http://www.kansascity.com/mld/kansascity/news/nation/9011159.htm?1c

Posted on Fri, Jun. 25, 2004




Next generation of breast implants creates buzz, worry

BY JULIA SOMMERFELD

The Seattle Times

SEATTLE - (KRT) - The quest for the perfect breast has come full
circle. Even as checks from Dow Corning slip into mailboxes this
month, finally settling thousands of silicone lawsuits, plastic
surgeons and patients are clamoring for the latest breast-boosting
technology - the next-generation silicone implant.

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 said 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, Canada, 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, Wash., plastic surgeon who does
about 100 breast augmentations a year.

His typical implant patient, he said, 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 said 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. He's implanted five pairs so far, and said
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."

Plastic surgeons Dr. Stanley Jackson and Dr. Philip Kierney in
Puyallup, Wash., 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.

When one of Remington's patients, Melissa, felt the CPG, her immediate
reaction was, "When can you get me in?" The 47-year-old 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.

"At the health club, I took off my clothes and walked to the shower.
Nobody looked, but I felt like I finally hit puberty and had a
positive locker-room experience at age 30," she said.

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.

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, 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, 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 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.

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."

---

BREAST AUGMENTATION THROUGH THE AGES

The surgical pursuit of bigger breasts dates back more than 100 years.

1890s: In an early approach to breast augmentation, an Austrian doctor
pioneers paraffin injections into the breast. The technique is
abandoned after hard lumps form.

1940s: Japanese prostitutes inject their breasts with industrial-grade
silicone to appeal to U.S. soldiers in World War II.

1950s: Doctors implant sponges made from polyvinyl and other synthetic
materials. They harden, and removal can be disfiguring.

1961: The first silicone implant is developed by two Houston surgeons.
Dow Corning takes it to market in 1963.

1965: Saline implant is invented in France, but doesn't catch on until
the 1990s.

1980s: Reports begin appearing of illnesses linked to silicone breast
implants.

1992: When silicone-implant makers can't provide sufficient safety
data, the federal Food and Drug Administration bans the implants' use
for cosmetic purposes and allows them only for reconstruction. First
class-action suit against silicone-implant makers, including Dow
Corning, is filed.

1999: The Institute of Medicine concludes there's no evidence of a
link between silicone implants and serious diseases.

1999-2000: Implants filled with soybean oil - sold as a natural
alternative to silicone in Europe - are pulled from the market because
of worries the oil may become toxic.

2000: Saline-filled implants, which had been available for years,
receive FDA approval.

2004: FDA continues the ban on silicone implants, saying questions
about leaks must be answered before they can be approved. Meanwhile,
two implant makers test new cohesive-silicone implants. Dow Corning
starts paying off the $2.35 billion class-action settlement.

Source: American Society of Aesthetic Plastic Surgery; American
Society of Plastic Surgeons; "Venus Envy: A History of Cosmetic
Surgery," by Elizabeth Haiken.

---

More information

FDA BREAST IMPLANT INFORMATION: www.fda.gov/cdrh/breastimplants
AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY: www.surgery.org
AMERICAN SOCIETY OF PLASTIC SURGEONS: www.plasticsurgery.org NATIONAL
CENTER FOR POLICY RESEARCH FOR WOMEN & FAMILIES: www.center4policy.org