The most commonly reported adverse events were acute postoperative pain, swelling, and bruising of the ears. In all patients, these resolved by week 2 posttreatment with no additional intervention or medication. Most patients were able to return to work or school within 1 week.
Adverse Events Requiring Treatment
Adverse events that required additional intervention or treatment affected 39 patients (9.7%) (Table 2). Each patient experienced 1 adverse event related to 1 implant. These events included revision of the implant’s position (17 patients [4.2%]; 1.4% of implants), erosion of skin over the implant (15 patients [3.7%]; 1.3% of implants), and infection (7 patients [1.7%]; 0.6% of implants). There were no recorded episodes of bleeding, hematoma, adverse scarring, recurrence of ear prominence, or asymmetry at final follow-up. Moreover, no patient experienced a deformity as a result of Earfold implantation.
Conversion to Standard Otoplasty or Implant Removal
Five patients who experienced no adverse events (1.2%) elected to have all their implants removed at intervals varying from 3 to 34 months after treatment. Three of these patients (1 child and 2 adults) then requested conversion to standard otoplasty, and the other 2 (both adults) declined any further treatment. The reasons given for requesting complete removal were (1) concerns over the visibility of the implant (2 cases); (2) dissatisfaction with the outcome of treatment (2 cases); and (3) change of mind. Four of these patients had conchal bowl depths of > 16 mm.
The most common adverse event was a request to reposition the implant (17 patients [4.2%]; 1.4% of implants), usually due to excessive visibility of the implant under the skin (15 patients; an example is shown in Fig. 5). However, 1 implant was also repositioned to address residual asymmetry and another to address over-correction of the prominence. All cases were the result of technical errors at the time of implantation, comprising either a failure to ensure that the implant was flush with the cartilage when deployed or a failure to ensure correct alignment of the implant with the skin markings. All patients requesting revision underwent successful implant removal, repositioning, and redeployment. In all 17 cases, repositioning was carried out within the first 3 months after the initial treatment. Repositioning was especially straightforward when performed within 3 months of the original procedure—before the scar tissue had matured.
Erosion of the skin over the implant affected 15 patients (3.7%; 1.3% of implants); in each case, a single implant was involved (ie, 15 implants) (Fig. 6). The most common factors associated with erosion were concurrent or history of heavy smoking (5 of 15 cases) and previous standard otoplasty involving degloving of the anterior skin (4 of 15 cases). Most erosions occurred through the anterior skin, commonly at the upper pole where the skin of the ear is thinnest. One patient had erosion of the implant through the posterior skin. The only way in which this could have occurred is for the implant to have migrated through the cartilage. We speculate that this was the result of needle perforation beyond the extent that is necessary, resulting in cartilage morcellization. Patients affected by skin erosion were advised to have their implants removed immediately and to allow their ears to heal for 2 to 3 months before considering reimplantation. Patients were also strongly advised to stop smoking before considering any further surgery. Thirteen of the implants removed because of erosion were subsequently reimplanted with a successful final outcome. The remaining 2 patients declined to have the affected implants replaced and 1 requested conversion to standard otoplasty.
A total of 7 patients (1.7%; 0.6% of implants) experienced an implant-related infection (Fig. 7). Five of the 7 patients with implants that became infected were successfully treated with a short course of oral antibiotics, and the implants were left in place. However, 2 patients required implant removal because of infection. In both patients, the infections resolved after implant removal. After 2 to 3 months, both patients underwent successful reimplantation with no further complications.
To assess the durability of the results, pre- and postoperative helical-mastoid distances were measured in a subset of patients treated by the principal author (n = 121). The preoperative mean helical-mastoid distance was 27 mm per ear. Immediately after treatment, the mean helical-mastoid distance was 18 mm per ear (reduction from baseline, −9 mm, −34%). At the final follow-up visit, the mean decrease in helical-mastoid distance from baseline was −9.5 mm (−35%), indicating a stable reduction in ear prominence.
In this series of patients treated with Earfold implants, the overall risk of adverse events requiring treatment was relatively low (9.7%), and all adverse events were resolved with simple interventions. Importantly, patients who requested complete removal of their implants (for whatever reason) were able to convert to standard otoplasty without difficulty if desired. The absence of cases of recurrence of prominence or residual asymmetry after 30 to 48 months of follow-up compares favorably to results with conventional otoplasty techniques where revision can be common,5 , 7 , 8 especially with suture-based techniques. For example, knots may loosen and sutures may break or cheese-wire through the cartilage. These problems are largely overcome with the Earfold implant because the implant is fatigue resistant and does not loosen or shift position, once in place for > 4 weeks. In a subset of patients, measurement of the helical-mastoid distances at the final postoperative visit confirmed that the corrections achieved at the time of insertion were stable over time. We acknowledge that interpretation of this finding is limited, since the helical-mastoid distance was only measured in patients treated by the principal author. However, this concurs with the findings of our pilot study after 18 months of follow-up.1
The overall rate of adverse events needing intervention (9.7%) was comparable with or less than that observed with other techniques for prominent ear correction (Table 2).5 , 7 , 9 Rates of infection (1.7%) and erosion (3.7%) were comparable with the rates observed with conventional otoplasty surgery, especially suture-based techniques.3–5 , 7 It was also notable that skin erosions occurred mainly in patients who were heavy smokers or who had undergone a previous otoplasty procedure involving the anterior skin. Therefore, improvements in the rate of this adverse event could be achieved by asking patients to stop smoking before treatment and through careful attention to technique in revision cases. Complications such as bleeding, wound dehiscence, and hematoma did not occur in the present series, which concurs with our experience in the pilot study. In contrast to the pilot study, there were no cases of hypertrophic scarring in this series. We speculate that the absence of problems with scarring might be due to differences in the behavior of the anterior skin compared with the posterior skin. Importantly, when complications did occur, remedial action was generally simple, and all cases were successfully resolved.
The most common adverse event was the need to reposition the implant [17 patients (4.2%)]. In most cases, this followed patient or surgeon concerns about the visibility of the implant (15 patients). Repositioning was advised because excessively visible implants are at greater risk of eroding the skin, whereas incorrectly positioned implants may fail to achieve the degree of correction agreed upon during preoperative assessment. To reduce the risk of visible or palpable implants, users of the Earfold system are advised to practice implant deployment using dummy silicone ears, which are provided by the manufacturer for this purpose. Intraoperatively, surgeons are advised that if the implant can be felt or seen easily through the skin then it should be removed and a new implant should be redeployed that is flush with the cartilage.
Advantages and Limitations of the Earfold Implant
Because implantation of the Earfold implant is quick, it is feasible to treat all or most patients (even children as young as 7 years of age) under local anesthesia. Typically, operating times range from 5 to 20 minutes—depending on the number of implants inserted. This compares favorably with American Society for Aesthetic Plastic Surgery data indicating that a standard otoplasty procedure takes an average of 2 to 3 hours.10 Similarly, removal of Earfold implants is quick, although we acknowledge that it is faster and easier to remove an extruding suture than an implant if a problem arises. Finally, training in the use of the Earfold system is simple, without the need for the very long learning curve associated with standard otoplasty surgery.
The Earfold system is not a replacement for conventional otoplasty and is only intended for use by surgeons already experienced with standard otoplasty. Surgeons should be mindful that Earfold is simply a tool for achieving a particular objective—to enhance a preexisting anthelical fold or to create one where this did not previously exist. Specifically, Earfold is not designed to address prominence related to a deep conchal bowl and using Earfold alone to treat patients with a deep conchal bowl can sometimes be problematic. Our data underline some of the difficulties encountered when trying to use the Earfold system alone to treat prominence associated with a deep conchal bowl, since 4 of the 5 patients who requested removal of all of their implants had a conchal bowl depth of > 16 mm. Nevertheless, there were also 32 patients in this series who had conchal bowl depths of > 16 mm who appear to have had satisfactory outcomes when using Earfold alone. It is possible to use the Earfold system to achieve some reduction in the conchal bowl depth by rolling part of the lateral wall of the concha into the new anthelix. Indeed, some patients prefer to compromise on the degree of reduction in conchal bowl depth achieved using Earfold because of the faster postoperative recovery compared with standard conchal reduction surgery. However, based on the first author’s experience, patients with a conchal bowl depth of > 16 mm for whom preoperative assessment with Prefold positioners has confirmed that reduction of their conchal bowl depth is inadequate for their aesthetic needs, should not be treated with Earfold alone. Instead, they should either consider treatment with Earfold combined with conchal reduction or proceed to standard otoplasty.
These clinical considerations emphasize the need for careful preoperative assessment with Prefold positioners to determine whether a patient is suitable for treatment with Earfold implants alone or whether the patient may benefit from other methods of correction or from a combined approach (eg, using Earfold combined with conchal reduction). It is also the preoperative assessment that makes it possible to determine how best to position the implant(s) to accommodate the wide variety of ear shapes and cartilage stiffness that may be encountered. Although the implant is manufactured with a preset shape and tension, the final shape adopted by the implant, once deployed, is not the same in every ear or in every position within the same ear. Instead, the final shape of the implant depends on the complex interplay between the stiffness of the implant and the stiffness of the cartilage at each specific position in the ear. These patient-specific effects can be predetermined through trial and error before surgery is attempted through the careful use of Prefold positioners. The positioners are highly predictive of the final outcome because they are identical to the Earfold implant in terms of shape, size, and tension. Therefore, once the surgeon and the patient have agreed upon a final position for the implants (using Prefold), there is no need for any further adjustment once the Earfold implants have been deployed in the ear because the shape created by Earfold will have been anticipated preoperatively through the use of Prefold. Finally, it is worth noting that the anthelical fold produced by Earfold implants can sometimes appear more tubular (Fig. 4) than that achieved using suture-based techniques. However, in practice, we have had no requests for revision for this reason.
This was an interim safety analysis of 403 patients who were treated with the Earfold system, and only 36% of the patients returned for a final postoperative visit, with a mean of 7.7 months of follow-up. Although it is reasonable to assume that patients who did not return did not encounter an adverse event, we cannot be certain that the outcome in such patients has been entirely satisfactory. Moreover, with the relatively short average follow-up time, the ability to assess patients for late complications, such as recurrence, secondary deformity, or possible device failure or shift in position, was limited. To obtain full information regarding long-term safety of the Earfold implant, we plan to extend safety monitoring for the entire cohort to > 5 years. Furthermore, pre- and postoperative photographs were not obtained systematically; the photographs shown in this article are intended for illustrative purposes only. Finally, the data collected relate to 7 surgeons with varying levels of experience with the Earfold system. Although this may have had an effect on the number of adverse events for each surgeon, analysis of the individual adverse event rates (data not shown) does not support this view. The adverse event rate for the principal author, who has performed the most cases, is currently higher than the overall rate, although this may reflect the larger number of difficult cases he has performed (especially in patients with a deep conchal bowl).
The Earfold prominent ear correction system is a new treatment option for the correction of prominent ears in cases where prominence is primarily related to a poorly defined or absent anthelical fold. It is intended for use by surgeons who are already comfortable with standard otoplasty techniques. This interim analysis of 403 patients indicates that the safety of the Earfold implant is generally acceptable, with relatively few adverse events that required intervention. Continued follow-up of this patient cohort to > 5 years will help to provide long-term safety information.
The authors thank Karen Dougherty, PhD, of Peloton Advantage for editorial support, which was funded by Allergan plc, Dublin, Ireland. The authors thank their patients for their assistance and cooperation with this study. The authors also acknowledge the advice and support of Michael Silberberg, MD, MBA, from Allergan plc.
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