Many expectant mothers are excited about the opportunity to obtain 3D or 4D (real-time 3D) ultrasounds to bond with their babies. Unfortunately, women do not know the potential risks involved in diagnostic testing when there is no medical indication. While women may be knowledgeable about obstetrical care, they may not understand the physiology of ultrasound and the potential risks of "fetal portraiture sessions." Nondiagnostic 3D ultrasound facilities are not regulated by any State or the U.S. government. They often have cute and appealing names, but they use powerful diagnostic equipment that produces high energy levels to create images. Obstetrical providers have long voiced concerns about the unregulated use of medical diagnostic equipment for nondiagnostic purposes, and the FDA Consumer Magazine has issued a statement against Fetal Portraiture Studios (FDA, 2004). In my opinion, ultrasound used just for fetal portraiture is unwise and potentially dangerous.

The decision to have a 3D or 4D ultrasound places a risk not only on the patient but also her developing baby. Potential risks include excessive exposure to high levels of energy with unknown future consequences for this unborn fetus(es). Although ultrasound in the care of obstetrical patients has been documented over the past 25 to 30 years, there are insufficient data to clearly state there is no risk. The energy utilized in different types of ultrasound machines varies, and the FDA has stated that centers providing 3D or 4D entertainment ultrasounds have been known to utilize higher levels of energy for longer periods of time (FDA, 2004).

Another concern is the possibility of failing to detect anomalies during "entertainment" scans. The unregulated ultrasonographer may not meet standards. Portraiture is not for diagnostic purposes, and often the ultrasound is performed by a technician who may be inexperienced in fetal diagnostics. Is it possible for the technician to recognize abnormalities and report them to the obstetric provider? Will the center know to refer to the appropriate medical provider or provide counseling? (FDA, 2004). Athough most of these centers require a signed release of responsibility, stating the ultrasound is for entertainment purposes only, what parent would not be upset if an abnormality was found at delivery?

In contrast, diagnostic imaging centers that provide ultrasound for diagnostic purposes use a physician to review all images for final interpretation. The patients are appropriately followed and counseled if necessary, and the centers follow guidelines from the American Institute of Ultrasound in Medicine (http://www.aiv.org). The FDA is now considering regulating medical diagnostic equipment to eliminate the promotion of medical industry equipment for a nonmedical need, and the use of medical equipment without a prescription (FDA, 2004). Having an EKG, EEG, or MRI for fun would be considered inappropriate, wouldn't it? Why then, do we subject the fetus to testing in an unregulated site, by unregulated practitioners? If a prescription was necessary for an ultrasound, it might assist in assuring that patients receive appropriate diagnostic care from trained and credentialed professionals who follow state and federal guidelines. Obstetric ultrasound imaging should only be done when medically indicated: to diagnose pregnancy, determine fetal age and growth, diagnose congenital anomalies, evaluate placenta implantation, and determine the number of fetus(es) (FDA, 2004). The FDA has asked to be notified by the public of the presence of nondiagnostic ultrasound facilities by contacting: Diagnostic Devices Branch, Office of Compliance, Center for Devices and Radiological Health, HFZ-322, 2098 Gaither Road, Rockville, MD 20850.

U.S. Food and Drug Administration (FDA). (2004). FDA Consumer Magazine, January-February. Retrieved October 4, 2004, from http://www.fda.gov/fdac/features/2004/104_images.html. [Context Link]