Press Office
Food and Drug Administration
U.S. Department of Health and Human Services

Correction to FDA Talk Paper T02-48 on the Approval of the Embosphere Microspheres Medical Device

FDA's November 26, 2002 Talk Paper on the approval of the Embosphere Microspheres device for treating uterine fibroids contained inaccurate information. The Talk Paper mistakenly implied that six percent of the patients in the clinical studies that were treated with this device had an allergic reaction to it. In fact, while six percent of the women in the trial experienced an allergic reaction during or following the procedure these reactions were generally judged by the treating physicians NOT to be related to the newly approved product.

FDA regrets this error.

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Please note: This correction has been made to the version of the FDA talk paper posted on the FDA website.

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