Background and Problem

Recently, there has been great interest among patients and their families to see the facial features of their unborn baby using 3D/4D ultrasound. While recent studies have demonstrated that this increases the bonding of the parents to their unborn child, the lack of diagnosis of fetal problems is a misuse of this technology.   As a result, hundreds of “fetal photo shops” have appeared in malls and offices throughout the United States.  Their only purpose is for entertainment, with no diagnostic value. Many offer several packages, depending upon whether the patient receives a videotape, CD-ROM, and/or pictures. The cost for such services ranges between $200 and $400.  Because there is no diagnostic value as it relates to the detection of birth defects or abnormal growth when 3D/4D ultrasound is performed in this manner, the American Institute of Ultrasound in Medicine has made the following statement:

“The promotion, selling, or leasing of ultrasound equipment for making “keepsake fetal videos” is considered by the US Food and Drug Administration to be an unapproved use of a medical device.”

Failure of “Keepsake Fetal Video” Programs

Because these facilities are operating in a medical-legal “gray” area, they do not perform at a level that enables them to identify fetal problems. In an attempt to protect these facilities from lawsuits for missing a problem, many of these facilities will have the patient sign a disclaimer explaining that the study is only for "entertainment."

During the years of performing diagnostic ultrasound, Dr. DeVore has never been referred a patient because a birth defect was identified at one of these facilities!  Dr. DeVore is aware, however, of a number of patients examined at these facilities in which major birth defects have not been identified. Dr. DeVore has examined fetuses that were referred for another indication and found a birth defect, only to learn that the patient had recently been seen at a "fetal photo" facility and was told "everything was OK." This is illustrated in the following report in the Journal of Ultrasound in Medicine, in 2005:

"The patient was a 29-year-old primigravid woman with no notable family history. She was referred to our prenatal diagnosis center because of positive Expanded AFP (California’s multiple-marker screening program) test results suggesting a risk of greater than 1 in 10 for both trisomy 18 and Smith-Lemli-Opitz syndrome. During the visit, the patient informed us that, in the intervening period from the time her blood was drawn, she had been to a local shopping mall and had a keepsake ultrasound examination performed, leaving with a "feeling of reassurance"; she brought in one of the pictures she was given .

After genetic counseling, a complete and detailed fetal anatomic survey was carried out. Seven markers of aneuploidy were identified: a strawberry-shaped skull and choroid plexus cysts, abnormal posterior fossa, complex congenital heart defects, clenched hands, a single umbilical artery, and micrognathia. Amniocentesis was carried out without complication, and fluid was sent for rapid analysis (fluorescence in situ hybridization) for chromosomes 13, 18, 21, X, and Y as well as full karyotyping. Both the fluorescence in situ hybridization analysis and final karyotype identified full trisomy 18. The patient subsequently terminated her pregnancy."

Solution to the Problem

Given the desires of the patient to see their fetus using 3D/4D technology and the objections of the medical community to performing ultrasound without any diagnostic value, the question can be asked, What is the solution to this problem?  For the solution, continue by clicking the remaining titles on the left of the screen.