Seeing an ultrasound image of your unborn baby can be an ecstatic experience for expectant parents. Its not surprising that many treasure the sonogram photos their doctors give them to take home.

But now a cottage industry has been born to provide parents with more sneak peeks at their impending bundles of joy. Nationwide, private ultrasound studios have sprung up charging parents an arm and a leg to see their babys fingers and toes.

While parents revel in the sometimes spectacular three-dimensional images giving them a real connection to their child weeks or months before delivery, doctors and public health officials warn that the practice is not without risks.

Last year, first-time mom Amber Elgin, of Redmond, had her standard diagnostic ultrasound done locally. She saw a two-dimensional cross-cut image of her baby on a black-and-white screen. But when she read about services that provide a range of 3-D images including live video to expectant parents, she was immediately intrigued.

The 3-D scans provided much more detail about a babys appearance than the flat images she had seen and could show the baby moving around. Unable to get the 3-D ultrasound done locally, she tracked down Northwest Prenatal Ultrasound, a Beaverton-based facility that provides elective as well as diagnostic ultrasound services.

In April, in her seventh month of pregnancy, she and her husband watched their baby, Emme, on a giant screen move around, kick her feet and even suck her tiny thumb.

It was a really neat process, Elgin recalls. It did allow you to have more of a connection to your baby knowing a little bit about what she looked like when she was born.

The Elgins came back across the mountains with a DVD of the half-hour session and a handful of still sepia-tone photographs.

We put them in a little frame, and of course, we had all the family come over and watch the video, she says. They thought that was quite neat.

The photos are now in Emmes baby book, and the DVD is stored away for her to watch someday.

Concerns raised

Fetal ultrasound creates images of the unborn baby in the womb using short bursts of sound vibrations. Echoes from the sound waves are converted into images on the computer monitor. Ultrasound has been in use for decades, and doctors have found no confirmed health risks for the mother or fetus.

However, there is evidence to suggest that the sound waves may have some effect on the fetus. Even as ultrasound technology continues to evolve, scientists ability to study its effects is also progressing. A study of more than 1,400 women in Australia in 1993 found that mothers who had five ultrasounds from 18 to 38 weeks of pregnancy gave birth to lower weight babies than women who had only one ultrasound. Other studies have linked ultrasound exposure to speech delays, which researchers posited could be a marker of earlier developmental problems.

And last year, a Yale University study published in the Proceedings of the National Academy of Sciences suggested that ultrasound may have affected brain development of embryonic mice. The researchers determined that ultrasound waves prevented at least some neurons from migrating to their proper position in the brains of unborn mice. The researchers said it was impossible to tell how much of an impact those changes would ultimately have.

The Yale study used frequencies slightly higher than those generally used in clinical practice, but the researchers noted that some of the latest ultrasound equipment with 3-D reconstruction often employs even higher frequencies.

Applying findings from animal studies to humans is never straightforward. The researchers noted the huge differences in the number of neurons and the size of the brain in mice and humans. The distance from the ultrasound device to the exposed cells in the mice was much shorter than it would normally be in humans, and the process of neurons migrating to their position in the brain lasts 18 times longer in humans than in mice. A half-hour exposure to ultrasound waves might have much less of an effect in humans, the researchers said.

Risk vs. reward

The Yale findings renewed the debate over the casual use of ultrasound. The American Institute of Ultrasound in Medicine formed a task force to examine the safety and ethics of keepsake ultrasound. Dr. Joshua Copel, who takes over as president of the group this month, chaired the panel.

The clinicians were worried about the adverse effects of people having ultrasounds that were not diagnostic, and the possibility of missing abnormalities in fetuses or for falsely telling people there might be abnormalities, he says. The basic scientists in the organization were worried about the potential for adverse effects on the fetus from medically unindicated ultrasound.

The committee concluded that there was a slight chance that ultrasound waves could harm the fetus, and while there was no conclusive evidence, they urged consumers not to take that chance without a valid reason.

Theres a trade-off, Copel says. While there might be and I emphasize might be a very, very small risk of adverse effect on the fetus from the ultrasound, were balancing that against the benefit to be gained by answering whatever clinical question we have. In the non-medical ultrasound, there is no medical question being answered, other than Can I see my cute baby?

Doctors and technicians using ultrasound must walk a fine line in warning the public about the dangers of keepsake imaging. Playing up the risks could discourage women from having even diagnostic ultrasounds performed. The Internet is ripe with stories of parents who dont believe a routine diagnostic ultrasound is safe or necessary.

Sonograms in humans are very safe when done properly, says Jean Spitz, president of the Society of Diagnostic Medical Sonography and a professor at the University of Oklahomas Health Sciences Center. However, the SDMS has long opposed entertainment sonograms; those that have no medical necessity or those repeatedly done to get a good picture of the baby.

Spitz says credentialed sonographers are trained to provide sonograms that use as little as reasonably achievable energy to ensure the fetus is not exposed to high levels of ultrasound for significant periods of time during normal sonograms.

In the hands of a credentialed sonographer, the benefits of a medically indicated sonogram outweigh the risks, and should not cause undue concern to the patient, she says.

Lack of oversight

Nonmedical ultrasound studios remain outside the scope of medical practice and therefore are for the most part unregulated. No federal or state laws ensure that the person performing the sonogram has been credentialed and is knowledgeable or skilled in the diagnostic procedures being performed, Spitz says.

We have continued to work to convince the Food and Drug Administration to stop the proliferation of entertainment use of ultrasound, she says. Unfortunately the FDA has failed to take action despite many reports and concerns filed with the agency.

The ultrasound groups Keepsake Ultrasound Task Force recommends that only licensed medical professionals who have received specialized training in fetal imaging perform fetal ultrasound. Licensed technicians and doctors are trained to recognize medically important conditions and to distinguish between actual problems and features associated with ultrasound scanning. Theyre also taught how to avoid ultrasound exposure beyond what is considered safe for the fetus.

With no oversight of keepsake ultrasound studios, Copel says, its impossible to tell whos operating the machine.

While they may well be using FDA-approved machines, theres no regulation about whos doing the scan and therefore we dont know what training they have on the possible adverse effects of ultrasound, Copel says. No matter what they say, the FDA does not provide guidance for them, the FDA does not regulate them, the FDA does not approve them.

The Food and Drug Administration has issued consumer warnings about keepsake ultrasound and has in some cases stepped in when companies overstepped their bounds, but the agencys ability to regulate a nonmedical industry is limited.

Heidi Rebello, a spokeswoman for the Food and Drug Administration, says the agency can act when it sees a company promoting an off-label use of an approved medical device. Ultrasound technology has only been approved for diagnostic purposes. Other uses of the equipment, such as for recreational or keepsake purposes, is considered an off-label use. Doctors are free to use equipment for those off-label purposes; thats considered the practice of medicine. But they cannot actively promote or market those uses.

Rebello said she could not comment on why keepsake imaging studios have been able to promote those off-label uses or whether the FDA was taking action to address it.

Medical practice itself remains the purview of state regulators. Several states have tried to pass limits on nonmedical use of ultrasound or to create standards to regulate sonographers. But the efforts have been haphazard. A bill introduced this year in the Oregon Senate would subject ultrasound technologists and all other imaging specialists to state licensing, just as X-ray technicians are.

Terry Lindsey, manager of the Radiation Protection Services Section at the states Office of Environmental Public Health, says additional rules would need to be developed within the current radiation protection statutory authority to provide oversight of ultrasound use in Oregon.

We are concerned that without evidence that this procedure is definitely safe, it is a questionable practice to submit a fetus to any medical procedure that may create any risk without a compelling medical reason for the exposure, Lindsey said in an

e-mail to The Bulletin.

The ties that bind

Ultrasound studio operators counter, however, that keepsake imaging does have some benefits. There is preliminary evidence that 3-D sonography has a positive impact on parental bonding with their child.

Many studios also send copies of the video and stills to the clients obstetrician. The 3-D images may also be more effective at identifying certain problems, such as a cleft palate, that can be corrected in the womb. Many doctors still use 2-D technology that appears to be less effective at finding such concerns.

Anti-abortion advocates have used the 3-D images to further their goals and have sent women considering abortions to keepsake studios in hopes the images will discourage them from aborting. The Pro Life America Web site, for example, links directly to Fetal Fotos USA, a national keepsake ultrasound chain with a franchise in Portland.

In part, the keepsake ultrasound industry has been driven by the rise of the new 3-D technology. But Copel says a similar phenomenon emerged in the 1980s when 2-D technology took a step up in quality.

The pictures are often spectacular, but not always. It depends on the gestational age, Copel says. Most of the women I see are between 16 and 22 weeks of pregnancy. Its hard to get the spectacular pictures because theres not a lot of meat on the kids bones at that time. Its more skin and bones than fat, cute faces.

Elgin says getting good photos is also a matter of good timing. Too early, and the fetus wont look like a child, too late and the baby is too big to be active and provide good video images.

Fetal Fotos in Portland charges about $155 for a 10-minute session including a 2-D video, or $195 for a 15-minute session with the 3-D video, also known as 4-D imaging. Northwest Prenatals 3-D packages start at $175. Neither establishment responded to requests for interviews by press time.

Copel believes that even without increased regulation, doctors and ultrasound technicians can help to limit demand for keepsake imaging by providing parents what they want during diagnostic imaging. Copel, an obstetrician himself, has a 3-D machine in his office, and often prints out pictures for his patients for free.

All my patients leave with a fistful of either 2-D or 3-D pictures, he says. I would like everyone who has a medically indicated ultrasound to get enough pictures during that medically indicated scan that she doesnt feel a need to get any more pictures until after the baby is born.