SINGAPORE — A Health Sciences Authority (HSA) investigation into the dermal filler AestheFill has found no evidence of product-related safety and quality issues, after a woman lost her vision in the first reported case of its kind in Singapore.
The authority on Thursday (Oct 12) said it had concluded its probe into AestheFill, a dermal filler from South Korea that temporarily reduces wrinkles and folds in the skin.
This came a month after The Straits Times broke the news that a woman went blind in July from being injected with the dermal filler at a Redhill clinic. HSA was alerted to the incident on July 29.
HSA said in a statement on Thursday that to mitigate the risk of blood vessel blockage causing blindness, Parvus — the Singapore distributor of AestheFill — would strengthen the training of healthcare professionals and retrain its existing providers.
It will also develop an information leaflet for healthcare professionals to explain the risks of the procedure to patients.
ST first reported in September that the woman apparently suffered sudden blindness after she was injected with AestheFill at the clinic. It is understood to have affected both her eyes.
On Thursday, HSA said that as part of its investigations, it reviewed the device history records for the specific lot of AestheFill that was injected into the woman. The records contain details about the manufacturing process, including quality checks and the results of these tests.
The results of the chemical and microbiological tests were within the specifications, indicating that the product was manufactured according to the required standards and is safe for use, it said.
Parvus earlier told ST that the outcome of its own investigations indicates that the accidental injection of AestheFill into the woman's bloodstream led to her losing her vision.
HSA classifies dermal fillers as Class D medical devices, which carry the highest risk. AestheFill has been registered in Singapore since Oct 1, 2021.
Blindness due to blood vessel blockage is a known risk for dermal fillers, and consumers should be aware of these risks, the authority said.
Such risks are typically explained in the instructions for use given to healthcare practitioners. The instructions for AestheFill caution against injecting into blood vessels, as it may cause blockage.
Other common complications that may arise from the use of dermal fillers include swelling, redness, raised bumps in or under the skin (nodules or granulomas), skin blanching or the paling of skin (associated with injection into blood vessels), and the temporary blurring of vision.
To minimise the risks associated with dermal fillers, HSA advised consumers to discuss the procedure with healthcare practitioners before undergoing treatment.
The Ministry of Health is also investigating the case.
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This article was first published in The Straits Times. Permission required for reproduction.