Revised draft guidance document for breast implants

FDA Consumer, March-April, 2004

A draft FDA guidance document released in January 2004 should give those seeking marketing approval for breast implants--particularly those filled with silicone gel--a better understanding of the information that should be provided for the FDA to evaluate the safety and effectiveness of these medical devices. The guidance document includes modified recommendations for mechanical testing, determining modes and causes of rupture, clinical studies, post-approval requirements, and labeling.

"This revised guidance is our view on the information needed to provide a reasonable assurance of safety and to allow women and physicians to make informed decisions about silicone implants," says Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs.

The January guidance document updates a previous version published in February 2003, which has been useful to sponsors and the FDA in preparing and reviewing premarket approval applications. By updating the document, the FDA is more clearly identifying the type and amount of scientific data that will allow the FDA to evaluate whether these products are sale and effective.

The draft updated guidance document can be viewed at www.fda.gov/ cdrh/ode/guidance/1239.html.