One of this year’s controversial topics is the risk of blindness following cosmetic injection of dermal fillers. Lorna Jackson reviews the latest research and manufacturer responses, as well as the importance of disclosure on patient consent forms
In 2013, one of the most common concerns raised at aesthetic educational conferences and association meetings was the risk of blindness following the administration of dermal fillers in the upper face.
This followed on from the revelation made in a systematic clinical review by Lazzeri et al. (Plast Recon Surg, 2012) documenting a number of cases published in medical journals and literature of blindness following cosmetic injection. The paper notes that the authors only included in the study cases in which blindness was a direct consequence of a cosmetic injection procedure of the face.
This amounted to 29 individual articles which described 32 patients. In 15 patients, blindness occurred after injections of adipose tissue or fat as a filling agent while in the other 17 cases, blindness followed injections of various materials, including corticosteroids, paraffin, silicone oil, bovine collagen, polymethylmethacrylate (PMMA), hyaluronic acid, and calcium hydroxyapatite.
This review, which highlights dermal filler product materials in regular use by UK medical practitioners—such as hyaluronic acid and calcium hydroxyapatite—has prompted much debate and discussion over the practical implications for both trained, experienced practitioners and the trend for non-medical and allied healthcare professionals entering the marketplace and offering cosmetic injectable treatments with dermal fillers, sometimes with limited facial anatomy training.
So how much potential for eye injury is there in treating areas such as the tear trough or perform non-surgical nose reshaping with fillers, and is this risk enough to warrant a mention in the complications listed to clients as part of the informed consent process?
According to Mr Ramon Malholtra, consent forms should point out to patients that treatment carries a risk of sight loss. Mr Malholtra, an oculoplastic surgeon and ophthalmologist, has noted that if a problem occurred and a practitioner hadn’t made the client aware of any published and possible complications, such as that noted in the Lazzeri paper, then this could have ramifications if a legal case were to be brought.
The Consulting Room conducted a short online poll this summer to find out how many clinicians were including this within their patient consent information. Around 75% of nurse- and doctor-led UK clinics responded that they do not list blindness as a potential complication. Feedback comments included; “I have wondered whether I should”, “I have thought about adding it but I haven’t got round to it”, and “I discuss it at consultation but will be amending my forms”.
As this topic has generated a huge amount of debate and repeated discussions, the opinions of filler manufacturers should be taken into consideration. Allergan (Juvéderm ULTRA), Galderma/Q-Med (Restylane and Emervel) and Merz Aesthetics (Belotero and Radiesse) have noted their thoughts on the Lazzeri paper, opinions on the potential risk of blindness or eye injury following the administration of dermal fillers, as well as provided advice on patient consent information for medical practitioners offering cosmetic injections.
“Historically, we have always based our patient consent forms on the Instructions for Use of the individual Restylane products. However, due to the increasing product range and the time taken by the regulatory authorities to review and approve applications for change we have decided to change our approach and will now use non-product specific patient consent forms to allow us to react promptly to market requirements such as the case with ocular complications.
“We have already drafted a general consent form applicable to hylauronic acid based dermal fillers which makes specific mention of potential ocular complications associated with injection of dermal fillers in the upper half of the face. “This is undergoing internal review. As you would no doubt appreciate, we endeavour to ensure that information on significant adverse events regardless of frequency is clearly communicated in the general consent form but the consent form is intended only as a service to aid the practitioners. It is the practitioner´s responsibility to ensure that informed consent is provided in accordance with professional standards. The general consent form should be available to share in the not too distant future.”
“Merz Aesthetics have always sought to ensure patient safety and satisfaction is at the heart of products and services they provide. Several years ago Merz Aesthetics designed a ‘Medical History and Consent to Treatment Form’ with the support of a practitioner panel. This is a generic document which is not product specific and is designed as a support tool to the aesthetics industry. This form is reviewed and updated as feedback and data becomes available and is currently in its fourth review.
Following discussion on the subject of consent at their recent Partnership in Practice Conference in September, Merz Aesthetics have included specifics for the patient to be made aware of the risks of visual disturbance with injectable treatments and are working with a specialist advisory panel to ensure that this form is both fully informative and usable. Copies will be available on request from Merz Aesthetics Customer Services.”
“Allergan Ltd take the safety of the patients using our products very seriously, and can confirm that based on adverse event reports from the last three years that visual problems associated with our hyaluronic acid (HA) dermal fillers are very rare. We have no clinical data or adverse event reports to suggest any causal link between our dermal filler products and blindness.
In fact, clinical trials as well as considerable post-marketing experience, has shown that the Juvéderm range of products are generally well‐tolerated. Looking more widely at the published clinical literature from the last ten years, the data shows that incidents of blindness that have been reported with dermal fillers (including HA fillers) have been attributed mostly to injection technique and the volume of filler injected (Coleman et al., 2002). This reinforces the need for healthcare professionals to receive training in anatomy in addition to injection technique as essential components in ensuring a safe and effective outcome for patients. Indeed, Allergan’s commitment to medical education is central to our business and we train over 7,000 physicians per year across Europe on facial anatomy and advanced injection techniques, aiming to avoid adverse events and deliver the best results for patients.”
Their responses show that companies whose products in the medical literature, namely Restylane and Radiesse, cited as causal to eye complications—albeit in singular rare cases—have acknowledged these adverse reports and taken steps to note this in their consent advice.
Of course, one could argue that it is probably not the product at fault, but the administration; so even those brands of dermal fillers yet to be linked to adverse ocular complications could cause them if improperly administered. The key, therefore, is in training, particularly for advanced techniques around the eye area.
This is something which many within the industry hope that the Keogh Implementation Team will take on board when deciding if non-medics should be permitted to provide cosmetic injectables to the public and, if so, the training requirements needed to avoid more cases of eye injury.
So what of Lazzeri et al’s conclusions on how best to avoid or prevent the chance of causing an eye injury as a consequence of administering a cosmetic injection?
The authors advise that a number of precautions could minimise the risk of embolisation of filler into the ophthalmic artery following facial cosmetic injections: Intravascular placement of the needle or cannula should be demonstrated by aspiration before injection and should be further prevented by application of local vasoconstrictor.
Needles, syringes, and cannulas of small size should be preferred to larger ones and be replaced with blunt flexible needles and microcannulas when possible.
Low-pressure injections with the release of the least amount of substance possible should be considered safer than bolus injections.
The total volume of filler injected during the entire treatment session should be limited, and injections into pretraumatised tissues should be avoided.
Our advice to you? Take a look at your current patient consent forms and associated information. If you don’t mention the (admittedly very rare) risk of eye injury or visual loss following cosmetic injections, then you may wish to update your documentation. Those with further questions should contact their product brand supplier and medical indemnity insurer for advice.