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FDA Cautions Against
Ultrasound 'Keepsake' Images By
Carol Rados 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.
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. 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."
The FDA first learned about keepsake video
productions from consumers in Texas in 1994. The Texas Department of Health
and the FDA's Dallas district office jointly inspected three firms. The FDA
then initiated investigations of similar firms in other parts of the
country. Investigators uncovered numerous companies offering a wide variety
of ultrasound packages. Among the agency's findings were that ultrasound was
being performed by untrained, unlicensed technicians and often without a
doctor's supervision. The FDA wrote about its concerns to 10 health
professional organizations and the National Electrical Manufacturers
Association, stating that anyone promoting, selling or leasing ultrasound
equipment for making keepsake fetal videos could be breaking the law. The
agency asked the organizations to have their members discourage patients
from having ultrasound procedures for non-medical reasons and to notify the
FDA of any keepsake video operations in their communities. For every reason a mother-to-be wants a
keepsake video, there are good reasons she shouldn't have one. Women cite
early bonding with their babies, determining the baby's sex, and a desire to
share their prenatal experiences with friends and families as major reasons
in favor of the videos. And the quality of images in commercial videos makes
them especially tempting. Because many obstetricians still use
two-dimensional imaging, which is considered standard in prenatal care,
women may seek the more advanced three- and four-dimensional images used by
some keepsake businesses, in which the features of an unborn infant are more
easily recognizable to the non-professional. But health experts say these are not medical
reasons for having an ultrasound. Lawrence D. Platt, M.D., president-elect
of the International Society of Ultrasound in Obstetrics and Gynecology and
a practicing obstetrician-gynecologist in Los Angeles, adds that while
physicians need to be sensitive to expectant mothers' feelings, "We have to
go beyond emotions in this case. We have to do the right thing," he says.
"Ultrasound is a form of energy and it must be respected." Besides concern that unskilled technicians
could be performing and interpreting such ultrasounds and that the procedure
is not always done under the supervision of a qualified physician, some
facilities may be using equipment that's not in good working order. "Not all ultrasounds are created equal," says
Nancy Hueppchen, M.D., a maternal fetal medicine specialist at Johns Hopkins
Hospital in Baltimore. "Patients don't know the level of expertise of the
person performing the procedure." Hueppchen says there's also the worry
about ultrasounds not being conducted in medical settings. "These portrait
facilities are not equipped to provide counseling should something go wrong,
or proper guidance if a gross abnormality is suspected," she says. The FDA also notes that some video companies
have been known to use the ultrasound machine on higher energy exposures for
as long as an hour to get the pictures. The procedure should always be done
at the lowest possible energy output and for the least amount of time.
Exposure to ultrasound for longer than the time specified by the FDA for
fetal monitoring could pose a potential risk to the health of the mother and
her developing fetus. Some companies make it clear that they are
not providing diagnostic ultrasounds, but those that don't may wrongly give
women the impression that their ultrasound examination will identify
problems. The FDA and the American Institute of
Ultrasound in Medicine (AIUM), which also strongly discourages the
non-medical use of ultrasound, have concerns that women are being wrongly
reassured by commercial sonograms. Women may misinterpret the studio
ultrasound as a medical examination, thus giving them a false sense of
security. And inaccurate findings may cause them to undergo unnecessary
follow-up tests. "Even in the best of hands," says Hueppchen,
"fetal structural problems can be missed due to technical and gestational
age limitations, thus falsely reassuring the patient." Ultrasound is conducted with a prescription
medical device that is regulated by the FDA. The agency sets the standard
for the level of energy to be used for various treatments or diagnoses,
including fetal ultrasounds. This standard restricts ultrasound exposure to
levels that produce few, if any, effects on the fetus, based on
epidemiological evidence. The FDA can take action against the keepsake
industry in two ways: for promoting a device for other than its approved
use, and for using a prescription device without a prescription from a
medical professional. By promoting and advertising keepsake videos, the
advertiser is creating a new intended use for the device, and this requires
premarket review by the FDA. And many keepsake facilities do not appear to
be requiring doctors' prescriptions from their customers. Kimber C. Richter, M.D., a deputy director in
the FDA's Office of Compliance, says that regulation of the commercial
ultrasonic imaging of fetuses is complicated because each video company
scenario is different. "In some cases, there may be no prescription
and no physician oversight," she says. "In others, there may be a physician
involved but no clear doctor-patient relationship." And in still others,
"the video might be made through an extra visit to the physician that the
patient normally sees." Richter says the regulatory approach in all these
cases varies. "FDA regulates devices, but the qualifications and behavior of
technicians and physicians would be regulated by the states," Richter says. The FDA announced in 2002 that anyone
administering ultrasound to consumers without a medical prescription is
breaking the law. "In the past," says Richter, "the FDA has taken regulatory
action, such as a warning letter or even seizure, when these devices were
used for entertainment purposes without a prescription." Margaret T. Tolbert, deputy director of the
FDA's Division of Device User Programs and Systems Analysis, says the agency
is updating its current Web statement warning consumers about the unknowns
of using ultrasound equipment for entertainment purposes and is developing a
set of questions and answers to educate those considering keepsake videos as
a business opportunity. Since a number of advertising examples
recently have come to the FDA's attention--suggesting an increase in
entertainment ultrasounds--the FDA is currently taking a closer look at
these businesses. "We are reviewing these cases and will consider regulatory
action as appropriate," says Richter. The prescription status of ultrasound
equipment ensures that pregnant women will receive professional care that
contributes to their health and to the health of their babies. Performing
prenatal ultrasounds without following state and federal guidelines puts a
mother and her unborn baby at risk. Therefore, the procedure should only be
used to provide medical benefit. Besides being inappropriate and contrary to
responsible medical practice, the bottom line is: Why take a chance with
your baby's health for the sake of a video?
Food and Drug Administration: American Institute of Ultrasound in
Medicine (AIUM): European Committee for Medical
Ultrasound:
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