Fw: NYTimes: Review Set of Silicone Gel in Breast Implants

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God help this planet.....will mankind ever see the folly in these things? Will we forever be careening on a path of self-destruction for such shallow ends? My heart aches for the truth to be revealed. Or for somebody to come up with some kind of safer alternative!!! GOD HELP US!

Patty

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

ilena@...

Sent: Friday, October 10, 2003 10:03 AM

Subject: NYTimes: Review Set of Silicone Gel in Breast Implants

http://nytimes.com/2003/10/10/business/10IMPL.html

October 10, 2003

Review Set of Silicone Gel in Breast ImplantsBy MELODY PETERSEN

or the first time in 11 years, women in the United States may be on the verge of gaining unrestricted access to silicone breast implants. Women who blame implants for chronic medical problems are fighting to keep them off the market, while plastic surgeons are expecting brisk demand.

On Tuesday, a Food and Drug Administration advisory panel will open a hearing to review the results of clinical trials conducted by the Inamed Corporation, which is based in Santa Barbara, Calif. Executives say the trials prove that the company's implants are safe and that the government should lift the sharp restrictions on implant sales. Data from the trials are scheduled to be disclosed today.

But Inamed faces opposition from an army of women who say they remain worried that the implants — palm-size sacks filled with silicone gel — can cause disease when they rupture and leak inside the body. Some women also express concern about a society in which more people than ever are turning to cosmetic surgery in a quest for bodily perfection.

"I would tell people to love their bodies as they are," said Nighswonger of St. Louis, who had silicone implants 27 years ago and recently had them removed after numerous complications.

The numbr of breast augmentation operations has grown sevenfold since 1992, when controversy over the safety of silicone implants prompted the F.D.A. to restrict their sale. Lawsuits contending that leaking implants caused life-threatening diseases drove one of the leading manufacturers at the time, Dow Corning, into bankruptcy proceedings, though scientific studies subsequently were unable to make the connection. Since then, women who want to enlarge their breasts have had to rely on implants filled with saline. Silicone implants have been available only to patients requiring breast reconstruction because of cancer or other medical reasons.

Inamed and its sole domestic competitor, the Mentor Corporation, which is also based in Santa Barbara, have spurred sales of their saline implants by offering low-interest loans to finance breast enlargement operations — which generally are not covered by insurance plans — and enlisting hundreds of cosmetic surgeons to swell their sales forces. Music videos, magazine covers and television programs like "Extreme Makeover" on ABC — whose producers arrange for people to have all the free cosmetic procedures that they desire — have helped promote surgical body enhancements.

Wall Street analysts and Inamed executives say government approval of the silicone implants will increase demand even more, because many women find that these implants have a more natural feel. The implants that Inamed hopes to resume selling are essentially unchanged from those in use a decade ago.

"We strongly believe that the approval of silicone gel filled implants in the United States has the potential to change the landscape for breast implant surgery in this country," L. Teti, Inamed's chief executive, said during a conference call with analysts earlier this year.

But first Inamed must convince the F.D.A. of the safety of its implants. At least 150 people are scheduled to testify at the hearings in Gaithersburg, Md., on Tuesday and Wednesday, with experts and activists lining up on each side.

Representatives of the Y-ME National Breast Cancer Organization, a nonprofit group, enlisted 11 other organizations, including the American Cancer Society, to sign a letter urging the F.D.A. advisory panel to support making silicone implants available to all breast cancer patients. They say it has been difficult for some mastectomy patients to find a surgeon willing to enter them in a clinical trial so that they can have silicone implants.

Y-ME has accepted money from implant manufacturers in the past, but says that it has received none in the last year and a half.

Plastic surgeons also argue that women should be able to choose silicone implants if they want them.

"People don't know how good these implants are," said Dr. M. Senderoff, a cosmetic surgeon in Manhattan.

Dozens of other women, however, plan to plead with regulators to withhold approval.

The women, including representatives of the National Organization for Women and other groups, argue that Inamed is presenting, at most, three years of safety data, even though, they say, injuries from implants often take much longer to emerge.

In the last two weeks, some of the opponents — using money from a trust set up from settlements of past silicone implant lawsuits — have paid for advertisements on radio, television and in newspapers, urging other women to join their campaign. "Tell the F.D.A. that what we don't know about silicone breast implants will hurt us," the ads say.

But Inamed executives point to myriad studies that failed to link the products to life-threatening diseases.

"There is no evidence that breast implants cause any kind of disease," said JoAnn M. Kuhne, senior director of regulatory and clinical affairs at Inamed. The company does acknowledge that implants — whether filled with silicone or saline — are not lifetime devices and will require additional operations when they leak.

"Implants do not last forever," Ms. Kuhne said. "How long they last in a person's body is a very individual thing."

While Inamed petitions the F.D.A., the Justice Department is trying to recoup a yet-undisclosed sum from implant makers to cover what Medicare has paid for injuries attributed to the products. Inamed has already settled Medicare's claim, agreeing to pay $100,000 in 1999.

In an Oct. 3 letter to the F.D.A., three Democratic senators — Dianne Feinstein and Barbara Boxer, both of California, and L. Landrieu of Louisiana — said it would be "irresponsible to permit unrestricted marketing of such implants, only to pay again for the treatment of avoidable injuries."

But analysts say they believe that the F.D.A. could approve the silicone implants within months if the advisory panel votes next week for their reintroduction. That, they say, would give Inamed a clear lead in a market that until now has been a tight race between it and Mentor.

Rauch, senior medical device analyst at SunTrust Humphrey, said he believed that the current market for implants, about $240 million, could rise to $340 million by 2005. A saline implant now sells for about $400, he said, while one filled with silicone is priced at $800.

Inamed's stock has more than doubled since the first of the year, partly in anticipation of positive action by the F.D.A.

Inamed executives declined to say how they would market the implants. To promote its saline implants, the company has a Web site called LookingYourBest.com that allows women to use a computer modeling program to see how the different implant sizes would look on their bodies. Surgeons pay the company to list their practices on the Web site and display before-and-after photos of patients.

Inamed also has a partnership with a finance company that offers a "12 months same as cash" loan to pay for the implants and the operation. Some doctors offer women a $50 Inamed gift certificate.

Dr. Zuckerman, president for the National Center for Policy Research for Women and Families, a nonprofit group in Washington, said that women do not realize that breast implants "are like cars" in that "the older they get, the more problems you have."

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