FDA Warns Against the Use of Ultrasounds for Baby Pictures
by Maria Gallagher
LifeNews.com Staff Writer
May 26, 2004
Washington, DC (LifeNews.com) — A new round of debate is arising from the Food and Drug Administration’s warning against using ultrasounds for entertainment.
Some pro-life activists wonder whether the warning could have a chilling effect on the use of ultrasound to save the lives of unborn children.
The FDA’s warning states, "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."
As a result, the FDA is encouraging pregnant women to forego prenatal portraits, videos, and CD-ROMs, which are available from specialty photo studios around the country.
The FDA says ultrasound imaging of an unborn child should only be used if it provides a medical benefit.
The acting director of the FDA’s Center for Devices and Radiological Health, physician Dan Schultz, told the Knight-Ridder news service that there is no one regulating ultrasounds used in a non-medical setting. He added that no government authority oversees who is performing the ultrasound and how large an energy dose is sent into the mother’s womb.
While Schultz indicated that ultrasound technology has proven to be safe, he said the FDA fears that an untrained or irresponsible operator will jeopardize a patient’s health.
"We don’t know what the long-term effects are," Schultz told Knight-Ridder. "We don’t know whether a mother is exposed to excessive doses (of) ultrasound energy."
Pro-life leaders around the country consider ultrasound to be a technological marvel that has saved countless unborn children from abortion. Research indicates that pregnant women are far less likely to abort, if given the chance to see ultrasound pictures of their babies.
Pregnancy resource centers around the country, which offer alternatives to abortion, have increasingly turned to in-house ultrasounds to help pregnant women see their developing children within the womb. Legislation in Congress would provide funding to pay for ultrasound
equipment in such centers.
Also, there has been little scientific evidence to suggest that ultrasound poses any danger to mother or child. In fact, ultrasound companies say that no studies have ever shown the imaging can cause harm.
Mel Stratmeyer of the FDA’s Office of Science and Technology concedes that animal studies have not shown any evidence of low-dose ultrasounds causing fetal harm.
"But the issue of keepsake videos has to be that if there’s even a possibility of potential risk, why take the chance?" Stratmeyer said in an FDA publication.
While animal studies have been performed during the last 30 years to measure the effects of ultrasound, Stratmeyer notes that human studies are not feasible because of the potential risk to the unborn baby.
Jeanette Burlbaw, the owner of a company called Prenatal Imaging, is a trained sonographer who worked for the University of Kansas Medical Center for more than a decade.
Burlbaw uses high-quality General Electric equipment in her facility, but says there are no regulations governing what kind of ultrasound machine a company uses or the credentials of the people operating the machines.
"This should be in the hands of a skilled clinician," Burlbaw told Knight Ridder. "You should not do anything differently than you would in an institution."
The FDA warning has prompted some lawmakers in New York to introduce legislation to ban "entertainment" ultrasound procedures.
Such efforts are likely to face opposition from the fetal photo industry, which has been making inroads in cities around the U.S. Owners note that they use certified sonographers for their portrait-taking.
Still, ultrasound pictures remain extremely popular among expectant mothers and fathers.
One father said that the ultrasound picture can be an eye-opener.
"It makes the whole experience much more real," Steve Ward told the newspaper. "It’s a wake-up call for the Dad."
Related web sites:
Food and Drug Administration – https://www.fda.gov