FDA warns against 'keepsake' ultrasound sessions

Citing the possibility of tissue heating, cavitation and inherent risks of untrained use, the U.S. Food and Drug Administration has discouraged pregnant women from getting keepsake ultrasounds and from using over-the-counter Doppler fetal ultrasound monitors.

Fetal ultrasound provides parents with real-time images of the fetus and some keepsake sessions can last up to an hour.

"Although there is a lack of evidence of any harm due to ultrasound imaging and heartbeat monitors, prudent use of these devices by trained health care providers is important," Shahram Vaezy, PhD, an FDA biomedical engineer, said in a statement released Dec. 16. "Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues."

The agency had similar reservations for the over-the-counter Doppler monitors used by parents to listen to fetal heartbeats and should only be used under the supervision of a healthcare professional.

"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," Vaezy said. "Furthermore, the number of sessions or the length of a session in scanning a fetus is uncontrolled, and that increases the potential for harm to the fetus and eventually the mother."

The agency said that despite the lack of evidence of harm caused by using these devices, they are meant for use only when there is a medical need, and only under medical supervision.