Fw: Unsafe At Any Size ...

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

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Sent: Wednesday, October 22, 2003 1:30 PM

Subject: Unsafe At Any Size ...

http://tompaine.com/feature2.cfm/ID/9197

Unsafe At Any Size

Flanders is the host of Working Assets Radio, heard on KALW-FM in San Francisco, and author of Real Majority, Media Minority: The Cost of Sidelining Women in Reporting.

An advisory panel to the Food and Drug Administration (FDA) voted on Oct. 16 to recommend that silicone breast implants be returned to the market after an 11-year ban. The verdict sent the share price of Inamed, the manufacturer, soaring to a record high and caused The New York Times to editorialize that "the verdict adds to a growing impression that the implants, once blamed for a range of serious illnesses in women, are relatively safe."

It's an impression that has everything to do with corporate spin and very little to do with science.

In 1992, testimony from implant recipients, physicians and scientists convinced the FDA that silicone gel-filled implants were dangerous. Clinical trials revealed a slew of problems ranging from breast pain, asymmetrical breasts and numbness of the nipples, to possible links to rheumatoid arthritis, lupus and connective tissue diseases. Sick women won huge damages from manufacturers including Dow Corning (an offshoot of Dow Chemical) and Inamed's parent company, McGhan Medical, on the basis that the companies had lied about the rupture-rate of the implants, and suppressed data on the ill effects of silicone when it leaked into the human body.

Ever since then, manufacturers have been working to reverse the ban. This month's FDA panel, while not the last word, is a big step in that direction.

As the panelists heard, serious problems persist. Most implants still rupture, requiring additional surgeries, and silicone implants—unlike saline devises—leak toxic silicone into the body. The company admitted it still had no idea what caused most ruptures, and applied for approval to market implants with a shelf life of just two and half years. (Women expect to live with their implants for at least a decade if not longer.) Long-term studies show that serious health problems don't typically show up until after five years. Inamed didn't disprove that research, it simply presented only three years of data.

"Safety long term remains to be answered," said Dr. Whalen, chair of the advisory group. Nonetheless, the panel voted nine to six to recommend approval. What turned panelists around was the company's promises to strengthen their research, and the argument that women should have more choices.

"The industry has managed to change the debate from 'Are these products safe for women?' to 'How can we get these products to market?'" said Sybill Goldrich, a mastectomy survivor who observed the proceedings.

Eleven years ago, the manufacturers set out to shift the debate. An internal memo from Dow Chemical revealed a plan to build corporate "believability" though contacts with plastic surgeons and patients. "The biggest hole still missing is in this whole arena of getting the patient grassroots movement going," wrote one of Dow's P.R. executives in a document uncovered by P.R. Watch, a watchdog group. At the FDA hearings, and in the coverage that followed, that corporate-created "movement" was much in evidence.

Four of the nine panelists who voted for the implants were plastic surgeons. Another 'yes' vote, Dr. Connell, serves as a senior consultant for Citizens Against Lawsuit Abuse (CALA), an industry-funded front group which wants to limit corporate liability for defective products. In her coverage of the FDA panel's decision, The New York Times' Kolata, who's been receiving accolades from industry for years, described CALA as "an advocacy group," with "no connection to Inamed." A quick Google search reveals that CALA is funded by health insurers, big tobacco and chemical companies including Dow Chemical. Many of the same corporations fund the Advancement of Sound Science Coalition, another industry-front group which in 1995, gave Kolata an award for her reporting.

On October 19, Kolata penned another story guaranteed to please Big Chemical. "A Sexual Subtext to the debate over breast implants?" Kolata's second story of the week, made the case that resistance to implants is psychological not scientific: the underlying question was "whether it was acceptable for a woman to enlarge or enhance her breasts," wrote Kolata.

It's an easy assertion for her readers to believe, because nowhere in days of coverage has Kolata given serious attention to the medical data. "I'm not against implants; I'm against unsafe implants," says Goldrich, who has had experience with four sets of silicone implants. "There's no freedom of choice unless there's safety."

Informed consent, fine in principle, is hard to assure in a society in which many women feel huge pressure to conform to certain body shapes. But even if one accepts that some women would freely choose even risky implants for cosmetic purposes (medically mandated implants have always been available), there's no guarantee that they'll get sufficient information to make an informed decision. And certainly not if they just rely on The New York Times.

Coming in between the advisory panel's recommendation and the FDA's final verdict, the Times' October 20 editorial not only reported on attitudes but sought to influence them. The editors called on the FDA to approve the silicone implants, as long as women who want them are "amply warned." Unfortunately, the Times and Kolata have a long shameful history of giving short shrift to the very women's groups and health advocates who seek to do the warning.

Published: Oct 22 2003

To respond:

http://tompaine.com/respond2.cfm?articleid=9162

W O R K I N G A S S E T S R A D I O with L A U R A F L A N D E R S

http://www.workingforchange.com/radio/index.cfm?CFID=1392984 & CFTOKEN=40397942

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Bravo to Flanders for again telling it like it is again.

PR Firm Finds "Grassroots" Support for Breast Implants ... from 1996 by Flanders:

http://groups.google.com/groups?hl=en & lr= & ie=UTF-8 & oe=UTF-8 & selm=19faaec.0310140951.41a8b436%40posting.google.com

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For more information on the FDA Panel on silicone gel implants, please visit:

www.BreastImplantAwareness.org

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