The Hindu : A medical procedure as photo opportunity

Online edition of India's National Newspaper
Sunday, Mar 28, 2004

International

International

A medical procedure as photo opportunity

PASADENA, MARCH 27. Shelly Bunker's due date is months away, but in an upscale shopping mall office, tucked among the hair salons and art galleries, she watches 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 about so-called entertainment ultrasounds from the Food and Drug Administration, the Bunkers — she is a dance teacher, he is finishing law school — are among thousands of couples 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 proven to be a safe diagnostic tool when done by licensed medical professionals within strict scientific guidelines.

In the past two years, something quite different has emerged — dozens of unregulated ultrasound centres have opened for business around the U.S. with names such as Fetal Fotos, Prenatal Peek and Womb With A View.

Operating without medical guidelines or standards, they charge about $200 (Rs. 9,000) 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 ultrasound studios about 10 years ago. Concerned about the resurgence of the business, the agency is now considering regulatory action, which typically can mean warning letters, injunctions, fines or seizures.

The agency says it is illegal to administer ultrasound without a prescription or to promote the device for non-medical use.

Some state laws also say that operating an ultrasound machine without proper credentials is "practising medicine without a licence." To date, no state medical boards have taken action.

Some franchise owners say they are operating legally because doctors run their businesses. Others, such as Fetal Fotos, do initial "limited medical" scans before the entertainment portion begins. Some also have got doctors to issue a blanket prescription for their machine, hoping this gets around the requirement that each patient have a prescription.

Most companies issue disclaimers, saying they do not provide prenatal care and are an optional service.

A leading seller of ultrasound equipment said in a statement that it "does not support the use of the 4D equipment for non-medical purposes."

While many doctors and midwives refer patients to the 4-D centres for additional, fun peeks, some warn against it. The Bunker couple said their doctor told them to "go for it."

"If doctors do it, it can't be that bad," Mr. 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 Gynaecology 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 centres rather than doctors?

Even worse, the American Institute of Ultrasound in Medicine warns that 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, foetal growth and position, and more. Millions of foetal 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 3D ultrasound systems that determine the volume of the foetus and then reconstruct the image in three dimensions. The 4D ultrasounds take those 3D pictures and turn them into moving images.

"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.

Some small, anecdotal studies in the U.S. and Europe have shown that it may affect human development, such as delayed speech in children. — AP

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