You’re expecting a child—perhaps, your first—and have never been happier or more excited. When a shopping-mall hawker offers to take an ultrasound “photo” or video of the precious fetus growing inside you, how can you resist? It will be a keepsake, she tells you, that you’ll treasure forever. Despite the temptation, the Food and Drug Administration (FDA) and at least 5 medical or health-related associations strongly urge you to decline.
On December 16, 2014, the FDA issued another in a long line of warnings, which began in 1994, about the possible harm that can be caused to fetuses through use of ultrasound equipment to create keepsake photos and videos of developing fetuses. (In the same alert, the FDA also warned against the non-medical use on fetuses of heartbeat monitors.)
Ultrasound imaging provides real-time images of fetuses in the womb through prescription sound-wave devices designed to be used only by trained health-care professionals. According to an FDA biomedical engineer, ultrasounds can slightly heat tissues and may also produce small bubbles, or cavitation, in some tissues. Untrained commercial operators may operate the equipment improperly and may also expose fetuses to these effects for an hour or longer when creating ultrasound videos.
As the long-term effects of tissue heating and cavitation are unknown, the FDA warns that fetal ultrasounds should be performed only when prompted by medical need and ordered by prescription—and only by adequately trained technicians. The potential for fetal and maternal harm increases, the FDA states, when the number and length of ultrasound sessions are not controlled by trained medical professionals.
The American Medical Association (AMA) has also issued opinions about the dangers of non-medical prenatal ultrasonography, stating that retail centers that offer non-diagnostic fetal ultrasounds are not medically regulated and that improper use of ultrasounds may be harmful to fetuses. The AMA adopted the FDA’s policy on the use of fetal ultrasounds to make “keepsake” fetal videos as the unapproved use of a medical device.
Likewise, in 2004, the American College of Obstetricians and Gynecologists (ACOG) issued a Committee Opinion endorsing a “Prudent Use” statement from the American Institute of Ultrasound in Medicine (AIUM) discouraging the use of ultrasounds to create keepsake photos or videos. In 2012, the AIUM issued a follow-up statement to the one endorsed by ACOG in 2004, which includes the following:
Although the general use of ultrasound for medical diagnosis is considered safe, ultrasound energy has the potential to produce biological effects. Ultrasound bioeffects may result from scanning for a prolonged period, inappropriate use of color or pulsed Doppler ultrasound without a medical indication, or excessive thermal or mechanical index settings.
In addition, the American College of Radiology (ACR) and the American Pregnancy Association (APA) have come out against the use of ultrasounds for non-medical reasons. The ACR issued a position statement supporting the performance of fetal ultrasounds “only for medical purposes with a prescription from an appropriately licensed provider,” and opposing “the use of fetal ultrasound solely for entertainment videos or keepsake images.” The APA recommended against such scans and videos because, though properly used ultrasounds by trained professionals have not demonstrated fetal harm, “the long term effects of repeated and/or lengthy ultrasound exposures on the fetus are not fully known.”
Can Non-medical Professionals Who Operate Ultrasound Devices Be Found Legally Responsible for Harm They Cause to Fetuses?
Undisputed evidence that these scans and videos cause injury to fetuses does not exist. But, the thoughtful and well-reasoned opinions of educated and experienced medical authorities that the non-medical use of ultrasound devices does indeed have the potential to cause fetal injury suggest that parents are well-advised to avoid risking the safety of their unborn children by subjecting them to the effects of uncontrolled tissue heating and cavitation. But, what if you have already purchased one of these scans or videos and your unborn child is later found to have been harmed as a result?
In light of the information and opinions published by the FDA and others, can commercial providers of these scans and videos be held legally responsible for harm caused to fetuses by the inappropriate use of ultrasound equipment? Though the answer will depend on the circumstances of a particular case, harm caused by the negligent use of a medical device such as ultrasound or heart-monitor equipment, whether or not that use is illegal, may result in the operator’s liability for injuries determined to have resulted from the negligent use of the device. The use of such equipment without receiving adequate training regarding its safe operation, for example, may be found to constitute negligence on the part of the operator. The use of the equipment for periods longer than those advised by medical authorities may also lead to a finding of negligence by the user.
In addition, the use of a medical device in a manner prohibited by law may be found to be negligence per se. The FDA announced, in 2002, that the administration of an ultrasound to anyone without a prescription is illegal. The use of ultrasounds for keepsake photos and videos may be found to violate that legal prohibition and may lead to liability for fetal injury determined to have resulted from the violation.
Obtain Legal Assistance from Birth-injury Attorney Jeff Killino
Birth-injury attorney Jeff Killino is known throughout the country for his dedication to achieving justice for children who suffer from birth injuries caused by someone’s negligence or medical malpractice. If your child is born with an injury of any kind and you suspect that the injury was caused by someone’s negligence or by medical malpractice, attorney Killino and his respected team of birth-injury lawyers will help you fight for the justice you and your family deserve.
