TORONTO - A person in Canada suffered lip necrosis -- tissue death -- and gangrene after being injected with a dermal filler, an adverse drug reaction newsletter from Health Canada reported Tuesday.
The case was among 32 adverse reaction reports Health Canada was alerted to by people who had used hyaluronic acid dermal fillers.
The products, sometimes called injectables, are used to fill in facial wrinkles and minimize the signs of aging. They are the most popular of the temporary fillers, and their use is growing, Health Canada said.
The July issue of Health Canada's Canadian Adverse Reaction newsletter says that as of March 15, there were more than 30 of these products licensed for use in Canada.
And as of that date, the department had received 32 adverse incident reports from people who had been injected with the dermal fillers. The reports covered complaints ranging from pain, swelling, nodules, abscesses and skin discolouration to difficulty talking, swallowing and breathing and partial loss of vision.
Fifteen of the 32 cases occurred the first time the people used dermal fillers.
"One patient who had received an injection of HA dermal filler (Restylane) into the lips reported gangrene and necrosis of the lips," the report read.
"Another patient experienced partial loss of vision after injection of Juvederm Ultra with Lidocaine to the tear trough (lower eyelid), Juvederm Ultra Plus with Lidocaine to the cheek and Juvederm Ultra Plus to marionette lines (lines that extend from the outer corner of the mouth towards the chin)."
The report noted the latter person received Botox injections into her face that same day. A followup scan showed no damage to the optic nerve, but the patient had not recovered by the time the report was written, the department said.
"Most patients required treatments ranging from abscess drainage to administration of local or systemic drugs such as corticosteroids, antibiotics, antihistamines and anti-inflammatory drugs," the report said.
In addition, several patients were given injections with hyaluronidase -- an enzyme that breaks down hyaluronic acid -- to get rid of nodular lesions.
Eight patients recovered and 19 were recovering or had not recovered at the time of reporting. The outcome was not reported for another five. Symptoms of the adverse reactions persisted for weeks and even months in some cases, Health Canada said.
The department said the dermal fillers mentioned in the case reports were: Elevess, Juvederm, Juvederm Ultra with Lidocaine, Juvederm Ultra Plus with Lidocaine, Juvederm Ultra Plus, Perlane, Restylane, Revanesse, Revanesse Ultra and Teosyal.
Patients who complained of adverse reactions ranged in age from 30 to 75, with the median age being 50.
The report said hyaluronic acid dermal fillers "are considered to provide an effective, non-invasive and non-surgical alternative for the correction of soft-tissue defects of the face" but must be administered by health-care professionals who are properly trained in their use.
Health-care professionals administering the products also need to be aware of the types of adverse incidents that can result, and must also know when the products should not be used, Health Canada said. For instance, they should not be injected into blood vessels.
