Sunday, February 04, 2007

FDA Cautions against Keepsake Ultrasounds

There is no conclusive evidence that keepsake ultrasounds-- or any ultrasounds-- do any significant harm to children, but the FDA is cautioning against them:

Although there is no evidence that these physical effects can harm a fetus, the FDA says the fact that these effects exist means that prenatal ultrasounds can't be considered completely innocuous.


Yeah, no evidence something hurts you, but let's ban it.

I think there's probably more evidence that sugar is bad for you. Should we ban that, too?


Mel Stratmeyer, Ph.D., in the FDA's Office of Science and Technology, says that most animal studies have not identified any fetal harm with low-dose ultrasound exposure.


You'd think that if ultrasound doesn't harm animals who are smaller than humans, then it wouldn't hurt humans.

"But the issue of keepsake videos has to be that if there's even a possibility of potential risk, why take the chance?" Stratmeyer says.



What precisely is the risk? What are the chances something wrong comes from an ultrasound?

These remind me of people who says all baby bottles should be sterilized and babies should never put dirty things in their mouths. (As if EVERYONE sterilizes the bottles and NEVER lets their babies mouth on their cars keys or a soother the kid picked up). Riding a trike probably has more potential risk than an ultrasound.

However, a few studies, Stratmeyer says, suggest that exposure to diagnostic ultrasound during pregnancy may have an effect on human development, such as delayed speech in children.


A couple of studies. But the vast majority have not. And what precisely constitutes "delayed speech"? Did this stop the kids from growing up to be happy, healthy citizens?

Danica Marinac-Dabic, M.D., an epidemiologist in the FDA's Office of Surveillance and Biometrics, says that the most consistent finding in the recent literature is a potential association between prenatal ultrasound exposure and subsequent left-handedness, especially among boys.


Oh my. Left-handedness!

That all being said:

The FDA can take action against the keepsake industry in two ways: for promoting a device for other than its approved use, and for using a prescription device without a prescription from a medical professional. By promoting and advertising keepsake videos, the advertiser is creating a new intended use for the device, and this requires premarket review by the FDA. And many keepsake facilities do not appear to be requiring doctors' prescriptions from their customers.

(...)

The FDA announced in 2002 that anyone administering ultrasound to consumers without a medical prescription is breaking the law. "In the past," says Richter, "the FDA has taken regulatory action, such as a warning letter or even seizure, when these devices were used for entertainment purposes without a prescription."