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Default Implants at impasse Ruling delayed on silicone use for breast augmentation (cancer rheumatoid arthritis scleroderma autoimmune lupus)

Implants at impasse Ruling delayed on silicone use for breast

By SUSAN JENKS Gannett News Service

Some women get embarrassed, but Lisa Darnall has few qualms about
discussing her breast implants

Not only do most of her colleagues at work know she has them, but she
is pleased with the cosmetic results, having researched the topic of
breast augmentation thoroughly beforehand, she said.

"You don't just go out and do it," Darnall said. "And it does hurt,
though how much depends on a person's level of pain tolerance."

Two years ago, Darnall chose saline implants, which are filled with
saltwater, rather than wait for the Food and Drug Administration to
bring silicone-gel implants back to the market.

As it turns out, it would have been a long wait.

In early January, the federal agency chose to continue a decade-plus
ban limiting silicone-gel implants' availability to women with breast
cancer and a few other medical conditions in tightly controlled
research studies.

The FDA told manufacturer Inamed Corp. that serious questions remain
about how often these devices rupture and the health problems women
may face as a result.

The California-based Inamed has until mid-April to respond. But the
agency left open when a final decision might be made.

"There is no set timetable," said Sharon Snyder, FDA spokeswoman.

Like silicone-gel implants, saline implants also can rupture over
time. But Darnall, for one, isn't worried about that prospect, which
Inamed and other manufacturers say occurs at a rate of about 1 percent
per year.

"If saltwater gets in your body, you're not in the same kind of
trouble" as with silicone, a slimy goo or rubbery material also found
in Silly Putty, according to Darnall. She said that's why she
preferred saline implants in the first place.

"I did a lot of Internet research before doing this," the 40-year-old
Darnall stressed.

Emotional topic

Not since the failed legacies of the Dalkon Shield intrauterine device
for contraception and the drug DES to prevent miscarriages has an
issue evoked so much emotion among women.

During a two-day hearing before an FDA scientific advisory panel last
fall, dozens of women gave testimony against the implants' return to
the broader market, citing silent ruptures, ongoing health problems
and agonizing pain.

For example, Elizabeth Anderson, a former director of an online health
hot line, testified about the lack of long-term reliable research
proving the safety of silicone-gel breast implants.

Taking issue with several studies, including an extensive literature
review by the Institute of Medicine, she said, "epidemiologists will
tell you the studies are seriously flawed," because many women in them
had implants for only a few months or years -- too short a period to
assess risks for developing connective-tissue disorders, such as
lupus, rheumatoid arthritis or scleroderma.

But other women argued the federal agency should preserve consumers'
rights to choose, given that existing studies have found little
evidence silicone-gel implants cause major diseases, such as cancer,
or significantly increase the risk for rare autoimmune disorders.

Even Susan Scherr, a spokeswoman for the National Coalition for Cancer
Survivorship, argued for wider availability of these products.

"Silicone breast implants for reconstruction should not be held to a
different, higher standard" than other medical devices, Scherr said.

Aesthetically, several women also spoke about silicone's more-natural
feel and look. Had she testified at the FDA hearing, as originally
planned, plastic surgeon Dr. Victoria Vitale-Lewis said she, too,
would have stressed the aesthetic superiority of silicone over saline,
both as a physician and as a patient.

"I would much rather have the gel because I can feel the wrinkling,"
she said, referring to her saline implants, which she has had since

Wrinkling or puckering of the breast is a common side effect,
especially in women whose breast tissue is too sparse to cover the
implant, she said. That can occur in women of slight build or in older
women whose breasts have begun to sag.

Under FDA restrictions, surgeons must follow strict procedures when
providing silicone implants to patients: breast-cancer patients
needing reconstruction after a mastectomy; women with congenital
deformities whose breasts are drastically misshapen; or women whose
breasts have been injured due to trauma.

Also, patients who get silicone-gel implants must carry some of the
burden. Substantial paperwork is required and regular physician
checkups for several years.

Vitale-Lewis expressed little surprise at the government's decision to
overrule its own scientific advisory panel, which happens rarely. The
panel voted 9-6 to approve Inamed's implants, with certain conditions.

"(But) FDA really didn't say yes or no," Vitale-Lewis stressed. "They
felt many concerns had been adequately addressed, but they tabled it
for further answers."

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Originally published Saturday, March 6, 2004
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