Cruise Slammed for Sonogram Machine Purchase
Tom Cruise has been slammed for buying a sonogram machine for his pregnant
fiancee Katie Holmes, with health experts warning that he's putting his
unborn child at risk. Officials at the American College of Radiology (ACR)
are highly concerned by Cruise's revelation that he purchased the device to
track his child's progress, and they're warning him that he could be
breaking the law if he's carrying out the scans himself. Dr. Carol M.
Rumack, of the ACR Ultrasound Commission, says, "This is a patient safety
issue. Untrained people, even if they have the financial means, should not
buy, or be allowed to buy and operate, ultrasound machines which are, in
fact, medical devices and should not be used without a medical indication.
Images of the fetus are an opportunity to diagnose problems before birth
that may require treatment. These images should be obtained by certified
technologists under the supervision of physicians properly trained in
ultrasound... The ACR is concerned that Tom Cruise has been badly advised
regarding the use and potential abuse of ultrasound. There are many
abnormalities that may be missed by the untrained eye. Also, if it is not
medically necessary, the use of ultrasound raises unnecessary physical risk
to the fetus."
I'm sure TC can afford to pay a team of Harvard-trained MDs to come to
his house every day of the week to operate that machine. Everyone
knows that those machines are as complicated as the control panel of a
jet; you need someone that knows how to use it and knows what they're
looking at. Anyone who thinks TC is using it by himself is a total
dumbass.
Crispee
I think the more important point, which you missed, is the last line.
"Also, if it is not
medically necessary, the use of ultrasound raises unnecessary physical
risk
to the fetus." Doctors have been saying for years that women should
get as few sonograms as possible, yet Tommy thinks hes hould be
checking up on "his baby" on what, a daily or weekly basis?
It probably has something to do with the "Fetal Foto" craze (as if
someone would really WANT an image of a bit of protoplasm before
it's born)?
The first line of this story cracks me up. "Risky business"...and
it was written pre-Comatose-Katie.
http://www.quackwatch.org/04ConsumerEducation/keepsake.hml.html
FDA Cautions against Ultrasound 'Keepsake' Images
Carol Rados
It's risky business taking pictures of unborn babies when there's no medical
need to do so. That's the word from the Food and Drug Administration, which
is concerned about companies trying to turn an important medical procedure
into a prenatal portrait tool.
Facilities with captivating names such as Fetal Fotos, Peek-a-Boo, Womb with
a View, and Baby Insight are popping up in strip malls and shopping centers
all over the country. And they're promoting "keepsake videos" that use the
latest ultrasound technology to produce high-resolution three-dimensional
and four-dimensional (moving) images showing the surface anatomy of babies
developing in the womb. The lure of this burgeoning industry is that
parents-to-be get to see characteristics like facial features, hair, and
even the baby's sex, and often they can count fingers and toes before their
baby is born. Some women even have videos made at various stages of their
baby's growth. And the videos are often being marketed as a prized addition
to collections of childhood memorabilia.
As compelling as these sneak previews may be, the FDA is warning women about
the potential hazards of getting keepsake videos. The agency also is warning
companies against creating them for entertainment purposes. While ultrasound
has been around for many years, expectant women and their families need to
know that the long-term effects of repeated ultrasound exposures on the
fetus are not fully known. In light of all that remains unknown, having a
prenatal ultrasound for non-medical reasons is not a good idea.
What is Ultrasound?
Ultrasound imaging is a common diagnostic medical procedure that uses
high-frequency sound waves to produce dynamic images (sonograms) of organs,
tissues, or blood flow inside the body. Prenatal ultrasound examinations are
performed by trained professionals, such as sonographers, radiologists, and
obstetricians. The procedure involves using a transducer, which sends a
stream of high-frequency sound waves into the body and detects their echoes
as they bounce off internal structures. The sound waves are then converted
to electric impulses, which are processed to form an image displayed on a
computer monitor. It is from these images that videos and portraits are
made.
Obstetricians use ultrasound at a very low power level to check the size,
location, number, and age of fetuses, the presence of some types of birth
defects, fetal movement, breathing, and heartbeat. When ultrasound is used
by a qualified clinician to check for this kind of medical information, the
FDA says the medical benefit far outweighs any risk.
At somewhat higher exposure levels, given daily for weeks at a time,
ultrasound is used to speed the healing of bone fractures. At even higher
levels, the technology produces a heating effect in tissue that is useful in
treating sprains and pulled muscles.
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 can't 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.
Mel Stratmeyer, Ph.D., in the FDA's Office of Science and Technology, says
that most animal studies have not identified any fetal harm with low-dose
ultrasound exposure. "But the issue of keepsake videos has to be that if
there's even a possibility of potential risk, why take the chance?"
Stratmeyer says. Animal studies have been performed during the last 30 years
to investigate the effects of the procedure on a fetus, due to the increased
use of obstetrical ultrasound in the 1970s. Human studies, however, are not
feasible for the same reason that experts are cautious about casual
ultrasound: It's too risky to subject unborn babies to any unknown effects.
"The problem with experimental research," Stratmeyer says, "is that you
really need both animal and human studies to make more predictable
outcomes." He adds that as technology advances and becomes more complex, the
potential for physical effects to be identified in the future also
increases. However, a few studies, Stratmeyer says, suggest that exposure to
diagnostic ultrasound during pregnancy may have an effect on human
development, such as delayed speech in children.
Danica Marinac-Dabic, M.D., an epidemiologist in the FDA's Office of
Surveillance and Biometrics, says that the most consistent finding in the
recent literature is a potential association between prenatal ultrasound
exposure and subsequent left-handedness, especially among boys. At least
three large follow-up studies involving thousands of school-age children in
Sweden and Norway suggested such an association. "Since ultrasound
examinations in these studies took place in the late 1970s and early 1980s,"
says Marinac-Dabic, "and the fact that modern ultrasound equipment is
capable of producing approximately eight times higher intensities than
equipment used a decade ago, we continue to study the possible long-term
effects of prenatal ultrasound in both animal and human epidemiologic
studies."
The History of Fetal Photos
The FDA first learned about keepsake video productions from consumers in
Texas in 1994. The Texas Department of Health and the FDA's Dallas district
office jointly inspected three firms. The FDA then initiated investigations
of similar firms in other parts of the country. Investigators uncovered
numerous companies offering a wide variety of ultrasound packages. Among the
agency's findings were that ultrasound was being performed by untrained,
unlicensed technicians and often without a doctor's supervision.
The FDA wrote about its concerns to 10 health professional organizations and
the National Electrical Manufacturers Association, stating that anyone
promoting, selling or leasing ultrasound equipment for making keepsake fetal
videos could be breaking the law. The agency asked the organizations to have
their members discourage patients from having ultrasound procedures for
non-medical reasons and to notify the FDA of any keepsake video operations
in their communities.
Not a Wise Choice
For every reason a mother-to-be wants a keepsake video, there are good
reasons she shouldn't have one. Women cite early bonding with their babies,
determining the baby's sex, and a desire to share their prenatal experiences
with friends and families as major reasons in favor of the videos. And the
quality of images in commercial videos makes them especially tempting.
Because many obstetricians still use two-dimensional imaging, which is
considered standard in prenatal care, women may seek the more advanced
three- and four-dimensional images used by some keepsake businesses, in
which the features of an unborn infant are more easily recognizable to the
non-professional.
But health experts say these are not medical reasons for having an
ultrasound. 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."
Besides concern that unskilled technicians could be performing and
interpreting such ultrasounds and that the procedure is not always done
under the supervision of a qualified physician, some facilities may be using
equipment that's not in good working order.
"Not all ultrasounds are created equal," says Nancy Hueppchen, M.D., a
maternal fetal medicine specialist at Johns Hopkins Hospital in Baltimore.
"Patients don't know the level of expertise of the person performing the
procedure." Hueppchen says there's also the worry about ultrasounds not
being conducted in medical settings. "These portrait facilities are not
equipped to provide counseling should something go wrong, or proper guidance
if a gross abnormality is suspected," she says.
The FDA also notes that some video companies have been known to use the
ultrasound machine on higher energy exposures for as long as an hour to get
the pictures. The procedure should always be done at the lowest possible
energy output and for the least amount of time. Exposure to ultrasound for
longer than the time specified by the FDA for fetal monitoring could pose a
potential risk to the health of the mother and her developing fetus.
Some companies make it clear that they are not providing diagnostic
ultrasounds, but those that don't may wrongly give women the impression that
their ultrasound examination will identify problems.
The FDA and the American Institute of Ultrasound in Medicine (AIUM), which
also strongly discourages the non-medical use of ultrasound, have concerns
that women are being wrongly reassured by commercial sonograms. Women may
misinterpret the studio ultrasound as a medical examination, thus giving
them a false sense of security. And inaccurate findings may cause them to
undergo unnecessary follow-up tests.
"Even in the best of hands," says Hueppchen, "fetal structural problems can
be missed due to technical and gestational age limitations, thus falsely
reassuring the patient."
Understanding the Laws
Ultrasound is conducted with a prescription medical device that is regulated
by the FDA. The agency sets the standard for the level of energy to be used
for various treatments or diagnoses, including fetal ultrasounds. This
standard restricts ultrasound exposure to levels that produce few, if any,
effects on the fetus, based on epidemiological evidence.
The FDA can take action against the keepsake industry in two ways: for
promoting a device for other than its approved use, and for using a
prescription device without a prescription from a medical professional. By
promoting and advertising keepsake videos, the advertiser is creating a new
intended use for the device, and this requires premarket review by the FDA.
And many keepsake facilities do not appear to be requiring doctors'
prescriptions from their customers.
Kimber C. Richter, M.D., a deputy director in the FDA's Office of
Compliance, says that regulation of the commercial ultrasonic imaging of
fetuses is complicated because each video company scenario is different. "In
some cases, there may be no prescription and no physician oversight," she
says. "In others, there may be a physician involved but no clear
doctor-patient relationship." And in still others, "the video might be made
through an extra visit to the physician that the patient normally sees."
Richter says the regulatory approach in all these cases varies. "FDA
regulates devices, but the qualifications and behavior of technicians and
physicians would be regulated by the states," Richter says. The FDA
announced in 2002 that anyone administering ultrasound to consumers without
a medical prescription is breaking the law. "In the past," says Richter,
"the FDA has taken regulatory action, such as a warning letter or even
seizure, when these devices were used for entertainment purposes without a
prescription."
Margaret T. Tolbert, deputy director of the FDA's Division of Device User
Programs and Systems Analysis, says the agency is updating its current Web
statement warning consumers about the unknowns of using ultrasound equipment
for entertainment purposes and is developing a set of questions and answers
to educate those considering keepsake videos as a business opportunity.
Since a number of advertising examples recently have come to the FDA's
attention -- suggesting an increase in entertainment ultrasounds -- the FDA
is currently taking a closer look at these businesses. "We are reviewing
these cases and will consider regulatory action as appropriate," says
Richter.
The Bottom Line
The prescription status of ultrasound equipment ensures that pregnant women
will receive professional care that contributes to their health and to the
health of their babies. Performing prenatal ultrasounds without following
state and federal guidelines puts a mother and her unborn baby at risk.
Therefore, the procedure should only be used to provide medical benefit.
Besides being inappropriate and contrary to responsible medical practice,
the bottom line is: Why take a chance with your baby's health for the sake
of a video?
--------------------------------------------------------------------------------
Legitimate Uses for Ultrasound Imaging
a.. Diagnosing pregnancy
b.. Determining fetal age
c.. Diagnosing congenital abnormalities
d.. Evaluating position of placenta
e.. Determining multiple pregnancies
--------------------------------------------------------------------------------
To report keepsake video operations in your community, write to:
Diagnostic Devices Branch, Office of Compliance, Center for Devices and
Radiological Health, HFZ-322, 2098 Gaither Road, Rockville, MD 20850.
--------------------------------------------------------------------------------
Official Statements on Ultrasonic Fetal Imaging
Food and Drug Administration:
Persons who promote, sell or lease ultrasound equipment for making
"keepsake" fetal videos should know that FDA views this as an unapproved use
of a medical device. In addition, those who subject individuals to
ultrasound exposure using a diagnostic ultrasound device (a prescription
device) without a physician's order may be in violation of state or local
laws or regulations regarding use of a prescription medical device.
American Institute of Ultrasound in Medicine (AIUM):
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM
strongly discourages the non-medical use of ultrasound for psychosocial or
entertainment purposes. The use of either two-dimensional (2D) or
three-dimensional (3D) ultrasound to only view the fetus, obtain a picture
of the fetus or determine the fetal gender without a medical indication is
inappropriate and contrary to responsible medical practice. Although there
are no confirmed biological effects on patients caused by exposures from
present diagnostic ultrasound instruments, the possibility exists that such
biological effects may be identified in the future. Thus ultrasound should
be used in a prudent manner to provide medical benefit to the patient.
European Committee for Medical Ultrasound:
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).
_________________
Carol Rados is a staff writerfor FDA Consumer magazine. This article was
reprinted from the magazine's January-February 2004 issue
Oh, come on, he's using it himself -- "I do my own stunts. I jump out
of airplanes. How hard can it be to use a sonogram? <insert maniacal
braying here>"
Besides, wouldn't the Harvard-trained MDs look at him strangely when he
points at the screen and repeatedly asks, "This squiggle? Is that...
it's not, is it?... are those remains of the body thetans?"
--Amy
Tom claims to understand all sort of control panels, languages and
Shakespeare (he read all the plays in a month or something) because of
his $cientology training. Brimming with that type of hubris, one can
expect him to wrest the jellied sensor away from the technician and
check for the signs of L Ron Hubbard's reincarnation all by himself, as
often as possible.
bel
>
>
Crispeeoi
> What makes you think they are using it daily/ weekly?
>
> Crispeeoi
Ultrasounds should be performed about 2ce through the course of a
pregnancy, if more ultrasounds are needed then it is probably to
monitor the health and general development of a baby and that makes it
pretty clear that mother and child should be under a doctor's care even
more than usual.
Why buy a sonogram machine to use it just 2ce or so? I know he has
money but it is stupid. Katie can make her way to her doctor's office
and if they have a personal physician then I am sure he has his own
equipment.
Why would you buy a sonogram machine to use it just once or twice? I
have a friend who is about 6 months pregnant and has had two. I think
she may be scheduled to have 1 more, but is 3 sonograms in 9 months
cause to PURCHASE a machine? He obviously plans on having a looksy at
that fetus as often as he pleases.
> I'm sure TC can afford to pay a team of Harvard-trained MDs to come to
> his house every day of the week to operate that machine.
So what? "I'm sure Tom Cruise can afford to pay a team of
Harvard-trained MDs to come to his house every day of the week and screw
his girlfriend until she gets pregnant." Both of these statements are
true: he CAN afford to do either of these things. Just because he can
*afford* to do something, doesn't mean he *does* do it ...
eggs.
would it really be worth purchasing the machine if one only intended to
use it monthly. Wouldn't Katie be getting monthly checkups anyway?
"YOU DON'T KNOW OBSTETRICS! I DO!"
I saw him on that Extra show today. They interviewed him in China
where he is making Mission Impossible 3. I'm not sure how long ago
this interview was done but the interviewer asked him how the baby was
doing and Tom told him how he bought a sonogram machine. He said, "I'm
a filmmaker, I have to see the dailies. I have to see the rushes"
then he laughed like the crazyman he is and acted like he was all so
clever.
How many times will these show keep interviewing him, every
entertainment show seem to be on his film set. What is wrong with him?
Cause he refused to sign a prenup that Katie's dad (an attorney) drew
up...Cruise is a control freak and perhaps nobody ever really stood up
to him before... Instead of wanting an ultrasound machine, he should
have been concentrating on marrying Katie.
My hairdresser works full-time at a large fertility Clinic in the
Southeast. She told me that one of the drs. moved here from LA and
knows Tom Cruise's case. He has a low sperm count. So the baby is
biologically not Tom's. That's why Tom divorced Nichole. She go
pregnant during an affair (while he was having some fun with his male
"friend") and that's why Tom told her "You know why we are divorcing."
Guess everything was hush-hush when Katie went for artificial
insemination...
If Katie had any sense, she should have told him that before any
artificial insemination, there will be a wedding. I wonder how his
adopted kids feel... they can't be too happy watching their father
obsessed by
seeing his child on a sonogram...
Sparky
Your hairdresser works full-time at a fertility clinic? Yeah.....and
she does your hair in her spare time, because she likes the
extra ten bucks?
A low sperm count doesn't mean the baby isn't his. In fact,
with all the weird stuff he's pulling, I'd say there's a 70%
certainty that the baby IS his. The other 30% says that
she was pregnant when they met, and this makes him
look virile.
Kris
He'll blow it off and tell the reporter they really don't "understand"
Obstretrics, because they've never STUDIED Obstetrics, which he has...
EXTENSIVELY - and then he'll tell the reporter he's being glib...
I hope that he get's arrested for illegally practicing medicine... or
something... and I hope the supplier gets nailed for selling the device to
an unlicensed facility... bah.
--
-J
** Keeper of Bette Midler and Betty Buckley **
damn.
teach me to respond before reading the entire thread...
It may well be against the law - according to USA Today news today. I
can only hope someone locks him up before he and Katie produce a
deformed baby because of the damage of doing too many sonograms.
N.
>>>Your hairdresser works full-time at a fertility clinic? Yeah.....and she does your hair in her spare time, because she likes the extra ten bucks? <<<
For your information, I have had the same hairdresser for 12 years.
She worked full-time as a hairdresser
until 2 years ago, when her hubby decided to spend their mortgage money
on cocaine. She needed a job with good benefits and a friends worked
at this fertility clinic and gave her a recommendation. She now works
with a specific Dr and his nurses, washing sperm, etc. Is this clear
enough for you, Kris. She has two girls to support. She works
Saturday as a hairdresser and has her faithful clients for years.
Wouldn't you do the same thing if you were in her shoes?? Now the
house is soley on her name and she pays the mortgage and the hubby is
still in denial but no longer has access to her hard earned money. And
the most ironic thing is that my hairdresser's name is Kris, too! Wait
until I tell her this Saturday...
Sparky
Way to go there Sparky, with providing highly specific information about
your friend who is violating her employment contract by telling you the
personal client information she learns on the job. You'd better hope
that no one else who works for that clinic reads the gossip boards, or
your "friend" will find herself out of a job and have you to thank for
it. Let's see, ex-hairdressers named Kris with two daughters and a
husband with a cocaine problem. Still works the clippers of a Saturday.
More specifically, works in the sperm washing department. Shouldn't be
too hard to work that one out. I'm sure your friend will thank you for
it, too.
eggs.
bkl...@yahoo.com wrote:
What if the sonogram blips, and he thinks it's being glib.....
Wild Monkshood
>
...and Sparky doesn't realize that google.groups doesn't protect his
posting location.
I didn't ask for that info. I just find it curious that such a mother
would be spending time out hairdressing on Saturdays, when she has two
children to care for.
Kris
I guess Sparky is the kind of "close friend","insider" that celebrities
are wary off, they sell your life without a moments' thought in the
name of showing care and concern.
Ohhhhhhhhhhhhhh, interesting theory. If they follow this up with Katie
having the "baby" at home, they would never have to prove if she was
ever pregnant or not. Just appear with a newborn. I've always felt
Cruise was sterile anyway. Probably his own doing b/c he is gay after
all.
No, if Sparky's story is true, then the person violating
confidentiality was the DOCTOR who told her friend ... he learned the
information when he was working at A DIFFERENT fertility clinic.
You don't know the beauty salon is the best place for gossip? You didn't
watch Beauty Shop?
>x-no-archive: yes
>
>"Solitary Sunshine" <getsome...@yahoo.com> wrote in message
>news:1133499807....@z14g2000cwz.googlegroups.com...
>Wait. Being gay makes you sterile now?
>
>
>
>
What a revelation. Who knew? And here I thought gay men were only
missing the eggs.
vxp