Canadian women will no longer have to jump through licensing loopholes to get silicone-gel breast implants after the government lifted a 14-year moratorium on the product yesterday.
But while many doctors and patients are elated by the news, others fear the implants are still dangerously unsafe, bringing the decades-old controversy full-circle.
Health Canada said it reviewed more than 65,000 pages of documents and cited comprehensive studies from Britain and the United States before concluding there was no evidence that silicone implants cause auto-immune diseases or other systemic illnesses. It was these very concerns that led the government in 1992 to partially ban the gel-filled implants. Only saline-filled ones have been widely available here since then.
"I think it's safe to say that these medical devices are the most intensively studied medical devices in medical history," said Supriya Sharma, associate director-general of the therapeutic products directorate for Health Canada.
One of the country's leading authorities on dangerous chemicals in women concurs that silicone breast implants are safe.
"Study after study has shown there's no apparent risk," said Gideon Koren, director of Motherisk at Toronto's Hospital for Sick Children. "So, we should not be orphaning women from things they need."
The licences granted to Inamed Corp. and Mentor Medical Systems are conditional, and require the manufacturers to continue to provide data for at least 10 years from a continuing clinical trial, as well as launch within one year another long-term study involving tens of thousands of women to look for rare side effects.
But news that long-term studies haven't concluded yet has at least one implant patient worried.
"This should have been done before they allowed them onto the market, [instead of]playing this game of roulette with women's lives," said Joyce Attis, president and founder of the Breast Implant Line of Canada and the lead plaintiff in a pending class-action lawsuit against Health Canada.
"It takes years before these implants can make you sick. Yet the studies Health Canada has relied upon are not of a long enough duration . . . and they're allowing this poison back on the market."
In 1972, Ms. Attis had a cohesive silicone prosthetic inserted because her right breast had never developed. She was 21 at the time and she "just wanted to be able to wear clothes properly and have breasts of equal size."
But by the late 1970s, her implanted breast had hardened and she was suffering from excruciating rib and back pain. The doctors couldn't diagnose her, and one even inserted a steel rod into her spine to ease the chronic pain.
Ten years later, doctors discovered silicone under her breasts, and around her rib cage to her spine.
"They were scraping the silicone gel off," said Ms. Attis, 55, who now suffers from fibromyalgia, lupus syndrome and osteoporosis, and knows of many other women with implants suffering from adverse effects.
In the 1990s, manufacturer Dow Corning paid out $2.35-billion (U.S.) to settle class-action lawsuits involving more than 300,000 women, including some from Canada, who said their health was harmed by the devices.
This year, the safety of gel implants was again brought into question when a significant Canadian study reported a 73-per-cent higher rate of suicide among women with breast implants than the general population.
And just last week, new allegations arose in the United States that Mentor misrepresented safety data for its gel breast implants. The scientist at the company who made the allegations was fired and he provided the information to the Food and Drug Administration. An investigation is under way.
But despite the controversy, plastic surgeons are wondering how much of an impact the new licences will have in a country where 200,000 women have had breast implants. Gel-filled implants have been available in Canada since the 1992 moratorium through Health Canada's special access program, under which doctors have to certify that suitable alternative procedures are not available.
According to one cosmetic surgeon, the application process was nothing more than a small hindrance, because everyone who applied was approved.
"[It]was virtually a rubber stamp, because it was seldom declined," said Peter Wyshynski, who has a plastic surgery practice in Waterloo, Ont.
"They were approved both for reconstruction after cancer, or injuries, or diseases of the breast, but they were also approved for cosmetic purposes."
A Health Canada official confirmed that there have been no refusals of special access program requests for silicone implants since December of 2004, and that an average of 8,000 cases are approved every year.