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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opinions'Entertainment ultrasounds of babies in the womb warning by FDA'
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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.
Visit our public health section for the latest news on this subject.
MLA
26 May. 2012. <http://www.medicalnewstoday.com/releases/6863.php>
APA
http://www.medicalnewstoday.com/releases/6863.php.
Please note: If no author information is provided, the source is cited instead.
Visitor Opinions (latest shown first)
Total 35 opinions, latest 20 shown. For all opinions, click through to the full thread.Should Ultrasounds Be The Biggest Area For Concern
posted by Jay on 11 Feb 2012 at 9:23 amIt is interesting that there is a debate about $d ultrasounds but as soon as the baby is born you will allow an hepatitis vaccination to a child that is 10 minutes old. What research do expecting mother do about vaccinations? being on piton during labor and constant scanning in the Labor and delivery. I find it truly amazing that people would waste their time on trivial issues when there are bigger ones to be dealt with. I am not for or against ultrasound but the people who are posting about its dangers will vaccinate their children and feed them harmful foods throughout their childhoods. Interesting where priorities lie.
You Don't Get To Define Radiation
posted by a guy on 17 Aug 2011 at 8:43 amJoe Schmoe you're just plain wrong about radiation. You can't make up your own definitions based on "general understanding"... especially if the "general understanding" you quote is wrong. You included 1% handwaving along with the other 99% truth you posted, and you almost got away with it. Sound is a mechanical wave whereas the others you mentioned are energy waves. Radiation is energy waves and energy waves only. Not sound waves... not ocean waves... not hand waves. I don't have a vested interest in this conversation, but I'd like to know the truth in case I ever do have a vest interest. I think that you trying to redefine the terms used in the conversation to fit your own purposes is (while a common technique used in debate) adds confusion to an already heated discussion.
A Clear Lack Of Knowledge
posted by EMW on 15 Sep 2010 at 7:09 amUltrasound is now accepted as being of considerable diagnostic value. There is no evidence that diagnostic ultrasound has produced any harm to patients in the four decades that it has been in use. However, the acoustic output of modern equipment is generally much greater than that of the early equipment and, in view of the continuing progress in equipment design and applications, outputs may be expected to continue to be subject to change. Also, investigations into the possibility of subtle or transient effects are still at an early stage. Consequently diagnostic ultrasound can only be considered safe if used prudently.
Thermal hazard exists with some diagnostic ultrasound equipment, if used imprudently. A temperature elevation of less than 1·5°C is considered to present no hazard to human or animal tissue, including a human embryo or fetus, even if maintained indefinitely. Temperature elevations in excess of this may cause harm, depending on the time for which they are maintained. A temperature elevation of 4°C, maintained for 5 minutes or more, is considered to be potentially hazardous to a fetus or embryo. Some diagnostic ultrasound equipment, operating in spectral pulsed Doppler mode, can produce temperature rises in excess of 4°C in bone, with an associated risk of high temperatures being produced in adjacent soft tissues by conduction. With some machines colour Doppler imaging modes may also produce high temperature rises, particularly if a deep focus or a narrow colour box is selected. In other modes, temperature elevations in excess of 1°C are possible, but are unlikely to reach 1·5°C with equipment currently in clinical use, except where significant self-heating of the transducer occurs.
Non-thermal damage has been demonstrated in animal tissues containing gas pockets, such as lung and intestine, using diagnostic levels of ultrasound (mechanical index values of 0.3 or more). In view of this, it is recommended that care should be taken to avoid unnecessary exposure of neonatal lung , and to maintain MI as low as possible when this is not possible. In other tissues there is no evidence that diagnostic ultrasound produces non-thermal damage, in the absence of gas-filled contrast agents. However, in view of the difficulty of demonstrating small, localised, regions of damage in vivo, the possibility of this cannot be excluded. The Mechanical Index, if displayed, acts as a guide to the operator. The use of contrast agents in the form of stabilised gas bubbles increases the probability of cavitation. Single beam modes (A-mode, M-mode and spectral pulsed Doppler) have a greater potential for non-thermal hazard than scanned modes (B-mode, Colour Doppler), although the use of a narrow write-zoom box increases this potential for scanning modes.
Developments in real-time three dimensional ultrasonic imaging have led to parents asking for souvenir (keepsake) video recordings of the fetus, sometimes at several stages during the pregnancy. An area of concern is the growth of services designed to provide such images and recordings without any diagnostic element to the scan. Often, such services are unable to provide counselling or offer guidance if signs of a fetal abnormality are unexpectedly revealed. Apart from such services, there many instances of diagnostic scans being prolonged in order to provide such recordings.
Very little information is currently available regarding possible subtle biological effects of diagnostic levels of ultrasound on the developing human embryo or fetus, and the possibility of developmental effects in the brain cannot be ruled out. There is evidence that diagnostic levels of ultrasound can influence development of the brain in small animals, although it is not possible to extrapolate this finding to the human situation. A balance must always be maintained between diagnostic benefit and risk to the patient. Therefore, it is difficult to justify souvenir or keepsake scanning that has no diagnostic benefit.
Recommendations are as follows:
Ultrasound scans should not be performed solely for producing souvenir images or recordings of a fetus or embryo.
The production of souvenir images or recordings for the parents to keep is reasonable if they are produced during a diagnostic scan, provided that this does not require the ultrasound exposure to be greater in time or magnitude (as indicated by the displayed MI and TI) than that necessary to produce the required diagnostic information.
Attention is drawn to the recommendation of the EFSUMB Clinical Safety Statement for Diagnostic Ultrasound that ultrasound examinations should be performed only by competent personnel who are trained and updated in ultrasound safety matters (which rather concerningly, does not appear to be the case given some of the comments above!).
Resposible....really. Ultrasound vs. x-rays
posted by Donna on 7 Oct 2009 at 6:18 pmMy credentials are RTR,RDMS,RVS and knowing that ultrasound waves can disrupt cells.....well? Surely, you were kidding when you asked why do women have to have mammograms which subject them to x-rays which can be harmful rather than an ultrasound of the breast.
There is no x-rays involved, it's much more detailed and has much better diagnostic value than a regular mammogram and NO PAIN". Ultrasound is not more detailed than mammography. Ultrasound is a compliment to a mammo and ultrasound could never image small calcifications and other specifics seen on mammography. How much do you know about ultrasound?
Government
posted by Dee on 14 Jan 2009 at 8:33 pmOk here's my issue. You all are convinced that this is harmful but as we've all read on here there is no "proof". You listen to what the FDA (or the government) has to say when it comes to this issue. So let me ask this, do you believe everything the government tells you? If so you are in for a treat because the same government (FDA) that "thinks" it's unsafe out of hospital setting is the same government that told you Iraq had WMD, HA! Anyway there ya go!
I Informed Myself
posted by Joe Schmoe on 9 Feb 2008 at 1:34 pmAlthough I don't espouse all the views of inform_yourselves, I found the information provided by the poster very elucidating. Thank you!
To answer some of the questions posed by other posters (hopefully my grammar is acceptable enough to prevent further ad hominem attacks):
Radiation is generally understood as any energy emitted, transmitted, or absorbed in the form of waves or particles. Thus radiation includes electromagnetic radiation, such as visible light, x-rays, radio waves, etc., as well as sound, a pressure wave.
The extent of the biological effects of radiation is related to the amounts of exposure per unit volume of tissue, localized and systemic. Using a magnifying glass with sunlight (electromagnetic radiation) illustrates this example very well. If one exposes one's skin to direct sunlight, a relatively long period is required to develop perceptible biological effect, i.e. warming of the tissue, sunburn, skin cancer, etc. On the other hand, if one exposes one's skin to sunlight focused into a narrow beam through a magnifying glass the biological effect will be much more immediate, i.e. dramatic rise in tissue temperature, severe burns, etc. In both instances the average amounts of sunlight absorbed by the body are almost identical. However, because the distribution of the energy differs, the damage done to tissue under the focused beam will be greater. The same analogy also holds true when comparing sunny days to cloudy days (high levels of incident radiation vs. low levels of incident radiation).
Moreover, the type of biological effect differs with the frequency of the radiation. Moving the above analogy further, visible light and infrared (IR) will likely only cause superficial warming or burning, depending on intensity and duration, whereas ultraviolet (UV) and higher frequency electromagnetic radiation (x-ray and gamma) will cause more penetrating damage and affect cells on the chromosomal level sometimes leading to cancer. (I neglected a discussion on so called "radio waves", t.i. microwaves and lower frequency waves which are actually lower in frequency than visible light, for the sake of simplicity. Also, forgive me for concentrating on electromagnetic radiation and not mentioning sound, but I feel that people are more attuned to the effects of various form of light and not so much on the effects of sound, as demonstrated by the discussion in this forum.) Suffice it to say that the actual biological effects depend on the particular absorption spectum of the given tissue and its resonant frequencies.
As far as sound (including ultrasound) is concerned, in addition to the heating effect due to friction inside the tissue due to motion, there is also the phenomenon of cavitation. Cavitation is the formation of gas bubbles due to vacuum created by a low presure phase of a pressure wave. Think of it as an implosion wave. When the microscopic gas bubbles eventually collapse then can generate intense amounts of heat (analogous to a highly focussed light beam), a shockwave, and a flash of light. The best analogy to cavitation that comes to mind is a rechargeable battery. Once the battery is charged, connecting a wire to the opposite poles will generate a spark, which is heat, a flash of light, and a shockwave (heard as a crack).
Now, because there is such a variety of sonographic and sonar equipment in use, it is hard to ascertain how much heating and cavitation is caused in every microscopic part of human tissues, not to mention fetal tissues in particular. What compounds the difficulty is that human tissues and bodies are very complex audio systems within which sonic waves are somewhat unpredictably refracted and reflected. All of the measurements of biological ultrasound effects I have seen are macroscopic and disturb the acoustic system being measured. However, from the non-righthandedness (the increased use of the left hand, not to be confused with the predominance of left hand over the right hand) study it appears that ultrasonography may have significant developmental effects. It is for the parents/patients to determine whether the benefits of using ultrasound diagnostic devices outweights the potential risks. As for me, conservative use of ultrasound diagnostics (similar to those covered by the non-righthandedness study) is desireable based on the risks involved, even though no data on current , higher power, ultrasound technologies is available. However, I am skeptical on the value of 3D/4D for "documentary and bonding" purposes given the potential risks, and thus will opt not to have those performed on my children unless medically warranted.
P.S. 3D and 4D ultrasounds now offered by physicians are no guarantee of their safety. There are plenty of money hungry, uninformed, ignorant, or simply stupid physicians in practice, no matter how well meaning they may be. The number of malpractice suits, though hardly conclusive, is some indication of this.
The increased use of 3D/4D techniques in high risk or complicated pregnancies also does not indicate their safety. All it shows is that in those instances the benefits outweight the risks for some. To analogize, we use gamma radiation and chemo to treat cancer though they take and incredible toll on the body and often lead to death themselves.
Are They Safe?
posted by Beth Phillips on 8 Aug 2007 at 12:59 pmMy husband and I were planning on having one done, then last night we were with some friends and one said that she had heard from a friend some of the problems you mentioned. I have tried to find more info supporting that and can't. Do you have any more information about the dangers?
Inform Yourselves Response
posted by Amy on 11 Apr 2007 at 6:22 pmI take no offense to your opposition. I am however confused by your use of the term "radiation". From the research that I have done, ultrasound uses select levels of sound waves to generate the picture. correct me if I am wrong but I didn't come across anything that implies that it has any radiation involved. How can you use that term and claim to know what you are talking about? Maybe your research was more extensive than mine. If you could provide me with research on the "radiation levels" that an ultrasound machines uses, I would love to see it.
This Isn't An Insult Contest...or Is It?
posted by Julie on 30 Mar 2007 at 1:11 amMessage for Inform_yourselves: This forum is meant for people to discuss and politely debate the issue of safety regarding 3D/4D ultrasound machines. The purpose is not to insult posters' "perceived" education level through their grammar and then use that ridiculous information to help one conclude that a poster is clueless.
If you are going to pick on a poster's ability to write well, then you might want to check your incorrect use and lack of hypens. As an educator, it is well-known in my community that a person's ability to spell or write with perfect grammar does not reflect stupidity, but rather a processing or visual recognition weakness. If this topic is supposed to be about ultrasound safety, then let's please allow great minds to come together to collectively offer many viewpoints so that we ALL may become more educated.
Believe it or not, nobody wants to listen to a "know it all" but they simply want to hear and expect to hear various viewpoints when coming to a forum of posts. Please lay off of the insults and don't assume that others will listen to your rhetoric any more than we will listen to another's; obviously, we don't know your "true" education background either.
Good luck to all those expectant mothers trying to find some good advice and studies. God knows that I am trying to sift through the garbage that can find its way to forums like this.
Quick Response
posted by inform_yourselves on 9 Mar 2007 at 10:34 pmAmy,
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
Quick Response
posted by Amy on 5 Mar 2007 at 7:51 pmIn 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?
Pardon My Ignorance But
posted by inform_yourselves on 26 Feb 2007 at 4:22 pmThese 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....
Not Worth The Risk
posted by inform_yourselves on 26 Feb 2007 at 3:54 pmJane, 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.
I Am Tired Of Some People's Ignorance
posted by Sue on 28 Jan 2007 at 8:47 pmI 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.
Confused
posted by Amy A. on 17 Jan 2007 at 4:38 pmWhile 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?
Follow Up
posted by Shari Hahn BBB on 22 Nov 2006 at 6:59 amA 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
WOW
posted by Virginia on 30 Jun 2006 at 12:05 pmLook 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.
tissue heating
posted by dwan on 3 May 2005 at 1:27 amWell 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...
fetal bones and ultrasound
posted by Vithu Kichodhan on 15 Mar 2005 at 5:18 amThe 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.
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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Bexhill-on-Sea, United Kingdom
MediLexicon International Ltd © 2004-2012 All rights reserved.
MNT (logo) is the registered EU trade mark of MediLexicon Int. Limited.
