- The Washington Times - Wednesday, October 15, 2003


Government advisers yesterday recommended lifting an 11-year-old ban on most silicone-gel breast implants, despite lingering questions about safety and durability.

But the Food and Drug Administration’s advisers urged that Inamed Corp.’s sales be allowed only under certain conditions, including ensuring that all users get detailed brochures explaining the known risks of the devices — such as a need for frequent reoperations for pain or breakage.

Women will need annual exams to ensure that their implants haven’t begun leaking, the panel stressed. That will be expensive and hard to insure, the scientists acknowledged. But they added that the exams are crucial because implants can break without exhibiting immediate symptoms. Once that happens, they should be removed.

“This is as important as your annual mammogram,” said FDA adviser Barbara Manno, a Louisiana State University toxicologist.

All implant recipients also must be enrolled in a registry to track their health.

The panel voted 9-6 and said Inamed must do more research tracking women’s health for 10 years after the implants. Many women say their devices begin breaking and causing painful disorders in that period. Inamed’s research currently tracks women’s health for three years.

Still, after two days of debate, the panel ultimately agreed with Inamed’s argument that it is not fair to restrict women’s access to silicone implants when research suggests that they break and cause other problems no more frequently than the main alternative today — implants filled with salt water.

The decision came after emotional testimony pitting women against women: those who say implants broke inside their bodies to leave them permanently damaged and those who want implants to repair cancer-ravaged breasts or make their breasts bigger.

If women keep their implants long enough, they all may break eventually, panelists said.

The question is how to tell: Saline-filled implants deflate so fast that women know they’ve broken, but silicone leaks slowly and may not manifest immediate symptoms. Because women may not be able to get all the leaking silicone out of their bodies, “we have to hold this to a different standard,” argued adviser Dr. Amy Newburger, a New York dermatologist.

The FDA ended routine sales of silicone breast implants in 1992, restricting them to breast-cancer patients in strictly controlled clinical trials.

Seeking to restart broader sales, Inamed Corp. argued the implants have been exonerated.

Indeed, studies show little evidence that implants cause major diseases such as cancer.

But the FDA worries that rare disease issues aren’t settled, and that some women might be more vulnerable to painful conditions such as fibromyalgia.

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