Southern California’s huge cosmetic surgery industry breathed a collective sigh of relief after the U.S. Food & Drug Administration recently lifted its nearly 15-year ban on widespread cosmetic use of silicone breast implants.
But local media accounts to the contrary; surgery centers and selected medical device companies from Santa Barbara to Irvine likely were not popping many champagne bottle corks after the FDA’s lukewarm endorsement of the product.
The Nov. 17 regulatory approval, which includes new and expensive patient monitoring, is apt to slow widespread adoption of the silicone implants despite their more realistic and comfortable fit and feel than saline-filled alternatives.
Still, the approval is a big win for the two firms now allowed to more freely market the product in the U.S.: Santa Barbara-based Mentor Corp., and Irvine-based Allergan Inc. Both companies, which also sell saline implants and other aesthetic products, got a nice uptick in their share prices last week.
“There’s been a lot of hype about it, but it’s good for women to have a choice,” said Dr. Renato Calabira, a Beverly Hills plastic surgeon who was among a select group allowed to use silicone implants under limited circumstances so the implant makers could gather safety data for regulators.
Silicone breast augmentation can range between $5,500 to $12,000, including the $1,600 cost of the silicone implants themselves, around twice the price of saline versions.
Neither Calabira nor Long Beach plastic surgeon Dr. Marcel Daniels expect prices to go down any time soon. With only two companies able to market implants in the U.S. and millions of dollars invested in clinical studies to get silicone back on the market, neither has an incentive to launch a price war.
Daniels notes that patients also may be deterred by significant ongoing maintenance costs over the average 10-year lifespan of the implants. To placate silicone critics, the FDA is requiring the companies establish a patient registry and direct patients to undergo MRI screenings at least four times a decade to detect potential abnormalities.
“Do you really think a Blue Cross or a Blue Shield is going to pay for that many MRIs when most third-party payers now exclude most all procedures involving women with augmented breasts?” said Daniels, who performs around 110 augmentation or reconstructive breast surgeries a year, 80 percent of them silicone. “Surgeons are really going to have to lay out the costs for patients.”
The FDA imposed strict restrictions on silicone implants for cosmetic purposes in 1992 following reports of implant ruptures and charges that the devices could lead to problems ranging from autoimmune diseases to cancer. The resulting litigation helped push Dow Corning Corp., then the leading implant supplier, into bankruptcy.
Since then studies have not been able to prove the disease link, and last year more than 290,000 women had breast augmentation surgery with either silicone or saline implants in the U.S.
Biomed Edge Dulls
The biotech industry is a leading provider of jobs in California, but that leadership is in danger of weakening as the higher cost of doing business here encourages companies to expand and even relocate out of state, according to a recent survey by the California Healthcare Institute and PricewaterhouseCoopers.
Three out of four biomed and biotech companies plan to expand their manufacturing capacity outside California, taking many jobs with them. A smaller percentage are looking to expand their research and administrative positions outside the state.
“On top of the whole taxation environment in California, you’ve got the cost-of-living issue that is a burden for companies to recruit and retain top talent,” said Tracy Lefteroff, global managing partner for life science industry services at PricewaterhouseCoopers.
Around 2,700 biomedical companies employ 258,600 Californians, more than the state’s entertainment, telecommunication or aerospace industries. They are largely in the hubs of San Diego, the San Francisco Bay Area and Los Angeles, which are facing aggressive recruitment drives from outside the state.
Just last week, Pennsylvania Gov. Ed Rendell signed tax abatement legislation widely seen there as an attempt to encourage Amgen Inc. to locate a large warehouse facility there. Thousand Oaks-base Amgen, the world’s largest biotech company, already has research, manufacturing and packaging operations in dozens of locations around the U.S. and overseas, both for strategic and economic reasons. But it has said it intends to maintain its corporate headquarters here.
Lefteroff said Amgen’s position points to coastal California’s strategic edge in research and capital funding.
“We have a research and development infrastructure here with educational institutions that is unrivaled in the United States,” he said. “There’s a highly skilled workforce in this state that can move from job to job as companies get bought and sold. And you can’t discount the fact that the majority of venture capital is right here in California. Those people like to be near their investments.”
Staff reporter Deborah Crowe can be reached at (323) 549-5225, ext. 232, or at
[email protected]
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