Fw: A return of silicone breast implants? ~ MSNBC News Link & Comment Forum

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From: " ilena rose " <ilena@...>

Sent: Tuesday, June 12, 2001 2:10 PM

Subject: A return of silicone breast implants? ~ MSNBC News Link & Comment

Forum

> ~~~ thanks so much for this from nancy & her wonderful husband, hank. and

> thanks to sybil and drs middleton and zuckerman for their comments. ~~~

>

> there is a place to comment on the website ... please do! love to all

> ... ilena ~~~

>

>

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>

>

> By Charlene Laino

>

> MSNBC

>

> 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.

>

> 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 of

> Aesthetic Plastic Surgeons 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.

>

>

> Vote to see results Should silicone implants be approved for breast

> enhancement?

> * 5565 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, Diane 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.

>

> Chat with cosmetic surgeon

>

> Dr. Baker at 6 pm ET on Thursday

>

> 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. "

>

> 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.

>

> 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.

>

>

> Write a letter to the Editor

>

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