A woman in Singapore has suffered vision loss following a dermal filler treatment, marking a concerning medical incident in the country. This case, reportedly the first of its kind in Singapore, has raised questions about the safety and regulation of such procedures.
The incident, which occurred in July, has prompted investigations by both the Health Sciences Authority (HSA) and the Ministry of Health (MOH). The woman underwent treatment with AestheFill, a dermal filler from South Korea, at a clinic in Redhill.
The Health Sciences Authority (HSA) has concluded its investigation into AestheFill and did not find any evidence of product-related safety or quality issues. The inquiry was initiated following an adverse event report received on July 29, 2023, from Parvus (S) Pte Ltd, the product’s registrant. The report detailed an incident of blood vessel occlusion resulting in blindness after the administration of AestheFill, which was the first reported case of blindness associated with dermal fillers in Singapore.
In the course of the investigation, HSA conducted a comprehensive examination of the Device History Records (DHR) for the specific batch of AestheFill used in the incident. The DHR contains comprehensive information about the manufacturing process, including quality assessments and the results of various tests, as documented in a Certificate of Analysis (CoA). The CoA includes the outcomes of chemical and microbiological tests, all of which met the specified standards. This indicates that the product was manufactured in accordance with the required standards and is deemed safe for use.
AestheFill is a type of dermal filler employed to temporarily enhance facial wrinkles and folds through subcutaneous injections. All dermal fillers are classified by HSA as Class D medical devices, which is the highest risk class. AestheFill has been registered in Singapore since October 1, 2021.
Blood vessel occlusion resulting in blindness is a recognized risk associated with all dermal fillers and is listed as a potential adverse event in the Instructions For Use (IFU) provided to clinicians. The IFU for AestheFill explicitly states that injection into blood vessels should be avoided, as it may lead to blood vessel occlusion. HSA has noted that to mitigate this risk, Parvus will enhance the training of healthcare professionals (HCPs) and offer retraining to existing providers. Additionally, a patient information leaflet will be developed for HCPs to explain the procedure’s risks to their patients.
Consumer Advisory:
Consumers should be aware that dermal fillers come with certain risks, including the potential for blood vessel occlusion leading to blindness. Other commonly reported complications associated with dermal fillers include swelling, redness, the development of raised bumps in or under the skin (nodules or granulomas), skin blanching (associated with injection into blood vessels), and temporary vision blurring. To minimize the risks linked to dermal fillers, consumers are strongly advised to consult with their trusted healthcare professionals (HCPs) before undergoing such treatments.
Related Key Points from a Review Article by Beleznay K, et al. (2019):
- Vision loss following filler injections is a rare but severe complication.
- A recent scientific review found 48 new cases of vision loss between 2015 and 2018, indicating an increasing trend compared to previous years.
- Hyaluronic acid (HA) fillers were implicated in the majority (81.3%) of these cases.
- In these recent cases, the nose was identified as the highest-risk injection site (56.3% of cases), followed by the glabella (27.1%), forehead (18.8%), and nasolabial fold (14.6%).
- While the risk of blindness from fillers remains low, it’s crucial for practitioners to be aware of potential complications.
- Open communication, knowledge-sharing, and consensus-building within the medical community are essential to address this rare but serious complication.
- Immediate action, including stopping the injection and administering drugs, is crucial in cases of vision loss post-filler injections.
Disclaimer: This article provides information about a recent incident involving dermal filler treatment. It is intended for informational purposes only and should not be considered medical advice. If you have questions or concerns about medical procedures or treatments, please consult with a qualified healthcare professional.
HA: hyaluronic acid; HSA: Health Sciences Authority; MOH: Ministry of Health
Link to the news article: https://www.hsa.gov.sg/announcements/news/hsa-concludes-its-investigation-into-aesthefill
HSA Investigation Updates (PDF): https://www.hsa.gov.sg/docs/default-source/default-document-library/hsa-update_aesthefill_121023_final.pdf
Reference: Beleznay K, Carruthers JDA, Humphrey S, Carruthers A, Jones D. Update on Avoiding and Treating Blindness From Fillers: A Recent Review of the World Literature. Aesthet Surg J. 2019;39(6):662-674. doi:10.1093/asj/sjz053
Link to the review article: https://pubmed.ncbi.nlm.nih.gov/30805636/
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