The diagnostic ultrasound has widespread acceptance due to its clinical utility, convenience, and noninvasiveness. In the United States, approximately 65% of pregnant women have at least one ultrasound examination.
3 We usually reassure any prospective mother that ultrasound is safe and does not have any harmful effects on the baby; therefore, it is of paramount importance to be familiar with ultrasound safety.
4 Some evidence exists that high-energy ultrasound may produce biological effects in exposed tissues. The most studied effects are the local increase in temperature (thermal changes) and oscillatory and potentially catastrophic motions of bubbles, if present, in the tissues (microcavitation).
5
The nature of ultrasound is such that, during its propagation through the tissue, portions of its energy are absorbed and converted into heat. Although the heat is dissipated by the adjacent tissues and blood flow through the insonated area, tissue temperature may rise a fraction of a degree Celsius.
6 Such temperature aberrations normally occur during the human diurnal cycle, and temperature may increase by 3° to 4°C in febrile states. Hyperthermia is a proven teratogenic agent in various animals (mouse, rat, hamster, monkey, sheep, and others) and is considered so in humans. In addition, certain stages of embryonic and fetal development may be more susceptible to thermal effects.
7 Effects appear to be a threshold phenomenon where temperature increases of 1.5°C or higher are considered necessary for damage to occur. However, the energy output of the diagnostic ultrasound is of such low intensity that it is unlikely to induce temperature changes of such a degree to produce adverse pregnancy effects.
8 In addition, no recently published study has demonstrated unequivocal adverse effects of diagnostic ultrasound. However, it is a theoretical possibility and should not be completely ignored.
The interaction of sound with microscopic gas bubbles that preexist in tissues may cause a bioeffect termed
microcavitation or acoustic cavitation.
5 Because of the succession of positive and negative pressures that can cause oscillatory motions of bubbles, stable cavitation or implosion of the bubbles, described as transient cavitation, may result. These can result in cell membrane disruption and even in the release of free radicals that are cytotoxic. Another potential effect is radiation stress, caused by acoustic streaming in liquid media secondary to the pressure gradient generated by the moving sound wave. These biological effects have been produced in plants, insects, and some mammalian tissues. Although there is no direct evidence to suggest that in humans, under clinical conditions, ultrasound-induced microcavitation produces biological effects, the U.S. Food and Drug Administration (FDA), together with the American Institute of Ultrasound in Medicine (AIUM), the American College of Obstetricians and Gynecologists (ACOG), and the National Electrical Manufacturers Association, introduced a method of displaying ultrasonic output that would control and minimize possible bioeffects in insonated fetal tissues.
6,8,9,10,11 If an ultrasound machine exceeds predetermined limits for output, either a thermal index or mechanical index must be displayed on the screen. If the thermal index, which is appropriate for Doppler applications, exceeds 1.0, there is a potential for the tissue temperature to rise. If the mechanical index, which is appropriate for scale imaging, exceeds 1.0, there is a potential for cavitational
effects.
6,9 It is important to note that although the more recent epidemiologic studies were published in 1998 through 2002, ultrasound examinations consisted exclusively of B-mode, and all machines used predated 1992, ie, the “new” FDA regulations, allowing output to rise to more than 94 mW/cm
2, the then-accepted upper limit for fetal application. Those acoustic outputs can be considered “low” by today’s standards. Still, available published evidence showed no difference in the prevalence of delayed speech or motor development; impaired neurological development, growth, vision, or hearing; low birthweight; dyslexia; or childhood cancer among children exposed to ultrasound
in utero.
12,13,14 The only well-designed study showing some effect was a 2013 article that presented a small increase in the frequency of non-right-handedness (ambiguity) in male infants of mothers exposed to diagnostic ultrasound.
15 Nevertheless, in general, it is safe to say that when sonography is performed for a valid medical indication by a well-trained individual who respects the basic rules of time and exposure, the information that can be obtained is of such great value that it clearly overshadows the remote risks that may exist.
16,17,18,19,20