FDA Cautions Against Ultrasound Keepsake Images


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Editor's note: News media brought up the issue again so we publish here an article reflecting the U.S. government's opinion regarding use of ultrasound imaging for non-medical purpose.  Foodconsumer.org strongly opposes use of ultrasound on fetuses for any non-medical purpose.

The medical circle is in part to be blamed for abuse of this modern technology.  They say there is no evidence to indicate any risk associated with ultrasound imaging. That is why ob/gyn often times suggest pregnant women do ultrasound imaging on the unborn fetus to identify his or her sex or just take a picture of the fetus for the parents to enjoy.

But doctors have forgotten to say that there is no evidence to suggest that ultrasound imaging is safe either.  Their definition of "safe" is that the ultrasound recipient does not show any acute clinical symptoms. But the damage can be subtle and of a long-lasting effect.   Early studies have linked ultrasound imaging on fetuses with damage to brain tissue.

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FDA Cautions Against Ultrasound 'Keepsake' Images

It's risky business taking pictures of unborn babies when there's no medical need to do so. That's the word from the Food and Drug Administration, which is concerned about companies trying to turn an important medical procedure into a prenatal portrait tool.
Facilities with captivating names such as Fetal Fotos, Peek-a-Boo, Womb with a View, and Baby Insight are popping up in strip malls and shopping centers all over the country. And they're promoting "keepsake videos" that use the latest ultrasound technology to produce high-resolution three-dimensional and four-dimensional (moving) images showing the surface anatomy of babies developing in the womb. The lure of this burgeoning industry is that parents-to-be get to see characteristics like facial features, hair, and even the baby's sex, and often they can count fingers and toes before their baby is born. Some women even have videos made at various stages of their baby's growth. And the videos are often being marketed as a prized addition to collections of childhood memorabilia.

As compelling as these sneak previews may be, the FDA is warning women about the potential hazards of getting keepsake videos. The agency also is warning companies against creating them for entertainment purposes. While ultrasound has been around for many years, expectant women and their families need to know that the long-term effects of repeated ultrasound exposures on the fetus are not fully known. In light of all that remains unknown, having a prenatal ultrasound for non-medical reasons is not a good idea.

What is Ultrasound?
Ultrasound imaging is a common diagnostic medical procedure that uses high-frequency sound waves to produce dynamic images (sonograms) of organs, tissues, or blood flow inside the body. Prenatal ultrasound examinations are performed by trained professionals, such as sonographers, radiologists, and obstetricians. The procedure involves using a transducer, which sends a stream of high-frequency sound waves into the body and detects their echoes as they bounce off internal structures. The sound waves are then converted to electric impulses, which are processed to form an image displayed on a computer monitor. It is from these images that videos and portraits are made.

Obstetricians use ultrasound at a very low power level to check the size, location, number, and age of fetuses, the presence of some types of birth defects, fetal movement, breathing, and heartbeat. When ultrasound is used by a qualified clinician to check for this kind of medical information, the FDA says the medical benefit far outweighs any risk.

At somewhat higher exposure levels, given daily for weeks at a time, ultrasound is used to speed the healing of bone fractures. At even higher levels, the technology produces a heating effect in tissue that is useful in treating sprains and pulled muscles.

Why All the Fuss?
Ultrasonic fetal scanning, from a medical standpoint, generally is considered safe if properly used when information is needed about a pregnancy. Still, ultrasound is a form of energy, and even at low levels, laboratory studies have shown it can produce physical effects in tissue, such as jarring vibrations and a rise in temperature. Although there is no evidence that these physical effects can harm a fetus, the FDA says the fact that these effects exist means that prenatal ultrasounds can't be considered completely innocuous.

As more advanced ultrasound technologies (usually using higher ultrasound intensities) become available, greater numbers of expectant mothers and their families are requesting fetal keepsake videos and portraits for souvenirs. Sometimes these images may be made by people not well trained, or for longer exposure times and at higher levels than are usually used in medical situations. At the same time, the medical community is discouraging the use of ultrasound unless it is medically necessary.

Mel Stratmeyer, Ph.D., in the FDA's Office of Science and Technology, says that most animal studies have not identified any fetal harm with low-dose ultrasound exposure.

"But the issue of keepsake videos has to be that if there's even a possibility of potential risk, why take the chance?" Stratmeyer says. Animal studies have been performed during the last 30 years to investigate the effects of the procedure on a fetus, due to the increased use of obstetrical ultrasound in the 1970s. Human studies, however, are not feasible for the same reason that experts are cautious about casual ultrasound: It's too risky to subject unborn babies to any unknown effects.

"The problem with experimental research," Stratmeyer says, "is that you really need both animal and human studies to make more predictable outcomes." He adds that as technology advances and becomes more complex, the potential for physical effects to be identified in the future also increases.

However, a few studies, Stratmeyer says, suggest that exposure to diagnostic ultrasound during pregnancy may have an effect on human development, such as delayed speech in children.

Danica Marinac-Dabic, M.D., an epidemiologist in the FDA's Office of Surveillance and Biometrics, says that the most consistent finding in the recent literature is a potential association between prenatal ultrasound exposure and subsequent left-handedness, especially among boys. At least three large follow-up studies involving thousands of school-age children in Sweden and Norway suggested such an association.

"Since ultrasound examinations in these studies took place in the late 1970s and early 1980s," says Marinac-Dabic, "and the fact that modern ultrasound equipment is capable of producing approximately eight times higher intensities than equipment used a decade ago, we continue to study the possible long-term effects of prenatal ultrasound in both animal and human epidemiologic studies."