Entertainment ultrasounds of babies in the womb warning by FDA
Main Category: Public HealthArticle Date: 28 Mar 2004 - 0:00 PDT
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If you are pregnant, you can watch your baby appear to smile, yawn and even wave - all from inside your womb. Mother and father can seemingly see their unborn baby's personality traits.
These baby pictures have become increasingly popular, despite the safety warnings the FDA has issued.
When carried out by trained medical professionals who work within strict scientific guidelines, ultrasounds are safe and useful. They have been since the early sixties.
A new type of 'service' has emerged over the last couple of years. In the USA, unregulated establishments have sprouted up. They open up with names such as Fetal Fotos or Prenatal Peek.
They use $100,000 high-density ultrasound machines that produce incredibly clear pictures. Clients pay $200 per photo session. These machines are three-dimensional and you can see everything in incredible detail. Most doctors use two-dimensional scans.
About a decade ago the FDA closed many centres down. The FDA is looking at the whole thing again. In the USA it is illegal to administer ultrasound without a prescription. It is also illegal to promote ultrasound for non-medical use.
However, no medical board has taken any action against these centres.
According to some of the centres, they are operating legally. They say that they are owned by doctors. Fetal Fotos gets around this by offering a limited medical prior to the entertainment part of the session.
GE Medical Systems, a company which sells this equipment, said that it does not support the use of 4D equipment for non-medical purposes (it said this to Associated Press). However, its ads sell only the great pictures it produces. Its adverts show parents super excited when they see fantastic pictures of their babies in the womb.
Doctors disagree on whether this is OK or not.
The Society of Medical Diagnostic Sonography, the Society of Maternal-Fetal Medicine and the American College of Obstetrics and Gynecology say that ultrasound should not be a photo opportunity, it should be used for medical purposes only. They wonder what would happen if an untrained person finds a malformation. An uninsured mother may depend on this service rather than her doctors.
The American Institute of Ultrasound in Medicine worries that these sessions are longer than the medical ones, a mother could be going to many sessions. This means that the baby is exposed to more energy from these machines.
Ultrasound uses high-frequency sound waves to produce diagnostic images of developing babies.
The difference between 3D and 4D ultrasound is that 4D ultrasound turns the 3D pictures into moving images.
The FDA said "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……..prenatal ultrasounds can't be considered completely innocuous."
Some studies have found problems exposure to these machines have on tissue and human development. However, they are very small studies and anecdotal.
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13 Feb. 2012. <http://www.medicalnewstoday.com/releases/6863.php>
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Visitor Opinions In Chronological Order (35)
responsible use of 4D ultrasound
posted by jane on 29 Mar 2004 at 12:51 amI am an owner of an elective 4D ultrasound studio. We require all of our customers to be receiving prenatal care from a licensed healthcare provider.
We require they have a signed acknowledgement from their doctor that they are okay with us performing the 3D/4D ultrasound and we require that they have had a full diagnostic ultrasound through their doctor before coming to our studio for an elective ultrasound.
We also use only certified RDMS sonographers to perform the ultrasound.
Yes, we have discovered problems that were not caught during the full diagnostic ultrasound performed at the doctors office and have sent the customer back to their doctor, called the doctor with a report and sent pictures of the problem with the customer back to their doctor for further evaluation.
I understand the FDA and the medical community having concerns over elective ultrasound services when they do not operate responsibly. They use what they call "highly trained techs" who have no more medical training or knowledge than the average person and are performing these scans after a couple of weeks training.
They wouldn't have a clue if they were seeing some anomalies. I do believe if ultrasounds are performed by a certified sonographer and there is proof the woman is receiving prenatal care through a doctor and the doctor is aware of the patient having an elective ultrasound that women should have the right to do so.
It really bothers me that women have the right to kill a fetus, but God forbid that she should choose to look at it, marvel at it, and bond with it before birth. I have seen fathers and siblings have such an overwhelming connection with the baby once they see it that they would never have had the chance to do without 3D ultrasound.
I think the medical community is having sour grapes that these elective ultrasound studios can offer their patients something that they can't and aren't receiving any of the money. What a poor excuse for banning these types of services for pregnant women.
I'm all for regulations that make these places operate responsibly but there is more proven danger for a women to ride in a car, or choke on food that she eats than any proven studies that ultrasound does any harm when used responsibly.
We do own a GE Voluson 730 machine and was told there is absolutely no danger. These machines are so regulated as to the amount of energy they put out that there is no danger in using them.
I think it's a bunch of politics and pressure from the medical community that just doesn't want women to have this opportunity because they aren't providing it. We have a doctors office in our community that is two Ob/Gyn women physicians who have this machine and you can have a 3D ultrasound with them, pictures and video included if you are one of their patients.
One more thing - why do women have to have mammograms which subject them to xrays which can be harmful rather than an ultrasound of the breast. There is no xrays involved, it's much more detailed and has much better diagnostic value than a regular mammogram and NO PAIN. Guess why - it's all a matter of politics again. Why won't insurance pay for the safer and painless evaluation of the breast. Answer me that one.
ABSOLUTELY no danger???
posted by Helaine Brenner on 30 Mar 2004 at 6:03 amI find the FDA very responsible in attempting to warn the public on the misuse of ultrasound. In fact, I would hope they would continue to shut down the centers mentioned.
The previous opinion posted stated that the author "was told" that there are absolutely no dangers to ultrasound to the mother and fetus. Did the research that concluded this information include the research on the high-density ultrasound machines in question. How long have the studies been running to tell us this information? ULTRASOUND CHANGES CELL STRUCTURE. It CREATES A RISE IN TEMPERATURE. This we know. It is a fact. These high density machines, are used for longer periods of time than the average ultrasound. Can we be ABSOLUTELY sure the damage that this extreme exposure is doing to the cells of the fetus has no effect on the life of the child? How many years will we wait and how many studies will be done before we receive conclusive results? What we hear is that damage done to the cells is insignificant. But is it? Can we truly be sure we are not endangering our child with each burst of energy?
X-rays were used for pregnant women before they were found to be dangerous. Drugs are continually pulled off the market once negative effects are determined. Should we be waiting for the day that a new technology arrives to replace ultrasound in order to find out its negative effects?
The previous author stated that a woman can choose to abort a fetus, but can not look at one. Any mother who CHOOSES to have a child would not be able to live with herself if she knew she was endangering her child. It can be argued that the benefits of having a medical ultrasound would outweigh the risks of not having one. However, why would any caring dedicated mother take a chance with her child’s life because of general curiosity? I, for one, would not take any chances with the life of my child. Would you?
Responsible Use
posted by Wendy on 1 Apr 2004 at 1:37 amI could not agree more with Jane. Ultrasound technology has been widely used (and studied) for over thirty years, quite safely I might add. Jane is correct in that the newer 3D and 4D machines are regulated by the FDA for intensity emission, etc. They operate at the same intensity as the widely used 2D technology. The higher intensity of concern is primarily as a result of new Doppler imaging features used to assess venus flow, etc. Doppler is rarely used in normal obstetric studies, and I seriously doubt it is used at all in an elective ultrasound used to generate prenatal images. If the elective center is operating with registered Sonographers, then I think there is absolutely no justification for alarm. After all, RDMS Sonographers are licensed, trained, and fully qualified to operate the equipment responsibly. They are the same folks you see at your OB's office when you get your 18-20 week gestation diagnostic ultrasound exam. I agree that the industry needs oversight, but again, there is no justification to shut down responsible operators, they provide a valuable service that many physicians simply do not have the time to offer. Best advice is to check out the credentials of the center…If they use only registered RDMS Sonographers, then relax and enjoy the amazing images of your new addition.
Commercial Sonography
posted by Sharon on 1 Apr 2004 at 8:55 pmI agree with the last post. What is the difference in seeing a registered sonographer at your Doctors office and seeing one in a commercial setting? The equipment is FDA regulated and RDMS sonographers are the same highly trained professionals your Doctor staffs. I should Know...I am one. I can promise you that 3d and 4d ultrasound is not going to go away, and it will even eventually replace the more common 2D scans. In all of my years of performing prenatal scans, I have never seen any adverse effects on mom or baby as a result of ultrasound exposure. Take that as anecdotal evidence to contrast with that provided by Helaine. The previous post put it best...RELAX!!!!
Ultrasounds Abound
posted by John F. on 7 Apr 2004 at 1:27 amI have a few strikes going against me in posting the following opinion. First, because I'm a male not a female. Second, because I've never had an ultrasound. And third, because I live in France (American, but overseas).
However (a) my wife is about to have a baby (4 weeks from now) (b) she's received incredible care here in France and (c) I've been present for at least half the ultrasounds she's received, which in this country means one ultrasound every five weeks.
Yes, it's France. Say what you wish. But know that in the list of infant mortality rates, the US ranks around Cuba, Guam, and Portugal. Even the Czech Republic has much lower rate. France on the other hand ranks with a much lower rate, around Switzerland and Austria which are among the healthiest places to have a baby in the world.
Also know that when you go to you OB/GYN here in France, they sit and talk to you. For a half hour... 40 minutes... whatever you need. The average in the US is only 12 minutes.
And last... in the States, an ultrasound that goes on your insurances can cost around $800. In France, it's $100.
Don't get me wrong. The US is great in a lot of ways. I'm just calling into question the whether this might really be a cloaked cost issue and not an issue about the health of the procedure.
The FDA does a lot of things. They say a lot of things. Some of it is in your best interest. Some of it isn't, either by intention or -- most of the time -- because they're just not sure themselves. Sure, the FDA has protected us from bad things in the past. But how many times have they also let us take drugs that kill? Did you know that doctors in the '50s used to advocate one brand of cigarettes over another? Did you know that the FDA almost allowed Thalidomide (the morning sickness drug that caused birth defects in the UK) onto the US market? It was only a paperwork error that kept it off long enough that the tragic effects were discovered.
If ultrasounds alter cell structure, why is one any more allowable than 5 or 8 or 10?
Our doctor here won't let me wife drink even one glass of wine -- which is more cautious than we were ready to be and much more conservative than we expected for a French physician -- and yet he's willing to allow the scans.
Anyway, I can appreciate that parents-to-be would be concerned. But it's a shame things like this start the frenzy they seem to inspire.
Ultrasound Money
posted by Ronda RDMS on 7 Apr 2004 at 8:49 pmI've been reading the recent articles about elective ultrasounds. It seems like there still are a lot of uninformed people out there. First of all I feel its all about the money. Who is getting paid for what? It doesn't matter the type of exam, equipment used or who is performing the exam. I have been doing ultrasound for 12 years and I feel I'm well versed on the subject. There are numerouse folks out there who are not registered in their medical profession. Over the last 30 years there have been hundreds of clinical studies done on ultrasound technology. Not one of the studies has shown bioeffects on mother or fetus. The 3D/4D technology uses the same sound waves as the 2D technology. No radiation has ever been involved with ultrasound, regarding Gwen 3/30/04. Absolutely no danger, regarding Helaine 3/30/04 you need to do some of your own research before saying no to this type of ultrasound use. Do you realize that there are numerous frequency used when doing ultrasound. Again 30 years of studies show no known bioeffects to the use of ultrasound. There is danger to extreme exposure of pollution outside. Should we live in a bubble? What about the increase of allergies in children? What do you call a doctor who got a D- in med. school? Doctor right! These doctors are out there practicing medicine with there outdated ultrasound machines also giving pictures of babes and pocketing the money for a sub standard exam. The difference is whose pockets are getting lined. We all need to be more responsible for our health care. I feel if the elective procedure you choose is being done with responsible use and credentialed people go for it!If we choose to have an elective procedure be it ultrasound or Ct scans its part of our American freedom of choice.
Switching Doctors
posted by Jon Kokko on 20 Apr 2004 at 8:29 pmMy wife's Ob/Gyn just denied our requested signature for an elective ultrasound since it wasn't "Medically Necessary". We have just sent our request to have our medical records forwarded to our new Ob/Gyn. Doctors (and the FDA) need to realize that the choices for health care reside with the patient. Patients will make that choice or they will find a new physician.
Outcomes NOT Improved!
posted by Shari Hahn AAHCC on 8 May 2004 at 1:15 pmI just wanted to add to this debate that even with all of this information and opionions, the fact is that ultrasound does NOT lead to better outcomes since it has become routine.
It is not proven to be completely harmless, which is why ACOG recommends against routine ultrasound.
It is very troubling for me to read how living tissue and cells are affected by ultrasound and the possible adverse affects of this procedure, including a study that shows that babies exposed to 5 or more ultrasounds were 30% more likely to develop intrauterine growth retardation(a condition that ultrasound is often used to detect!).
Again, it's all about weighing risks and benefits; if there is a medical indication for this procedure then I totally support it.
Please give study info
posted by Mark MD on 31 May 2004 at 2:49 amRegarding the last post by Shari, please post the reference to the study you quoted regarding a 30% increase in IUGR with 5 or more ultrasounds. Were these pregnancies with significant underlying complications that would predispose to IUGR? I would love to read it.
Doctors Needed to Stop Saying it's Safe without Question
posted by Emma on 1 Jul 2004 at 10:02 pmI just had a 13 week ultrasound for no good reason whatsoever. My doctor was questioning my dates because I said I could feel the baby even though there was NO WAY they were wrong (the ultrasound confirmed this).
I ended up getting an hour long scan (I was expecting it to last just 15-20 minutes). I came home wondering whether such a long exposure would be harmful.
I went online looking for reassurance but I have come to understand that the truth is anything but reassuring. We just don't know, and people need to understand that. It's not harmless the way taking a picture of your newborn is.
Most people don't understand that because doctors don't tell them. I find it particularly troubling that three large studies have now should that males are 30% more likely to be left handed it their mother had a scan.
Left handedness (beyond the % genetically expected) is known to be caused by brain injury. I am now questioning whether I should even allow the 20 week scan, something I had been really looking forward to. I will also refuse doptones.
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