Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance
We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants. The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons. The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make. We will keep working closely with the FDA, patients, and plastic surgeons to make that goal a reality.
For more information see FDA’s Draft Guidance here.