implant utilization. However, even when implants are aligned with the cartilage, their contour tends to be discernible as a mildly elevated area¹⁷⁾. Patients should be informed of this phenomenon before undergoing treatment. Implant-related infection arose in 2 cases, of which one followed after a traumatic injury exposing the implant. Both patients were treated with oral antibiotics, and implants were removed afterwards when the infection was cleared. However, it might be unnecessary to remove every infected implant if the overlaying skin remains closed.

In their pilot study, Kang and Kerstein¹³⁾ describe the occurrence of a small moulding effect after removal of the Earfold™ implant within 18 months and suggest permanent moulding after longer periods of implantation. We also observed a moulding effect in the individuals who got their implants removed, especially when implants were left in place for several years. None of them needed additional otoplasty to improve aesthetics. The idea arose that this procedure might be addressed through a two-step approach, involving the systematic removal of implants after a specific period. This approach could potentially prevent long-term complications.

As data were collected in retrospect, we strongly depended on the accuracy and completeness of existing records. Furthermore, the study encountered a loss to follow-up in some individuals. We find it reasonable to assume that patients who do not suffer from adverse events related to the implant have little to no reason to return after the initial few follow-up visits, although we cannot assert with absolute certainty that the results have completely met the expectations of these patients, and complication rate might be underestimated. Additionally, the collection of pre- and postoperative photographs lacked a systematic approach. The images presented in this article are solely for illustrative purposes. Ultimately, the collected data depict a single surgeon's results and may lack the breadth of viewpoints and expertise a multi-surgeon study can offer.

Conclusion

In summary, the Earfold™ technique, which involves a minimally invasive implantation of preformed clips to create an antihelical fold, is a fast and predictable procedure in patients with prominent ears. Patients recover quickly with minor swelling at the implantation site and do not require postoperative head bandages. A high complication rate was observed executing this procedure, often requiring the removal of implants, particularly in the long term, which suggests factors like mechanical irritation should be considered besides the surgery-related complications. This operation should therefore be performed only by surgeons with experience in standard otoplasty and its complication management. It is crucial that implants are placed flush with the cartilage to minimize clip visibility and risk of extrusion. Patients should be informed that clips could be visible to some degree. Although the surgeon in this study acknowledges the presence of a learning curve, he decided to discontinue using Earfold™ implants. More long-term data are necessary to further evaluate the long-term effects of this technique. Hybrid techniques, combining Earfold™ with other surgical approaches to correct prominent ears, should be performed with caution, but might offer better aesthetic outcomes in certain cases.

Author Contributions J.P. conducted the literature search, formal analysis, data curation, writing, reviewing and editing of the original draft, and visualisation.

B.C. contributed to the conceptualization, methodology, resources, data curation, writing, review and editing, and supervision.

Conflicts of Interest There are no conflicts of interest.

Ethical Approval As a retrospective study, no ethical approval was necessary.

Consent to Participate The authors certify that they have obtained all appropriate written patient consent forms. In the form, the patient has given his consent for his images and other clinical information to be reported in the journal. The patient understands that their name and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.