The PMFA Journal and Hamilton Fraser Cosmetic Insurance have teamed up to provide a series of articles that will give examples of claims that occur from different procedures.
The case in question
The patient underwent VASER to the abdomen and thighs, but post treatment advised of burns and uneven results. The difficulty with this was that the burns that presented themselves were external but with the nature of the technique any burns should be internal. The questions were raised as to what the patient did post treatment in respect to following the aftercare instructions and whether this was as a result of the actual treatment itself or some other interference such as an external skin tightening procedure.
Post treatment there were unsightly scars and bruising along with wound infection from where the probe had been inserted. The patient also alleged that the garment provided to them to wear post treatment was the wrong size and too tight which meant they could not wear it and instead of returning to the clinic they waited until their review appointment to seek advice.
The patient then went on to have remedial treatment with another surgeon to manage the situation but the patient was left with permanent scarring and disfigurement.
Vibration amplification of sound energy at resonance (VASER) liposuction is a minimally invasive procedure, performed under local anaesthetic, IV sedation or general anaesthesia. A small probe is used to transmit ultrasound energy which can selectively liquefy fat cells prior to removal through a gentle suction process. The VASER technique has to be differentiated from Smart lipo on the one hand and Laser lipo on the other, and you can throw in Ultrasonic lipo as yet another variation on the theme. The theme being disruption of the lipo-architecture with subsequent liquefaction to allow the removal through negative pressure (suction). There are differences in the power and modality to create the lipo destruction and these will be reflected in the cost, duration, side-effects and outcome of treatment.
With the VASER, a probe is inserted into the fatty deposits and ultrasonic waves are created that disrupt the fat containing cells but leave other structures such as blood vessels and nerves intact. In principle and in practice, with a highly experienced operator, this is a very safe and effective way of producing a sculpting effect that does make it a highly sought-after procedure. The problem is that, although an experienced operator will make it look like a relatively simple procedure, it is not. The operator needs a high aesthetic sense to create the sculpted shape the patients desire but this has to be done in the context of a three dimensional awareness of the location of the ultrasonic probe, the direction of advancement, the resistance of the tissues and the duration of probe being stationary at any moment of time.
The ultrasound waves are created by a transducer. The waves will radiate out from the transducer and in the process the tip will heat up. It is this heating effect of the tip that causes burns. To reduce this side-effect the operator may use cooled tumescent fluid, use cooling drapes on the patient’s skin, but of critical importance they will keep the probe moving and keep it away from the superficial layers of fat immediately under the skin.
In the case described there are problems of both irregularity in contour and also of burns in the skin. It is unfortunately not true to say that external burns are not a recognised complication of VASER liposuction. Such burns are caused internally and in severe cases there will be full thickness skin involvement with the outer wound being less extensive than the inner wound. Nevertheless, in the healing process there will be significant scarring. If this is associated with irregularity in contour a patient may rightly feel that they have not been treated well. Under the circumstances, it would not appear to be the wisest of actions to try and mitigate a poor result by trying to blame the patient for not following postoperative instructions (that were not reasonable).
These cases illustrate learning points for clinicians but also possibly for the insurance companies providing cover for medico-legal problems. A criticism that is often raised against the large indemnity assurance companies such as the MPS, MDU and MDDUS, is that the cover they provide is discretionary and people have been left exposed and uncovered with no explanation. It is a bit like paying for car insurance but not knowing if you will be covered in the event of an accident. The car insurance market is risk based; how many years have you been driving? What type of car are you driving? How many accidents have you had? Put in this context the VASER is a highly sophisticated device that gives excellent and safe results in experienced hands. This would translate to the middle-aged Porsche driver (of any gender) who has had no previous accidents.
When the VASER first came on the market the company was very cautious about who should buy the machine. Poor results, poor publicity, poor sales. So, sales were targeted, and for the higher end VASER liposculpture limited accreditation was given following quite expensive high-end training.
The results described in this case reflect a poor practitioner who is neither trained in achieving good results but also not trained to the degree to avoid avoidable complications. To protect patients from this level of harm should first of all be the responsibility of the treating practitioner. Primum non nocere. I personally think that it should also be part of the responsibility of the device manufacturer to ensure it gets into the right hands. World sales must be booming but the spectre of bad publicity following increasing reports of poor outcomes cannot be good for business. And finally, the insurance companies. I wonder how risk is assessed and premiums are calculated? There is the experience and background of the practitioner and there is the procedure or procedures being performed. It may be that a combination of goodwill from the aesthetic medicine professionals, good business sense from the device providers and a more flexible and pragmatic view to insurance will achieve a safer environment for those seeking cosmetic interventions than government regulation.
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