Mr David Gault is the inventor of Ear Buddies™, a method of correcting prominent ears without the need for surgery. Here he describes how moulding can be used in the place of surgery to correct this common condition during childhood.
Advances in surgery filter down slowly, but eventually, and if they are good, they change the way we all practice. We now insert coronary stents rather than pore for hours over vein grafts, and the appendix can be removed through the mouth using an endoscope. Time will tell, but for the time being, appendicectomy is a standard first operation for junior surgical trainees, and one of the first procedures they do alone. Setting back the ears remains plastic surgery's appendicectomy, but is it really safe, and why are we not avoiding it altogether when non-surgical correction has been around for over 20 years?
Surgery to set back prominent ears (pinnaplasty) is the most common paediatric plastic surgical procedure in the UK. About 5% of the population have ears which stick out more than 20mm from the side of the head, although in a recent study, over 20% of adults admitted embarrassment about the shape of their ears to the extent that it affected their hairstyle or their behaviour.
Teasing is the most common reason for surgery in children, but pinnaplasty is best delayed until at least the age of five, when the cartilage has hardened sufficiently to hold the sutures, but many children are already being teased by this age. The other notable groups who come to surgery are those whose prominent ears prevent them from wearing hearing aids, and adult males, often motivated by the onset of hair loss. Pinnaplasty is perceived as a simple procedure by doctors and the public alike. My own organisation, the British Association of Aesthetic Plastic Surgeons (BAAPS), states on their website that "the vast majority of patients....are well pleased by the result, and the procedure has a high satisfaction rate" but a detailed review shows a steady incidence of problems.
Well-acknowledged complications are pain and discomfort 4%, recurrence (ears sticking out again) 7%, haematoma (a collection of blood beneath the skin) 1%, infection 1% and keloid (raised and itchy) scars 1%. However, some surgeons have a haematoma rate of over 10%, and whilst this is bad enough, every now and then a haematoma becomes infected. The resulting chondritis (a serious inflammation of the cartilage framework of the ear), can cause a devastating deformity of the ear. Of the ears that have presented to me at the London Centre for Ear Reconstruction over the last three years, about one quarter resulted from failed pinnaplasty surgery. In some of these patients, a complete autogenous (using the body's own tissues) reconstruction of the ear is needed. Some adult patients, especially men, become reclusive and never work again. From a much anticipated minor op in the school holidays, a child is catapulted into major 4-6 hour surgery involving the removal of a rib and a week's stay in hospital. Whilst it is true that those that are pleased are very well pleased, those that are not are often devastated.
There are a number of surgical techniques in use, but of the cases in which I have acted as an expert in a medico-legal claim for failed pinnaplasty, ALL have resulted from use of the 'anterior scoring technique', where the cartilage framework of the ear is scored. This requires some explanation. The cartilage framework is 'scored' as you would the fat on a pork joint, to weaken it so that it can be bent into a better shape. Occasionally, bleeding continues after surgery, and the collection of blood beneath the skin becomes infected, causing loss of tissue. Despite this, 'Scoring' remains the most commonly used technique in the UK. Plastic surgery trainees cut their teeth on it, but some of the most accomplished and reputable surgeons also fall prey not because they failed to carry out the technique well enough but that the technique failed them, given enough opportunity.
Neonatal moulding of ears has been around for at least 20 years, but early splintage has yet to become routine despite excellent results and few complications. Controlling the very soft cartilage of a newborn ear using a splint can reshape it as it hardens over the first few months of life, such that prominent or otherwise deformed ears are cured within a few weeks, but the technique is underused. Indeed, what is worse, it is not unusual for a concerned parent to seek advice about their baby's ears only to be told to "leave well alone", or to "allow it to settle", when common sense would dictate that, if this were true, no infant would grow up to need surgery. When one of my own children was born with a misshapen ear, I developed Ear Buddies™ splints.
There are great advantages in splinting to correct ear deformity. There is no teasing to prompt a referral for surgery. The cost of splinting is a mere fraction of the cost of surgery at £50 versus at least £800 within the NHS, assuming that funding is available, and around £4000 including surgical, anaesthetic and hospital fees for a general anaesthetic, day case stay in private practice. Almost 98% of splintage is performed by the parents themselves. Anaesthesia is not required, nor surgery, nor admission to hospital, nor is there a risk of post operative complications. The only down side is that a precious long-awaited infant has some tape applied to the ear to hold a splint in place. A little hair might require shaving if it is abundant or the baby is older. All is easily camouflaged by a mother-in-law-friendly hat.
Neonatal moulding can correct over 97% of all external ear deformities, including all folding deformities of the ear (stick-out ears, rim kinks, lop ear, Stahl's bar) and cryptotia (a hidden ear - a condition in which the ear, particularly the top or upper pole, is hidden beneath the skin of the side of the head). Although the speed at which the ear cartilage hardens after birth is variable, it begins in all babies with the withdrawal of maternal oestrogens. Successful splintage requires the cartilage to be soft enough to be remoulded, and then to become hard enough to maintain the new shape. In most babies, this period is shortest in the first few weeks of life.
Correction of the neonate's ear is especially straightforward. In addition to a favourable moulding/hardening profile, newborns do not have the dexterity to dislodge ear splints, the head is mostly still, and the skin sweats little so adhesive tapes stick well. Thus, early splintage is better tolerated by parent and child alike.
The main ear deformity encountered is prominence. However, only two-thirds present at birth and some arise or are made worse by external deforming forces from, for example, the head cosies of car seats or high-collared clothing. In these children, splintage is both prophylactic and curative. More parental persistence is required is older babies, however, and certainly, where there is a family history of late presentation of bat ears, or where the antihelical fold is absent, there is a case to be made for prophylactic splinting at birth. Splintage is especially important in children likely to need a hearing aid, since a well-developed antehelical fold is required as a supporting pillar. Likewise, in cases of Stahl's bar, splints are almost universally successful whereas surgery is unpredictable.
Another variable is delayed hardening of the cartilage, which can relate to breast-feeding. Such ears are especially susceptible to being pushed forward when sleeping, for example, and parents report that the ears are bent forwards at night. Splintage is again indicated, but extra patience is required to ensure that the cartilage is sufficiently patterned by the moulding to give a permanent benefit. A "wibble-meter" to test such malleability would identify susceptible ears for early splintage more reliably, and would also identify those not yet "cooked".
The benefits of the introduction of Ear Buddies™ splints into the UK in 1996 may already be showing in statistics. Despite an increase in most types of aesthetic procedures, pinnaplasty rates have not followed, and in some studies, in Scotland, for example, rates have decreased. Ear splintage is increasingly audiology-, nurse- or occupational therapist-led and this is to be encouraged. In some UK units, such as The Portland Hospital, it is now almost routine to check the ears to see if splints are required, but this is an exception.
Off-label use of wires and tubing not manufactured for the purpose risks a variety of unforeseen complications, and liability insurance should be first checked with the relevant authorities in each country. In the UK, advice from the MHRA is as follows:
As well as the possible risks to the patient and user, there is the potential for litigation against the hospital or healthcare professional. Liability for off-label use rests with the user, not the manufacturer of the medical device or product in question. Healthcare professionals should also be aware that the modification of a medical device (other than those sanctioned by the instructions for use) may lead to the healthcare professional becoming the manufacturer of a new device and thus subject to the requirements of the Medical Devices Regulations.
The use of metal cores within clear plastic tubes in patients undergoing phototherapy is a particular hazard.
As surgeons, we need to be as sure as is possible that we, at least, do no harm. We look out for clicky hips and instigate measures to limit the consequences, and ears should be treated the same way. Pinnaplasty complications are common and sometimes devastating, and the less surgery is required, the better, so that it is a last resort, rather than a first. This certainly resonates with parents, who dislike the idea of waiting until the child is at least five years of age for a surgical fix. I believe that it is both desirable and possible to drastically cut the need for pinnaplasty such that it is a rare event in the UK, Europe and the USA by 2030.
- Complications of otoplasty: a literature review. GC LImandjaja, CC Breugem, AB Mink van der Molen, M Kon. JPRAS 2009, 62, 19-27.
- Ear reconstruction following severe complications of otoplasty. F Firmin, C Sanger, G O'Toole JPRAS 2008 61, S13-S20.
- Calder JC, Naasan A. Morbidity of otoplasty: a review of 562 consecutive cases. British Journal Plastic Surgery 1994; 47: 170-174.
- Chan LKW, Stewart KJ. Pinnaplasty tends in Scottish Children. JPRAS 2007; 60: 687-9.
- Medical and Health Care Products Regulatory Agency document MDA/2004/006 issued 2nd February 2004