The supporters of ultrasound bills sweeping the Red States started out ignorant of the the fact that intra-vaginal is the only effective way to perform an ultrasound in early pregnancies. They also ignore another important fact that its detractors have failed to notice: ultrasound is a complicated piece of medical machinery with risks inseparable from benefits. FDA says these "baby pictures," taken for no medical reason, are an untested, unapproved, risky use of ultrasound equipment which should not be used.
In testimony by FDA’s Center for Devices and Radiological Health (CDRH) just last March, FDA’s Center Director Jeffrey Shuren said: in his testimony (page 47-48):
There are literally many chances to cause harm with ultrasound. You wouldn't think that but it is possible... It's not just simply, "put some gel on the stomach, put a wand, and [create] a photograph."
Shuren continued,
Ultrasound equipment is typically considered a Class II or III medical device and requires a physician order.… Although it's non-ionizing radiation like x-rays, it still has risks. There are potential mechanical and thermal bioeffects on human tissue resulting from exposure to ultrasound, the medical community agrees that ultrasound exposure should be kept as low as reasonably achievable, also known as ALARA… They can create a picture, but they do not know what harm they're causing.
In 2004, FDA had cautioned about using ultrasound for the sole purpose producing images.
The article, published February 20, 2004, said:
It's risky business taking pictures of unborn babies when there's no medical need to do so.… As compelling as these sneak previews may be, the FDA is warning women about the potential hazards of getting keepsake videos…. While ultrasound has been around for many years, expectant women and their families need to know that the long-term effects of repeated ultrasound exposures on the fetus are not fully known. In light of all that remains unknown, having a prenatal ultrasound for non-medical reasons is not a good idea.
For years, FDA had been monitoring the illegal practice of using this complex medical equipment to take “baby pictures.” In the Journal of Applied Radiology, a “Guest Editorial: Entertainment ultrasound: Risky Business or Mission Impossible?” by Michael M. Raskin, MD, MPH, JD, FACR, he reported that:
The FDA notified the medical community and the ultrasound industry in August 1994 regarding its concerns about the misuse of diagnostic ultrasound equipment for nonmedical purposes and asked them to discourage their patients from having sonograms for nonmedical reasons. They have stated that fetal ultrasound should be performed only for medical purposes with a prescription from an appropriately licensed provider. The FDA considers a diagnostic ultrasound device to be a prescription device. Any person who promotes, sells, or leases ultrasound equipment for making “keepsake” fetal videos should be aware that the FDA considers this an unapproved use of a medical device.… Although the general use of ultrasound for medical diagnosis is considered safe, ultrasound energy has the potential to produce biological effects.
FDA has taken regulatory and administrative action against this practice. From a “Warning Letter” in 1999 against PK Ultrasound (PDF).
The ultrasound system is adulterated under the Act because the manufacturer of this device did not obtain premarket approval based on information developed by them that shows that this device is safe and effective for this new intended use. The device is misbranded under the Act because the manufacturer did not submit information respecting the new intended use of the ultrasound system to the Food and Drug Administration.
FDA issued a letter for the same violation in
2000 against Focus Imaging Groupand in
1997 against Fetal Fotos.
Doctors and ultrasound manufacturers are stuck violating an array of laws. They can assault patients with unnecessary medical procedures, charge insurance companies and patients for procedures they don’t medically require, and obtain and use complex medical equipment for unapproved risky uses. Or they can join their patients in challenging this terrible policy.