FDA proposes “explanatory letter” on mammography results

The American agency equivalent to ANVISA, the FDA, wants to change some regulations on the examination of mammography . In 20 years, this is the first change proposed by the agency.

Among the changes is the requirement to report the density of the breast to the patient – the information should appear in a document delivered after screening, recommends the FDA.

In denser breasts it is more difficult to identify the likelihood of developing breast cancer . Therefore, the explanatory letter would help the patient to know her real state of health.

Even doctors have some difficulties in interpreting dense breast mammograms.

In these cases, the quality of the examination may be compromised by a dark image that makes it difficult to identify nodules and tumors.

This new recommendation will help the medical community to clarify any doubts, in addition to helping patients, who may have more information to make decisions.

The importance of mammography in the diagnosis

Mammography is a test for the detection of tumors or nodules in the breasts. It is made by a device, called a mammograph, which emits X-rays.

This test is able to identify changes in the breasts before there are palpable lumps.

The Ministry of Health recommends that preventive mammograms be done every two years by all women over 50 . Even so, the doctor can order the exam at any age or frequency, depending on each case.

However, data show that a large number of women still ignore the test.

According to the Brazilian Society of Mastology, about 2 million mammograms were performed in 2017 by the Unified Health System (SUS). The estimate is that approximately 11 million would be realized. That was the worst number in the past five years.

SUS offers mammography to all women, at any age, as long as they have medical clearance to take the exam. If in doubt, consult a gynecologist.


Mammography is still the best test for diagnosing breast cancer. Other information helps doctors and patients to know the degree of the situation, facilitating decision making.

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