A Return to Silicone Valley?

[Guest guest]

Incredible....even Dr. Baker's own daughter has implants....and

a diagnosis of MS...!!! The tendency to be in denial runs oh, so deep.

How sad, so very sad. Just how can they be soooooo sure the implants

didn't have anything to do with MS, when so many of us have suffered the

same symptoms?

A Return to Silicone Valley?

By Charlene LainoMSNBC

June 11 — While many American women were still reeling from the silicone scare of the early 1990s — when gel implants were yanked off the market in the wake of purported links to everything from arthritis to lupus — the industry quietly began working to reintroduce silicone for breast enhancement. Now, many predict silicone gel formulations could clear U.S. Food and Drug Administration hurdles within two years. Will they be embraced by women seeking a bigger bust? Plastic surgeons think so. Are they really safe? That jury is still out.

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THE BUZZ about silicone was as palpable as the nodules of scar tissue that can form around implants. The setting: The recent annual meeting of the American Society for Aesthetic Plastic Surgery at the Hilton Hotel in midtown New York. The prediction: Silicone breast implants — some of the very same ones banned in 1992 — will be reintroduced for routine cosmetic use in the United States within two years. And approval of a totally novel gel implant known as Style 410 — designed to offer not only a more natural breast, but also a safer experience — will follow soon afterward. The reasons: Silicone’s once marred reputation has been vindicated, ASAPS members said. More to the point, they added, their patients want it. When it comes to breast implants, silicone better mimics the soft, fleshy fullness of the real thing than saline or other fillers.

In the exhibit hall at the meeting, a steady stream of cosmetic surgeons waited their turn at McGhan Medical Corp.’s booth to cup in their hands the 410 implant. Its firm Jello-like consistency makes it safer — less likely to rupture, leak or migrate, according to its inventor. The gel entered the large-scale clinical trial needed for FDA approval in the United States in April, though it’s been used for seven years in Europe. Others gathered to discuss ongoing studies of conventional silicone gels routinely used for cosmetic surgery until the FDA’s 1992 moratorium. Manufacturers McGhan and Mentor Corp., the only two major U.S. companies left in the once competitive implant market, are collecting safety data to satisfy FDA requirements for approval. Enrollment in these trials is complete, with researchers now following the women to see if any complications develop. SAFETY CONCERNS

Should silicone implants be approved for breast enhancement?

Yes. It should be a woman's choice.

No, They haven't been proven safe.

Unsure.

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Should silicone implants be approved for breast enhancement?

* 11028 responses

Yes. It should be a woman's choice. 59%

No, They haven't been proven safe. 31%

Unsure. 10%

Survey results tallied every 60 seconds. Live Votes reflect respondents' views and are not scientifically valid surveys.

In juxtaposition to the upbeat scene at the New York hotel, concerned critics of breast implants gathered 300 miles away to analyze the findings of three recent studies that pose questions about their safety. Within weeks, the Washington, D.C.-based National Center for Policy Research for Women and Families would issue a statement headlined, “Long-awaited government studies raise new concerns about silicone and saline breast implants.” One study suggested a link between gel and cancers of the brain and lung, while another found that women with ruptured silicone implants may be more likely to develop the painful autoimmune condition known as fibromyalgia. “These are dramatic, upsetting results,” said the group’s head, Zuckerman, that re-open the debate about the safety of silicone. A BIT OF HISTORY That debate reached its pinnacle in 1992 when the FDA pulled silicone gel implants off the market amid concerns they might cause health problems, chiefly autoimmune diseases. But the regulatory agency soon announced its decision to allow use of silicone implants in certain instances, such as reconstructive surgery after breast cancer, correction of congenital deformities or replacement of ruptured implants. Throughout the ’90s, barely a month went by that a study didn’t find — or refute — a link between silicone and health woes. Dow Corning Corp., once the giant among implant makers, declared bankruptcy after ruinous litigation by women who claimed their health had been harmed.

Then, after reviewing dozens of studies, the Institute of Medicine concluded in its landmark 1999 report that gel implants do not cause the autoimmune disorders such as lupus or arthritis it was purported to. The main safety concern, the report said, is the implants’ tendency to rupture. The gook can bleed or leak out of its shell, causing infections. Another problem is so-called capsular contracture — a hardening of tissue surrounding the implant that can cause disfiguring, even painful, swellings on the breast. This can occur with any type of implant, all of which are seen as foreign by the body; with silicone breast devices, it’s estimated to afflict 3 percent to 12 percent of patients. These risks, say plastic surgeons, are acceptable to most women seeking to enhance their figure. “The IOM report was the turning point,” said ASAPS spokesperson Dr. Mark Jewell of Eugene, Ore., opening the door for the return of silicone breast implants for cosmetic use. Many women, it would seem, are waiting. In the decade before the FDA ban, about 100,000 women a year are estimated to have undergone implant surgery, the vast majority of whom opted for silicone gel. While there was a drop in popularity in the wake of the ’92 brouhaha, women soon again began enhancing their breasts, choosing the only option sanctioned by the FDA — saline implants. In 2000, more than 200,000 women underwent breast enlargement, double the figure in 1997, according to ASAPS. If silicone is approved, plastic surgeons have no doubt the pendulum will swing from saline back to silicone. “Four in five of my patients undergoing reconstructive surgery opt for gel,” said Dr. Baker, a clinical professor plastic surgery at the University of South Florida. “If silicone was offered to cosmetic patients, 80 percent of them would choose it, too,” said Baker, who also has a private practice in Winter Park, Fla. WHY SILICONE? “Silicone’s chief advantage is that it feels very natural — it has a good viscosity, a consistency almost like real tissue,” said Dr. Elkwood, a plastic and reconstructive surgeon in Shrewsbury, N.J. Its main disadvantage is a perceived risk of systemic illness that has been disproved by the IOM report, he said. “But that said, when it ruptures — and all implants can rupture — you can get a real mess in there, with bleeding and leeching out over time.”

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But, added Jewell, the silicone gel implants in use at the time of the ’92 ban were fairly firm — like gelatin that is just about to set — and thus much safer than the thin gels of the 1970s that were prone to rupture and leakage. “They never should have been taken off the market,” he said. Nevertheless, the filler is not as innocuous as saline: If it ruptures, the body simply absorbs the salt water. On the minus side, though, saline “is real water balloon-ish,” Elkwood said, “with puckering, rippling and scallop appearance all common.” “And if you get a [saline] rupture, the water will leak out, like air in a flat tire,” Baker said. “If you’re on your honeymoon or vacation, as happened to two of my patients, you are stuck until you can get to the doctor.”

Silicone is more cohesive so it will tend to stay in place even after a rupture, agreed Baker, who has performed some 12,000 implant procedures, including on his nurses and his daughter, McGrath. McGrath, who has had the same pair of silicone implants since 1983, said they improved her appearance and increased her self-confidence. And despite a relatively recent diagnosis of multiple sclerosis, she dismissed the possibility of a link between silicone and her autoimmune disease. “Think about it,” said McGrath. “If there was any risk that silicone was dangerous — any risk, no matter how teeny — my dad would have had me on the table and cut the implant out in a second,” she said, recalling what he told her back in 1992 when the silicone scare hit the media. Plus, the IOM report found no link, McGrath said. Nor has her neurologist, “who is world-renowned,” ever suggested implants could be the cause of her MS, she said. NOT A BIBLE Zuckerman said she wished that doctors and their patients would stop viewing the IOM report as the silicone bible. “The analysis was based on studies done before 1999,” she said. “So when a new study comes out, and now there are three, we need to pay attention.” One study, led by the FDA’s Lori Brown, found that women whose implants ruptured and leaked silicone outside the breast scar tissue may be more likely to develop fibromyalgia, a condition with no clear cause.

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But Brown stopped short of concluding there is a cause-and-effect relationship and called for further studies. A second study conducted by the National Cancer Institute found that women with breast implants are not at increased risk for most cancers, although they appear more likely to die from brain and lung cancer than other women who undergo plastic surgery. A third study also suggested a link between cancer and breast implants. Together, “these articles are a wake-up call for the almost 300,000 women and teenagers who plan to get breast implants this year,” Zuckerman said. “These studies remind us that we still know very little about the long-term dangers of breast implants.”

Her group supports a bill in Congress that would provide monies to be given to the National Institutes of Health for independent studies on the long-term safety of implants. ASAPS members expressed mixed feelings about the importance of the new studies. While Jewell said he has not seen any such serious complications in his practice, he said it is prudent to inform women about findings of any ongoing studies. But Baker said the new studies were flawed. “In the cancer trial, for example, they need to go back through participants’ medical records and find out more about their family and medical histories before they can conclude that any increased risk was due to silicone. And until that is done, there is no reason to tell patients of the findings.” ENTER THE 410 McGhan’s Style 410 implant is made of a thicker, stickier gel in a multi-layer pouch designed to prevent the leakage and migration associated with conventional gels, according to Terrye Tebbetts, a patient educator in Dallas and wife of inventor Dr. B. Tebbetts. “Even if the outside shell breaks down, the gel will not bleed out or migrate over time,” she said, explaining that it’s made from larger molecules that stick tightly together.

McGhan’s Style 410 implant

“It’s so cohesive that if you cut a triangle out of it and pulled it out, you could slip it right back in, like a puzzle,” she said. Plus, the design is an improvement aesthetically over conventional round gel implants, Tebbetts said. “It allows you to achieve a natural appearance — not the Baywatch look.” Jewell said he and his patients like it, and his slots for the 410 trial are filling up quickly. One of those enrollees, 45-year-old ,* said she was going to get a saline implant until some of her friends told her they “feel off.” “The 410s are so real, it’s amazing,” said the Eugene, Ore., mother of three. “I’d always been a little small. Now I’m larger, my clothes fit a lot better.” said she had no concerns about 410’s safety. “I did a lot of research, talked to women who had the procedure and Dr. Jewell gave me information to read. For me, the plusses outweighed the negative.” But Baker said he sees a downside. “It’s firmer than conventional gel,” he said. “It’s textured as opposed to smooth, which can cause rippling, and shaped as opposed to round, which I don’t think looks as good. “I don’t know how patient acceptance will be,” Baker said. Since the 410 is thicker, there is reason to believe they would leak less and thus be safer, Zuckerman acknowledged. But she said long-term data are needed before it can be given a clean bill of health. “Every time they change the formulation, there is all this excitement — this time we got it right,” Zuckerman said. “Then a few years later, problems only begin to surface.” PREDICTIONS OF A COMEBACK Sybil Nyden Goodrich — the whistleblower who set off the silicone brouhaha after she found out the implants were not approved by the FDA and published an article describing her experience in Ms. magazine — said she is not surprised manufacturers and plastic surgeons are trying to bring gel implants back. After a mastectomy, Goodrich had four pairs of silicone implants from 1983-1984, all of which ruptured.

“The FDA has dropped the ball. They approved saline implants despite a complication rate they themselves admit is relatively high,” said Goodrich, a plaintiff in the Dow Corning lawsuit. “So why wouldn’t companies think they can push silicone through, too?” Dr. Middleton, a radiologist at the University of California, San Diego, who studies implant images, said he has no doubt that we’ll see a return to silicone — mainly due to changing public sentiment. “The constant stream of bad press is over, for the most part,” he said. “Plastic surgeons are in favor of them. “The patients want them and now better know the risks. “And just like with smoking,” Middleton said, “there is group of people for whom those risks are acceptable.” *Name has been changed at the request of the patient to protect her privacy. Return next Monday for Skin Deep Part 3: Growing your own breast tissue.

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