After more than 13 years, silicone breast implants are returning to the Canadian market for use in augmentation, revision, and reconstruction procedures. Silicone breast implants had previously been partially banned because of concern over potential health risks.

Saline-filled breast implants became standard when silicone breast implants came under scrutiny in the early 1990s. However, silicone implants were still used in special cases and are currently poised to return to the market in the United States as well.

Two California-based implant manufacturers, Allergan Inc. and Mentor Corp., are awaiting approval for their silicone-filled breast implants from the U.S. Food and Drug Administration. Both companies have received a license to sell the implants in Canada.

Canadian health officials are requiring the implant makers to meet certain requirements as part of the license, such as:

• Provide updates of long-term clinical trials
• Provide implant registration cards
• Report sales and marketing histories, including any recalls or problems
• Conduct patient focus groups
• Include survey of plastic surgeons on product labeling and brochures

If approved for use in the U.S., the companies will be required to meet similar conditions.

Considering breast augmentation, revision or reconstruction? Please contact us today to schedule a consultation with a board certified plastic surgeon near you.