[Update from HSA]
MCA reached out to the Health Sciences Authority, Singapore’s governing body for comment. This is their response in full.
“AestheFill is a brand of dermal filler used to temporarily improve facial wrinkles and folds by injection into the subcutaneous layer of facial skin. Dermal fillers are classified by the Health Sciences Authority (HSA) as Class D medical devices, the highest risk class. AestheFill has been registered in Singapore since 1 October 2021.
Blood vessel occlusion resulting in blindness is a known risk for dermal fillers and is commonly listed as a potential adverse event in the Instructions For Use (IFU) which are provided to clinicians. The IFU for AestheFill states that injection into blood vessels should be avoided as it may cause blood vessel occlusion. Other common complications reported for dermal fillers include swelling, redness, raised bumps in or under the skin (nodules or granulomas), skin blanching (associated with injection into blood vessel), temporary blurring of vision etc. Clinicians administering dermal fillers such as AestheFill are required to undergo training by the respective companies. Consumers are advised to discuss with their clinician about the risks and suitability of the dermal fillers before going for the procedure.
Parvus (S) Pte Ltd reported the incident of blood vessel occlusion following the administration of AestheFill to HSA on 29 July 2023. Locally, this is the first adverse event report for blindness resulting from dermal fillers. Based on HSA’s regulatory requirements, companies are required to report such adverse events to HSA within the stipulated timeline of 10 days, which the company has adhered to. There has been no noticeable increase in adverse event reports received for aesthetic implants such as dermal fillers.
HSA is currently investigating whether there are any batch-related defects that may have affected product safety or quality. Should there be any product or batch-related issues, HSA will take the necessary actions such as to recall the affected product and/or require the company to rectify the issues.”
In a shocking incident last month, a woman lost her vision following a dermal filler treatment at a Redhill clinic.
This marked the first reported case in Singapore involving the AestheFill dermal filler, a product designed to reduce wrinkles and skin folds.
In Singapore’s first reported case, a woman became blind in both eyes in July. She was receiving a dermal filler to reduce skin wrinkles and folds. Parvus, the Singapore distributor of AestheFill, is closely working with all relevant parties to ascertain the circumstances leading to this tragic outcome.
Regulators on High Alert
The Health Sciences Authority (HSA), responsible for health product regulation, informed The Straits Times about their ongoing investigation. The probe aims to identify if any batch-related defects have compromised the safety and quality of AestheFill, a product that gained registration approval in Singapore in October 2021.
Highlighting the severity, an HSA spokesperson confirmed this was the first-ever local report of blindness due to dermal fillers. She further added that companies need to report any such adverse events within a 10-day window promptly.
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Dermal Filler: A Procedure Not Without Risks
Brendan Pang, Parvus’s general manager, emphasised that AestheFill is internationally acknowledged and is only administered by qualified healthcare professionals. He remarked, “As with any medical procedure, inherent risks are involved.”
Insiders revealed the victim to be a young, married woman who experienced sudden blindness in both eyes following the AestheFill treatment.
While such events are alarming, HSA noted that there hasn’t been a rise in adverse reports linked to aesthetic implants like dermal fillers locally.
However, blindness due to blood vessel blockage is a known associated risk. AestheFill’s instructions explicitly warn against injections into blood vessels.
Previous Global Incidents Raise Concern
An article from the BMC Ophthalmology journal in March 2023 cited a 23-year-old Taiwanese woman experiencing sudden blindness in an eye after an AestheFill injection. Records from Taiwan (2017) and Australia (2018) also indicated vision loss incidents due to dermal fillers.
Furthermore, a 2018 report by Australia’s Four Corners mentioned nearly 100 such blindness cases globally.
A study in 2019 found 190 cases of blindness due to soft-tissue fillers. The study suggests exploratory research on this phenomenon. It suggests creating a registry to report blindness cases, detailing the injection techniques, filler types, needle or cannula use, and local anaesthesia application, so we can gain deeper insights into the causes of blindness. This will then allow us to set up preventive measures.
The Doctor’s Perspective
Dr Stephanie Young is a Senior Consultant eye surgeon and Director of Ophthalmic Plastic & Reconstructive Surgery at Eagle Eye Centre. Therefore, she is uniquely qualified to speak about this topic. She stated that “filler injections have always carried the risk of vascular occlusion. It is extremely rare but possible.”
She also explained that there is currently a study on an alternative theory that “embolism: injection of small amounts of filler is injected into the vessel lumen, the collateral flow is towards the orbit, and hence the embolism is injected anterograde. It means it’s a numbers game. The more you do, the higher the risk it might happen one day. It can happen to the best injectors as it’s not a matter of skill but a random mingling of rare events with rare predisposition (aka just unlucky).”
An Expensive Gamble
In Singapore, dermal fillers can set one back by a minimum of $700. The frequency of these treatments varies, with nose fillers needed annually and lip treatments recommended every six to nine months.
HSA’s spokesperson advises potential consumers to discuss the risks and evaluate the suitability of dermal fillers with clinicians before undergoing any procedure.
While rare, vision loss from HA injections is catastrophic. Recognising it early and treating it promptly is essential because there’s a narrow window to restore vision. Currently, no gold standard exists for treating vision loss. Therefore, while consensus recommendations exist, no guidelines have consistently reversed this complication.
Though HA-based fillers seem like safer options for soft-tissue enhancements, it’s crucial to emphasise the importance of in-depth medical, anatomical, and product knowledge. This expertise helps reduce severe side effects like blindness linked to their use.