It's a rite of passage for many expectant parents: baby's first ultrasound. The fuzzy images of the fetus, produced during an examination in an obstetrician's office, are prized by couples, passed around proudly among friends and relatives.

Now, trying to capitalize on this phenomenon, a number of companies are selling elective ultrasounds that have little to do with neonatal health. The services, often in small offices or shopping malls, amount to fetal photo studios and use newer 3-D ultrasound technology to produce more realistic images than conventional machines.

Parents-to-be typically pay from about $80 for a short ultrasound session primarily to determine the fetus's sex to $300 for a half-hour session that is recorded on a videocassette or DVD and includes color photos.

While medical professionals warn of potential health risks from unnecessary ultrasounds, those who offer the elective examinations say they are safe and fulfill a need.

Women love it," said Matt Evans, a lawyer, who started his company, Baby Insight, a few years ago. "They get to see their baby and have an emotional experience with their baby."

Mr. Evans said his technicians have performed more than 2,000 ultrasounds at the company's only location, in Potomac, Md. Baby Insight's highest-priced package, for $260, includes a video with background music, one 8-by-10, two 5-by-7, and 10 wallet-size color photos, four announcement cards and a chance for friends and family members to view the ultrasound images as they are produced on a large screen in the company's theater room.

Mr. Evans said his employees tell customers that the ultrasounds are not meant to be a substitute for a doctor's exam.

Shirlesa Glaspie, 24, of Lanham, Md., underwent an ultrasound at Baby Insight late last month, when she was about 30 weeks pregnant (at its Web site, the company recommends the procedure be performed between 28 and 32 weeks for the "cutest" results). Ms. Glaspie said the images, while a bit "scary," have made the experience much more real.

"He's yawning, he sticks his tongue out, he smiles," she said. "It gives you a realization of what's going on when your stomach is moving around and bouncing around."

While doctors typically conduct ultrasounds at 20 weeks (when the fetus is large enough to show abnormalities), nonmedical ultrasounds are generally performed later, when the fetus is more developed and more photogenic.

Proponents of elective ultrasounds say they can be performed at the customer's convenience in a relaxed atmosphere, and more frequently employ 3-D machines, which are not as useful for observing internal organs for diagnostic purposes but are excellent at capturing realistic still or video images of the face and body.

"As the technology improves, more and more women will be wanting to see it," said Mr. Evans, who has plans to open 75 more centers nationwide by the end of 2005. "That's why we're trying to get in while the market is still undeveloped."

He has plenty of competition. Other companies offering the services include Peek-a-Boo Ultrasounds in California; Womb With a View in Pennsylvania, New Jersey and Texas; FetalFotos in Georgia; and Prenatal Peek, which has branches in North Carolina, South Carolina and California and is opening another in Hawaii, according to its Web site.

Many companies buy new or used medical equipment made by companies like General Electric, Siemens, Philips and Medison. Prices range from around $25,000 to more than $150,000.

Mr. Evans said he bought his used GE Voluson 730 from a national distributor, for $75,000. He would not name the company, in part, he acknowledged, because he feared that the Food and Drug Administration, which regulates medical equipment, might crack down on distributors.

Some doctors and federal regulators think ultrasounds performed outside the medical establishment may pose health risks. The American Institute of Ultrasound in Medicine, a professional group, and the Food and Drug Administration have strongly opposed elective ultrasounds, saying that unnecessary exposure to high-frequency sound waves could be unhealthy.

"Although there are no confirmed biological effects for patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future," the American Institute of Ultrasound in Medicine said in a statement.

Dr. Lawrence Platt, former president of the group and a professor of obstetrics and gynecology at the University of California at Los Angeles, said elective ultrasounds could lead to mistaken diagnoses. "What if something is wrong with the baby?" Dr. Platt said. "Do these people know what to tell you?"

He said one of his patients came in thinking her baby was healthy after a nonmedical ultrasound. Other tests revealed a rare chromosomal condition that could have led to severe retardation and death. The woman ended her pregnancy. "There's no doubt that ultrasounds have been an incredible advance for science," he said. "We need to use the technology correctly. I hate to see this trend have a negative impact on the practice."

While the Food and Drug Administration regulates the equipment, licensing of health care providers is left to individual states. For the time being the companies do not need to be licensed, and the technicians do not need to be certified.

But Dr. Daniel G. Schultz, director of the agency's Center for Devices and Radiological Health, said the agency was advising states about the potential health risks of elective ultrasounds and ensuring that machines were labeled for specific medical functions. "In the end it's up to the states," he said.

So would the F.D.A. never ban such practices? "I wouldn't say never," Dr. Schultz said. "It's a gray area where our authority ends and the states' begins."

The closest step to a ban has come in the form of a bill proposed in New York to ensure that ultrasounds only be performed after a referral or order by a "licensed health care professional." The bill is now with the Senate Rules Committee. California passed a legislation to make elective ultrasound customers sign a waiver acknowledging that they know the F.D.A. does not approve of the practice. The legislation will take effect shortly.

Mr. Evans, who asks patients to be in contact with their own doctors and hires technicians certified by the American Registry of Diagnostic Medical Sonographers, strongly disagrees with dire assessments of elective ultrasounds' health risks. There is no proof that ultrasounds are harmful, he said, and mentioned that doctors often perform numerous ultrasounds when investigating possible fetal health problems. "The F.D.A. has scared a lot of women, but from my experience women aren't worried," he said.

Marilyn Crisp, who opened a similar service, Womb's Window, in Wilmington, N.C., wondered whether the F.D.A. had been swayed by the persuasive voice of the medical community, which may fear that business is being taken away by independent operators.

Some doctors do not object to elective ultrasounds. Dr. Haig Yeni-Komshian, an obstetrician-gynecologist in Chevy Chase, Md., recently accompanied a patient to Baby Insight and found the practice safe, likening it to portrait work. "There's no radiation involved with ultrasounds, just high-frequency waves," Dr. Yeni-Komshian said. "As long as women are still seeing their doctors, if they want to have this done, that's fine."

But for now such companies will continue to operate under intense scrutiny from medical officials. Not that it matters to Ms. Glaspie, whose doctor told her the procedure presented no risk to her baby as long as she "didn't get one done every day." She purchased a video of the experience and has shared it with her son, her boyfriend, her parents, her brother, sister and grandmother, along with "anyone else who is interested."

"Every time we watch, it gets us more excited," she said.

© New York Times
December 2004

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