FDA Panel Calls for Silicone Breast Implant Registry

Posted: September 2, 2011 in Health, US News, World News
Tags: , ,

Emily P. Walker
MedPage Today
September 2, 2011

GAITHERSBURG, Md. — A federal advisory panel has recommended the creation of a nationwide database to follow women who have had silicone-gel breast implants for at least a decade after they had the surgery.

The two companies that manufacture silicone implants — Allergan and Mentor — are required to follow women who’ve had their implants for a number of FDA-mandated studies, but enrollment in those follow-up studies has been disappointing, and in some cases the number of women being followed is so small that FDA cannot definitely rule out a connection between implants and a rare disease, such as anaplastic large-cell lymphoma or connective tissue diseases.

The FDA’s General and Plastic Surgery Devices Panel, which wrapped up a two-day meeting Wednesday afternoon, said that current data collection demands are too onerous. Both companies ask women who’ve received their implants to fill out a 25-plus page questionnaire every year following surgery. Not surprisingly, not many women do that.

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