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FDA Warning for Ultrasound Videos and Heartbeat Monitors

FDA Warning for Ultrasound Videos and Heartbeat Monitors

December 17, 2014 — As the popularity of fetal ultrasound “keepsake” videos and heartbeat monitors increases, the FDA is warning that these tests have no medical value and could put the baby at risk of complications.

Ultrasounds, also known as “sonograms,” use high-frequency sound waves to create a real-time image of the fetus in the womb. The prenatal tests are used to check for birth defects and the gender of the baby.

Most pregnant women have an ultrasound as part of routine prenatal care during the second trimester, although first-trimester ultrasounds are sometimes recommended.

The problem is that ultrasounds can heat tissues slightly. In some cases, they produce very small bubbles (called cavitation) in tissues. The long-term health effects of these bubbles are unknown.

The FDA is concerned about several companies in the United States selling “keepsake” ultrasound videos. There is no knowing how long the sessions will last, how often they will occur, or whether the devices will be used properly. In at least one case, a fetus was exposed to ultrasound for nearly an hour to get a “keepsake” video.

Doppler ultrasound heartbeat monitors are also being sold over-the-counter. Again, the FDA warns that these devices should only be used by a medical professional or under their supervision.

According to Shahram Vaezy, Ph.D, an FDA biomedical engineer:

“When the product is purchased over the counter and used without consultation with a health care professional taking care of the pregnant woman, there is no oversight of how the device is used. Also, there is little or no medical benefit expected from the exposure.”

Do I have an Ultrasound Malpractice Lawsuit?

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