Blindness caused by 'inadvertent' injection of dermal filler into bloodstream; product is safe, says distributor
SINGAPORE: It was the procedure, not the product, that caused a woman to go blind after receiving dermal fillers during aesthetic treatment, the product's distributor said on Tuesday (Sep 19).
In response to CNA's queries, Parvus - the company that distributes the dermal filler, AestheFill - said its investigations revealed that the incident "was caused by a blood vessel occlusion during the procedure, which in turn was caused by an inadvertent administration of the product into the bloodstream".
Parvus added that AestheFill is safe and continues to be approved by Singapore's Health Sciences Authority (HSA).
The woman was administered with AestheFill in July, a brand of dermal filler used to temporarily improve facial wrinkles and folds "by injection into the subcutaneous layer of facial skin", said HSA on Sep 12.
HSA and the Ministry of Health (MOH) are investigating the case, which Parvus reported on Jul 29.
"We are actively cooperating with the HSA in their ongoing investigation, and we maintain that product quality and patient safety are our utmost priorities," said a spokesperson for Parvus.
The spokesperson added that the batch in question has "undergone a comprehensive evaluation, adhering to Korean Food & Drug Administration (KFDA) manufacturing standards and complying with the ISO 13485 quality management system".
AestheFill has been registered in Singapore since Oct 1, 2021.
This is the first local adverse event report for blindness resulting from dermal fillers, according to HSA.
Dermal fillers are classified in Singapore as Class D medical devices - the highest-risk class.
"As shared by many qualified medical aesthetic practitioners and doctors since the incident, this is a risk inherent in all dermal filler treatments," said Parvus, adding that it should not be injected into blood vessels "as it may cause blood vessel occlusion and serious adverse effects including the loss of eyesight".
Parvus said: "Doctors have also shared that complications from aesthetic treatments were primarily due to the technique of administration and not the product."
The spokesperson added that AestheFill "meets all stringent international safety guidelines and remains approved by the HSA in Singapore. The product's license remains valid to-date and is still listed on the Singapore Medical Device Register (SMDR)".