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Mammogram System That Lets Patients Control Pressure Cleared by FDA

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On Sept. 1, 2017, the U.S. Food and Drug Administration (FDA) gave clearance to a 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their breast before the mammogram is taken.

The Senographe Pristina with Self-Compression is made by GE Healthcare. The system uses a hand-held wireless remote control that patients can use to adjust the amount of compression after the breast is positioned for the mammogram.

During a mammogram, the technologist positions the patient and starts the compression. The technologist then guides the patient to gradually increase the compression using the remote control until enough pressure is applied. The technologist then checks the level of compression and breast positioning and makes the final decision on whether there is enough compression or if the compression needs to be adjusted.

"Regular mammograms are an important tool in detecting breast cancer," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. "However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam."

There's only one of you and you deserve the best care possible. Don't let any obstacles get in the way of your regular screening mammograms.

  • If you're worried about cost, talk to your doctor, a local hospital social worker, or staff members at a mammogram center. Ask about free programs in your area.
  • If you're having problems scheduling a mammogram, call the National Cancer Institute (800-4-CANCER) or the American College of Radiology (800-227-5463) to find certified mammogram providers near you.
  • If you find mammograms painful, ask the mammography center staff members how the experience can be as easy and as comfortable as possible for you. You may want to ask if the center has a system that allows you to control the pressure of the mammogram.
  • If you’re concerned about unknown results or being called back for more testing, talk to your doctor about what happens when mammogram results are unclear, as well as what to expect if you’re called back for more testing.

For more information on mammograms, including where to get one and the benefits and risks, visit the Mammograms page.

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