Fw: NYTIimes: Company Making Case to Allow Breast Implants ... Kolata's version

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

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Sent: Saturday, October 11, 2003 5:17 PM

Subject: NYTIimes: Company Making Case to Allow Breast Implants ... Kolata's version

From Barton Hutts brain ... to God and the FDA Panel's hearts and minds.

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Excerpt:It would be highly unusual for the agency to allow the implants, a leading drug law expert said. The expert, Barton Hutt, a Washington lawyer who was chief counsel at the drug agency from 1971 to 1975, said products that were removed from the market for safety reasons almost never came back.

"Most are just abandoned, and for good reason," Mr. Hutt said. "Once the F.D.A. takes a position that something is unsafe, it is virtually impossible to get them to reverse it."

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http://www.nytimes.com/2003/10/11/health/11IMPL.html?pagewanted=print & position=

October 11, 2003

Company Making Case to Allow Breast ImplantsBy GINA KOLATA

esterday morning, the breast implant documents appeared on the Food and Drug Administration Web site, voluminous files constituting one company's arguments for bringing silicone breast implants back on the market.

The files included laboratory data, animal studies, data from a decade of large epidemiological studies conducted after implants were removed from the market in 1992 and the company's own studies, over several years, following women who had had its implants.

For example, data from the company, the Inamed Corporation, showed, unsurprisingly, that silicone implants could rupture or lead to complications like scarring and that many must be removed or replaced after a period of time.

But the company argues that the devices are generally safe, with no links to serious diseases like lupus or cancer, as has been asserted.

The posting of the files is a formal prelude to an all-but-unprecedented F.D.A. meeting next week, in sessions scheduled to run from 8 a.m. to 10 p.m. on Tuesday and 7:30 a.m. to 5 p.m. on Wednesday.

In a hotel meeting room, in Gaithersburg, Md., an expert advisory committee will weigh the company's data and hear the pleadings of implant supporters and critics. Then it will decide whether the company has made its case, that silicone breast implants are safe enough to return to the market after a 10-year hiatus.

It would be highly unusual for the agency to allow the implants, a leading drug law expert said. The expert, Barton Hutt, a Washington lawyer who was chief counsel at the drug agency from 1971 to 1975, said products that were removed from the market for safety reasons almost never came back.

"Most are just abandoned, and for good reason," Mr. Hutt said. "Once the F.D.A. takes a position that something is unsafe, it is virtually impossible to get them to reverse it."

Arguments about implant safety, and even whether women should be enlarging their breasts in the first place, have been heated, emotional and wrenching. Lawsuits sent one implant maker, Dow Corning, into bankruptcy and forced it and other companies to set up a multibillion-dollar fund to compensate women who the implant makers had argued were never sickened by the devices in the first place.

But now, Inamed, a company that specializes in aesthetics, says it has more than enough data to persuade the drug agency to let it sell silicone breast implants in the United States. If the agency agrees, the implants will join the company's roster of appearance-enhancing products, like collagen to fill in facial wrinkles and a band that can be surgically implanted around the stomach to help obese people lose weight.

The drug agency has asked panel members not to discuss the data before the meeting, but it has posted on its Web site the questions members will be addressing. In essence, the issue before them is: what safety data suffice to bring back a device whose purpose, for many women, would be to enhance their appearance, not to treat a disease or correct a medical condition? The panel will also ask whether there should be a different standard for women who want breast reconstruction, not simply larger breasts.

The safety questions involve complications, like ruptures, and whether implants can cause serious diseases.

Inamed reported that in a two-year study, the rupture rate was 1.2 percent and that 7.5 percent of its 987 implants were removed or replaced. Some women had infections; others developed hard and painful scar tissue over the implant. The F.D.A. data from other studies indicated that on average, a quarter of implants had ruptured within 12 years and 55 percent had ruptured within 16 years.

The big difference between this year and a decade ago, when the agency pulled silicone implants from the market, is that now there are data to address the question of whether the devices cause serious illnesses, medical experts said.

"There's just so much," said Dr. Connell, a professor emeritus of obstetrics and gynecology at Emory University.

In 1991 and 1992, Dr. Connell led the drug agency's advisory committee that first considered the question of whether implants should remain on the market.

"If we had had all of the data then," she said, "it would have been so different."

JoAnn M. Kuhne, the senior vice president for regulatory affairs at Inamed, said, "There is more information on breast implants than on any other device in the history of the F.D.A."

The company argues, in accord with groups like the Institute of Medicine, which reviewed implant data from large epidemiological studies a few years ago, that there is no conclusive evidence that the devices lead to serious diseases, which was the concern that resulted in their withdrawal from the market and the thousands of lawsuits against their makers.

Dr. Stuart Bondurant, who was chairman of the Institute of Medicine committee that reviewed the epidemiological data, said the group, part of the National Academy of Sciences, found no evidence that the implants led to serious disease. The committee, which issued its report in 2000, considered, for example, cancer, neurological diseases, autoimmune diseases like lupus, and connective tissue diseases like arthritis.

"We could find no evidence to support a causal relationship between the breast implants and any systemic disease," Dr. Bondurant said. "As far as I know there has been no information since the report was written that would materially change the conclusion."

Dr. Bondurant, who is professor of medicine and dean emeritus at the University of North Carolina School of Medicine, added that the committee believed that the lawsuits and wrenching claims of serious illnesses had diverted attention from the problem of complications like ruptures and scarring.

The Institute of Medicine recommended that if the drug agency decided to permit implants again, the agency should require a study after the devices were on the market, to glean information on how often such complications occur. That is exactly what Inamed is proposing.

Asked if Inamed was worried about being destroyed by lawsuits if it tried to market implants, Ms. Kuhne said no.

"We're confident in the science," she said, "and that's what we've been building on since the last go-round 10 years ago." ~~~~~~~~~~~~~

For more articles and links, please visit:

www.BreastImplantAwareness.org

www.BreastImplantInfo.org

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Please sign the Petition asking the FDA to delay approval to Inamed based on only 2 years of data:

http://www.thepetitionsite.com/takeaction/705718085

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