Allergan Inc. and Mentor Corp. breast implant makers on Friday said that Canadian regulators have given them the green signal to put silicone gel breast implants back on the market.
Allergan Inc., popular for its Botox wrinkle treatment, said that Health Canada has granted the company a license for sale of both its round, smooth and textured silicone implants as well as Style 410 Shaped and Textured implants. Earlier this year Allergan entered the implant market when it acquired Inamed Corp. Mentor said it received a license to sell its round and contour MemoryGel breast implants.
The general market had only allowed the distribution of saline-filled implants had only been available through a special access medical device program in Canada.
Under the licenses,the makers of breast implant must keep provide an update on the trial results conducted in the clinics. They should also report on the focus groups and also be a large long-term study.
The Manufacturers must also update the Canadian health authorities on the reported problems or recalls and the registration cards with the implant details
A decision is awaied from the Food and Drug Administration with regards to the implants.
The FDA had banned the implants after a number of women had complained of becoming seriously ill when the silicon had leaked or burst. This was done about 14 yesrs ago..