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Monday, December 12, 2005

Byline: Maura Lerner; Josephine Marcotty; Staff Writers

Suzanne McLain of Minneapolis is amazed that the federal government is even thinking of lifting the ban on silicone breast implants. After all, she believes they made her and thousands of other women chronically ill.

But Dr. Jennifer Harrington, an Edina surgeon, says it's the right time to consider bringing them back because science has shown they were never as dangerous as critics made them out to be.

On Tuesday, a federal panel of experts narrowly rejected a California company request to bring the controversial implants back to the market. The panel said there still isn't data to show how long the implants last or what happens when they break.

The panel will vote today on whether or not to recommend approval for a second California manufacturer.

For 13 years, silicone implants have been in medical purgatory. They were banned by the Food and Drug Administration (FDA), except for limited use, in the face of one of the largest class-action suits in legal history. Now the FDA must decide whether to make them available to the thousands of women who want them for cosmetic reasons or for reconstruction after cancer surgery. It is the second time since 2003 that an FDA expert panel has debated the question. Tuesday's vote followed two days of hearings that reawakened passions on both sides of the debate in Minnesota and throughout the country. For some, the bitterness and fear still linger despite a decade's worth of studies showing that the implants do not cause disease.

"There seems to be a body of evidence supporting that they're not as dangerous as originally thought," said Charles Zimmerman, a Minneapolis lawyer who once handled hundreds of lawsuits against implant manufacturers. Yet, he says, "I think the burden is to prove they're safe."

An array of problems

In Minnesota, hundreds of women filed lawsuits in the 1980s and 1990s claiming that their silicone implants had ruptured and caused chronic health problems. The complaints ranged from depression to cancer to diseases involving the immune system, such as lupus and rheumatoid arthritis.

Eventually, manufacturers - including the 3M Co. in Maplewood - agreed to create a $4.3 billion fund to settle more than 100,000 claims, a settlement that helped bankrupt the largest manufacturer, Dow Corning. But many women have yet to receive payment because of lingering legal disputes.

The furor prompted the FDA to impose a ban on the use of the silicone implants in 1992. Since then, the ban has been eased for research and for women who want them for reconstructive surgery after breast cancer. But the lawsuits and the FDA ban resulted in a stream of scientific studies over the past decade that have found no connection between the implants and disease.

No problems found

"Good studies were done," said Harrington, the Edina surgeon. "And it has not panned out that silicone was the cause of any these problems." She said silicone implants are softer and more natural looking than the saline-filled implants that are more commonly used. She has implanted hundreds of silicone implants in women who needed reconstructive surgery and in those who are part of a research study for a third manufacturer.

"I've never had a problem," she said.

Now two companies, Mentor and Inamed Corp., are making their case that the FDA should lift the ban so they can sell silicone implants to anyone who wants them.

Inamed Corp. acquired the implant business that 3M had once owned. Mentor Corp. was founded in Minneapolis by three Minnesota businessmen but moved to California in 1985. It still operates a manufacturing plant in Minneapolis.

On Tuesday, the FDA's expert panel decided that Inamed had not succeeded in making its case. The members voted 5 to 4 that lingering questions about how long the implants last must be answered before they are widely sold.

Without that information, "How can we get an informed consent from our patients?" asked FDA adviser Dr. Amy Newburger, a New York dermatologist. "It makes me very uneasy. I don't feel secure about the safety."

The FDA isn't bound by its panel's recommendation, and it will make the ultimate decision at a later date.

For some, the new debate has reopened old wounds.

"It surprises me that anyone would do it again," said McLain, 70, who had silicone implants following a double mastectomy at age 50. At the time, "Safety wasn't even discussed. They said this was for life." But the implants leaked, and when she had them removed in 1993, she learned that silicone had spread like "silly putty" throughout her body, she said. She developed several disorders, including Graves' disease, anemia and numbness, all of which she blames on the implants.

Lorri Rowe, 59, of White Bear Lake, who once led the group Women Against Silicone Poisoning (WASP), is equally appalled at the idea of bringing them back. She got silicone implants after a double mastectomy 21 years ago. She blames them for chronic fatigue, pain and numbness that eventually cost her marriage, her home and her career as a psychotherapist.

Never mind the volumes of research, she said: "I was fine until I had the implants."

But Joseph Price, a Minneapolis lawyer who defended 3M against implant suits, says this is a case of "junk science run amok." After all these studies, he said, "Anybody who says there's still a risk these implants cause disease is saying the world is flat."

The FDA's ban prompted the kind of research that critics say should have been done years earlier. None of the studies found a link between the implants and disease in women.

The first was published in the New England Journal of Medicine in 1994 by epidemiologist Dr. Sherine Gabriel at the Mayo Clinic. She found that women with silicone implants and those without had the same rates of immune disorders that many blamed on the implants.

The most definitive scientific finding to date was delivered by the Institute of Medicine, the independent medical advisory body to the federal government. At the request of Congress, the institute's panel of 13 experts reviewed a thousand research reports on silicone breast implants and listened to days of testimony. In 1999 it issued a 400-page report that concluded there was no evidence implants caused any harm.

"The question is," Harrington said, "when will the FDA and the general public have enough information to put them back on the marketplace?"

The Associated Press and staff writer Janet Moore contributed to this report. The writers are at marcotty@startribune.com and mlerner@startribune.com.

 
Plastic surgery
Top five female cosmetic surgical procedures, 2004
- Liposuction 292,402
- Breast implants# 264,041
- Eyelid surgery 200,667
- Nose reshaping 195,504
- Facelift 103,994

Surgical breast implant procedures, 2000-2004
(See microfilm for chart.)

* Data does not specify between restricted silicone implants (available only in research studies and for reconstructive surgery) and saline implants, which account for the vast majority of implants.

SOURCE:American Society of Plastic Surgeons

Associated Press

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