Charlie Fidelman, CanWest News Service
Published: Friday, November 23, 2007MONTREAL -- Nancy De Rosa went to her plastic surgeon for anti-aging treatments to recapture her youthful looks, but saw her dream turn into a nightmare.
Instead of getting plumper lips and smoother skin, the Montreal woman's face became disfigured, following injections with a filler known as Dermalive.
"There are days I'd look in the mirror and couldn't go on with my day," De Rosa, 44, said of the ugly complications after the treatment.
Nancy De Rosa bears the scars of Dermalive, injections that went wrong leaving permanent damage to her face.
Allen McInnis, CanWest News Service
Health Canada approved Dermalive in 2003, the same year its licence as a medical product was suspended in France.
Banned in the United States, the product is now under scrutiny in legal suits in Europe.
Health Canada quietly suspended Dermalive's use this past summer after logging eight cases of problems with the implant this year.
For De Rosa and dozens of women like her, the suspension came too late.
Having tried Botox and other temporary fillers whose effects tend to disappear, De Rosa opted for Dermalive, touted as a permanent filler, a non-animal derivative that was safe to use.
The product is made of acrylic hydrogel particles suspended in hyaluronic acid solution. The plastic particles stimulate collagen growth in the soft tissue to plump out dimples and wrinkles. Results are seen within months.
In 2005, De Rosa had four syringes of Dermalive injected at $800 each.
"I put it everywhere I had wrinkles," she said.
Within a year, her face erupted in painful lumps at every injection site, and her lips swelled alarmingly. The condition is called granuloma.
De Rosa panicked when her face became distorted and her lips blistered.
"It started to grow out of control," she said. Cortisone and laser treatments didn't help. "There is no cure. I have to learn to live with it," De Rosa said.
De Rosa isn't alone. Doris Durand, another Montreal Dermalive victim, is seeking permission to launch a $10-million class action in Quebec Superior Court on behalf of about 1,500 women affected by the product.
Durand had her lips opened and the implant scraped away, but the swelling reaction persisted.
Long-lasting implants can come with long-lasting problems, Trevor Born of the Canadian Society of Plastic Surgeons said from his Toronto office. "The reports are not good," he said of Dermalive. "I stick to what's tried and true so I don't run into problems."
Stay away from injectables used "by people who aren't trained," Born warned. "It's frightening, because there are irreversible results."
Michelle Albagli, executive director of the Canadian Dermatology Association, said knots and bumps from plastic fillers happen often.
"A lot of our dermatologists end up repairing damage, or trying to rectify it," Albagli said.
Respected Montreal plastic surgeon Arthur Swift, who treated De Rosa with Dermalive, said the product seemed like a fabulous idea when it first came out.
"Patients love the idea of a product that lasts a long time. They don't have to see the surgeon more than once a year but it's a double-edged sword," he said. If a medical device is approved by Health Canada, surgeons have no reason to not use it, he said. De Rosa was the patient who turned the tables, Swift said. "The product had an excellent safety profile, so what happened?"
That's what lawyer Roseanne Provost wants to know.
The risk of problems seems higher in Europe at 2.5 per cent, said Provost, who filed Durand's suit against Health Canada, Dermatech -- the French company that created the product -- and Montreal-based Vivier Pharma and Intradermal Distribution, the Canadian distributor of the product.
For De Rosa, the Dermalive experience was a painful lesson in self-acceptance.
"Luckily, now I don't look like too much of a freak, but I did. I've learned to grow older gracefully. You have accept yourself the way you are."
© Times Colonist (Victoria) 2007
