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Complications associated with dermal fillers and collagen stimulators

Societal demands on the individual to remain youthful have resulted in many non-surgical cosmetic options becoming available. The usual profile is of a healthy individual seeking anti-ageing, corrective or enhancement treatments. The reasons someone may seek these types of procedures vary enormously, from an insensitive comment, to a psychological or psychosocial impact on quality of life that starts to interfere with daily living, or the influences of images seen in the media. 

Patients' desires, choices and expectations may not always be possible or even realistic, and accessing or choosing where to go does have an impact financially and may manipulate the patient's final decision. 

Cosmetic practice sits outside the NHS, although there is an exception for HIV-related facial lipoatrophy treatment. To correct this iatrogenic condition, treatment is offered to patients with moderate to severe facial volume loss using poly-L-lactic acid injections (New-Fill). This treatment is not thought of as cosmetic but corrective. Sometimes when a patient's expectations have not been met, they find themselves in local GP surgery hoping for a resolution. Often these patients may well be further distressed or vulnerable as well as coping with complications from their treatment. This is an expanding UK industry; in 2005 it was worth £750 million, and it is estimated that by 2015 it will have reached £3.6 billion.1

In 2013 the Department of Health (DH) conducted a review of cosmetic interventions and found that there were between 140-190 dermal filler products classified as medical devices introduced into the UK, and that manufacturers were not required to inform the Medicines and Healthcare Products Regulatory Agency (MHRA). In the USA all dermal fillers are classified as medical and are regulated by the Food and Drug Administration (FDA). Only 14 different dermal fillers are permitted for sale, and information about these products can be accessed by the public on the FDA website.

The review also found that there was no central collection of data regarding adverse issues or complications. The British Association of Cosmetic Nurses (BACN) conducted a survey of their members in 2012 and found that 72% (n=231) had treated a patient who had experienced a minor adverse event (bruising, swelling discomfort) which was expected and self-limiting.

As rejuvenating and anti-ageing treatments increase in popularity, so do the potential complications. Most of these will resolve without any medical intervention. Serious complications remain infrequent when carried out by properly trained and competent surgeons, doctors, nurses and dentists compared to the many hundreds of procedures carried out yearly. 

A recent paper stated that non-invasive and minimal cosmetic dermatologic procedures including soft tissue dermal fillers, neurotoxin injections and laser energy devices are safe when performed by experienced competent dermatologist, with adverse events occurring in less than 1% of treated patients, which are usually minor and transient.2

There have been cases where individuals have attempted to treat themselves with products bought over the internet and self-administered, with disastrous outcomes. It is alarming that if you do an internet search that there are YouTube videos on how to inject fillers and neurotoxins as well as web-based pharmaceutical sites outside of the UK that are willing to sell to untrained non-medical practitioners. This easy availability is potentially a serious risk to patients; these treatments are not without risk or complications and should be seen as a medical procedure.3,4

 

Constituent

Hyaluronic acid is a type of sugar (polysaccharide) present in the body tissues, such as in skin and cartilage. Is able to combine with water and swell when in gel form, causing a smoothing/filling effect. Hyaluronic acid used in dermal fillers is chemically modified (cross-linked) to make it last longer in the body. 

Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and bones. Calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle or area of volume loss. 

Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible synthetic polymer. This material has wide uses in absorbable stitches and bone screws. PLLA is a collagen stimulator that is given in a series of injections over a period of several months. 

The effects of PLLA generally become increasingly apparent 

over time.

Common problems associated with temporary fillers or collagen stimulators are often transient bleeding, bruising, discomfort, and swelling, usually resolving with minimal interventions and probably would not be seen in the general practice, as the individual should in the first instance contact the clinic or person who had treated them for advice. 

There have been more serious reactions reported and these are usually related to injection technique, product placement and over-correction of the treated area. Ocularocclusion is rare but has been reported following injections. This is obviously a medical emergency with a very short window before the damage is irreversible. Vascular necrosis also has a short window and is immediately apparent due to blanching of the skin post injection which might suggest vascular compromise and therefore 

would require immediate treatment consisting of aspirin, nitro-glycerine paste to the area, hyaluronidase an enzyme injected to dissolve hyaluronic acid gels injected and possibly steroids to help reduce swelling.6,7,8

Biofilm infections can develop within weeks after being injected. Usual presentation is erythema, mildly tender nodules which have persisted for months and often improve and worsen. They may be visible and therefore distressing to the patient. If there is any fluctuant it is usually culture negative. These nodules are often small localised and have no associated antibody formation. Biofilms are a collection of micro-organisms sticking to surfaces, not recognisable by the immune system and are thought to be 100 times more resistant to antibiotics. 

Treatment involved a broad spectrum antibiotic, such as ciprofloxacin and a macrolide such as clarithromycin, for at least four to six weeks to cover for atypical mycobacterial infection which may be difficult to culture. Removal of the filler will reduce post-inflammatory recurrence after the course of antibiotics. If a hyaluronic acid filler was used then hyaluronidase would be used to break down the induration or nodule - otherwise intralesional steroids. Practising asepsis when injecting and cleansing the skin with a chlorhexidine based skin cleanser reduces this risk.9,10,11

Sometimes patients with a history of recurrent oral herpes have a higher risk of lip and cheek augmentation triggering an outbreak and therefore should consider antiviral prophylaxis prior to treatment.12

Patients may worry that further treatment may be at a cost to them, so turn to the NHS seeking help to resolve their complication. If possible when a patient presents with complications that may be related to previous dermal filler injections or soft tissue augmentation they should be to encouraged to return to the clinic or practitioner that originally treated them. A complication should not incur extra cost to the patient. 

Permanent fillers use synthetic materials and complications may appear years later and are often long-lasting. These include nodules, granuloma formation, migration of the implant, persistent erythema or redness, pain, infections and chronic inflammatory reactions asymmetry and disfigurement. Removal is difficult as these implants often have migrated and infiltrated into the surrounding facial tissue. Often the patient will need to have either a magnetic resonance imaging (MRI) or computed tomography (CT) scan to correctly locate all of the implant.4,11 

Surgical removal can pose several problems for the patient; the prospect of multiple procedures, scarring, and nerve damage as well as worries about who will pay for the procedure. 

Some patients have tried to get NHS funding by applying for Individual Funding Requests (IFR) the criteria are very stringent so funding is often refused. 

Granuloma is often used inaccurately when the term nodules should be used. The term granulomas can be used after the nodule has been surgically excised sent to a pathology lab specially stained and looked at under a microscope for a definitive diagnosis.

A foreign body granuloma is a collection of immune cells called macrophages which form when the immune system attempts 

to isolate a substance it perceives as foreign but is unable to 

break it down so encapsulates it they are rare estimated at 0.01% and 1%.10,13

 

Conclusion 

As patients have an increasing list of treatments available that can be used to perform more skilful facial contouring and address volume loss but maintain a natural looking result. All injectable dermal fillers have the potential to cause adverse reactions, to limit this risk certain things should be considered before treatment appropriate patient selection; taking a full medical history, fully informing the patient on the benefits as well as probable and possible adverse issues before consenting. It is important to understand the mechanism of action of the product being used and to recognise, diagnosis and treat adverse issues or complications as well as how to avoid them.

For patients seeking anti-ageing treatments it is imperative that they ask questions of the medical professional prior to them being treated. They should avoid being swayed financially as it is a medical procedure and not a bargain hunt. 

The BACN has developed a professional competency framework to help ongoing continuing development14  and 64% of BACN members are independent nurse prescribers

The BACN state when looking for or choosing cosmetic treatments that the points below are important to ensure journey as the patient is informed, safe and treated with consent and with realistic expectations of outcomes. Cosmetic nurses should:

Be Nursing and Midwifery Council (NMC) registered. 

Be a BACN member. 

Be honest and transparent with the information given.

Take pre and post photographs to record response to treatment.

Have a 'cooling off' period before commencing treatments.

Be ethical regarding the suitability of procedures and treatments offered taking into account the patient's budget and lifestyle. 

If a complication occurs as a direct or indirect result of a procedure, have protocols in place to manage accordingly, or a referral system to obtain the best possible advice or appropriate treatment.