Panel supports silicone implant maker
A panel of experts has advised the U.S. government to end a 13-year ban and let one brand of silicone-gel breast implants go on the market.
The panel of doctors and scientists voted 7-2 Wednesday to ask the U.S. Food and Drug Administration to allow Mentor Corp. to sell a new style of silicone implants that the company calls safer and more durable than older types.
On Tuesday, the same panel voted against allowing a rival manufacturer Inamed, to market its silicone implant products, saying they weren't convinced of the safety and durability claims.
On Wednesday, the panel said Mentor offered more evidence that its silicone implants rarely rupture in the first few years and may last up to a decade.
The panel recommended strict conditions on any breast implant sales, such as:
- Signing a consent form.
- Tracking the long-term progress of all recipients.
- Permitting only certified plastic surgeons to perform the procedure.
In 1992, the Canadian government asked for a voluntary moratorium on the sale of silicone implants after some implants ruptured and leaked. But about 15 per cent of women receiving implants still ask for and receive the silicone type, which may feel more natural than saline implants.
Canadian health officials are about to review the moratorium for both Mentor and Inamed.
Health Minister Ujjal Dosanjh said a panel of scientific experts is expected to make a decision on the ban in two weeks. The public is then invited to comment.