Fw: Inamed Wants Silicone Back In Breast Implants ~ 6/2000 ~ Forbes

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From: " ilena rose " <ilena@...>

Sent: Thursday, July 05, 2001 12:16 PM

Subject: Inamed Wants Silicone Back In Breast Implants ~ 6/2000 ~ Forbes

> http://www.forbes.com/2000/06/13/feat_print.html

>

> Inamed Wants Silicone Back In Breast Implants

>

> It's been eight years since the U.S. Food and Drug Administration banned

> silicone breast implants, but the desire among women to boost their bust

> size hasn't gone away. In the midst of a nationwide health scare, the FDA

> banned silicone implants in 1992. Since then, most implants are made of

> either saline or, more rarely, soybean oil. But Ilan Reich, co-CEO of

> Inamed imdc (nasdaq: imdc), is betting that silicone implants will make a

> comeback.

>

> Massive lawsuits from women who believed leaky silicone implants made them

> ill forced market leader Dow Corning, a joint venture of Dow dow (nyse:

> dow) and Corning glm (nyse: glm), into bankruptcy after a jury awarded

> plaintiffs billions of dollars in compensation.

>

> Despite negative publicity, the breast augmentation business is again

> thriving. The number of breast augmentations performed in the U.S. dropped

> to 32,000 by 1992 from a high of at least 120,000 two years before,

> according to the American Society of Plastic and Reconstructive Surgeons.

> By 1998, that number had grown to 122,000.

>

> Inamed and its competitor, Mentor mntr (nasdaq: mntr), both based in Santa

> Barbara, Calif., are the only companies whose saline implants have been

> approved by the FDA. Saline implants accounted for 95% of Inamed's $189

> million in 1999 sales, but the company has since diversified into other

> areas of cosmetic surgery, acquiring a collagen company and developing a

> surgical alternative to stomach-stapling which has been submitted for FDA

> approval. Still, the company estimates that implants will account for more

> than half its sales this year.

> Inamed has launched a new ten-year study of silicone implants involving

900

> patients in hopes of reversing the FDA ban. A new generation of thicker,

> less leak-prone silicone implants will prove safe, Inamed argues.

>

> Saline implants are safe. If a breast implant springs a leak, the body

> simply excretes the excess fluid in urine. Silicone was banned mainly

> because the companies making the implants couldn't prove at the time that

> it was safe.

>

> But there is a problem with saline. It doesn't feel natural to the touch;

> silicone does.

> " If a man touches a silicone breast as opposed to a real breast, he's much

> more likely to mistake it for the real thing, " says Wood-, a

> plastic surgeon and professor at Columbia-Presbyterian Medical School who

> performs breast augmentations in both New York and London.

>

> Soybean oil has been hyped as a natural-feeling alternative to saline. But

> clinical trials have found it to be more harmful than silicone. If a

> soybean oil implant leaks, the soy oil breaks down into products that may

> be harmful either to the surrounding tissue or a fetus, according to the

> British Department of Health.* On June 6, the British government decided

> that soy-filled implants posed a danger. Inamed had acquired the rights to

> those implants when it bought a Swiss company called Lipomatrix, and it

> agreed to pay to remove or replace the soybean implants of the 10,500

women

> worldwide,** including 165 Americans, who had the augmentation surgery.

>

> Now Inamed's Reich wants to start selling silicone-filled implants in the

> U.S. again. He argues that silicone gel is the perfect goop to go inside a

> breast implant and says it is safe and effective. He says no studies have

> ever shown that the silicone gel used to fill breast implants causes

health

> problems.

>

> " I made Dow Corning go bankrupt. That's why they call me the lawyer from

> hell. "

> " The silicone got a bad rap, " says Wood-. The main problem with

breast

> implants, he says, is that they make mammography more difficult. " It

> perhaps requires an extra shot from the X-ray to get a good view. "

>

> " We never thought soy was an appropriate filler, " Reich says. He hopes

that

> Inamed's clinical study will prove that its silicone implants are safe and

> will eventually result in FDA approval for the implants.

>

> But will numerous studies and FDA approval protect Inamed from the kind of

> massive litigation that killed Dow Corning? Dow Corning went down because

> it didn't conduct any studies on silicone implants and could not refute

any

> of the " science " that lawyers like O'Quinn of Texas threw at it. But

> would the thought of the kind of dollar signs torn from Dow Corning again

> make the lawyers swarm like so many angry wasps?

> Well, O'Quinn would. " I made Dow Corning go bankrupt, " he brags in a

> thick Texas drawl. " That's why they call me the lawyer from hell. " He says

> that he would be ready to sue if silicone implants again hit the market.

>

> " I think if they market them, they're subjecting women to an unacceptable

> risk of disease and injury, " O'Quinn says. " I think it would be a shameful

> exercise in greed to put making money ahead of public health. If people

> have to have breast implants, they ought to market saline. "

>

> But Reich is unconcerned. " I'm not afraid of lawsuits, " he says. " And

> that's because the conditions under which the product would be introduced

> would be after FDA approval, and that's a whole higher standard. What

we're

> doing is doing it right, and we'll have a very safe product. More people

> have died from Viagra than from breast implants. " Although it is not clear

> that Viagra has caused any deaths, some heart attacks have been linked to

> the drug.

>

> Calcagnini, a financial analyst with CIBC World Markets in Beverly

> Hills, Calif., still thinks the implants are a hot prospect. He rates

> Inamed as a " strong buy " and says the market for breast implants has been

> growing at 19% a year.

>

> However, Steve Broznak, an analyst at the Vanguard Group, disagrees: " I'm

> not a big fan of the technology. I would not be an investor. The benefits

> of the surgical procedures do not outweigh the risks. "

>

> But it's hard to think of anyone who ever went broke by betting on the

> persistence of human vanity.

>

> * A previous version of this story stated that leakage from soy implants

> was poisonous to the surrounding tissue.

>

> ** A previous version of this story said that all 10,500 women were

British.

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