Silicone implants have been banned for general use in the U.S. since 1992, except in the case of breast deformities or for reconstruction following breast cancer surgery.
Mentor and Allergan (which inherited the breast implant technology through its Inamed acquisition) have been trying to get silicone gel-filled implants back on the market, because they say they feel more natural than the saline implants now in use.
Breast augmentation is the No. 1 surgical cosmetic procedure performed in the U.S., with nearly 340,000 American women undergoing breast implant surgery last year--85 percent of those for cosmetic enlargement--according to the American Society for Aesthetic Plastic Surgery. That number is expected to increase if silicone becomes available.
Amit Hazan of CIBC World Markets Corp. says Mentor's Canadian implant sales alone were $15 million over the last 12 months, and he estimates that figure to increase by $5 million in the next 12 months.
Louise Chen of Morgan Stanley said that if the U.S. does approve silicone implants, she expects Allergan, which markets two different kinds, to get approval for its responsive gel implant--perhaps as soon as the end of this year.
But even with a U.S. approval, Mentor and Allergan--which also markets Botox--could eventually find their silicone implants are a bust: Canadian regulators are requiring a long-term, post-approval study to start within a year.
In addition, Hazan said in a research report that the Food & Drug Administration and Health Canada have been having regular discussions regarding silicone implants, and that the FDA may want to conduct a wide-scale post-approval study in the U.S. as well, enrolling perhaps as many as 40,000 to 50,000 women.
"That may take "a number of quarters to enroll women, train doctors, and set up clinical sites," said Hazan.
That's not the only anticipated obstacle to reintroduction. Ralph Nader's consumer activist group Public Citizen has already geared up, and contacted the FDA about a scientist and former employee of Mentor who says the company was aware of silicone leakage and dangerous side-effects of the implants, but hid those findings from the FDA.