Health Canada warns of problems with injectible wrinkle fillers

A new Health Canada report is warning of complications — including gangrene of the lip in one case — suspected of being associated with the most popular injectable wrinkle fillers on the market.

The fillers contain synthetic forms of hyaluronic acid (HA), a substance produced naturally by the body that binds with water to plump up sunken, aging skin.

According to Health Canada’s latest newsletter on adverse reaction reports, “HA dermal fillers are the most popular temporary fillers, and their use is growing.”

As of March 15, more than 30 HA dermal fillers had been licenced for sale in Canada.

As of the same date, the federal agency had received 32 reports of adverse reactions in people using those fillers. Reported reactions included pain, swelling, nodules, abscesses, pus or infection, skin discolouration, difficulty talking, swallowing or breathing and partial loss of vision, according to the article.

Some reactions persisted for weeks or months after the injection, according to Health Canada. Fifteen patients reported having had the reaction when they were injected with the fillers for the first time.

The report cites one patient who reported gangrene and necrosis (death of tissue) of the lips after an injection of Restylane.

Medicis Aesthetics Canada, which markets Restylane in Canada, declined to comment.

Another patient experienced partial loss of vision after injections of Juvederm fillers to the tear trough (lower eyelid) and cheek, according to Health Canada. The person also had Botox injections the same day. According to Health Canada, “a follow-up scan was normal, with no dermal filler detected intra-orbitally; no injury to the optic nerve was observed. The patient had not recovered at the time of reporting.”

In an e-mail statement, Allergan, manufacturer of Juvederm, said vision abnormalities following treatment with its filler are “very rare,” occurring at a rate of 0.0005 per cent according to its post-market research.

The company said Juvederm has a “highly favorable safety profile based on long-term use and volume.” The filler is approved in nearly 50 countries; more than two million Juvederm syringes have been distributed to doctors in North America since its approval in the U.S. in 2006, and in Canada in 2004. Overall adverse events reported following treatment with Juvederm is less than 0.27 per cent, the company said.

Other fillers mentioned in the reports included Elevess, Perlane, Revanesse, and Teosyal.

HA fillers generally carry warnings about possible reactions such as pain, swelling, abscesses and skin discolouration. According to Health Canada, the fillers are considered an “effective” and non-surgical way to correct “soft-tissue defects of the face.”

They are normally administered by a health professional.

The reports are based on suspicions only, and don’t prove cause and effect. They also can’t be used to estimate the incidence of reactions because drug reactions are underreported. It’s been estimated that as few as one per cent of suspected reactions are ever reported under Canada’s voluntary reporting system.

Toronto dermatologist Dr. Lisa Kellett said the reported reactions need to be put into context.

“Since 2004 in North America, there have been two million syringes of Juvederm distributed. That’s just one drug,” she said.

However, she said facial fillers should only be given by specialists trained in their use. If accidentally injected into a blood vessel, the filler can cut off blood supply to the area, “and that piece of skin will die,” Kellet said.

She said the fillers appeal to people “who don’t want surgery, they don’t want the look of surgery. They just want to look a little fresher.”

Source:  Sharon Kirkey, Postmedia News July 14, 2010 at http://www.vancouversun.com/health/Health+Canada+warns+problems+with+injectible+wrinkle+fillers/3275938/story.html#ixzz0tgUo7Ops

For a copy of Health Canada’s Findings, go to http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v20n3-eng.php#adv