USNEWS: Health Risk or a Woman's Choice?

[Guest guest]

http://www.usnews.com/usnews/health/articles/050425/25breast.htm

To respond: letters@...

4/25/05

Health Risk or a Woman's Choice?

No scientific consensus on silicone breast implants

By Querna

Both Carolyn Wolf and Michele Columbo came to the Food and Drug

Administration's advisory panel meeting on breast implants last week

with strong feelings about the availability of silicone implants.

Wolf, now 74, had her implants put in more than 30 years ago after a

mastectomy. For the first seven years things went all right. Then,

she started getting blisters on her neck and boil-like growths on

her forehead. She had chest pains so bad they put her in intensive

care. Five years ago she felt intense pain in her left eye. A string

of silicone, about an inch long, came out of that eye. Then strings

started coming out of her ears. Wolf had her severely ruptured

implants removed in 2000, but she still suffers from short-term

memory loss that she attributes to the implants. " Please, " she told

the panel, " do not inflict this on another generation. "

Columbo, 35, got implants last year to correct a condition she'd had

since birth. Before she did, she researched implants exhaustively to

convince herself they were safe. She hasn't had any problems,

including when she breast-fed her son. In 1992 an FDA decision had

restricted silicone implants to women who've had mastectomies or

have a congenital deformity like Columbo's. She testified that she

believes that women are competent and educated enough to make their

own decisions about what type of implant is right for them. " I don't

understand why the FDA can decide they are safe for me or breast

cancer patients but not for someone else, " she says. " The difference

here is a moral one, not a medical one. "

The two women's different experiences epitomize last week's

emotionally charged hearings, which yielded more questions than

answers about whether breast implants should be restricted as a

health hazard or offered as a woman's personal choice. The FDA panel

voted 7 to 2 to recommend the approval of Mentor's silicone implant

and 5 to 4 to reject Inamed's similar implant. Many thought such a

split vote was unlikely, and the result makes it hard to predict

what the FDA's final decision will be when it considers the

recommendations in the months ahead. If it agrees with the panel,

silicone implants will once again be available to all American women.

Silicone breast implants were first used in the United States in the

1960s, but the FDA pulled them from the market in 1992, saying there

were insufficient safety data. In 2003, Inamed presented an

application to the FDA to bring silicone back to the market. That

was approved by the advisory panel but turned down by the agency,

which asked for more long-term safety studies. Though last week's

panel gave silicone implants a vote of confidence, lingering safety

concerns prompted it to impose stringent approval conditions to make

sure that both patients and surgeons are educated and to ensure that

any problems are reported. " We don't have exhaustive knowledge about

these devices, " , a plastic surgeon and panel member,

said at the meeting. " But we have sufficient knowledge to justify

their use. "

Not everyone agreed. Dermatologist Amy Newburger, one of two panel

members to vote against Mentor's approval, wanted to wait for more

data before green-lighting the implant: " My concern is that since

hundreds of thousands of patients will be exposed to this, the

urgency was not warranted. "

Last year, more than 264,000 women had breast implants for cosmetic

reasons. Nearly all those implants were saline, but Mentor CEO Josh

Levine estimated that, if silicone implants are once again approved,

about half the women who currently get saline implants would choose

silicone. In Europe, he said, where silicone implants have been on

the market continuously, about 90 percent of women get silicone

implants. Silicone implants cost about $800 per breast, excluding

surgery and physicians' fees. That's about twice as much as saline

implants. But, among both patients and surgeons, they are considered

more natural feeling and looking.

Unknown safety. The main safety issues at last week's hearing had to

do with how long the implants last and what happens if they break

inside a woman's body. Most everyone agrees that the implants rarely

last for a woman's entire life. But how long before they rupture and

when women should think about replacing them are still unknown. Some

implants rupture almost immediately, while some women go for more

than a decade without a problem. Most ruptures are " silent "

ruptures, meaning that there are no immediate signs or symptoms;

such ruptures can be detected only by an MRI scan. Both companies

presented data at the meeting showing rupture rates of less than 5

percent after three years, but the FDA scientists who reviewed the

data said in both cases that they could not make solid estimates

about how long the implants would last.

The consequences of rupture are equally unclear. Dozens of women

gave gut-wrenching testimony about horrible health problems ranging

from breathing difficulties to memory decline to searing pain. " I

was put on full disability at age 34, " said Kim Hoffman, who got

Mentor's implants in 1995. There's speculation that silicone

implants could be linked to connective-tissue diseases, such as

fibromyalgia and rheumatoid arthritis, though the scientific

literature shows little evidence. Still, there were sharp divisions

of opinion at the meeting, even among panel members.

" We are still in a state of ignorance about whether there are

notable changes in the incidence of connective-tissue disease after

an implant, " said Brent Blumenstein, a statistician and consultant.

, the plastic surgeon, countered that arguments that implants

increase the risk of connective-tissue diseases " should be laid to

rest. "

No studies show why some women do well with the implants, while for

others the implants gravely endanger their health. It may be that

there is a subgroup of women, says Melmed, a plastic surgeon

in Dallas, who inherently do not tolerate the silicone. " There seems

to be a small group of women predisposed to symptoms, " he said. One

study, by plastic surgeon Leroy Young, investigated whether women

with a certain immune system makeup, called an HLA subtype, may be

more susceptible to problems; the study found no such link. " There's

no evidence, " Young says, " of any immune-system reaction to

silicone. "

If the FDA does grant approval to one or both of the implant

companies, tens of thousands of women are expected to have their

breasts enlarged with silicone implants when they are on the market

again. Still, it will be years before detailed safety information is

known. " I would love to know everything about the device, "

said during last week's hearing. " [but] that's an impossible

standard. At some point we'll have to cross over and say, 'That's

enough.' "

~~~~~~~~

www.BreastImplantAwareness.org

For many links to this ongoing controversy.