Fw: FDA/Health Canada to Evaluate Silicone Gel Implants ... 4 articles

August 22, 2003

----- Original Message ----- From: ilena rose

ilena@...

Sent: Friday, August 22, 2003 6:53 AM

Subject: FDA/Health Canada to Evaluate Silicone Gel Implants ... 4 articles

Dear Friends,

Hope you can find this email and it doesn't get lost in the madness of the Virus Wars ... in the last several days, I've received over 1500 garbage emails ...

I've put 4 articles and one letter in this one email to lower the load.

This is a very important time in the Breast Implant Awareness cause ... as you will read below, Inamed (any who know me, know it is my least favorite or truthworthy corporation!) is pushing HARD to get approval for their "latest and greatest" silicone gel implants ... and both the FDA and Health Canada have agreed to review their applications for safety "approval."

There's also an excellent rebuttal by Dr. Zuckerman in the first article below to the propaganda being spread.

This morning I received a message from a good friend and longtime member of our support group ... her disintegrated silicone gel implants were removed about 5 years ago ... I've excerpted part of her message since I find it more than upsetting ... PS's are skirting the rules and finding ways to sell silicone gel implants NOW ... this excuse was for a "breast lift" for a young woman, they classified as "reconstruction."

Details like this . .. as well as reading the total and utter denials of high profile PS's and Inamed's PR machine ... are very frightening and dangerous, in my opinion.

It is my hope that women will speak and be heard at the FDA hearings ... and in Canada ... about the very, very real dangers and risks of this medical device.

To your health.

Ilena Rosenthal

www.BreastImplantAwareness

Inamed & the SEC

http://www.sec.gov/litigation/litreleases/lr16466.htmhttp://www.sec.gov/litigation/admin/34-41751.htm

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ARTICLE #1

Aug 21 2003Silicone Implants Generate Renewed Debate http://health.discovery.com/news/healthscout/article.jsp?aid=514623(HealthDay is the new name for HealthScoutNews.)THURSDAY, Aug. 21 (HealthDayNews) -- As federal health officials readyfor hearings on whether silicone breast implants should be allowedback on the U.S. market, a new study offers evidence of a reduced rateof implant rupture.The study, conducted by a group of Danish researchers, used magneticresonance imaging (MRI) to study implant rupture rates in some 300women for a period of three years. From that data, the researchersextrapolated a rupture rate of 15 percent to 17 percent 10 years afterthe w omen received the implants.But not all experts agree with the accuracy of the projection. Zuckerman, a former member of the National Cancer Instituteadvisory committee on breast implants, says the study offers a grossunderestimate of the implant rupture problem."If it were truly 15 percent at 10 years, that would be animprovement, but I do not believe for a minute that it is 15 percent.It's an estimate based on an assumption that I don't believe thisstudy supports," says Zuckerman, executive director of the NationalCenter for Policy Research for Women and Families.Zuckerman notes the new research, published in a recent issue of theArchives of Surgery, only studied women for three years. And withoutspecific 10-year data, there's no real way to accurately project therate of rupture across an entire decade, she says.A study published in 2000 by the U.S. Food and Drug Administration(FDA) found a silicone implant rupture rate as high as 55 percent,with up to 69 percent of all women likely to experience a rupture inat least one breast.However, some plastic surgeons agree with the new study results. Andone, Dr. Barry Zide of New York University, remains unconvinced thatsilicone implants pose any significant health problems even if arupture does occur.He believes the number of implant ruptures is probably lower than 15percent."First, I object to the use of the term rupture, because in reality weare mostly talking about small and very slow leaks, which more oftenthan not, you would not even notice unless you had an MRI. We aretalking about a very small amount of silicone leaving the implant,"says Zide, a professor of surgery at New York University School ofMedicine.But more important, he says, there is no direct evidence that siliconethat does leave the implant has any ill effects on a woman 's health."It's been studied over and over and there is just no proof that it islinked to any major health problems. So I don't see the leakage as anymajor concern, regardless of what the percentage is," says Zide.Not surprisingly, Zuckerman believes otherwise."Up until two years ago there were no specific studies done on thehealth problems of women whose implants ruptured. And when thisresearch was finally conducted, in one study by the FDA and two by theNCI (National Cancer Institute), there was a significant increase incertain health problems in the women with the ruptured implants,"Zuckerman says.In the FDA study, researchers compared women who had silicone implantswith no rupture to women with ruptured silicone implants. They found astatistically significant increase in the incidence of fibromyalgiaand several other potentially debilitating autoimmune diseases amongthe women whose implants ruptu red.Zuckerman says the findings from the NCI studies were even moretroubling. In this research, doctors compared women who had breastimplants to other plastic surgery patients, and found the implantgroup (most of whom had silicone gel implants) were more than twice aslikely to die from brain cancer, and three times as likely to die oflung cancer."If I were a woman contemplating silicone breast implants, this wouldsure scare me," Zuckerman says.The new Danish study, which began in 1999, recruited 271 women who hadreceived silicone implants at least three years before. Each womanreceived a baseline MRI exam to judge the integrity of the implant anddocument leakage. Two years later, 206 of these women had a secondMRI.The doctors also tracked the number of women found to have leaks onthe first MRI, and who subsequently had their implants removed orreplaced. All these women were included in the final calculations.The result: The researchers found 33 definite ruptures (10 percent)and 23 possible ruptures (7 percent) in the implants between 1999 and2001.They concluded the overall rate of implant rupture is approximately5.3 incidences for every 100 implants. However, they report therupture rate significantly increased according to the age of theimplant itself, with the newer, double-lumen type implant associatedwith a substantially lower risk profile than the older single-lumenimplant.For the most up-to-date implants, the Danish researchers estimate arupture rate of about 15 percent to 17 percent at the 10-year mark.The FDA has agreed to reexamine the possibility of bringing backsilicone breast implants to the American market. The agency banned theimplants in 1991 after numerous reports that ruptured implants couldlead to health problems in women.Saline-filled implants continue to be availab le to women seekingbreast augmentation.More informationFor the latest data on silicone breast implants, check this 2003 U.S.Food and Drug Administration report. For more about other types ofbreast augmentation options, visit The American Society of PlasticSurgeons.

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Article #2

MISLEADING EXCERPTS:

“Surgery now often involves saline implants, which have not been

linked to the complications associated with silicone.”

"The breast implants have been on the market for years, for decades

.. . . and there have been no studies that have truly linked breast

implants with being responsible for causing diseases."

Silicone implants poised for return

U.S. firm lobbies for approval

Sharon Kirkey

CanWest News Service

Thursday, August 21, 2003

Silicone gel-filled breast implants are on track for a possible

comeback to the open market in North America just as surgeons report a new comfort level with the devices.

Eleven years after the implants were pulled from the market

following reports linking them to arthritis, vascular disease and a

range of autoimmune disorders, at least one company is seeking

Health Canada approval to sell its product in the country.

Inamed Corp. has submitted new safety data from clinical studies of

its McGhan implants to Health Canada, a company spokeswoman said

this week.

"We're asking for full approval for all indications," said JoAnn

Kuhne, senior director of regulatory and clinical affairs for the

company based in Santa Barbara, Calif.

Silicone breast implants are now only available through the

government's special access program, meaning doctors must apply to

Health Canada for permission to use them on a case-by-case basis.

Demand for breast augmentation is higher than ever.

While there are no comparable Canadian statistics,

nearly 237,000 of the procedures

were performed in the U.S. last year, according to the American

Society of Plastic Surgeons. It was the first time in a decade that

breast surgery topped the list of the most popular cosmetic plastic

surgery procedures in women.

Surgery now often involves saline implants, which have not been

linked to the complications associated with silicone.

Inamed is also seeking U.S. Food and Drug Administration endorsement to market its silicone breast implants in the U.S. The agency is expected to hold a public hearing this fall to decide whether to end its moratorium.

If that happens, "the floodgate will open," said Dr. Sydney Wolfe,

director of the Public Citizen's Health Research Group, a U.S.

consumer advocacy group.

Wolfe said unrestricted access to the implants could lead to

"massive amounts of renewed damage to women."

Silicone, Wolfe said, elicits a reaction in the body that can lead

to scarring, nerve damage and intense, localized pain. He argues

studies haven't been conducted long enough to rule out the risks of

ruptured or leaking implants.

If a saline implant -- a sac filled with salt water -- ruptures,

"salt water comes out," she said. "But 90 per cent of your body and

my body is salt water. That's very different than this sticky, gooey

foreign body gel called silicone."

Wolfe, an internist, said "the FDA seems to be content with allowing

the companies to apply for approval based on relatively short-term

data. It's just unconscionable."

However, Kuhne said her company has submitted at least two years of

clinical data to the FDA and Health Canada.

"The breast implants have been on the market for years, for decades

.. . . and there have been no studies that have truly linked breast

implants with being responsible for causing diseases."

Kuhne said any implant carries a risk, whether it's a breast

implant, a knee joint or a pacemaker.

A 1999 report from the Institute of Medicine of the National

Academies, an advisory group based in Washington, D.C., concluded

women with silicone implants are no more likely to develop cancer,

immune disorders or neurological problems than other women.

But the group also warned the devices commonly cause complications that can lead to "substantial pain and discomfort" in women.

Those include rupture, infections and capsular contractures, where scar tissue forms and the breast tissue around the devices contracts.

An article in the June issue of Plastic and Reconstructive Surgery

reported the risk of complications is low. The report was based on

early results of a study involving more than 1,400 women with breast

implants, 88 per cent of whom have silicone gel implants, who are

part of a Danish breast surgery registry. Overall, 16 per cent

reported adverse effects, mostly a change in feeling in the breast.

Of those, four per cent had hardening of the breast due to scar

tissue and one per cent needed additional surgery.

Calgary Herald

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Article #3

http://www.businesswire.com/cgi-bin/cb_headline.cgi? & story_file=bw.082103/232335436 & directory=/google & header_file=header.htm & footer_file=

Note the disclaimers!

EXCERPT:

These forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially from those expressed or implied here.

( BW)(CA-INAMED-CORPORATION)(IMDC) FDA Schedules Advisory Panel Hearing for Inamed's Silicone Gel-Filled Breast Implant PMA

Business Editors/Health/Medical Writers SANTA BARBARA, Calif.--(BUSINESS WIRE)--Aug. 21, 2003--The U.S. Food and Drug Administration (FDA) notified Inamed Corporation (Nasdaq:IMDC), a global medical device company, that its request for Pre-Market Approval (PMA) for silicone gel-filled breast implants will be considered at a FDA Advisory Panel Meeting scheduled for October 14 and 15, 2003.

"We are pleased the FDA will review our PMA," said Nick Teti, Chairman, President and Chief Executive Officer. "We support the FDA's upcoming review, and we welcome the opportunity to present our data to the FDA Panel." About Inamed Corporation Inamed (Nasdaq:IMDC) is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. These products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND® System for morbid obesity. The Company's web site is www.inamed.com. Forward-Looking Statements This press statement contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ or differ materially from those described in the forward-looking statements. Inamed is providing this information as of August 21, 2003 and expressly disclaims any duty to update information contained in this press statement.

This press statement contains additional forward-looking statements, including, without limitation, Inamed's anticipated product development program. These forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially from those expressed or implied here. Readers are referred to the documents filed by Inamed Corporation with the Securities and Exchange Commission, specifically the most recent reports which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements, including but not limited to: exposure to product liability claims; exposure to liabilities that may not be adequately covered by insurance; potential negative publicity concerning product safety; potential fluctuations in quarterly results; the effect of changing accounting and public reporting rules and regulations; volatility of Inamed's stock price; changes in the economy and consumer spending; uncertainty in receiving timely regulatory approval or market acceptance for new products; introduction of new products by competitors; dependence on a single supplier for each of Inamed's silicone raw materials and bovine and human collagen-based products; and adverse changes in the regulatory or legislative environment (both in the U.S. and internationally) affecting our business.

The information contained in this press statement is a statement of Inamed's present intention, belief or expectation and is based upon, among other things, the existing regulatory environment, industry conditions, market conditions and prices, the economy in general and Inamed's assumptions. Inamed may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, in Inamed's assumptions or otherwise. Inamed undertakes no obligation to review or confirm analysts' expectations or estimates or to state publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

By including any information in this press statement, Inamed does not necessarily acknowledge that disclosure of such information is required by applicable law or that the information is material.

--30--MTB/la*

CONTACT: McGinn Group

Rod Young or , 703-312-0147

KEYWORD: CALIFORNIA

INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL DEVICES MEDICAL

SOURCE: Inamed Corporation

Article #4

http://www.forbes.com/markets/newswire/2003/08/21/rtr1063920.htmlFDA sets hearing on Inamed silicone breast implantsReuters, 08.21.03, 5:06 PM ET

LOS ANGELES, Aug 21 (Reuters) - Inamed Corp. (nasdaq: IMDC - news - people/ STRONG>), which makes products for cosmetic and reconstructive surgery, on Thursday said a U.S. Food and Drug Administration advisory panel will review on Oct. 14-15 its application to resume sales of silicone breast implants.The Santa Barbara, California-based company filed its application last December, including data from two years of clinical trials. The FDA usually, but not always, follows the advice of its expert advisory panels.The United States banned silicone implants for most women in 1992 amid a controversy over whether they caused chronic diseases. A 1999 Institute of Medicine study found that the implants did not cause cancer, lupus or other chronic disorders, although they can rupture and present other problems.The National Organization for Women and consumer groups like Public Citizen have asked the FDA to delay its review of any applications until longer studies are completed, arguing that many problems do not appear for years after implantation.Since 1992, silicone implants have been available only through clinical trials. Saline-filled implants remained on the market, but plastic surgeons say many women prefer the look and feel of silicone.Another company, Mentor Corp. (nyse: MNT - news - people), has said it plans to submit an application for silicone breast implants sometime this y ear.Shares of Inamed rose $1.23 or 1.9 percent to $67.12 in Nasdaq trading on Thursday, while Mentor's stock gained 37 cents or 1.7 percent to $21.84 on the New York Stock Exchange~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Letter from a friend in our support group:

Ilena … Just tonight, I had dinner with a friend ... I hadn't seen her in several months, and low and behold, she showed up with new silicone breast implants (never had implants before). Apparently, she went to have a "lift", due to post-nursing sag (her son is nearly 8 yrs. old now) and ended up convinced she needed implants to fill the hollow area that would remain at the top of her breasts. She was also convinced silicone was best, and was reassured they're going to be available again to the general public within a year or two. She was able to have silicone now because the "lift" portion is viewed as "reconstructive surgery". (Can that be???)

couldn't go into it with her, as it's after the fact. I didn't even tell her I had them, or my experience, at all, and it broke my heart to listen to her go on and on all night about how overjoyed (thrilled, really) she is with the results. (She is a gorgeous girl, and yes, she looked fabulous...*SIGH*) I suppose I did the right thing holding my tongue, since it's too late, but it felt terrible, Ilena! I came home with a viscious headache. Advice welcome. I certainly don't want to scare her or anger her -- she's very headstrong and said she did "a lot of research on the internet" before deciding, and determined that saline is harmful, but not silicone. Yikes!

Get MSN 8 and help protect your children with advanced parental controls.

August 22, 2003

Oh man, does this stuff tick me OFF! How can they be so obstinate about our illness? How can they just blow this all off? The thought of more and more women getting breast implants without knowing the real risks makes me sad, sick, and tired just to think about all the support that will have to be given...all the while having the doctors oppose us at every turn...it is just plain wrong. Why are these supposedly "smart" people so ignorant? How can they be so blind?