Kristin Sanborn figures her new breasts were a bargain. In early March, after reading frightening headlines about silicone-gel implants, the 29-year-old Los Angeles hotel renovator decided to have hers removed. Her doctor replaced the three-year-old gel sacs with saltwater implants. Now, Sanborn figures she was smart to act when she did, even though, at $950 a pair, the sacs cost $400 more than in December. Next year the implants could run $1,500 or more--if they're still on the market.
Indeed, Dow Corning Corp.'s Mar. 19 announcement that it would quit the breast-implant business altogether leaves just two small outfits selling the devices to U.S. plastic surgeons. Unhindered by big-time competitors, both have suddenly and dramatically raised prices on their saline-based products. Since January, when the Food & Drug Administration imposed a moratorium on silicone-gel implants, Mentor Corp. and McGhan Medical Corp. have imposed 50% hikes on their saline alternatives. And more hikes are coming, executives at the two companies say.
HIGHER COSTS. Behind the price surge, Mentor and McGhan maintain, is a fear of increased litigation and the cost of preparing new research to meet regulators' demands. "You just have to pick up a newspaper, and you can see that the cost of doing business is up," says Jan Varner, president of McGhan, a Santa Barbara-based subsidiary of California medical-products maker Inamed Corp. Mentor, another Santa Barbara company, will say only that the pricing on its products reflects the high cost of selling breast implants. While neither will break out implant revenues, analysts figure each company sold $20 million to $30 million worth of the devices last year.
To many women's advocates, the price hikes are little more than greed. "I guess the price of salt water is going up," says Sybil Niden Goldrich, co-founder of Los Angeles-based Command Trust Network, which distributes information about implants. She argues that today's patients are being forced to shoulder the cost of past mistakes with the much-embattled gel devices. "They're gouging," she says.
Yet there's no question that government regulators are beginning to question data about the safety of saline implants. FDA Commissioner David A. Kessler has said he will review the saltwater types as part of his review of other implants, including pumps used in heart surgery and penile and testicular devices made of silicone. To prepare, companies selling such products are undertaking elaborate--and costly--new studies.
The implant companies say those bills will have to be paid by the consumer. Besides, says Oppenheimer & Co. analyst Glenn Reicin, the companies' unit costs will soon rise, since the demand for breast implants is expected to drop dramatically. Today, Mentor and McGhan are hard put to keep up with orders, particularly among women who want their silicone sacs replaced with the saline alternative. But over time, women who want larger breasts for cosmetic reasons--who have made up perhaps 80% mf the $90 million market--may shun all implants. "That demand has basically disappeared," reports Dr. Scott L. Spear, a Georgetown University Medical Center professor and practicing plastic surgeon.
Women have good reason to be wary of even the saline sacs. Surgeons report that as many as 1 in 5 of the sacs made before 1985 will burst or leak after being in place for five years. And even the newer, sturdier versions can blow out during rigorous activity. While seeping sterilized saltwater isn't anywhere near as harmful as silicone gel, new surgery is required to replace the implant. And the devices can interfere with cancer-diagnosing mammograms. What's more, many plastic surgeons believe there may be undetected risks to the implants, noting that scientific data are scarce. "I'm not sure any of us knows the story yet," says Dr. Norman Anderson, an internist and FDA adviser at Johns Hopkins University.
Still, there are many women whoinsist that they have a right to breast implants. Kessler is set to rule on an FDA panel's recommendation that implants be widely available to women, as long as they are closely monitored. No matter what Kessler decides, however, he is sure to take a lot of heat. "Pro-hibition has never been shown to work in this country, and women will demand access to these products," says Dr. W. Grant Stevens, a plastic surgeon from Marina del Rey, Calif. Probably so--but they will be paying lots more for them.