Controversial keepsakes

Molly Ball

Wednesday, Jan. 4, 2006 | 7:23 a.m.

Hearing an unborn child's heartbeat for the first time. Finding out whether the baby will be a boy or a girl. Seeing it kick, yawn and suck its tiny thumb on a computer monitor.

These can be some of an expectant parent's most joyous moments, which is one reason that ultrasound videos and photos have grown popular. The "keepsake" ultrasounds of fetuses in the womb often provide the very first images in a baby book.

But businesses that offer them -- and there are several in the Las Vegas Valley -- are operating on the fringes of the law. The U.S. Food and Drug Administration considers keepsake ultrasounds illegal because they are an unapproved use of a medical device.

The sound waves that power the devices could harm fetuses' sensitive tissues, regulators and physicians fear. Although they concede that no studies to date have found such injury, they caution parents to avoid the risk, at least until more research is done.

Nevada companies offering keepsake ultrasounds consider those warnings unfair. Owners point out that ultrasounds, which bounce high-frequency sound off structures inside the body to create two- or three-dimensional images, have been in use for more than 40 years without evidence of harm.

The owners also suspect that complaints about their businesses often can be traced to radiologists, who perform ultrasounds for diagnostic purposes and thus are protecting their turf.

The Nevada Board of Medical Examiners frequently is urged to investigate businesses offering keepsake ultrasounds on grounds that they are not performed by medical professionals, board investigator Doug Cooper said. The identities of those making the complaints are confidential.

At 4-D Baby Imaging in Henderson, ultrasounds are conducted in a comfortable room with a couch for spectators and a flat-screen television mounted on a wall. With the touch of an ultrasound wand to a pregnant woman's abdomen, the delicate, crinkly image of the fetus appears in three dimensions, moving tentatively through the amniotic fluid.

The sight is exciting and emotional for parents-to-be, the company's owner, Brett Tompkins, said. "We put the whole session on video for the parents to take home."

They also get still photographs and a CD of e-mailable images. The company urges customers to come back for repeat ultrasounds to witness the baby's development. Prices range from $75 to $200.

Except for the cold feeling of the gel that coats the woman's belly, the ultrasound causes no discomfort, Tompkins noted. And while the company cautions customers that its service is strictly nonmedical, Tompkins said no risks have been proven with the procedure.

Many medical professionals, however, view businesses such as Tompkins' with distaste.

"Ultrasound is a diagnostic tool," said Allison Newton, ultrasound supervisor at Steinberg Diagnostic Medical Imaging Centers of Las Vegas. "It's not for entertainment."

Doctors usually recommend that pregnant women get a single ultrasound at about the five-month mark to check for birth defects and make sure the fetus is maturing properly. But the keepsake ultrasounds are just pictures, with no medical insight as to what they mean, Newton said.

"People say, 'I'm sure if there was something wrong, they would tell me.' That's not true," said Dr. Carol Rumack, a Denver radiologist who chairs the Commission on Ultrasound for the American College of Radiology and has authored a textbook on ultrasound.

Especially in the case of fetuses, the unknown effects of ultrasound are simply too big a risk to take for nothing more than a souvenir, Rumack said.

The sound waves put out by the ultrasound cause vibrations that are known to alter tissue.

"This is a developing baby," she said. "The cells are not yet tightly organized. Something that vibrates and shakes them could damage the heart or lungs or brain, and congenital defects could be caused."

In August, the FDA issued a declaration stating that it considered such ultrasounds unsafe.

"Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations and rise in temperature," it stated.

"Although there is no evidence that these physical effects can harm the fetus, public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided."

Although the FDA's ruling means the nondiagnostic use of ultrasound is illegal, there is little enforcement, Rumack said. The agency will hold another hearing on ultrasound in March.

The radiology college has urged its members to file complaints against specific businesses to force the FDA to enforce its position, and a few ultrasound shops have been shut down, Rumack said.

The college also issued a statement last month criticizing actors Tom Cruise and Katie Holmes for buying an ultrasound machine -- which can cost as much as $200,000 -- to monitor Holmes' pregnancy at home.

No loving parents would ever intentionally put their unborn children at risk, however small, Rumack said. But most people don't know that medical professionals have warned against the keepsake ultrasounds.

To Kent Newell, owner of Early Images in Las Vegas, the radiologists' concerns are overblown and possibly boil down to trying to stifle competition.

Newell is a registered sonographer whose business is the valley's oldest fetal-imaging shop, offering two-dimensional videos and pictures for $60 a session.

He offers a money-back guarantee on detecting the baby's gender and says he's only been wrong once in more than 25,000 ultrasounds. (Many doctors won't tell parents the gender, fearing liability if they're wrong and the nursery has already been painted pink.)

"People want to see their baby," Newell said. "And there are absolutely no proven biological effects."

Molly Ball can be reached at 259-8814 or at molly@lasvegassun.com.