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Stop the FDA Practice of Withholding Material Medical Information From Mammogram Reports

Withholding this material medical information about breast density and its impact on mammogram effectiveness has created a national health crisis which denies women the opportunity to make informed medical decisions, and results in the preventable de

The FDA has failed to adequately implement and enforce the patient notification amendment of the Mammogram Quality Standards Act, which requires that women receive mammogram results directly in "terms easily understood by a layperson." Material medical information is systematially withheld from these mammogram results. Because this information is withheld, women are denied the right to make informed medical decisions regarding their own health. This practice also results in the preventable deaths of 10,000 women every year.



We are asking members of Congress to hold a Congressional hearing on this issue to detemine what steps must be taken to stop this practice, which is a violation of the federal statute, as well as the ethical guidelines of the AMA ("Withholding medical information from a patient without his or her knowledge or consent is ethically unacceptable." Opinion 8.082)



For years, peer reviewed studies have demonstrated that mammograms are ineffective screening tools for the 40% of women with dense breast tissue, missing an average of 50% to 75% of cancers. Despite this, if a woman with dense breast tissue obtains a mammogram in which no cancer is detected, she is informed that her results are "normal."



Information about her breast density and the ability of the mammogram to detect cancer is systematically withheld from the report, meaning that most women do not seek out additional screening which has been proven to increase cancer detection to above 95%.



Detailed information and supporting documentation is available at www.inhqe.com.