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FDA - Once More With FeelingFrom: art fougner, md (evsono@pipeline.com)Thu Apr 15 09:54:57 2004
FDA warns against nonmedical sonograms Obstetrics April 15, 2004 2004 APR 15 - (LawRx.com) -- It is March 2004 and Shelly Bunker's due date is months away; but in an upscale shopping mall office last week, tucked among the hair salons and art galleries, she and her husband watched their baby boy appear to smile, yawn, and wave from inside her womb. Despite safety warnings about so-called "entertainment ultrasounds" from the U.S. Food and Drug Administration (FDA), the Bunkers are among thousands of parents eager to take advantage of this latest trend in baby pictures. Ultrasounds have been an important part of routine prenatal care for millions of women since the 1960s and have proven to be a safe diagnostic tool when done by licensed medical professionals within strict scientific guidelines. But in the past 2 years, something quite different has emerged: dozens of unregulated ultrasound centers have opened for business around the United States with cute names like Fetal Fotos, Prenatal Peek, and Womb With A View. Operating without medical guidelines or standards, they charge about $200 a session, using $100,000 high-density ultrasound machines that provide a much clearer picture - chubby cheeks, hair, even muscular definition - than the two-dimensional scans most doctors use. The FDA shut down several ultrasound studios about 10 years ago. Due to the resurgence of the business, Deputy Director Kimber C. Richter said the agency is now considering regulatory action, which typically can mean warning letters, injunctions, fines, or seizures. The agency says it's illegal to administer ultrasound without a prescription or to promote the device for nonmedical use. Some state laws also say that operating an ultrasound machine without the proper credentials is "practicing medicine without a license." To date, no state medical boards have taken action. Some franchise owners say they are operating legally because doctors own and run their businesses. Others, like Fetal Fotos, do initial "limited medical" scans before the entertainment portion begins. Some also have gotten doctors to issue a blanket prescription for their machine, hoping this gets around the requirement that each patient have a prescription. Most companies also issue disclaimers, saying they don't provide prenatal care and are an optional service. GE Medical Systems, a leading seller of ultrasound equipment, said in a statement to The Associated Press that it "does not support the use of the 4-D [4-dimensional] equipment for nonmedical purposes." But in its advertisements, GE seems to be selling only the great pictures it produces. One ad plays the song, "The first time ever I saw your face, I thought the sun rose in your eyes" as a pair of tearful, excited parents watch their baby's image on a monitor. The announcer then says: "When you see your baby for the first time on the new GE 4D ultrasound system, it really is a miracle." While many doctors and midwives refer patients to the 4-D centers for additional, fun peeks at their babies, some warn against it. The Bunkers said their doctor told them to "go for it." "If doctors do it, it can't be that bad," reasoned Shelly Bunker's husband, Ben. Several medical groups disagree. Doctors with the Society of Medical Diagnostic Sonography, the Society of Maternal-Fetal Medicine, and the American College of Obstetrics and Gynecology stress that ultrasound is a medical procedure, not a photo opportunity. What if an untrained, unregulated scanner finds a malformation? What if uninsured women depend on ultrasound centers rather than doctors? Even worse, the American Institute of Ultrasound in Medicine warns that although there are no confirmed biological effects from prenatal ultrasounds, possible problems could be identified in the future, especially because these unregulated scans are longer, use more energy, and can be more frequent. Ultrasound uses high-frequency sound waves to produce diagnostic images of developing babies. Millions of 2-dimensional fetal ultrasounds are done each year, and more than 30 years of research and practice have found them to be safe. In recent years, medical technologists have developed 3-D ultrasound systems that determine the volume of the fetus and then reconstruct the image in three dimensions. The 4-D ultrasounds take those 3-D pictures and turn them into moving images. Outside of obstetrics, ultrasound is widely used for an array of diagnostic and therapeutic reasons, from heating and healing tissue to locating gallstones. "Ultrasound is a form of energy, and even at low levels, laboratory studies have shown it can produce physical effects in tissue, such as jarring vibrations and a rise in temperature," the FDA said. Because of this, the agency said, "prenatal ultrasounds can't be considered completely innocuous." Some small, anecdotal studies in the United States and Europe have shown that it may affect human development, such as delayed speech in children. Lawrence Platt, MD, an obstetrician in Los Angeles, California, is both a leading proponent of the 4-D ultrasound machines and an outspoken critic of their nonmedical use. "From diagnostic point of view, it's the most major advance we've had in last 10 years, so how can I help but be enthusiastic about this?" he said. The higher definition ultrasounds help him diagnose everything from cleft palates to heart problems, he says, and can give babies a better chance of survival by making sure the necessary medical care is standing by. But Platt is quick to add that "while it can be helpful, it also can be harmful." "Used inappropriately, this can be very dangerous," he said. Platt also said several patients have come to him after prenatal portrait sessions turned tragic when problems were discovered. "[The ultrasound technicians] are not trained to diagnose nor counsel patients in these situations," he said. Valerie Christensen, who owns four Fetal Foto studios in Southern California, said her operators have, at times, found fetuses that were malformed or dead. "At that point we stop the session, switch off the machine, and advise them that they need to see their doctor immediately," she said. Christensen, and many proponents, claim the benefits - a richer bonding experience for parents with their unborn baby - outweigh any possible risks. This article was prepared by FDA Law Weeklyly editors from staff and other reports. Copyright 2004, FDA Law Weeklyly via LawRx.com. http://www.obgyn.net/newsheadlines/womens_health-Obstetrics-20040415-18.asp
-- art fougner, md ich bin ein New Yorker
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