Nearly 15 years after banning silicone breast implants in most cases, the Food and Drug Administration approved revamped versions at a time of soaring demand for cosmetic procedures.
Many of the original marketers, who lost billions of dollars in lawsuits related to allegedly flawed silicone implants, are long out of the business. Still, the FDA's approval late Friday will accelerate a push into aesthetic medicine by two companies that are heirs to the U.S. breast-implant business: Allergan Inc. and Mentor Corp.
Both companies are betting big on the burgeoning cosmetic-medicine market. They expect the new implants -- approved for cosmetic augmentation in women age 22 and older, and for reconstructive use in women of all ages -- to draw a generation of body-conscious buyers too young to remember the high-profile health concerns that silicone implants once sparked.
Still, the companies face a delicate task in overcoming the devices' long history of safety concerns. The FDA banned silicone implants for use in cosmetic augmentation surgery in 1992 amid complaints of rupturing and worries that they could lead to problems ranging from connective-tissue disorders to cancer. While those links were never confirmed, manufacturers set aside billions of dollars to pay out to women who sued over alleged injuries. The litigation drove many companies out of the business and helped push Dow Corning Corp. into bankruptcy.
Consumer groups have raised objections to silicone implants for years, saying there isn't enough evidence of their long-term safety. A 2000 report by the Institute of Medicine, an independent federal research organization, found no link between silicone implants and systemic neurological or connective-tissue diseases. Still, it concluded there was "cause for concern" about complications such as infections, scar tissue and leaking. Another 2000 study, by the FDA, found that of 344 women participating, two-thirds had ruptured silicone implants and showed no symptoms before the leaks were detected.
Allergan and Mentor are expected to soon launch marketing campaigns aimed at surmounting women's fears about the implants and pointing to the differences between their products and the ones largely banned by the FDA in 1992. The newer devices contain a thicker silicone gel that the companies say makes implants less likely to leak. An even firmer gel is used in more advanced technology implants that still are under FDA review; those recently were approved in Canada.
Both companies expect high demand. Allergan, of Irvine, Calif., in March acquired Inamed Corp., developer of the breast implants that Allergan now sells. Mentor, of Santa Barbara, Calif., in recent months has transformed itself into a purely aesthetic company by divesting unrelated operations. Both are developing rival injectables for facial rejuvenation, a category currently dominated by Allergan's Botox.
Since 1992, women seeking breast implants for cosmetic reasons have had to use saline implants, which are filled with salt water. They are generally viewed as less natural-looking because they can be too hard or become wrinkly if underfilled.
Demand for the new silicone implants may be tempered by costs. The FDA is recommending that patients get regular screening, including magnetic-resonance-imaging examinations every few years, to detect possible rupture and leaking silicone. Like other cosmetic surgery, implant surgery isn't covered by insurance. It is highly unlikely that screening tests would be covered. The FDA also warned that women who get the implants likely will need further surgery at some point because of issues including ruptures and hardening of breast tissue.
Currently, with saline implants, the total cost of breast augmentation surgery ranges from about $6,000 to $10,000. A set of silicone implants alone costs $1,600 -- twice the price of saline implants -- but prices could fall as the market shifts to cosmetic applications that aren't reimbursed by insurance.
Still, the availability of silicone implants seems likely to boost a breast-augmentation market that already is growing significantly. In Europe, where both types of implant are available, roughly 90% of sales are of silicone products. Plastic surgeons expect a similar pattern to develop in the U.S.
Before the controversy over silicone implants peaked in late 1991, an estimated 150,000 women a year underwent implant surgery, including 20% for breast reconstruction. The number of procedures plunged 60% the following year, according to statistics compiled by the American Society of Plastic Surgeons.
Last year, there were about 291,000 breast-augmentation procedures in the U.S., making such surgery the third most common cosmetic procedure behind liposuction and nose reshaping, according to the plastic surgeons group. More than 80% of breast-implantation surgeries last year were done for cosmetic reasons, the rest for reconstruction. Based on industry estimates, the annual implant market appears to be about $400 million, not including surgeons' fees.
Physicians and market experts say there could be a spurt in demand for cosmetic breast surgery now that the silicone implants can be marketed for cosmetic use. Growth predictions vary from 5% to more than 50%. Some plastic surgeons say they have lists of women waiting for silicone implants.
Given the longstanding health concerns, the FDA will require extensive studies, including that each company conduct a 10-year study that will include 40,000 women. The device makers also will have to track the implants to ensure patients can be notified of any problems. Daniel Schultz, the director of the FDA's device center, said FDA officials felt that in contrast to 1992, "we have data that has been reviewed extensively by the agency," which met the FDA's standard of providing a "reasonable assurance" of safety and effectiveness.
The implants remain a politically charged issue that could draw scrutiny from the newly elected Democratic-controlled Congress. Lawmakers already are likely to be examining the FDA's handling of medical devices, as they reauthorize the user fees that fund part of the agency's device budget. Connecticut Democrat Rosa DeLauro, who will head the House Appropriations subcommittee that oversees the FDA's budget, has proposed a bill that includes safety requirements for breast implants.
Roxanne Guy, a plastic surgeon in Melbourne, Fla., said patients will need "re-education to understand that the new-generation product is superior and not like the old one." She said the typical breast-implant patient is a married woman in her mid-30s who is finished having children and breastfeeding and now "wants to get back what was lost."
Both companies were "ready to ship the minute approval happens," said Jose Haresco, an analyst at Merriman, Curhan Ford & Co., recently. Mentor and Allergan have nearly equal shares of the U.S. market, though Mentor's share has been edging up this year. Breast implants account for more than 80% of Mentor's revenue, while they are a relatively small business for Allergan, a much larger, diversified company with eyecare and dermatology products.
Mr. Haresco said he expects the U.S. breast-implant market to expand to $600 million to $700 million in the next two to three years, assuming the companies can continue to charge about $1,600 for a set of silicone implants. Alex Arrow, an analyst at Lazard Capital Markets, is more cautious. He said the high price of silicone implants reflects their current use for breast reconstruction, an application that is covered by medical insurance. He predicts silicone-implant prices will fall as the silicone market shifts to a largely cash cosmetic business.
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Silicone Saga Major developments in the history of silicone breast implants: 1980s: Women file lawsuits against makers of silicone breast implants, claiming they caused health problems. 1992: FDA bans silicone implants broad use. 1999: Institute of Medicine links silicone implants to local complications but not systemic health problems. 2003: FDA advisory panel backs bid by Inamed to widely sell silicone implants. 2004: FDA rejects Inamed's request to widely sell silicone implants and seeks more information. 2005: Another FDA advisory panel narrowly endorses approval of Mentor's implants, but rejects Inamed's. 2006: Botox maker Allergan buys Inamed.
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