Historically, men and women around the globe have submitted to the introduction of all sorts of substances, some more desirable than others, into their bodies in order to achieve an augmentation of areas such as the breasts and buttocks, or to even out discrepancies in the skin’s surface caused by trauma or disease. From early attempts with paraffin and non-medical grade silicone to harvested autologous fat and permanent dermal filler products, the science of adding volume to the body has thankfully come along way.

Now, in 2008, a new product on the UK market, Macrolane™ VRF, has become the first body shaping and volume restoration product which uses hyaluronic acid, a natural component of our own bodies.

In this month’s feature article, we investigate its uses and speak to the UK surgeon leading the clinical research.

Macrolane™ VRF

Macrolane™ VRF, which stands for ‘Volume Restoration Factor’, is a new product offering from Q-Med, the makers of the highly successful Restylane® dermal filler range. Macrolane uses the same patented NASHA™ (Non-Animal Stabilised Hyaluronic Acid) technology as Restylane to produce a thicker, more viscous hyaluronic acid gel designed to be injected into the body with long lasting results and no migration.

The product range includes two different formulations - Macrolane VRF 20 and Macrolane VRF 30, with VRF 30 providing increased volume over VRF 20. These formulations can be used separately or combined to achieve an optimum result.

It is currently indicated and CE approved for ‘volume restoration and shaping of body surfaces’, for example, shaping of the breasts, calves and buttocks and also for evening out discrepancies in skin surface such as those sometimes caused by liposuction. Due to its formulation it cannot and should not however be used on areas of the face.

Although the use of Macrolane in the breast is currently available under the ‘body shaping’ indication, and can achieve approximately a one to one and a half cup size increase in most women, ongoing research is being conducted to further evaluate the efficacy of its use in this area and to establish the best techniques and protocols for the procedure. Ideally treatment for this indication should be carried out by a qualified cosmetic or plastic surgeon who has experience of traditional breast augmentation procedures and the anatomy involved, as well as having had bespoke training with Macrolane.

Currently about two dozen UK practitioners, both surgeons and cosmetic doctors, have been trained and certified in the use of Macrolane for body contouring, with approximately half of those also trained and certified for breast reshaping.

Treatment, lasting 30 – 45 minutes, involves a small 2-3mm incision in the area, (e.g., normally the crease under each breast or buttock), and the injection of the substance using a thin cannula or large gauge spinal needle deep into the subcutaneous skin layer above the muscle, under local anaesthetic. Often a course of antibiotics may be prescribed both pre and post treatment to reduce any possible risk of infection. Mild bruising, swelling and slight discomfort in the area are expected during the first few days post treatment but should all resolve within a week. Depending on the area treated, physical activity may need to be restricted for a couple of weeks and a support garment worn, such as a sports bra or lycra cycling shorts.

In the case of breast reshaping the product is placed underneath the breast tissue, much like an implant, so does not threaten the functioning of the breast in the event of future breast feeding.

As with breast implants, the use of Macrolane in this area has also raised concerns over its effect on the visibility of mammograms and the early detection of breast cancers, however following a recent study presented in January 2008 by a group of highly respected European surgeons who have been using Macrolane for this indication it was concluded that;

“The presence of Macrolane in the breast does not compromise the detection, diagnosis or management of breast disease." (1)

Initial patient feedback following the addition of Macrolane to the breast is very positive, with many noting that they are unable to feel anything significantly different in their treated breasts from how their own natural breasts felt; this is particularly noted in those patients where only one breast is treated for asymmetry, giving an immediate split-body comparison. Additionally the free movement of the breast to create a natural cleavage and to fit correctly in underwear is said to be unaffected, areas which are often dramatically altered with the addition of traditional silicone implants.

According to Q-Med, Macrolane is intended to last for 12-18 months in the body, depending on the area treated and the amount of volume used, although it recommends that each individual treatment programme includes a yearly top-up, as required, to maintain the optimal results, and that potentially over time this top-up may reduce in quantity. It will be some time however before long term data on the average duration for particular indications is properly known.

Treatment cost will be very much dependant on the area treated and the amount of the product used. Q-Med quotes that typically an initial breast shaping treatment using 200ml (100ml for each breast) will cost in the region of £2,800, with top-up treatment in a year's time in the region of £1,400. Although they note that the cost of the top-up treatments is likely to decrease because less of the product will be needed over time to maintain the optimum results.

 

 

 

Consultant Plastic Surgeon at London Bridge Plastic Surgery, Christopher Inglefield, is leading the Macrolane clinical research in the UK, and has himself treated over 20 patients to date with Macrolane, primarily for breast reshaping.

 

He notes that there is a mixture in the type of person who makes an ideal candidate for breast reshaping with Macrolane. From the self-conscious woman in her early 20s whose breast tissue never properly developed at puberty, but who doesn’t want obvious implants, to a similarly aged woman whose breasts did develop but with significant asymmetry, where only one breast requires correction to match the other. Or the older lady in her 30s or 40s who is adamant that she doesn’t want surgical implants, but whose breasts have lost volume due to childbirth, and is seeking an alternative to padded bras and ‘chicken fillets’ while she’s still young enough to wear fashionable low cut tops. In addition, ladies in their 40s or 50s who may be post cancer treatment patients and are looking to restore volume and a natural shape to their breast following a lumpectomy will find satisfaction with this treatment.

 

In fact it would seem very likely that the use of Macrolane as a reconstructive tool, as opposed to a means for purely cosmetic augmentation or ‘boob job in a jab’, is likely to become the primary focus of procedures in the future.

 

 

Macrolane truly represents a new and innovative product to the hit the aesthetic marketplace; unlike anything currently available for body reshaping and volume restoration. It requires no general anaesthetic, major surgery or overnight hospital stay and produces significantly less scarring and a more natural outcome, both in terms of visual and palpable body shape and long term metabolisation by the body, which is not achievable with permanent dermal filler products or silicone based implants.

 

The arena of breast augmentation and reshaping itself is likely to become heavily contested in the near future with advances in many technologies, including Macrolane, seriously challenging the domination of traditional surgical implants. For example, a new study is currently underway in Japan examining the effects of augmenting a patient’s breast with their own liposuction derived fat, which has also been combined with a concentration of their own fat derived stem and regenerative cells that have been shown in previous trials to improve the tissue retention of the transferred fat. Of course, unlike Macrolane or traditional implants, this type of procedure relies on the patient having enough available excess fat to utilise, which isn’t always going to be the case.

 

Chris Inglefield also feels that with advances such as these becoming more widely available in the future, and patient’s general leaning away from truly invasive surgeries, the chances are that we will see a reduction in the number of traditional implant based breast augmentation procedures performed as the years go by.