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Please note that any comments expressed in these forum posts do not reflect the opinions of Medical News Today in any way at all. Opinions posted in this forum do not constitute medical
advice, which should be sought from qualified medical advisers. Disclaimer.
responsible use of 4D ultrasound
posted by jane on 29 Mar 2004 at 12:51 am
I 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.
Read the news article that this opinion was posted about:
Entertainment ultrasounds of babies in the womb warning by FDA
ABSOLUTELY no danger???
posted by Helaine Brenner on 30 Mar 2004 at 6:03 am
I 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 01 Apr 2004 at 1:37 am
I 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 01 Apr 2004 at 8:55 pm
I 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 07 Apr 2004 at 1:27 am
I 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 07 Apr 2004 at 8:49 pm
I'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 pm
My 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 08 May 2004 at 1:15 pm
I 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 am
Regarding 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 01 July 2004 at 10:02 pm
I 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.
Reference your sources
posted by Joe PHD on 05 July 2004 at 3:12 am
Everyone loves to talk about studies and findings - but yet I have not seen a single one cited yet. Maybe that is because studies on humans are ridiculously difficult to govern. If I have an agenda, I can easily create a study on humans, "interpret" the data, and prove my case.
Unless you take all of your control mothers and isolate them for nine months, you simply CANNOT get a conclusive study. There are far too many unaccountable variables - diet, genetics, lifestyle, home location, etc.
I have multiple engineering degrees under my belt - so I am quite comfortable talking about the science and physics of ultrasound. By definition, ultrasound is not radiation - and I hate the relationship that the uninformed media has made between the two. Radiation is energy in transit in the form of high speed particles and electromagnetic waves. Ultrasound are sound waves (big difference) that are simply outside the range of human hearing. Since no ionizing radiation (X-rays) are used, it is ideal for looking at pregnant women and their fetuses.
It's been around for a long, long time - and it has helped far too many people than it has ever hurt (or claimed to have hurt).
There are plenty more forms of energy that are outside your control - microwave ovens, cellular phones, wireless networking devices. Please don't lie to me (or yourself) and claim that you are going to radically change the way you live your modern lives for nine months.
I also love the argument regarding "fetal temperature increase". Have you ever stopped to think that a mother eating hot soup has a similar effect? What about cold ice cream - I bet there could be a study out there claiming a negative "fetal freeze effect".
Helaine's (3/30/2004) comments are simply absurd. She probably gets most of her information from primetime television than from a real classroom or laboratory setting. Hey Helaine - if I'm wrong, then list your sources here in this forum. Let's all become better educated in this area. After all, it is an ELECTIVE PROCEDURE.
Get real.
Fetal Doppler for in home use by parents VS. Elective 4D ultrasound performed by trained Diagnostic Medical Sonographer
posted by Nicole on 08 July 2004 at 3:06 am
There is alot of controversy regarding 4D ultrasound. I have a big problem though. Can you help me to explain why a fetal doppler is FDA approved for in home use by parents and a 4d Ultrasound carries such controversy?
According to some research that I have done a fetal doppler (FDA Approved) that is sold for in home use and can be purchased "over the Counter" or even at Babies R Us Typically has a frequency of about 2.5 Mhz. Does that sound right? Okay, and we know that to scan an abdomen we have to use a lower frequency that is typically about 2.5Mhz to get adequate penetration. Why does the FDA state that we use such a high frequency? It really aggravates and frustrates me. How can they approve a piece of ultrasound equipment for in home use that is using the same Frequency and then try to discourage the use of 4d Ultrasound. Is there something that I don't understand?
A fetal doppler is continuous wave.
An ultrasound imaging probe is pulsed.
Right there if they are concerned about the exposure time then those fetal dopplers would definitely run a much higher risk then a 4D machine. Also there are numerous pauses as a technologist will freeze and cine and at that time there is no sound being produced which also limits the exposure to sound, right?
Ok...My next issue is that the FDA stresses about how 4d ultrasound is sometimes ran my individuals who have no medical background or specific training to recognize any abnormalities. What about the parents who are listening to the heart beat from a fetal doppler? They don't know how to recognize a drop in heart rate or to recognize any type of abnormalities or defects. Does it make it more tolerable because they can't see an image? I don't think that is enough to approve one over the other.
It is my understanding that 2.5 Mhz is 2.5 Mhz no matter where the sound source originates. Isn't that correct? And just because that is a hand held machine does it make it any safer. Now 4D machines are much bigger but it has other software that produces the image. As well as other modalities. Also the 4d image is produced by software not a higher frequency or longer exposure time. The information is always there it is the machine that processes this information and produces the image from the imformation that it recieves.
I am not saying that every pregnant women should be able to rent a 4d ultrasound machine like they can these fetal dopplers. I do think that anyone performing any type of ultrasound shoud be qualified and have adequate education and experience to recognize if there may be a problem. That said I don't see what the problem is with an elective 4D ultrasound. Most facilities that have 4D capabilites do offer the same services as a 4D center. Also most Dr's offices and outpatient Diagnostic centers that have standard 2D equipment will be more than happy to provide you with a video tape for a nominal fee. Some places won't even require a doctors consent or prescription. This I don't agree with. But if your client has a physician and has had their scheduled ultrasound and their physician agrees that it is okay to have an elective ultrasound then Why not?
Right now and over the past 30 years there has been no proven biological affects that have been caused by the frequencies commonly used in obstetrical ultrasound. Sure if used in extreme situations and by persons who have no knowledge or specific training it can be a dangerous but the same can be said about a car or any other object.
I was hoping to get some feedback regarding all of your opinons in this matter. I believe that this is a wonderful opportunity for parents, sonographers and physicians alike. This should be something that is embraced not shuned. It is an advance in technology. If the Fetal Doppler is approved for in home use then I hope that one day soon the 4D ultrasound technology will also make its way towards approval for use by trained sonographers with certains guidlines as an elective procedure for moms to be.
Benefits of 3/4D Ultrasound
posted by Valerie Christensen on 09 Aug 2004 at 5:50 pm
There are many good points made here surrounding the territorialism and financial issues which drive this debate and the somewhat arbitrary nature of FDA decisions (I have also been concerned about home Doppler since I know women use them for hours at time). The fuel coming from the choice vs. life argument hasn’t been addressed, but also is a strong factor in the controversy.
I own four responsible commercial ultrasound centers and am the public representative for Fetal Fotos USA, the largest provider of commercial ultrasounds in the US. From a personal standpoint, I researched this topic heavily before joining this industry, as I tend to opt out of any intervention during a healthy pregnancy, labor and delivery. With all the studies I've read, I am convinced of the safety of responsible OB ultrasound and see that many of the scares on ultrasound's impact on tissue are not relevant to the pulsed frequencies FDA approved for OB. Extensive studies are listed on the Dr. Woo's respected website ob-ultrasound.com. (I'd also like to add that with the quantity of ultrasounds done in this country, we would be seeing a full blown epidemic of left-handedness if that connection were valid.)
That said, the one thing not addressed in this string is what the benefits of parent-focused ultrasound are, which I have witnessed first hand for almost 3 years.
> It supports improved prenatal care and public health. Recent research in the UK is showing the connection between parent-focused ultrasound and improved maternal health behavior while pregnant. Although we agree with the statements from the FDA and AIUM in general (and have been reviewed successfully by the FDA for over 10 years), the recent AIUM statement against the "psycho-social" benefits of ultrasound is absurd. Traditional medicine still often fails to recognize that our mental and physical health is related. Commercial ultrasound is a positive tool with “medical benefits” beyond the limited reassurance of a minimal medical study; these benefits extend into improved prenatal care behavior. In the thousands of scans performed by Fetal Fotos over the last decade, we have personally seen women commit to improving diet or giving up smoking and alcohol consumption as a result of parent-focused ultrasound making the pregnancy “real” to expecting parents. Family members (even previously antagonistic, even violent fathers) become more committed to positively supporting the pregnancy. Because providers are aware of this (contrary to many reports which dwell on antagonistic physicians) a large number of doctors and midwives refer their patients to us regularly.
> It avoids higher health care costs. Physicians routinely provide patient-requested ultrasounds for reassurance purposes and are then forced to either not be compensated or bill insurance for this procedure. Limited-study regular (2D) ultrasounds performed by providers cost up to $250 and full diagnostic 3/4D scans cost up to $600. This drives up insurance premiums due to optional ultrasounds, which are now affordably available, out-of-pocket at commercial ultrasound centers for a fraction of this cost. This is another reason busy providers refer our service to their patients.
> It enables access to information. Women can elect this safe technology to see for themselves the heartbeat, behavior, and features of their baby. Clinical ultrasounds seek for pathology and provide diagnostic information to the physician to provide prenatal care; commercial ultrasounds are designed to address the parents’ needs and desire for information. This follows the same precedent of home Doppler kits and pregnancy tests.
> It respects women’s rights. Women choose this service during pregnancy because they feel it will have a positive impact and help their families invest further in the child. The right for a pregnant woman to choose abortion (also an optional, not medically necessary procedure, yet with proven potential complications) is fiercely defended in the nation and authorized by the FDA. It follows, then, that the right for a pregnant woman to choose a non-invasive, out-of-pocket technology to *positively* invest in the pregnancy should be strongly defended.
Lastly, so much of the controversy is misinformed in its core assumptions. “Commercial ultrasound” is NOT synonymous with “entertainment” or “keepsake” ultrasound. Companies who use the ultrasound machine as a picture toy are not representative of what responsible commercial ultrasound makes possible and should not be held up as examples of our industry. As the leader in this industry, our primary goal is not entertainment or scrapbook keepsakes, but to solidify the bonding experience between mother and baby which will, in turn, create greater care for that baby—both prenatally and beyond.
I have a mountain of information and studies on this topic, but my conviction comes from personally seeing the positive impact on the diverse families we serve and knowing that in the tens of thousands of scans performed by Fetal Fotos in the last decade, not a single adverse impact of ultrasound has been shown with our customers. A post-market survey showing this is underway and will be forthcoming. This comment is long, I apologize, but the degree of uninformed and misinformed media out there needs addressing.
Valerie Christensen
pr@fetalfotosusa.com
Fetal Doppler Use Vs Sonography
posted by Bryan Mozeliak on 12 Nov 2004 at 10:01 pm
The following is in reference to Nicole and her lack of an educated commentary on the use and approval of the fetal doppler vs sonography.
First of all a sonograph uses between a 3 and 10mghz probe, not a 2.5mghz probe. Did you know the higher the mghz probe that is used the more heat that is produced? With this you can conclude that if it takes between 20-60 minutes to do a sonograph that the potential of raising the level of heat in the tissue and thus damaging those cells is a very real possibility. Also know that recently the FDA increased the allowable level of ultrasound some 8X. Why? Probably because of pressure from corporations such as GE who manufacture the unit or because each of these new generation sonographs give the sonographer the ability to change the level of ultrasound being used. With the fetal doppler, ultrasound levels are much more strict and most FDA approved fetal dopplers on the market use far less than maximum level determined by the FDA. What you should understand ,Nicole, is that 3D & 4D units do in fact use higher levels of ultrasound enegy to gain, capture and regnerate the information into the imagery you see.
Now for a lesson on fetal dopplers. Most "medical grade" fetal dopplers on the market that have been approved by the FDA use 2 or 3 mghz transducers. Use of anything higher would be used for vascular study. A fetal doppler regenerates an audible fetal heart rate through continouous ultrasound. A typical exam with a fetal doppler lasts less than 10 minutes. I could go on and on but armed with just this basic information one can conclude that the risks of harming the fetus with a fetal doppler compared to a sonograph is incomparable.
The FDA was correct with this one! Do a little more objective reading, Nicole, before you subject us to your logorrhea.
A BIG difference between pulsed and continous wave bioeffect potential
posted by Valerie Christensen on 08 Feb 2005 at 1:46 am
Sorry, Bryan, but it is true the bioeffects between continuous doppler and pulsed ultrasound such as that used in OB are different. Continuous doppler has the highest risk of tissue heating (thermal bioeffects) and the lowest risk of cavitation (mechanical bioeffects). Continuous doppler is a modality which sends an acoustic line in a single direction at a low intensity level continuously. How much energy distributed over time determines how much heating potential there is, which is why home dopplers are of concern because the duration is unmonitored and there is a continuous acoustic signal being absorbed by the same group of cells for the duration of the Doppler exam.
Doppler exams are not recommended the first trimester of pregnancy and NEVER should a fetal Doppler exam be conducted for 10 minutes, as Bryan stated.
Contrary to poorly researched media articles, not thermal, but mechanical bioeffects such as cavitation, are the ones of concern in irresponsible b-mode scanning (b-mode OB). These effects are related to the peak power delivered. The FDA regulations determining what is safe for OB scanning keep systems within safe levels to avoid this. However, OB ultrasound is pulsed, the acoustic signal is off and the system is “listening” the majority of the time (only 9 seconds of any 15 minute 2D ultrasound is spent sending an acoustic signal).
Even with the cavitation potential, which is the more likely in these OB scans than heating, it has never been shown or measured, and is only theoretical. If scan time is kept within the ranges shown safe for the last 40 years and the systems are used at levels dictated by the FDA, tissue heating as well as cavitation will never be an issue.
The recent long-range Australian study also reflects that multiple scans in a pregnancy have shown no negative outcomes. (The study was published in the December 4, 2004 edition of The Lancet and conducted at King Edward Memorial Hospital in Perth, Australia.)
The many studies showing the positive benefit of these scans even beyond diagnosing pathology can be found in the "Public Education" section of our website: http://www.ultrasona.com. Sources are listed.
FDA and ultrasound for pregnancy testing
posted by Vithu Kichodhan on 14 Mar 2005 at 9:39 pm
First, the Ultrasound has been in used for quite a number of years and yet the FDA still does not approve the use in all facets of pregnancy testing - the same way as the delay in approval for the use of detection of breast cancer and prostate gland cancer in place of X-rays.
I both agree and disagree with the opinions posted from March 29, 2005 and up to today regarding the use of ultrasound in pregnancy test and this is my respond and what I have found out from other websites.
From FDA website:
http://www.fda.gov/fdac/features/2004/104_images.html
[Why All the Fuss?
Ultrasonic fetal scanning, from a medical standpoint, generally is considered safe if properly used when information is needed about a pregnancy. Still,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. Although there is no evidence that these physical effects can harm a fetus, the FDA says the fact that these effects exist means that prenatal ultrasounds cannot be considered completely innocuous.
As more advanced ultrasound technologies (usually using higher ultrasound intensities) become available, greater numbers of expectant mothers and their families are requesting fetal keepsake videos and portraits for souvenirs. Sometimes these images may be made by people not well trained, or for longer exposure times and at higher levels than are usually used in medical situations. At the same time, the medical community is discouraging the use of ultrasound unless it is medically necessary.]
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From: The American Institute of Ultrasound in Medicine (AIUM):
http://www.aium.org/provider/statements/_statementSelected.asp?statement=23
3D Technology
Approved October 18, 1999
Currently, two-dimensional (2D) gray-scale real-time sonography is the primary method of medically indicated anatomic imaging with ultrasound. While three-dimensional (3D) sonography may be helpful in diagnosis, it should not be considered more than a developing technology. Its role is restricted to an adjunct of, but not a replacement for, 2D ultrasound. As with any developing technology, its diagnostic value may improve, and its diagnostic role will be periodically re-evaluated.
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The American Institute of Ultrasound in Medicine (AIUM) has addressed the concerns relating to the safety of ultrasound and has issued the following statement as of 1997:
The AIUM statement on the Safety of Clinical Ultrasound released in 1982 and again in 1997:
"No confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound instruments have ever been reported.
Although the possibility exists that such biological effects may be identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present. "
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Ultrasound affects the development of right and left hand fetus:
http://www.ob-ultrasound.net/safeKieler.htm
Department of Obstetrics and Gynecology, Uppsala University, Sweden
(CONCLUSION: This study could not rule out a possible association between non-right handedness among boys and ultrasound exposure in early fetal life)
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Case-control study of prenatal ultrasonography exposure in children with delayed speech
http://www.ob-ultrasound.net/safecamp.htm
Campbell JD; Elford RW; Brant RF, Department of Surgery, University of Calgary, Alta.
(CONCLUSION: An association between prenatal ultrasonography exposure and delayed speech was found. If there is no obvious clinical indication for diagnostic in-utero ultrasonography, physicians might be wise to caution their patients about the vulnerability of the fetus to noxious agents.)
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Finally, to answers specifically the two arguments brought up in the subject of ultrasound application, so what are a handheld Fetal Ultrasonic Personal Doppler and the 3-D sonography?
The following is my input to this subject:
Ultrasonic Dropper is a non-intrusive listening device using ultrasound waves and their echoes to pick-up baby's heartbeat. Dopplers operate on the principle of listening to reflections of small, high frequency sound waves with very low energy generated. Therefore, it transmits sound pulses into the body and converts into a sound when it rebounds on meeting an object, e.g. a fetus. It is treated as a non-medical device and it cannot be compared with the high-power ultrasonic imaging and fetal monitoring or other doppler use by healthcare professionals in clinical settings.
The same way as the old-time magnetic telephones, or electric hairdryers that only generates small amount of electromagnetic or electrical field that would do no harm to the users. On the other hand, the 3-D sonography requires more power than that of the 2-D. The AIUM as stated previously and as shown above that "the 3-D is a new and developing technology and its diagnostic role will be periodically re-evaluated".
Lastly, I would like to quote the paragraph from the FDA website as indicated at the beginning of my message:
Dr. Lawrence D. Platt, M.D. sums it up nicely at the above-mentioned FDA's website as follow:
... (Lawrence D. Platt, M.D., president-elect of the International Society of Ultrasound in Obstetrics and Gynecology and a practicing obstetrician-gynecologist in Los Angeles, adds that while physicians need to be sensitive to expectant mothers' feelings, "We have to go beyond emotions in this case. We have to do the right thing," he says. "Ultrasound is a form of energy and it must be respected.")...
Vithu Kichodhan, BS in EE, 1956 -The Ohio University
TO EACH HIS OWN
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fetal bones and ultrasound
posted by Vithu Kichodhan on 15 Mar 2005 at 5:18 am
The finding and Official Statements on Ultrasonic Fetal Imaging by the European Committee for Medical Ultrasound needs to be brought to discussion regarding the heating of critical structures such as the fetus bones. The following is the Committee statement:
"The embryonic period is known to be particularly sensitive to any external influences. Until further scientific information is available, investigations should be carried out with careful control of output levels and exposure times.
With increasing mineralization of the fetal bone as the fetus develops the possibility of heating fetal bone increases. The user should prudently limit exposure of critical structures such as the fetal skull or spine during Doppler studies (a type of ultrasound that detects movement, direction and speed, such as fetal heartbeat)."
(Ref. FDA: http://www.fda.gov/fdac/features/2004/104_images.html)
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Title: The effects of prenatal ultrasound exposure on postnatal growth and acquisition of reflexes.
Author: Jensh RP; Lewin PA; Poczobutt MT; Goldberg BB; Oler J; Brent RL
Address: Department of Anatomy, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania 19107.
Source: Radiat Res, 1994 Nov, 140:2, 284-93
(Ref. http://www.ob-ultrasound.net/safejens.htm)
Abstract and brief overview:
......Twelve other rats were exposed to 1500 W/cm2, ISPTP (ISPPA, 350 W/cm2; ISPTA, 58 mW/cm2; Im, 600 W/cm2). Twelve additional rats were sham-exposed. Since the focal area was about 0.5 cm2, computer-controlled stepper motors moved the rats through the ultrasound field to assure uniform exposure of the abdominal/pelvic region. Total exposure time was 35 min.
Additionally, a miniature thermocouple was implanted in a few (pregnant) rats to verify that no significant increase in body temperature took place during exposure.
All neonates were subjected to five reflex tests and observed for four physiological parameters. Postnatal growth also was monitored. Analyses of the data indicate there were no significant alterations in neonatal development or postnatal growth due to exposure to 5.0 MHz ultrasound below an intensity (ISPTP) of 1500 W/cm2.
Studies continue to be completed at higher exposure levels to determine the margin of safety, and the animals will continue to be monitored and evaluated through young adulthood to determine if there are long-term behavioral effects due to fetal exposure to ultrasound.
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From the two references indicated above, we know that: ".... with increasing mineralization of the fetal bone as the fetus develops, the possibility of heating fetal bone increases (by the use of ultrasound)." On the other hand, "no significant increase in temperature body (of the rats') took place during exposure." That is when the rats were subjected to 5.0 MHz ultrasound and below an intensity (ISPTP) of 1500 W/cm2" -- and 1500W/cm2 may seem to be a typo mistake.
Since we cannot subject fetus to any test of this kind and not under any circumstances, we will never know within a short time frame how the exposure time or the power-output levels and frequency of ultrasound will affect the fetus on long-term basis. It is understandable why the FDA is still not officially approve extensive use of ultrasound on pregnancy and not until further scientific information is available.
tissue heating
posted by dwan on 03 May 2005 at 1:27 am
Well I am still a little confused..Someone said that the amount of tissue heating as a result of a 2D or 3D ultrasound is the same as mom being in the sun for 30 min...But on one of the posts I thought I understood that thermal heating doesn't take place only cavitation . Is this correct...If so then what about the statement jarring vibrations.The only thing vibrating is the crystal in the transducer if it is a 3d one right...
WOW
posted by Virginia on 30 Jun 2006 at 12:05 pm
Look at all the women smoking, drinking and drugging while they are pregnant. I see that as a danger. While looking online, I could find NO credible information saying ultrasounds are dangerous. Actually I heard the opposite. They are safe.
Follow Up
posted by Shari Hahn BBB on 22 Nov 2006 at 6:59 am
A great article which cites studies and research at the end of the article:
http://www.mothering.com/articles/pregnancy_birth/birth_preparation/ultrasound-risks.html
Confused
posted by Amy A. on 17 Jan 2007 at 4:38 pm
While pregnant, I told my OBGYN that I wanted to know the sex of my child. I had already had one ultrasound earlier in the pregnancy. She told me that she would come up with a medical reason to have a second scan done. I went through the second scan to find I was having a boy. For no other reason was the scan done. Why was this safe to do because the doctor prescrided it and not have been safe if one of the 3D/4D centers would have preformed the scan?
I Am Tired Of Some People's Ignorance
posted by Sue on 28 Jan 2007 at 8:47 pm
I am a Registered sono tech with 12 yrs of experience in OBGYN. I am tired if how some people confuse diagnostic ultrasound with therapeutic ultrasound. The therapeutic one creates bubbles and thermoeffect, etc. (lithotripsy of renal stones, physical therapy equipment, etc). The diagnostic ultrasound is thousand folds weaker, and from my experience, there is no side effect for the fetus.
The people who are really greatly affected from the ultrasound use are the sonographers, because 20% of us are completely useless after 10 yrs from the stress repetition injuries imposed on our muscles and bones. Those fears of ultrasound effects really put a toll on people who work so hard, including those who own 4d ultrasound studios.
Not Worth The Risk
posted by inform_yourselves on 26 Feb 2007 at 3:54 pm
Jane, as the owner of an elective 4D ultrasound studio, can you please tell me which university is responsible for teaching you those impeccable grammar skills? Are you a certified RDMS sonographer as well? I am sorry but I find it hard to take advice from a self proclaimed professional that uses sentences like, "We do own a GE Voluson 730 machine and was told there is absolutely no danger."
I'm not sure what you 'was told,' but can you please tell me, exactly how much output your GE Voluson 730 machine emits (milliwatts, milligauss, etc.) What type of mechanical and thermal index thresholds does it sustain?
I am not willing to risk my baby's health and have you heat his brain 8 degrees every minute (for up to an hour!?!!) because you were told it is ok.
I can't believe you have the audacity to claim that the medical community is not making profits from the ultrasounds and is attempting to shut businesses like yours down. What a careless response!! I'm not a medical professional, just an informed consumer, but it seems I have more knowledge on the subject matter than yourself. As far as your claim that women have a greater risk of choking or getting in a car wreck, well that is yet another careless remark that cannot be validated. Just because a baby that went through your facility wasn't born with mental retardation, autism, bone cancer, pituitary gland issue doesn't mean that they cannot develop these conditions later. It almost seems like you haven't done your research or even read the FDA's or ECMUS's reports.
As well, your quote about mammograms doesn't apply here. With breast cancer, there is an obvious benefit: that the cancer can be identified and removed. What is the benefit in your facility, having a couple of pretty pictures or movies at the risk of developing brain damage or worse? Is this what God would want, that we would amuse ourselves at the mercy our children? "Answer me that one!"
I don't get the impression that you are doing this to harm the many unborn children that you see. I do ask, however, that you cease this careless business until more research is done, better training and education is attained and safeguards are in place. Otherwise, I hope your business goes bankrupt and you find wealth in another occupation that does not risk the life and well-being of other living creatures.
Pardon My Ignorance But
posted by inform_yourselves on 26 Feb 2007 at 4:22 pm
These reports make no distinction about the types of ultrasound. The findings show that prenatal ultrasound on the brain of a pig fetus heats up 4.5 degrees C (8 degrees) in only 2 minutes!!! Do you as a sonographer not EVEN LOOK AT the thermal and mechanical indexes while scanning??
Here is only one of MANY well-cited, easy-to-find articles on the subject. http://www.askquestions.org/articles/ultrasound/
They are currently doing more research on monkeys, because it is NOT safe enough to perform these TESTs on human babies. I'd say your (Sue) claim that it is safe is rather premature, wouldn't you? I'm sorry that you're so tired, must be hard work endangering all of those lives.
To all of the misinformed sonographers:
Inform yourselves, deal with your guilt, find forgiveness and find a fulfilling occupation....
Quick Response
posted by Amy on 05 Mar 2007 at 7:51 pm
In response to inform_yourselves post... Just recently, our local OBGYN office has started offering the service of 3D/4D ultrasound packages to their patients. I believe they have 20 doctors on staff that all support and are now selling these prenatal keepsakes packages. What would your response be to an actual OBGYN office selling these services? I am a confused, if doctors are selling the service, is it safe even though they are not using it for a medical purpose?
Quick Response
posted by inform_yourselves on 09 Mar 2007 at 10:34 pm
Amy,
My intent is not to demean anyone's profession or professional ability. I would like to clarify however that there is a major distinction between the OBGYN profession and sonography. Technology advances at least as fast as medical science does, which requires the practitioners to be proficiently adapted to both areas. These machines have their own proprieties and idiosyncrasies as well. It has been my experience that these experts cannot answer me when I simply ask, "What safety precautions are in place and how do you use them?"
It is imperative that we heed the warnings of the medical community on this matter and protect human lives. I would love for someone to prove me wrong, in the meantime however, I would rather err on the side of safety for mine as well as other babies (any of which could do something great like cure cancer if they aren’t inflicted with some type of brain damage or learning disability). I am sure that your local OB/GYN clinic does not have any ill intent, but to assume that it is safe only because it is performed by doctors is unsound. Some of these well trusted doctors inflict liver damage and often much worse to their patients by excessively prescribing medicine. The fact of the matter is that doctors are not radiologists and radiologists are not doctors. The main difference between the 2D, 3D, & 4D ultrasounds is the amount of time (every second matters) that the fetus is exposed to the radiation. If you feel that you disagree with my views, then do your own research. (I am glad that the FDA, ECMUS, and others have provided the research for us). Just please don't settle for the doctor(s)' words themselves and subject yourself to a tragedy of the commons.
http://www.askquestions.org/articles/ultrasound/ultrasound.pdf
http://www.fda.gov/fdac/features/2004/104_images.html
http://www.devicelink.com/mddi/archive/02/07/010.html
http://www.nature.com/news/2004/041025/pf/4311026a_pf.html
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