What is your opinion on the use of earFold implants for otoplasty?

Question

My surgeon says they wouldn't work because cartilage cannot be moulded after three months and that the implant would fall off anyway...

Walid Sabbagh, FRCS (Plast) · Answer

The earFold is a very clever invention. It works by recreating the antihelical fold (the curved prominence of cartilage parallel with the rim of the ear). It is effective and simple to insert. The outcome can be predicted by using the the Pre-Fold implant over the skin and this is a very helpful tool.
The earFold, however, is not effective for all ears. This is because the mechanism of the earFold is to fold the cartilage where the antihelix should be. In some ears the prominence is partly because the conchal bowl (concavity of the ear) is very stiff and sticks out. This cannot be corrected by the earFold. Also, even if the cause of the prominence is the lack of an antihelical fold, the earFold may not give the best possible cosmetic result as it only has one strength and its effect is not the same in all ears.
If you are interested in the earFold you should see a Surgeon who offers both the earFold as well as suture based ear pinning. The latter is safe, precise and can be performed under local anaesthetic (Bandages are optional and only for a few days). The advantages and disadvantages of both procedures should be explained to you. If the pre-Fold produces a good cosmetic appearance to your ear then I would recommend it otherwise you should opt for pinnaplasty using stitches.

Nilesh Sojitra, MSc, FRCS (Plast) · Answer

I have to completely agree with Norbert Kang and stress that as a group having done over 3000 implants our data and knowledge is ever increasing.for appropriately selected patients this is a fantastic procedure.the 'stitch' method is not novel and is essential an otoplasty using sutures with the risk of recurrence that goes with standard suture based otoplastic techniques.all the best Nilesh SojitraLondon

Norbert Kang, MD · Answer

As of September 2014,  my colleagues and I have treated >450 patients, mostly in the United Kingdom (where I am based) but also in Croatia.  These patients have provided us with a reasonable database on which to form our opinions on the effectiveness of treatment, indications for treatment and risks of treatment with earFold.

Dr Hunsacker is partly correct that there is no good method for moulding human ear cartilage after infancy (i.e beyond the age of 5 years).   The data we have, so far, from using earFold supports this view in adults.  In my opinion, once an individual reaches the age of 14 - 15 years, the ear cartilage behaves like adult cartilage.  However, our data suggests that there is still a partial moulding effect in children (i.e. less than 15 years) with earFold.  Moreover, we have found that there is an enhanced moulding effect using earFold if it is combined with a procedure to weaken the cartilage - and this applies to both adults and children.  Furthermore, the effect is time-dependent.  In other words, the longer you leave the earFold implant in place, the greater the level of confidence you have that the moulding effect is permanent.   This means that there is a good chance that we can take the implants out after a few years (especially in children) and expect that the ears will not change position by very much.  Unfortunately, in adults, the only way of guaranteeing that the shape does not change at all is to leave the implants in place permanently.

Dr Merck has also raised a number of important points about earFold which I am in a position to answer.

1) It is true that treatment with earFold will leave small scars on the front of the ear.  However, incisions on the front of the ear (generally) heal very well and in the majority of patients, these are largely inconspicuous since they are (typically) only 8-10 mm long.

2) The earFold implant is made of nitinol - a metal alloy which is also used for coronary artery stents and dental braces.  The key properties of the alloy are its super-elasticity and its memory effect.  In other words, it will always return to its original shape after being compressed or flattened.  It will also remain elastic forever.  Therefore, we have yet to experience a case of recurrence of prominence - while the implants remain in place.  Moreover, there are no concerns about loss of shape if the patient lies on their ears or engages in other activities (e.g. wearing a hat or helmet).  The implant and your ears will always return to the intended shape.

3) In our experience, earFold can be used to correct a deep conchal bowl.  However, the surgeon must be experienced in the use of earFold to achieve this effect and it is not always possible to correct every case of prominence due to a deep conchal bowl.  Therefore, we sometimes combine treatment of a conchal bowl (by excision or reshaping) with earFold for the rest of the antihelical fold.  Importantly, the earFold treatment system includes the use of preFold locators which allow both the patient and the surgeon to plan their treatment in advance of surgery.  This allows both parties to avoid an unwanted outcome in advance of treatment.

4) The earFold implant can be visible under the skin in some patients with very thin skin.  However, in the majority of patients, especially if the implant is placed correctly, the earFold implant is largely inconspicuous.

5) We have not yet had any patients requesting removal of their earFold implants due to intolerance.

6) The number of patients treated with earFold continues to increase every day.  We have not yet reached the same numbers as those treated by Dr Merck because we have not been available for the same length of time.

The main advantages of earFold over other forms of treatment for prominent ears are:
a) Predictability - through use of preFold locators during the initial assessment
b) Quick (typically 15-20 minutes to insert 4 implants - 2 per ear).
c) Quick recovery
d) Reversibility (if you really do not like the outcome, we simply remove the implants - as long as removal is carried out within the first 3 months)
e) No head-bandage
f) Local anaesthetic procedure

Robert H. Hunsaker, MD · Answer

Thus far, the science does not support the alue of trying to mold cartilage after infancy. Neither does the experience support it. Until their is good evidence of a mothod that predictably and permanently owrks, I would not recommend exploring those options.

Waldemar Merck, MD · Answer

There has not been enough long-term experience of the EarFold implants up till now.There is another minimally invasive ear pinning method, the so-called stitch method, that is even less invasive than the Earfold surgery. Compared to the Earfold surgery, the stitch method has the following advantages:1.Incisions on the front of the ear are not necessary by the stitch method; there are only stitch points, in contrast to incisions, that always heal without scars.2.There is the question whether the metal implant of the EarFold method is bent when lying on the ear, thus causing the ear to return to its original position. With the stitch method, the position of the ears is not changed if one lies or sleeps on them.3.With the Earfold surgery, a large cavum conchae must be reduced by the excision of cartilage, i.e. it must be combined with a traditional method. This is not necessary with the stitch method.4.With the EarFold Surgery and in patients with thin skin, the metal colour can be visible through the skin even if the implant itself is not prominent.5.If the metal implant has to be removed due to intolerance, you must count on the ear returning to its original protruding position.6.The occasionally observed sensitivity problems with the EarFold method do not occur with the stitch method.7.With the stitch method, there are meanwhile long-term results over a time period of 18 years based on more than 8000 operated ears. With the Earfold surgery, there is only a limited experience of less than 100 ears over 2 to 3 years.

What is your opinion on the use of earFold implants for otoplasty?

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