A second chance for silicone
Implant makers are setting the stage for a new FDA review of the gel-filled devices, claiming
they're safe.
Jane E. Allen
01/13/2003
Copyright 2003 Los Angeles Times
For more than a decade, silicone breast implants have been banned
in the United States, pulled from the market amid claims that they
made women ill. By the mid-1990s, the devices had become a
symbol of what many regarded as corporate America's indifference
to women's health, with one company, Dow Corning, eventually
filing for bankruptcy protection.
Now, silicone implants are poised for a comeback.
With no fanfare, longtime implant maker Inamed Inc., formerly
known as McGhan, has taken the first step toward returning the gelfilled
devices to the marketplace. On New Year's Eve, the company
quietly asked the Food and Drug Administration to allow it to again
sell silicone breast implants. A rival firm expects to make a similar
request soon, and a third company hopes to follow. Manufacturers
also are testing a thicker, gumdrop-like gel that doesn't leak.
Inamed's filing sets the stage for a new examination of silicone gel.
Although some of the debate is expected to echo the original, this
time the FDA will be ruling in a markedly changed climate -- and
will have safety data in hand.
At the time the silicone implants were pulled from the market, an
estimated 1 million to 2 million women had gotten them. No one
denies that some implants ruptured, requiring repair or removal, and
that some women became ill. "We know there hasn't been a breast
implant manufactured that doesn't sometimes rupture," said Dr.
David W. Feigal, the FDA's top regulator of devices. Even Inamed's
patient literature tells women they may need additional surgery at
some point to replace or remove the breast implant.
But scores of studies have failed to prove that implants cause the
connective tissue diseases, such as rheumatoid arthritis, lupus and
scleroderma, which thousands of women claimed in class-action
lawsuits against the manufacturers. In a 1996 book, Dr. Marcia
Angell, then executive editor of the New England Journal of
Medicine, said that unscrupulous trial lawyers had manipulated the
science to convince women -- and an unquestioning media -- that
silicone implants were dangerous. Then came a widely publicized
report from the prestigious Institute of Medicine. That report,
released in 2000, found that women with silicone implants were no
more likely to have connective tissue disorders than women without
implants.
The furor temporarily dampened the demand for breast implants.
But as plastic surgery has become more acceptable, the number of
women seeking the devices has grown as well. And with it has come
an increasing dissatisfaction with saline implants, the only option
available to most women.
Meanwhile, even as Inamed and Mentor Corp., both headquartered
in Santa Barbara, continued to produce saline implants, they were
working to improve the durability of silicone implants -- laying the
groundwork to ask regulators to reconsider their decision. They've
changed both the composition and design of silicone implants and
their outer coverings, or shells. They've made the shells thicker and
more durable, to guard against silicone leakage, and they've added
an extra membrane to keep silicone from bleeding through the shell.
Safety is the main issue
The focus of yet-to-be scheduled hearings before an FDA advisory
panel, which could come as soon as this summer, is likely to come
down to whether today's silicone implants are safe enough. Much of
the attention will focus on the rate of complications: Implants don't
last a lifetime and can cause infection, rupture and capsular
contracture -- the painful shrinkage of the scar tissue that forms
around implant shells. When saline implants rupture, the salt water
is absorbed by the body. When silicone implants rupture, the gel can
migrate outside the chest, causing lumps called granulomas; longterm
effects aren't known.
Nevertheless, many women gravitate to the more natural look and
feel of silicone .
"A good silicone you can't feel, and a good saline you can always
feel," said Dr. Debra Johnson, a plastic surgeon in Sacramento. "
Silicone is not a perfect implant. It feels oh-so-nice, but if it breaks,
it's a bit of a hassle.... Free silicone in the tissues can be nasty to get
rid of."
Introduced in 1962, silicone implants went unregulated until 1988,
when the FDA asked manufacturers to provide evidence they were
safe.
But in January 1992, after multimillion-dollar jury awards and
hundreds of lawsuits, FDA Commissioner David A. Kessler called
for a moratorium on the sale of silicone implants, noting that women
still had access to saltwater-filled implants. That April, Kessler
made an exception: Women who had undergone a mastectomy
would be able to get silicone implants through research studies;
otherwise healthy women later were allowed to enter the studies.
The mushrooming controversy and FDA action had a temporarily
chilling effect, but demand has since grown dramatically. The
American Society of Plastic Surgeons reported 32,607
augmentations and 29,607 breast reconstructions the year Kessler
restricted silicone . In 2001, less than 10 years later, the group
reported 206,354 breast augmentations and 81,089 reconstructions.
Feigal, director of the FDA Center for Medical Devices and
Radiological Health, said regulators will review all prior studies of
implant safety, including an FDA-sponsored report published in
2001 that found a higher rate of fibromyalgia among women who
had silicone leaks from implants that were at least 8 years old.
"The [Institute of Medicine] report didn't find convincing evidence
about connective tissue diseases, but commented quite extensively
about local complications," he said. Depending on the agency's
satisfaction with manufacturers' silicone studies and two years of
patient follow-up (90,000 women have gotten the implants through
research studies), the FDA could approve the sale of silicone gels
next year. It could also request further studies.
Claims of health damage
But many women say they are not satisfied with the safety of
silicone implants. And it's their testimony that is most likely to echo
the earlier proceedings.
Kim Hoffman, 42, of Niangua, Mo., is among the women likely to
testify at the FDA hearings. She never gave silicone a second
thought when she was 29 and had her breasts enlarged to B-cup size.
Then one implant developed a bubble. In March 1995, she had them
replaced with "new and improved" silicone implants through a
study. Her surgeon assured her these would last a lifetime. But she
soon developed health problems, including chronic demyelinating
polyneuropathy, a degenerative muscle disease. Eight months later,
she had the implants removed.
"I lost my house, my business, my health insurance, my credit. And
I lost my dignity, my faith in our government and my faith in
doctors," said Hoffman, who had owned two preschools. She has
testified before Congress, contending that research studies may be
ignoring health effects of the implants, and enlisted the help of a
Missouri congressman on the House Energy and Commerce
Committee. That committee has been looking over the FDA's
shoulder, conducting its own investigations of silicone implant
safety issues.
But the alternative to silicone is saline, and for many women, saline
implants simply aren't good enough.
Overfilled, they're hard; underfilled, they wrinkle. Saline implants
also make a sloshing sound and rupture easily. If a woman has scant
tissue left after a mastectomy, a saline implant is harder to
camouflage.
As a result, many women are willing to take a chance on the still
unknown effects of silicone in the body.
Fifteen months after losing a breast to cancer, Beckie Kersting, a
school nurse from Yuba City, Calif., elected to have a second
mastectomy and reconstructive surgery. After weighing the pros and
cons of both saline and silicone implants, she and her husband chose
to go with silicone ; her surgery was Dec. 11.
"It's just amazing to me how natural-feeling they are," Kersting, 52,
said. "I feel like myself again. I know there are some risks, but I also
think the technology has come a long way in the last 20 years."
Nancy Dubler, a biomedical ethicist at Montefiore Medical Center in
the Bronx, N.Y., says silicone implants offer clear benefits to some
women. A member of the FDA expert panel that recommended
approval of saline implants in 2000, she dissented. She said
manufacturers' data showed that one in four women with saline
implants undergo additional surgery within five years to replace or
remove her implants.
Ruptures without leaks?
If the FDA approves traditional silicone implants, the companies
plan to seek approval for a new, contoured implant containing a
thicker, so-called cohesive gel that won't leak, even if the shell
ruptures. Dr. Steven Teitelbaum, a Santa Monica plastic surgeon
who participated in Inamed's cohesive-gel study, said these implants
can provide peace of mind. "Women feel better knowing they can't
leak out," he added.
Patients report cohesive gel implants feel natural, and doctors say
the thicker gel is more likely to maintain its shape over the years.
That's important because over time, gravity can make standard
silicone gel accumulate toward the bottom of the implant, leading to
folds in the shell and possible leakage.
But whether any silicone implant is approved will depend on
whether the FDA decides not that they are safe, but they are safe
enough.
Feigal said many people have the misconception that an FDAapproved
product is a safe product. In reality, he said, the agency
must evaluate risks, see if they outweigh benefits and finally
determine whether it's "reasonable to let the consumer decide
whether or not they're willing to take those risks."
