Inamed Gets Conditional OK to Resume Silicone Implant Sales

The dramatic comeback of silicone breast implants -- which were once virtually extinct amid health worries and a crush of litigation -- accelerated Wednesday with a conditional approval from regulators for a second manufacturer to resume sales in the United States.

Santa Barbara-based Inamed Corp. said the Food and Drug Administration had given it an “approvable letter” for silicone gel-filled implants. Inamed joins another Santa Barbara firm, Mentor Corp., which received conditional FDA approval of its silicone implants in July.

Like Mentor, Inamed still must comply with certain conditions, which were not disclosed, before it receives final government approval to sell the implants for cosmetic surgery -- ending a 13-year ban.

“Certainly this action by the FDA is a step forward to bringing silicone implants back,” said Jayson Bedford, an analyst with Adams Harkness Inc. in San Francisco who has followed medical devices. Analysts said the companies could get final FDA approval by the end of this year or early next year.

Shares of Inamed on Wednesday jumped $6.36, nearly 9%, to $77.42. Mentor declined $1.86, or 3.5%, to $50.70.

Once viewed as a health hazard, silicone implants were the subject of extensive litigation in the 1990s that drove at least one manufacturer, Dow Corning, into bankruptcy.

Although a series of studies did not bear out many of the fears of health problems, such as links between silicone breast implants and cancer, some women have had complications related to surgery and some experts see a link between leaking silicone and some illnesses.

The implants were ordered off the market for cosmetic use in 1992 because of concerns about health problems from leaks or ruptures.

Silicone implants now are available only to women undergoing breast reconstruction or for FDA-approved clinical trials. They are, however, still available in Europe, where a majority of women choose silicone implants, as they are regarded to have a more natural look than the saline version.

Worldwide sales from breast implants were about $500 million in fiscal 2004, analyst Bedford said, with about 70% of those sales from saline implants in the United States. Inamed and Mentor control nearly the entire U.S. market and are responsible for about 80% of sales worldwide, Bedford said.

Founded in 1969, Mentor makes cosmetic and urology medical products, including saline and silicone breast implants. It employs about 2,000 worldwide, with manufacturing and research facilities in the U.S., France, the Netherlands and Britain.

Inamed was formed in 1974 to make medical devices for the plastics and reconstructive surgery markets and eventually expanded into breast implants and collagen products. With manufacturing facilities in Fremont, Calif., Ireland and Costa Rica, it has more than 500 employees.

In getting its FDA conditional approval, Inamed had to overcome a rejection from an FDA panel in April that at the same time recommended conditional approval of Mentor’s product. After that meeting, Inamed gave the FDA new safety study data that excluded samples from one type of silicone implant that had high rupture rates, an analyst said. The company has discontinued that model.

One consumer activist pointed out that the two California companies had received only conditional approval and said she believed that the products would not come to market because the FDA would eventually discover there wasn’t enough scientific backing for the implants.

“So far, from what we’ve seen, the products from these companies aren’t proven safe,” said Diana Zuckerman, president of the National Research Center for Women and Families, a Washington-based nonprofit.

Zuckerman criticized recent studies that both companies offered the FDA on implant safety, saying they didn’t have enough women in the sample groups and weren’t sufficiently long-term.

Still, Wall Street sees potential profits in the conditional approval. Thomas Gunderson, an analyst at investment firm Piper Jaffray who follows the industry, predicted that Mentor and Inamed would each see annual sales increases of about $32 million a year if both companies got final FDA approval.

Inamed this year announced plans to be acquired by Medicis Pharmaceuticals Corp. of Scottsdale, Ariz., in a $2.8-billion deal that was expected to close by the end of the year.