Posts Tagged FDA

Ob/gyn Hypocrisy Regarding 3D Ultrasounds-Part 2

In part 2 of my slowly advancing series, I will explore the often repeated argument that the ultrasound machine is a medical device and should not be used for non-medical purposes.  This is the stated position of the FDA and is what many ob/gyn doctors repeat to their patients.

So what falls under a non-medical purpose?

1. Seeing your baby

2. Determining if your baby is a boy or a girl

Yet a few hospitals in the Chicago area have 3D ultrasound machines in their ob/gyn clinics, and after the patient is done with her appointment, the doctor will quickly switch over to 3D mode and show the baby to the mother.  (This quick add-on period is added onto the medical ultrasound session which normally lasts 30 minutes.  In other words, the ultrasound session now exceeds the 30-minute threshold touted by the ob/gyn community.)

Also, it must be pointed out that ob/gyn doctors routinely check the gender of the baby at the 20-week ultrasound.  If the gender can not be determined at this time, the insurance company usually does not pay for an additional ultrasound.  The pregnant woman can sometimes plead for the ob/gyn to check the gender at another visit, ”off the record,” as my wife did when she was pregnant, or she can wait another 20 weeks not knowing whether her baby is a boy or a girl.

Ob/gyn physicians who happen to have the privilege of having a 3D ultrasound machine in their hospital often go against the rules and perform 3D ultrasounds off the books, as they have done in the past by checking the gender on extra ultrasound visits.

If 3D ultrasounds used for non-medical purposes were truly harmful and if there was truly a consensus among ob/gyn physicians that these elective ultrasounds are harmful, there would not be this growing trend of ob/gyn clinics and hospitals, including Northwestern Memorial Hospital in Chicago, to offer free 3D ultrasounds during routine screening visits of  their pregnant patients.  In fact, many of these ob/gyn clinics are starting to offer these 3D ultrasounds as a “free” service in order to attract more patients, sometimes also offering CD’s and DVD’s of the session.  By offering it for free, it appears that they are providing a service with no economic benefit out of the goodness of their heart, yet the economic benefit for these clinics from the increased number of patients is very real.

In other words, the argument currently held by most ob/gyn physicians is that elective non-medical 3D ultrasounds are harmful to pregnant women and their babies and is an affront to the medical profession and an embarrassment to the profession of ultrasound technicians, unless it is provided off the record by ob/gyn physicians in ob/gyn clinics or hospitals for their own economic benefit.  It’s fine if we do it, but no one else should do it.

This hypocrisy can only be explained by my overall premise that the current bias against 3D ultrasounds among ob/gyn physicians has nothing to do with the concern for pregnant women or their babies but has to do with money, which is a rerun of the routine elective circumcisions performed by ob/gyn’s without informed consent in the 1970’s while rabbis were prohibited from performing circumcisions without a medical license (remember that?).

(Of course, there are many other ob/gyn physicians and ultrasound technicians who are genuinely concerned for the welfare of their patients and have only had the misfortune of having been taught this bias in school and in residency training and so they have carried this bias as well.  But the source of the bias is still originally based on economics.)

Please note that this is a risky subject to deal with head on, as there is a genuine risk of sounding angry and at odds with the medical community.  As a pediatrician myself, I definitely do not want to alienate other physicians or sound like I know better than ob/gyn physicians when it comes to dealing with pregnant patients.  I simply want to point out this one isolated instance of a medical bias based on non-medical reasons.  Please note that at First Peek Ultrasound, we have a very good working relationship with the physicians and midwives of our customers, and more and more physicians are actually actively referring their customers to us.   In this series, I am only speaking about some ob/gyn physicians.

When we first started First Peek Ultrasound, the majority of ob/gyn physicians were deeply against 3D ultrasounds.  Also, it was very difficult to find good ultrasound technicians due to the fact that these technicians are taught in school that 3D ultrasounds are definitely harmful to babies (which is untrue) and other related falsehoods.  Now, we are seeing that the percentage of ob/gyn physicians  in the Chicago area who are against 3D ultrasounds have dropped (roughly to about 50%), and this is in part due to many of their patients coming to see us and other 3D ultrasound centers and reporting their experiences back to their physicians.

For our physicians who want to learn more about what we do, please visit our dedicated 3D ultrasound page for Chicago-area physicians and midwives.

Do you have any comments? We especially want to hear from ob/gyn physicians, the ones who agree and disagree with what I have posted here.

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Is 3D ultrasound safe?

Every once in a while, we get a question as to whether 3D ultrasounds are safe. As a board-certified pediatrician, I have a bias towards making sure things are safe for the baby, and I researched the safety of 3D ultrasounds extensively before deciding to see my own baby in 3D when my wife was pregnant. As a father, being able to see my baby through this window moved me so much, that I felt like I had to bring this experience to others.

Just to set the record straight, 3D ultrasound uses the same ultrasound waves used in your doctor’s office, with the same intensity, and for the same length of time. In 35 years of widespread almost universal use of ultrasounds, there has not been a single known case of a miscarriage or abnormality attributed to the use of ultrasounds. Its safety profile has been proven over the decades.

This being said, I do want to deal with a few arguments here. Also, I am so sure about the safety of what we do that I will open it up for discussion here on this blog. If you have any research or factual evidence on 3D ultrasounds being unsafe, then please bring it here. If you prove to me that 3D ultrasounds are unsafe for either the mother or the child, I will be the first to close down this studio and be on the forefront of shutting down all the others as well.

The arguments that are not valid are as follows:
“We just don’t know about the safety, and it is not necessary, so we should avoid it.”
That argument can be used for cell phones, microwaves, and a thousand other things and dismisses the very real benefits that pregnant women get when viewing their baby while pregnant. Also, it is impossible to prove something is 100% without any harm. We can only prove if there is a harm. The best we can hope for is a long track record of use without any known harms, which already exists for ultrasounds.

“It is not medically indicated.”
Who said this is a medical procedure? Seeing your baby for the first time while you are pregnant is an emotional, social, and cultural phenomenon that is spreading and soon taking over. Baby showers and bar mitzvahs are also not “medically indicated.” Also, just to point out the hypocrisy of those bringing forth these arguments, there are ob/gyn physicians who strongly advise against 3D ultrasounds because they are not medically indicated and yet perform elective circumcisions on a routine basis (also not medically indicated), perform elective C-sections for social reasons or to fit their own schedules (also not medically indicated), and even will allow their own patients to come back for an extra 2D ultrasound, off the books, to see if it’s a boy or a girl. It makes me wonder if the real issue they have with 3D ultrasounds is that they are not making any money off of it themselves and begrudge those who do. Meanwhile, there are plenty of ob/gyn physicians who have set up their own 3D ultrasound clinics across the U.S. after they have retired from their regular role as a physician.

“This is not what this medical device was intended for.”
It is a curious state of affairs when GE’s official policy is that the 3D ultrasound machine is not intended for non-medical or entertainment purposes and yet on their website and on all of their brochures, a picture of a pregnant woman seeing her baby in 3D is prominently displayed (and she is not wearing a medical gown). What irks me more is that major advances in 3D ultrasound technology and 3D ultrasound techniques have grown out of the increased use of this machine by ob/gyn’s and ultrasound technicians, spurred by the demand of these elective ultrasounds. You can’t have it both ways, GE. You can’t have your biggest clientele be 3D ultrasound studios and yet declare publicly that you have no idea that these machines are being used in this way.

But assuming that the above statement is true, that 3D ultrasound machines are not being used “as intended,” this still is not a valid argument, as most medical instruments have been used in more ways than as intended. For example, the stethoscope is intended to be used by a physician or nurse to hear heart sounds. However, as a pediatrician, I have used my trusted stethoscope to hear arterial blood flow in a baby’s head to diagnose an AV fistula. No one chided me for using the stethoscope as something other than what was intended. I have knocked it against a child’s knees to test for reflexes; I have used it as a toy pendulum to distract an infant as I examined his ears; I have held it outside my car window, using it as a signal, as I rested on my horn, and sped through red lights reaching the hospital just in time to resusscitate a blue baby just born who wasn’t breathing. I have worn my stethoscope around my neck as part of my uniform and clothing so as to indicate to others who was running the code. I have used that same stethoscope to hold my seat at the hospital cafeteria. I have used it as collateral when I needed money to eat and my paycheck wasn’t going to arrive until the next week. I have tried to use it to hypnotize someone, swaying it back and forth in front of my 2-year-old son, trying desperately to get him to sleep, but it didn’t work. I have even once used my stethoscope as a short-range weapon when stationed in Iraq (don’t even ask me about that one!), and I now have it hanging in my closet as I currently use it as a reminder of my crazy past. Ultrasounds were never meant for medical use to begin with–they were initially used to find cracks in dams. It was a doctor who decided to use it to detect abscesses and other things within the body which led to how it is used today. At that time, you could have told the doctor that it is not being used as intended, but I am glad no one did.

The FDA advises against it.
The FDA knows that there is no evidence linking any harm to the use of 3D ultrasound, as stated on their website, and so they are not legally allowed to ban 3D ultrasounds. They can say that this is a medical device used for non-medical purposes. But I can also easily say that this is a non-medical device sometimes used for medical purposes.

It’s not natural.
Yes, using a 3D ultrasound machine to see your baby has not been done in the more natural state of things during the caveman days. However, it is very natural for a woman to want to see her baby, bond with her baby, and these feelings begin while you are still pregnant. It is also very natural for a father to want to experience this joy as well. From the beginning of time, cavemen dads have been putting their ears up against the cavemen mom’s belly, using regular sound, not ultrasound, to hear their baby’s heart beating. The 3D ultrasound is just a natural extension of these deep desires.

Also, just as it is not natural to drive or fly by airplane, we do many things that are in retrospect very natural when you consider the other animals that can run as fast as a car or fly as high as an airplane. Likewise, there are many animals that employ ultrasounds to communicate and navigate through their world, including elephants, dolphins, and bats. When the tsunami hit Indonesia, it was natural ultrasound signals created by the tsunami that warned the elephants to flee from the shoreline moments before the tsunami struck. It was the humans who followed the elephants that benefited from these natural ultrasounds.

Do you have an argument against 3D ultrasounds? Do you have research or evidence showing that it is unsafe? Please write it here in the comments.

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