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FDA warns expectant couples against medically unnecessary ‘keepsake’ ultrasounds

REUTERS/Joshua Lott
Pregnancy ultrasound uses high-frequency sound waves to evaluate the fetus’ age, growth and development.

The U.S. Food and Drug Administration (FDA) issued a warning this week to expectant parents: Stay away from the commercial ultrasound businesses — now often found in malls and other shopping areas  — that sell “keepsake” ultrasound photos or videos of your developing fetus.

The agency also advised parents against buying and using over-the-counter Doppler fetal ultrasound heartbeat monitors.

Both alerts were published in the agency’s Dec. 16 “Consumer Update.”

Pregnancy ultrasound uses high-frequency sound waves to evaluate the fetus’ age, growth and development. It’s also a helpful screening tool for certain birth defects. The heartbeat monitors are hand-held devices that use the same type of sound waves to listen to the fetus’ heartbeat.

These ultrasound procedures should be performed during pregnancy only when there is a medical need — and only under the supervision of trained health-care providers, the FDA update stresses.

“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,” says Shahram Vaezy, an FDA biomedical engineer, in the update. “Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues.”

A growing fad

In recent years, nonmedical “ultrasound parties” in which friends and relatives join with the expectant parents to view the unborn baby — often to share in the discovery of the baby’s gender — have grown increasingly popular. So have ultrasound “photo sessions” in which photos and videos are taken and then (in the case of the videos) set to music and sent to friends and family as “keepsakes.” Some companies will even bring the technology into the couple’s home.

But, as the FDA alert points out, during such parties there is no control over how long the imaging session will last, or how many images will be taken, or even whether the ultrasound equipment is being operated properly. Sometimes, such operators may spend as long as an hour to create a “keepsake” video of the fetus for the couple.

FDA officials express similar concerns for the ultrasound heartbeat monitors. Such devices are legally marketed only as “prescription devices,” they point out, and thus should be used by — or under — the supervision of a health-care 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,” says Vaezy. “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.”

False reassurance

The American College of Obstetrics and Gynecology (ACOG) also strongly discourages the use of ultrasound for nonmedical purposes. They note that such use may falsely reassure women that everything about their pregnancy is OK. “Women may incorrectly believe that the limited scan is, in fact, diagnostic,” the organization explains.

Equally concerning is the possibility that an abnormality in the fetus may be detected during one of these non-medical, “keepsake” sessions.

“Without the ready availability of appropriate prenatal health care professionals, customers at sites for nonmedical ultrasonography may be left without necessary support, information, and follow-up for concerning findings,” says ACOG.

You can read the new FDA consumer update on the agency’s website.

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