Angela and Michael watched with joy as their second child sucked its thumb and kicked up its toes. Their delight was tempered with some disappointment, however, as they couldn't completely see their baby's face.
"My placenta obstructed the view of the head, the forehead, and the eyes," says Angela, who is seven months pregnant. She and her husband went to a private ob-gyn clinic in New Jersey that performs keepsake prenatal ultrasounds.
For $180, the couple was promised four 5X7 photos and a 30-minute videotape of their little one in the womb, set to lullaby music. Plus, since they had a blurry image of the baby's face, they were offered a repeat visit at no charge.
The Souvenir Sonogram Frontier
Hundreds of parents like Michael and Angela have taken advantage of the latest ultrasound technology to get a sneak peek of their unborn children.
Compared to the traditional 2-D images, the 3-D portraits and videos offer much more detail of the fetuses' features, such as the face, fingers, toes, heart, and genitals. They also promise to highlight endearing womb activity such as yawns, winks, kicks, rubbing of noses, and thumb sucking.
Keepsake ultrasounds have become so popular that dozens of sites have opened up nationwide. The centers have names such as Little Sprout Imaging, Baby Insight, Peekaboobaby, and First Look Sonogram.
One company, Fetal Fotos, has branches in 22 states. Another firm, 3DBabyVu, has four locations in the San Francisco Bay Area and claims to perform up to 200 screenings per site each month.
The FDA and several medical organizations such as the American Institute of Ultrasound in Medicine (AIUM) have come out against the so-called entertainment sonograms, citing potential health hazards with non-medically justified ultrasound energy and possible misinterpretation of sonograms by patients and unskilled personnel.
The FDA considers it illegal for anyone to promote, sell, or lease ultrasound equipment for the purpose of making keepsake fetal videos, particularly if there is no medical prescription.
The official disapprovals have apparently not swayed some doctors and patients.
Angela, who had received an attractive brochure in the mail for prenatal portraits, was initially concerned about the controversy. But when she broached the topic with her obstetrician, he told her the ultrasound would probably do no harm to the baby. He warned her, though, that the pictures might not be as good as advertised.
Some prenatal portrait centers claim they first obtain approval from their clients' doctors before performing any ultrasounds. Others take the keepsake images after a limited diagnostic scan or conduct the entertainment screens after hours in doctors' offices.
The diverse makeup of each keepsake ultrasound business makes it difficult for the FDA to take action. In the past, officials have sent warning letters to rule breakers and seized equipment.
The federal government has limited power and staff to stem the growth of keepsake ultrasound entities, however. The agency only has the authority to regulate the sale and distribution of medical devices. Jurisdiction over ultrasound services and behavior of technicians and doctors belong to the individual states.
Nonetheless, because of the increasing number of entertainment ultrasound businesses, the government is currently reviewing its enforcement options.
The Power of Imaging
In medicine, the advantages and disadvantages of procedures and treatments are constantly evaluated. As Patricia D. Stahr, executive director of the Society of Maternal-Fetal Medicine remarks, "Risk exists in everything."
For her and for her organization, the risk of a keepsake ultrasound outweighs its benefits. "I wouldn't undergo any procedure that may cause a harmful effect unless I had to," says Stahr.
The Society endorses the AIUM's statement on ultrasounds, which recommends use only when there is a medical need. Other groups that support this position include the Society of Diagnostic Medical Sonography (SDMS), the American Registry of Diagnostic Medical Sonographers (ARDMS), and the American College of Obstetricians and Gynecologists (ACOG).
According to the AIUM, diagnostic ultrasound has been around since the late 1950s. Since its use, there has been no significant evidence showing imaging harms patients or operators. One problem is that it would be unethical to expose people to ultrasound energy for research purposes.
Officials at the FDA point to research suggesting prenatal ultrasound exposure may cause delayed speech in children and left-handedness in boys. In higher doses, ultrasound energy can raise temperature in metals and treat bone fractures, sprains, and pulled muscles.
The power of ultrasound energy must be respected, say experts.
"One must be cautious [with ultrasound], not just use it because you want to use it," says Lawrence Platt, MD, director of the Center for Fetal Medicine and Woman's Ultrasound in Los Angeles and past president of the AIUM. "It doesn't mean that we believe that every time you use an ultrasound, you're harming a fetus. But it also doesn't mean we can guarantee that it is safe. No one can guarantee it is safe."
Mark Hayward, owner of 3DBabyVu, disagrees. "It's totally safe," he says. "High-risk [obstetric] patients are actually put through a protocol of weekly or biweekly ultrasound exams in their last trimester. It makes me wonder, why would the babies at most risk see the highest amount of ultrasound if it wasn't safe?"
To reassure customers, Hayward says 3DBabyVu employs licensed sonographers who use the lowest ultrasound frequency possible and for no more than 20 minutes.
Platt says ultrasound exposure at any length of time or level does not ensure protection from harm. "This isn't something that should be randomly done without really strong medical indications."
Laurinda Andrist, RDMS, RDCS, president of SDMS, agrees, noting that in the obstetrics office where she works, she is careful not to overuse ultrasound on even the most high-risk patients. "The women don't come in and have an ultrasound at every visit," she says. "We need to manage their care and have medical information extracted from that examination."
Emphasizing the need for prudence, Andrist points to radiographers who used to take random X-ray pictures of their hands, only to find out years later that the radiation was harmful for them.
"I'd just really like to hug my baby now."
Robert Wolfson, MD, PhD, a maternal-fetal medicine specialist with a private practice in Colorado Springs, Colo., says he hears this comment all the time from parents who see their baby through his 3-D ultrasound machine. His office provides keepsake imaging in conjunction with, or independent of, a diagnostic exam.
"People respond to a 3-D ultrasound imaging experience in a wholly different way than they ever, ever did," says Wolfson. "What families have told me is that they can really see their baby. They feel that this is someone, not a something."
The experience usually elicits a positive reaction from his patients, with many women vowing to take better care of themselves. Some begin to recognize that their smoking habits and other risky behaviors may affect their child.
While there is no scientific evidence demonstrating the medical value of keepsake imaging, Wolfson says he and his colleagues in Colorado Springs see its true worth: "The physicians in my community consider it a medically indicated procedure because they personally refer people in for services. They see the value it brings to the pregnancy in terms of the connection and the commitment to the pregnancy that results."
Not all keepsake imaging centers have medical doctors and licensed technicians on board, which is what concerns Jeffrey Ecker, MD, vice chairman of the ACOG Committee on Ethics. He worries that non-medical sonography may falsely reassure women of their baby's health or cause undue anxiety over findings that may turn out to be nothing at all.
In an extreme case, a woman might get a keepsake ultrasound, and thinking that her baby is fine, fails to see a doctor either because of insurance, financial, or scheduling issues.
"She goes along, and, indeed, it turns out that there was some issue with growth, development, or positioning of the baby," says Ecker. "The patient was inappropriately reassured by having an ultrasound that looked nice to her and to the folks performing it."
Another concern has to do with abnormalities that may be detected during entertainment ultrasounds. Non-medical personnel may not be able to provide proper counseling to patients, says Ecker, who notes that even a prior medical ultrasound does not guarantee a normal outcome at the next screening.
Moms and dads make decisions about their children all the time. If they are provided with as much information as possible, and are presented with quality service that meets FDA and AIUM guidelines in regards to experienced personnel, they should have the right to choose whether they want to take keepsake portraits, says Wolfson. He is a fellow of the AIUM and a consultant to the FDA.
If a woman gets a prescription from her obstetrician to get a keepsake ultrasound done, then that's fine, says Tom Dunham, director of communications for New York State Sen. Dean G. Skelos. "But there needs to be some oversight from a licensed medical professional."
Last spring, Skelos introduced legislation to restrict the use of ultrasound on a pregnant woman, unless she had a prescription or a referral by a licensed physician, nurse practitioner, or licensed midwife. The bill, S.6776-A, also prohibits ultrasounds for entertainment purposes or for reasons that are not warranted by the patient's condition.
A senate committee is currently reviewing the bill. If it goes through, ultrasound operators that violate the law could face a maximum prison sentence of one year.
"One of the things that is clearly troubling about the practice of providing entertainment ultrasounds is that it's a volume business," says Dunham. He says the ultrasound machines cost more than $100,000 and the centers would need to generate enough business to not only cover costs, but to make a profit. Some sites offer discounts for repeat visits.
"That clearly demonstrates the conflict of interest between the woman's and baby's health and operating business," says Dunham.
Business aside, the keepsake ultrasounds appear to bring lots of joy to parents and their families. "Virtually everybody that walks out of our service loves what we do," says Hayward. "I believe our numbers are above 99% for patient satisfaction."
Published Aug. 10, 2004.