Medsafe Logo
<% Dim q q = request.form("q") If len(q) > 0 Then Response.redirect "/searchResults.asp?q=" & q End if %>
Hide menus
Show menus

Publications

Published: 5 September 2014

Dermal Fillers - Blinded for Beauty

Prescriber Update 35(3): 39
September 2014

Key Messages

  • Dermal fillers used for cosmetic purposes have been associated with a small risk of reversible and irreversible vision disorders, including blindness.
  • Practitioners are advised to discuss this potential risk with patients prior to administration.
  • Dermal fillers are now categorised as medical devices, not medicines.
  • Dermal fillers should not be used on certain areas of the face.


Dermal fillers including collagen, hyaluronic acid and autologous adipose tissue are injected into the face for cosmetic purposes. Reports from overseas, dating back to 1988, highlighted both temporary and permanent visual disorders that occurred following dermal injection of these substances during aesthetic procedures1. Visual disorders included both partial and total visual losses, including cases of temporary and permanent blindness.

Practitioners are advised to discuss this risk with patients who are considering having dermal fillers injected. Complications affecting patients' vision have occurred both during administration and more than a year following the procedure1. Patients should be advised to seek medical advice immediately if any visual disturbances occur.

Dermal fillers should not be injected into certain areas of the face2. Complications may occur due to the technique applied and the vulnerability of the facial vasculature to blockage from injected substances1. Treatment to restore normal vision requires early recognition, identification and removal of blockages to recover perfusion1.

Since 1 July 2014, dermal fillers have been re-categorised from medicines to medical devices. It is important to note that there is no pre-market approval process for medical devices in New Zealand under the Medicines Act 1981. Clinicians who use or would consider using dermal fillers should ensure the product has been approved by a regulatory authority for the intended purpose.

Summary of data sheet information for hyaluronate sodium/hyaluronic acid dermal fillers prior to re-categorisation as medical devices
  • Not all products are suitable for injection into the periorbital area, check with the manufacturer first.
  • Do not overcorrect.
  • Do not inject into blood vessels (intravascular). Inadvertent injection into blood vessels could potentially lead to vascular occlusion, ischaemia and necrosis.
  • Must not be used in patients who are known to be hypersensitive to the contents of the filler or who have a history of severe allergic reactions
  • Simultaneous use with laser therapy, chemical peeling or dermabrasion may cause inflammation at the injection site
  • Safety has not been established in women who are pregnant or breast feeding, or in children or those with autoimmune deficiency.
  • Must not be used in areas showing skin problems such as inflammation and/or infections (e.g. acne, herpes, etc).
  • Special caution should be exercised when treating areas with limited collateral circulation, due to increased risk of ischaemia.
  • Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
  • Patients who are using substances that affect platelet function, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.
  • It is recommended that patients avoid make up for 12 hours after injection and sunlight/UV light and temperature extremes for 2 weeks after injection
  • May not be suitable in patients with a tendency to develop hypertrophic scars
References
  1. Lazzeri D, Agostini T, Figus M, Nardi M, Pantaloni M, Lazzeri S. 2012. Blindness following Cosmetic Injections of the Face. Plastic and Reconstructive Surgery 129(4): 995-1012.
  2. Carle MV, Roe R, Novack R, Boyer DS. 2014. Cosmetic Facial Fillers and Severe Vision Loss. Journal of the American Medical Association Ophthalmology 132(5): 637-639.
0 1 2 4 5 6 7 9 [ /