Unsafe At Any Size

By Laura Flanders, TomPaine.com. Posted October 23, 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.

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