Silicone Breast Implants Gain Approval in Canada
Silicone Breast Implants Gain Approval in Canada
October 23, 2006 -
Health Canada has just approved the return of silicone gel breast implants, giving two companies permission to make and market the products in Canada. This is one of the first steps of the reintroduction of silicone implants around the globe, including the United States market.
Until this recent approval, the only available implants licensed to be sold in Canada were saline-filled. With the government’s decision to lift the restrictions on silicone implants, women now have more options when undergoing breast augmentation or reconstructive surgery.
The decision comes after a comprehensive review of nearly 65,000 pages of data provided by silicone implant makers, as well as evidence from 2,500 independent studies, an expert advisory panel, and publics reports.
“By virtue of the fact that we are issuing a license, we’re saying they do meet safety effectiveness and quality standards in the medical device regulations,” said Health Canada’s Dr. Supriya Sharma.
Previous Concerns Over Silicone Implants
In the early 90s, manufacturers of silicon implants were ordered to pull their product off the market after class action lawsuits claimed the rupture or leakage of the devices could lead to serious heart conditions and auto-immune diseases.
However, over the last decade researchers have continued to intensely analyze and study silicone implants in an effort to reach safety effectiveness.
“There have been a number of changes that have happened since the early 90s in terms of manufacturing,” said Dr. Sharma. “The gel that’s actually inside the breast implants is much thicker, more cohesive; the layers outside the breast implant are thicker. So we believe that it’s actually a safer product than it was back in the 1990s.”
Restrictions
Health Canada has okayed the use of silicone implants, but has outlined a number of conditions and restrictions for the sale and marketing of the devices. “What the conditions allow us to do is they allow us to be very specific about how we want these products to be followed once they are licensed,” said Dr. Sharma. “Should any new information come to light, we would obviously analyze that information and then take appropriate action.”
Some restrictions include:
Continue to conduct studies and report results on a minimum of two patient groups to monitor the safety and effectiveness of product labeling.
Provide frequent updates on long-term clinical trial results for up to 10 years.
Within one year, carry out a long-term study involving a large sample size of women.
Gather and evaluate the options of Canadian plastic surgeons.
Considering breast augmentation surgery? Please click here to set up a consultation with a board certified plastic surgeon near you.
