- Jan 7, 2002
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Unregulated ultrasounds alarm FDA
Despite safety warnings, parents-to-be flock to prenatal portrait studios to watch scans of their baby
PASADENA, Calif. -- Shelly Bunker?s due date is months away, but in an upscale shopping mall office last week, 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 about so-called entertainment ultrasounds from the Food and Drug Administration, 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 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 centers have opened for business around the United States with cute names like 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 ultrasound studios about 10 years ago. Due to the resurgence of the business, Deputy Director Dr. Kimber C. Richter said the agency is now 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.
Some state laws also say that 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, like Fetal Fotos, do initial ?limited medical? scans before the entertainment portion begins. Some also have gotten doctors to issue a blanket prescription for their machine, hoping this gets around the requirement that each patient have a prescription.
Most companies also issue disclaimers, saying they don?t provide prenatal care and are an optional service.
GE Medical Systems, a leading seller of ultrasound equipment, said in a statement to The Associated Press that it ?does not support the use of the 4D equipment for nonmedical purposes.?
But in its advertisements, GE seems to be selling only the great pictures it produces.
One ad plays the song, ?The first time ever I saw your face, I thought the sun rose in your eyes? 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 4D ultrasound system, it really is a miracle.?
While many doctors and midwives refer patients to the 4-D centers for additional, 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,? said Ben Bunker.
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 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, fetal growth and position, and more. 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 3D ultrasound systems that determine the volume of the fetus and then reconstruct the image in three dimensions. The 4D ultrasounds take those 3D 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 it may affect human development, such as delayed speech in children.
In response to a request from the AP, the FDA said it has received a total of 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 4D ultrasound machines and an outspoken critic of their nonmedical use.
?From diagnostic point of view, it?s the most major advance we?ve had in last 10 years, so how can I help but be enthusiastic about this?? he said.
The higher definition ultrasounds help him diagnose everything from cleft palates to heart problems, he says, and can give babies a better chance of survival by making sure 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 Foto 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, Calif., 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,? said Bravo. ?It was so touching.?
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Despite safety warnings, parents-to-be flock to prenatal portrait studios to watch scans of their baby
PASADENA, Calif. -- Shelly Bunker?s due date is months away, but in an upscale shopping mall office last week, 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 about so-called entertainment ultrasounds from the Food and Drug Administration, 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 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 centers have opened for business around the United States with cute names like 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 ultrasound studios about 10 years ago. Due to the resurgence of the business, Deputy Director Dr. Kimber C. Richter said the agency is now 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.
Some state laws also say that 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, like Fetal Fotos, do initial ?limited medical? scans before the entertainment portion begins. Some also have gotten doctors to issue a blanket prescription for their machine, hoping this gets around the requirement that each patient have a prescription.
Most companies also issue disclaimers, saying they don?t provide prenatal care and are an optional service.
GE Medical Systems, a leading seller of ultrasound equipment, said in a statement to The Associated Press that it ?does not support the use of the 4D equipment for nonmedical purposes.?
But in its advertisements, GE seems to be selling only the great pictures it produces.
One ad plays the song, ?The first time ever I saw your face, I thought the sun rose in your eyes? 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 4D ultrasound system, it really is a miracle.?
While many doctors and midwives refer patients to the 4-D centers for additional, 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,? said Ben Bunker.
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 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, fetal growth and position, and more. 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 3D ultrasound systems that determine the volume of the fetus and then reconstruct the image in three dimensions. The 4D ultrasounds take those 3D 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 it may affect human development, such as delayed speech in children.
In response to a request from the AP, the FDA said it has received a total of 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 4D ultrasound machines and an outspoken critic of their nonmedical use.
?From diagnostic point of view, it?s the most major advance we?ve had in last 10 years, so how can I help but be enthusiastic about this?? he said.
The higher definition ultrasounds help him diagnose everything from cleft palates to heart problems, he says, and can give babies a better chance of survival by making sure 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 Foto 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, Calif., 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,? said Bravo. ?It was so touching.?
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