FDA Leery of Ultrasound for Prenatal Entertainment Shots

Shelly Bunker’s due date is months away, but last week in an upscale shopping mall office, tucked among the hair salons and art galleries, she watched her baby boy appear to smile, yawn and wave from inside her womb.

“You can kind of see his personality too,” said the beaming father, Ben Bunker, watching the image of his unborn son captured by a bath of ultrasound waves. “He’s pretty active.”

Despite safety warnings from the Food and Drug Administration about so-called entertainment ultrasounds, the Bunkers -- she’s a dance teacher, he’s finishing law school -- are among thousands of parents eager to take advantage of this latest trend in baby pictures.

Ultrasounds have been an important part of routine prenatal care for millions of women since the 1960s and have proved to be a safe diagnostic tool when done by licensed medical professionals within strict scientific guidelines.

In the last two years, something quite different has emerged -- dozens of unregulated ultrasound centers have opened for business around the United States with cute names such as Fetal Fotos, Prenatal Peek and Womb With a View.

Operating without medical guidelines or standards, they charge about $200 a session, using $100,000 high-density ultrasound machines that provide a much clearer picture -- chubby cheeks, hair, even muscular definition -- than the two-dimensional scans most doctors use.

The FDA shut down several of the so-called 4-D studios about 10 years ago. Because of the resurgence of the business, Deputy Director Dr. Kimber C. Richter said the agency was considering regulatory action, which typically can mean warning letters, injunctions, fines or seizures.

The agency says it’s illegal to administer ultrasound without a prescription or to promote the device for nonmedical use. According to some state laws, operating an ultrasound machine without the proper credentials is “practicing medicine without a license.” To date, no state medical boards have taken action.

Some franchise owners say they are operating legally because doctors own and run their businesses. Others, such as Fetal Fotos, do initial “limited medical” scans before the entertainment portion begins. Some also have obtained blanket prescriptions from doctors for their machines, hoping this gets around the requirement that each patient have a prescription.

GE Medical Systems, a leading seller of ultrasound equipment, said it “does not support the use of the 4-D equipment for nonmedical purposes.”

But in its advertisements, GE seems to be selling only the great pictures it produces.

One ad plays the opening passage to the song “The First Time Ever I Saw Your Face” as a pair of tearful, excited parents watch their baby’s image on a monitor. The announcer then says: “When you see your baby for the first time on the new GE 4-D ultrasound system, it really is a miracle.”

Though many doctors and midwives refer patients to 4-D centers for fun peeks at their babies, some warn against it. The Bunkers said their doctor told them to “go for it.”

“If doctors do it, it can’t be that bad,” Ben Bunker said.

Several medical groups disagree.

Doctors with the Society of Medical Diagnostic Sonography, the Society of Maternal-Fetal Medicine and the American College of Obstetrics and Gynecology stress that ultrasound is a medical procedure, not a photo opportunity. What if an untrained, unregulated scanner finds a malformation? What if uninsured women depend on ultrasound centers rather than doctors?

Even worse, the American Institute of Ultrasound in Medicine warns, although there are no confirmed biological effects from prenatal ultrasounds, possible problems could be identified in the future -- especially because these unregulated scans are longer, use more energy and can be more frequent.

Ultrasound uses high-frequency sound waves to produce diagnostic images of developing babies.

Two-dimensional ultrasound has been around since the 1960s, helping doctors diagnose birth defects and determine fetal growth and position. Millions of fetal ultrasounds are done each year, and more than 30 years of research and practice have found them to be safe.

In recent years, medical technologists have developed 3-D ultrasound systems that determine the volume of the fetus and then reconstruct the image in three dimensions. The 4-D ultrasounds take 3-D pictures and turn them into moving images.

Outside of obstetrics, ultrasound is widely used for an array of diagnostic and therapeutic reasons, from heating and healing tissue to locating gallstones.

“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,” the FDA said.

Because of this, “prenatal ultrasounds can’t be considered completely innocuous.”

Some small, anecdotal studies in the United States and Europe have shown that ultrasounds may affect human development, such as delaying speech in children.

The FDA said it has received 93 reports of problems from all ultrasound machines, not just prenatal. Of those, 63 involved serious injury, 20 involved machine malfunctions and 10 could not be categorized. The agency said it couldn’t immediately provide further details.

Dr. Lawrence Platt, an obstetrician in Los Angeles, is both a leading proponent of the 4-D ultrasound machines and an outspoken critic of their nonmedical use.

“From a diagnostic point of view, it’s the most major advance we’ve had in the last 10 years, so how can I help but be enthusiastic about this?” he said.

The higher-definition ultrasounds help diagnose problems ranging from cleft palates to heart defects, he says, and can give babies a better chance of survival when the necessary medical care is standing by.

But he’s quick to add that “while it can be helpful, it also can be harmful.”

“Used inappropriately, this can be very dangerous,” he said. Platt also said several patients have come to him after prenatal portrait sessions turned tragic when problems were discovered.

“These people are not trained to diagnose, nor counsel patients in these situations,” he said.

Valerie Christensen, who owns four Fetal Fotos studios in Southern California, said her operators have, at times, found fetuses that were malformed or dead.

“At that point we stop the session, switch off the machine, and advise them that they need to see their doctor immediately,” she said.

Christensen, and many proponents, said the benefits -- a richer bonding experience for parents with their unborn baby -- outweigh any possible risks.

Many parents say they leave the sessions more excited about the impending birth.

Carmina Bravo of Lakeview Terrace teared up when she viewed her baby boy last week with her 4-year-old daughter, Gissel.

“I kind of made a new connection with this baby,” Bravo said. “It was so touching.”