Unsafe At Any Size

[Guest guest]

http://www.alternet.org/story.html?StoryID=17023

 

Unsafe At Any SizeLaura Flanders, TomPaine.com

October 22, 2003

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 devices—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. Thomas Whalen, chair of the

advisory group. Nonetheless, the panel voted nine to six to recommend approval.

What turned panelists around were 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. Elizabeth Connell, serves as a senior consultant for

Citizens Against Lawsuit Abuse (CALA), an industry-funded front group that wants

to limit corporate liability for defective products. In her coverage of the FDA

panel's decision, The New York Times ' Gina Kolata, who has 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 also

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.

 

Laura 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. "

 

 

 

© 2003 Independent Media Institute. All rights reserved.

 

 

 

 

 

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