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Sunday, June 20, 2004 - Page updated at 12:00 A.M. Next generation of breast implants creates buzz, worry By Julia Sommerfeld
Now, U.S. women who want larger breasts for purely cosmetic reasons can get only implants filled with saline. That hasn't hurt the breast business any: More than a quarter-million women had breast-augmentation surgery last year. That's a nearly 700 percent increase since 1992, the year silicone implants were restricted for safety reasons and the first lawsuit against Dow Corning and other manufacturers was filed. Even the bikini-unfriendly Northwest isn't immune to the lure of artificial curves. Seattle plastic surgeon Dr. Phil Haeck says his office does at least 1,000 pairs of implants per year. Still, some women complain of sloshy results from the salt-water implants and pine for the fleshy feel of silicone gel. "This is cosmetic — patients expect perfection," Haeck said. Enter the "cohesive" silicone gel implant, so-called because the gel is thicker. These devices, yet to be approved by the Food and Drug Administration, were the darlings of a plastic surgeon's convention recently in Vancouver, B.C., where doctors with foreheads as free of creases as their perfectly tailored suits poked, pinched and squeezed the rubber teardrops. They see cohesive implants as the best bet in their ongoing pursuit of a better bosom, promising the feel of silicone without the fear of leaks, the flaw that brought down their predecessors. That's yet to be proven. But despite nagging questions about health risks, some women are lining up to find out with their own bodies in clinical trials.
But why go there? America's breast fetish far predates racy, lacy Victoria's Secret ads, and wardrobe malfunctions. The first reports of breast-augmentation surgery go back to the 1890s, when injections of paraffin were used to plump breasts — with rock-hard consequences. What has changed since then, especially since the debut of Pamela Anderson's zero-gravity orbs, is that now it's almost impossible for a real breast to stack up. "The sense of what is a normal breast has gotten way out of whack," said Seattle director Francine Strickwerda, whose film "Busting Out" about America's breast obsession premiered this month at the Seattle International Film Festival. "The breast-implant look is the new normal." On the reality shows "Extreme Makeover" and "The Swan," most females, whether their stated complaint was a hump nose or snaggle teeth, also left with a standard-issue cantilevered bosom. The preternaturally perky breast looms large not just over starlets and strippers. "You'd be surprised who gets them — it's not who you'd think," said Dr. Bradley Remington, a Kirkland plastic surgeon who does about 100 breast augmentations a year. His typical implant patient, he says, is a 30-something mother whose breasts deflated after nursing, or a young professional who can finally afford to do something about the flat chest that's soured her beach vacations for years. She generally asks for a fairly modest C-cup, not the DD's standard for L.A. and Miami. And most of all, she says she wants to look "natural." But keep in mind that word has a peculiar definition in plastic-surgery circles. When uttered to a cosmetic surgeon, "make me look natural" translates to: "make me look like Halle Berry's body double." The appeals for more natural-looking artificial curves are why Remington is helping test one of the new cohesive-silicone implants, the Contour Profile Gel (CPG). He's implanted five pairs so far, and says their maker, Mentor, will release more slots for an expanded clinical trial next month. He's eagerly awaiting his new allotment so he can attend to the handful of women already on his waiting list. Remington stands the CPG upright in his palm, showing how the implant holds its shape like a Jell-O mold, unlike the saline version, which collapses into a rubber puddle in the other hand. "The gel is more solid, like a gummy bear — it maintains its shape and stays where it's supposed to," he said. "This is the implant of the future." Puyallup plastic surgeons Dr. Stanley Jackson and Dr. Philip Kierney also are taking part in the cohesive trial. Together, they've implanted 40 pairs of CPGs. They're also studying a cohesive implant further along in trials, the Style 410 made by Inamed, and have used them in 26 patients. Women have flocked to Puyallup from around the state to give silicone a second chance, but Jackson was at first reluctant. In the early 1990s, he settled two silicone lawsuits when patients reported health problems. "There was a lot of trepidation on my part about going back into silicone," he said. "But it seemed to me these were a major improvement." Still surgeons don't think the new silicone will completely supplant saline. A recent survey found that women are happier with saline than with silicone on almost all counts, except for one: Saline didn't feel as natural But for breast aficionados that's like saying fat-free ice cream is better on every count, but it just doesn't taste as good. Implants 'favorite so far' When one of Remington's patients, Melissa, felt the CPG, her immediate reaction was, "When can you get me in?" The 47-year-old Eastside mother asked that her last name not be published because she doesn't want co-workers appraising her chest. Looking at the handsome blonde with a well-proportioned figure, you'd never guess she's sporting cutting-edge breast implants, much less that she's on her third pair. Her breast insecurities go back nearly 35 years — to the familiar root of preteen angst and psychic scars: the junior-high locker room, where, "At 13 it's such a big deal when a girl gets a bra," she said, "and when it doesn't happen to you, it's an even bigger deal." Over the years, she became obsessed with every other woman's chest. So, in 1986, after having two kids, she got silicone gel implants.
Then women began suing silicone-implant makers, blaming their health ills such as chronic fatigue, arthritis and fibromyalgia on leaking silicone. After the FDA restricted silicone-implant use to breast-cancer patients and others needing reconstructive surgery, Melissa replaced her implants with saline. She's regretted it ever since. Because she's thin, she could see the outline and wrinkling of the round saline implant under her skin. And to her, they felt like independently animated water balloons. "I would hold people at a distance when I hugged them; I was afraid they'd be able to feel them," she said. When she heard that a new, more cohesive silicone implant was in clinical trials, she jumped at the chance. She paid $5,800 for the surgery, but will get back more than half the price over 10 years if she makes all her follow-up appointments for the trial. "I've now had all three, and these are my favorite so far; they feel like part of my body." She's not worried about a silicone-scare redux. She read up on it and decided most of the fears were overblown. "I did have a brief moment of fear, where I worried about my obituary reading, 'She died having her breasts enlarged,' " she said. "Anyway, in my mind at least, these are new and improved so probably safer." Plastic surgeons and silicone's critics have very different takes on that assumption. Mysterious symptoms Diana Zuckerman, president of the National Center for Policy Research for Women & Families, a vocal critic of breast implants, sees the zeal for the latest implants as a case of "wishful thinking over science." "The history of breast implants is full of 'new and improveds' and riddled with failures," Zuckerman said, pointing to the polyurethane foam-coated implants in the 1980s, a so-called improvement meant to prevent scar tissue from forming. They were pulled from the market when the FDA raised concerns the foam could break down into a carcinogen. And silicone gel is not off the hook, as far as she's concerned. Patti Settle, a 65-year-old breast-cancer survivor who lives in Port Ludlow, Jefferson County, is one of hundreds of thousands of women who believe silicone implants made them ill. After a double-mastectomy in 1986, Settle went through several pairs of silicone implants. A couple of years later, she developed sarcoidosis, an autoimmune disease where nodules form on the lungs. "I started feeling like my body was turning on me; I developed asthma, arthritis, peculiar things I don't know how to explain," she said. Her symptoms were a mystery until her lung doctor suggested they might be due to the silicone implants. When she had her implants removed, they had broken and were oozing silicone, so the surgeon had to carve out chunks of tissue. She's part of the Dow Corning class action because one of her sets of implants was filled with the company's silicone. Dow Corning just came out of bankruptcy, brought on by hundreds of thousands of such cases, and started paying off the $2.35 billion settlement last week. More than 500 women in Seattle are set to receive checks, ranging from $2,000 to $250,000. But Settle isn't sure she'll see any money because she already won a $15,000 settlement from Mentor, the maker of another of her implants. In the years since the lawsuits were filed, studies have disputed the link between silicone and autoimmune diseases. In 1999, the Institute of Medicine (IOM), an independent agency that advises the government, reviewed the research and concluded that implants don't cause diseases. Zuckerman doesn't buy the report. She cites studies that suggest links to brain cancer, suicide and fibromyalgia, and notes that scientists haven't ruled out the possibility that a subset of people, like Settle, are allergic to silicone. Still, the IOM report was no ringing endorsement. It warned that implants often leak and up to one-quarter of recipients need repeat surgery within five years. Many plastic surgeons, however, think that silicone's bad rap is undeserved. "I have no reservations whatsoever about using silicone for my patients," said Dr. Mark Jewell, a Eugene, Ore., plastic surgeon and a top user of cohesive implants. In fact, Jewell and other surgeons pressed for a return of the original silicone sacs when implant maker Inamed sought FDA approval last fall. Most of the FDA's experts believed the implants don't cause diseases, but the agency denied approval — for now, anyway — until the company can answer what happens over time when the devices leak silicone into the body. That's why surgeons are betting the new cohesives are the best shot to get silicone past the FDA. Early reports from doctors in the trial suggest the thicker shell and gummy-bear consistency lower the risk of ruptures and leaks. Pursuit of perfection Smack in the center of the silicone buzz at the Vancouver meeting of the American Society for Aesthetic Plastic Surgery was Hani Zeini, executive vice president of Inamed Aesthethics. "When? When? That's all doctors keep asking me," he said, gesturing to the surgeons hovering around the sample implants as impatiently as children who've already picked out their Christmas present in June. The company has two years of data on nearly 1,000 women who've received the Style 410 cohesive implant and will submit it for FDA approval by the end of the year, he said. Mentor is close on its heels with the CPG study. Both brands of cohesive implants are already used in Europe, South America and, on a limited basis, Canada. "If you look at worldwide sales outside of the U.S., more than 90 percent of implants sold are silicone. That's our future," Zeini said. But critics are vexed by his vision — even if these newfangled devices don't spill silicone into the body, they are expected to carry the same risks of local complications as saline and the old silicone version — namely, they can obscure mammograms; can cause infections, painfully hard scar tissue and disfigurement; and frequently require repeat surgery. Plus, many young women may not realize they aren't buying a lifetime device. Odds are they'll need at least a couple more surgeries over the years to swap them out. But Melissa, the three-time breast-implant recipient, notes the upside: Maybe the next pair will be even better. After all, the whole point of this business is to come closer to perfection, a perspective neatly summed up in a banner ad at the plastic-surgery conference. The wall-sized promotion for a European silicone maker featured a pretty, chesty blonde and issued the challenge: "Beauty is natural. Perfection is surgical." Julia Sommerfeld: 206-464-2708 or jsommerfeld@seattletimes.com
Copyright © 2004 The Seattle Times Company
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