The distributor of AestheFill, a brand of dermal filler available in Singapore, has completed its investigations into a freak accident where a customer went blind after receiving the injection.
Parvus, the distributor, told Mothership on Sep. 19 that the complication occurred due to an "inadvertent administration of the product into the bloodstream".
It then caused a blood vessel occlusion - blockage of the blood vessel - that led to blindness in the female customer.
Parvus said it is currently actively cooperating with the Health Sciences Authority (HSA) in the agency's own investigations.
Distributor: Product remains safe
It also maintained that "AestheFill meets all stringent international safety guidelines and remains approved" by the HSA.
While the accident is the first of its kind to be reported in Singapore, the dermal filler has not been pulled off the shelves.
Parvus pointed out that AestheFill is still listed on the Singapore Medical Device Register (SMDR).
In the last update by HSA on Sep. 12, the authority said it was investigating if there were "batch-related defects that might have affected the product safety or quality".
Parvus said the batch in question had undergone "a comprehensive evaluation, adhering to Korean Food & Drug Administration (KFDA) manufacturing standards and complying with the ISO 13485 quality management system".
These products, said the distributor, continue to be of "good product safety and quality".
Lastly, Parvus pointed out that there is a risk inherent in dermal filler treatments:
"Dermal filler treatments must not be injected into blood vessels as it may cause blood vessel occlusion and serious adverse effects including the loss of eyesight.
Doctors have also shared that complications from aesthetic treatments were primarily due to the technique of administration and not the product."
Top image: Regen Biotech
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