What are the alternatives to jaw-breaking for fixing retrusive lower jaw?
Alex Maas
After several orthodontal consultations about my almost nine-year-old
son, I am quite confused. The internet makes it worse as I have no
idea how to evaluate what is B.S. and what is true in regards to
orthodontal theory. But treatment plans seem to vary widely.
My son has a retrusive lower jaw. One orthodontist said flat-out
that the only way to fix everything right would be to break his jaw at
age 15. Another said although we could opt for that, we could just
opt to live without it. Yet another never mentioned anything about
it. However, he wants to get started right away with the braces and
more upper expanders. This may in itself help to reduce vertical
growth, as I understand it.
However, I am not sure what the right approach is. I have also
read the page at www.braceface.com, with Dr. Michael Echols advising
the use of light-pull elastics to pull the lower jaw forward and keep
the upper jaw somewhat in place. And, according to Dr. Echols, the
elimination of tongue-thrust is imperative with this approach. I have
also read that some orthodontists believe that jaws are genetically
pre-programmed to grow the amount they are going to grow. So, I don't
know what to think about this method of treatment and I know a lot of
orthodontists do not think that the lower jaw can be pulled forward.
But this approach seems a better alternative than breaking the jaw, or
just being stuck with a retrusive lower jaw.
My son already goes to myofunctional therapy,to eliminate tongue
thrust, but more for speech than anything else. However, one
orthodontist told me flat out that he believes tongue thrust is a
result of poor skeletal-jaw structure. When the problem is fixed
orthodontically, the tongue thrust disappears in 90% if the cases.
This orthodontist never refers anyone for tongue thrust therapy.
Other orthodontists seem to think problems like tongue thrusting
are the cause of all malocclusions, such as the inventor of Biobloc at
www.orthotropics. I read the web postings from this newsgroup about
Biobloc from two years ago, and I came away with a a more complex
understanding of vertical growth. However, the pictures on the
website are hard to argue with, although they may be only a small
percentage of cases. But I have seen similar pictures at my son's
orofacial myologist, but she promises nothing, and she works with
standard orthodontists. But it does seem something goes on with the
elimination of the tongue thrust.
So, is it a fantasy to think that there are alternatives to fixing
retrusive lower jaw and vertical growth besides breaking the jaw at
15? After reading the website at www.orthotropics.com I came to think
so, but I am old enough to know not to believe everything I read on
the internet. And I read the many negative comments about this
approach on this newsgroup. But there are others I am sure.
What are true alternatives to the breaking of the jaw?
carabelli
One orthodontist said flat-out
>that the only way to fix everything right would be to break his jaw at
>age 15. Another said although we could opt for that, we could just
>opt to live without it. Yet another never mentioned anything about
>it. However, he wants to get started right away with the braces and
>more upper expanders. This may in itself help to reduce vertical
I don't have time to reply in detail this morning, however # 2 is probably
the most realistic. Jaw surgery on a male at 15 is too soon, there can be
more growth after that age - females are a different story.
In difficult cases the more you consult, the more opinions you will get -
and each may be appropriate in the hands of the practicioner. Again, in
difficult cases be wary of one approach fixes everything, and the approach
that promises a perfect result yet avoids all the things parents don't want
to hear (no extractions, no surgery, etc.).
carabelli
Dave King
You sound very frustrated so I hope my opinions can help. This is from a
surgeons viewpoint, not an orthodontists. There are a few ortho docs here
that should also be able to help with regards to lengthening appliances.
Concerning yourself with the need for corrective jaw surgery now is
premature. The lower jaw will lag behind the upper in terms of growth for
some time and may not require surgical correction later. Of course this is
stated without personally examining your son. IMO, any orthodontic
approaches to lengthening the mandible are limited. Surgery also has its
limits but there are other approaches besides the standard 'jaw breaking'
procedures (i.e.: distraction osteogenesis).You are correct with reference
to a predetermined growth potential but your son hasn't reached that yet.
Starting orthodontics now sounds like the correct choice but an accurate
prediction of growth at his young age is highly variable. Selling out to
corrective jaw surgery when he is 15 or sooner is also premature unless his
jaw is so retrusive that it is affecting his overall health (i.e.:
obstructive sleep apnea).
The standard ways to surgically correct jaw position requires atleast one
overnight stay in the hospital and has a low likelihood of permanent
complications (<3-4%). Relapse is possible so that it is why waiting for
skeletal growth to complete is in your best interest. Distraction is not
much different except that the complication and relapse rates are much
lower. In this type of surgery, the jaws are repostioned slowly with a
device that spreads the bones apart after they have been surgically
seperated. These devices are placed intraorally and are removed several
weeks after the desired length is reached.
DAK
--
~~~~~~~~~~~~~~~~~~~~~
Oral & Maxillofacial Surgery
Diplomate, American Board of Oral & Maxillofacial Surgery
HTTP://WWW.DEOMFS.COM
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"Alex Maas" <a.m...@att.net> wrote in message
news:1c647bc3.02050...@posting.google.com...
Sabra Broock
SB
Sabra Broock
>>Again, in
>>difficult cases be wary of one approach fixes everything, and the approach
>>that promises a perfect result yet avoids all the things parents don't want
>>to hear (no extractions, no surgery, etc.).
>>
>>carabelli
>>
Please allow me to interject what I think he meant to write:
Again, in difficult cases be wary of one approach fixes everything,
and the approach that promises a perfect result yet avoids all the
things parents don't want to hear ( extractions, surgery, etc.).
(no quotations because carabelli's passage was altered)
--
A meddler; but, well intending,
SB
On Thu, 02 May 2002 17:43:04 GMT, sa...@mesadrive.com (Sabra Broock)
wrote:
Alex Maas
> carabelli wrote:
>
> >>Again, in
> >>difficult cases be wary of one approach fixes everything, and the approach
> >>that promises a perfect result yet avoids all the things parents don't want
> >>to hear (no extractions, no surgery, etc.).
> >>
> >>carabelli
> >>
>
> Please allow me to interject what I think he meant to write:
>
> Again, in difficult cases be wary of one approach fixes everything,
> and the approach that promises a perfect result yet avoids all the
> things parents don't want to hear ( extractions, surgery, etc.).
>
> (no quotations because carabelli's passage was altered)
> --
>
> A meddler; but, well intending,
>
teeth extracted, and I never even thought about it. But by educating
myself, I have learned that more progressive orthodontists seemed to
have learned that sometimes extracting teeth to make space can have
the opposite effect and make the jaw smaller. I don't pretend to be
qualified to know if this is true, but I believe this is the general
direction orthodontia has moved over the years--the fewer extractions
the better. Although I had teeth extracted and mouth subsequently
became once again crowded, I don't have even pretend to know why this
happened. But the actual removing of teeth doesn't bother me.
But modern-thinking orthodontists do try to extract as little as
possible, as I understand it, because of further consequences,
balanced of course by possible consequences that can happen when
extraction is not done. However, even of the orthodontists who extract
as little as possible there is tremendous difference.
See www.braceface.com for an orthodontist who extracts only in 1 to 5%
of cases.
This orthodontist, Dr. Echols, uses a specific approach that he has
evolved over the years. His views might be considered heretical by
some, but look at his results.
Breaking the jaw is another matter. I cannot think of another
part of the body that is broken to make it better by some other type
of medical specialist.
If jaw surgery must be done eventually, I can easily accept that.
However, I have seen enough pictures of tremendous results from
orthodontists who believe retrusive lower jaws can be fixed through
various techniques--whether through the use of light-pull elastics,
functional appliances, other appliances, palatal expansion, the
elimination of tongue thrust, avoiding extractions, clearing the
airways, or whatever else-- to try something now before the surgery my
son is supposed to have to fix everything later.
The fact is it is a lot easier for an orthodontist to have a
patient's jaw fixed through surgery than it is to try a combination
of other methods to avoid it. This fixes the jaw overnight--the other
methods may take years and year. Surgery is probably simpler for the
patient as well.
And, as I understand it, some (?retrogressive) orthodontists
strongly believe that the tongue, for example, has no effect on
malocllusion, retrusive growth, and so forth. I have come not to
believe this, even though I know I am not qualified to make that
evaluation. I have seen enough pictures of people who have gone
through myofunctional therapy for elimination of tongue thrust that
later needed no braces, although previously recommended, to know
something goes on. Why this happens, I don't know. How many people
this happens to, I don't know.
I can't seem any harm in trying all this other stuff first. For
example, my son goes to tongue thrust therapy for his speech. But this
will have an orthodontal effect, also, I believe. If he were going
for tongue thrust therapy for orthodontal purposes, it would effect
his speech in a positive way, as an added benefit. And I believe that
opening the airways as completely as possible would have positive
health benefits beside orthodontia.
I don't see the harm in trying these other things first. I could
see that non-extraction could possibly cause harm, if things have to
be pushed past their boundaries. But I don't think trying any of these
other things could actually hurt my son.
It is complicated even for me, and I know that orthodontists
simplify things.
But as a parent as a child that has been advised that his speech
negatively impaired by the use of palatal expanders, when I think it
is the right thing to do orthodontically, it is complicated also.
Thanks for your input. I appreciate it.
Nadine
> The fact is it is a lot easier for an orthodontist to have a
>patient's jaw fixed through surgery than it is to try a combination
>of other methods to avoid it. This fixes the jaw overnight--the other
>methods may take years and year. Surgery is probably simpler for the
>patient as well.
Caveat Emptor!
Surgery was not simple for Sabra. If I'm not mistaken, the first
unsolicited, unnecessary surgery to 'correct an overbite', and others
that followed nearly killed her.
Jaw surgery was not simple for the 25,000+ patients described below.
<.....>
>I have seen enough pictures of people who have gone
>through myofunctional therapy for elimination of tongue thrust that
>later needed no braces, although previously recommended, to know
>something goes on. Why this happens, I don't know. How many people
>this happens to, I don't know.
> I can't seem any harm in trying all this other stuff first. For
>example, my son goes to tongue thrust therapy for his speech. But this
>will have an orthodontal effect, also, I believe. If he were going
>for tongue thrust therapy for orthodontal purposes, it would effect
>his speech in a positive way, as an added benefit. And I believe that
>opening the airways as completely as possible would have positive
>health benefits beside orthodontia.
> I don't see the harm in trying these other things first.
Then do it. First do no harm.
<....>
>But as a parent as a child that has been advised that his speech
>negatively impaired by the use of palatal expanders, when I think it
>is the right thing to do orthodontically, it is complicated also.
> Thanks for your input. I appreciate it.
*****
Medical Mess: Implants in Jaw Joints Fail, Leaving Patients
In
Pain and Disfigured
Teflon-Coated Disk Seemed A Boon for TMJD at First But Had
Little Testing
By Bruce Ingersoll and Rose Gutfeld
Staff Reporters of The Wall Street Journal
August 31, 1993
Surgical Merry-Go-Round
Roblyn Ruggles in weeping. "This isn't my face," she says. "I
used to be real pretty."
Eight oral-surgery operations have left her disfigured, without
jaw joints, her mouth permanently agape. She can't bite
into a sandwich. She can't purse her lips for a kiss.
And alone at night, she can hardly bear the muscle spasms
and the pain. "It never goes away; it's a God-awful pain,"
says the onetime nurse, who lives in Cuyahoga Falls, Ohio. "I
have to pretend it's something else to hold onto my sanity."
Ms. Ruggles, 37 years old, is a victim of biomaterials
engineering gone awry, caught up in a medical
catastrophe that is claiming new casualties almost every
day. The cause of her pain and disfigurement: synthetic jaw
implants aggressively marketed by Charles Homsy, founder
of Vitek Inc., without adequate premarket testing. Hundreds
of oral surgeons embraced the so-called interpositional
implants as a breakthrough of sorts in the 1980s. One
prominent surgeon, John Kent, lent his name to Vitek
products and served as Dr. Homsy's clinical consultant.
An Unfolding Disaster
More than 25,000 patients afflicted with the same jaw
disorder as Ms. Ruggles - temporomandibular joint disorder,
or TMJD - received Vitek implants before liability-protected
insurance problems forced the small Houston company to
take them off the market in mid-1998. In 1990 the Food and
Drug Administration forced the company to issue a safety
alert and eventually seized its products.
But for thousands of patients, the implant affair is far from
over. Medical experts new expect a high percentage, if not
all, of the implants to break up into microscopic fragments
and beget a biochemical reaction in patients that erodes
jaw bone, creating many other painful complications. Says
Larry Wolford, a Dallas oral surgeon: "This is the worst disaster
our specialty has ever faced."
It is one with many contributing factors. Federal regulation
of the medical-devices industry was lax when the device
was introduced in 1983. Vitek was headed by a zealous
entrepreneur who, according to the FDA and experts in
biomechanics, neglected to run a critical test of the
implant's durability. The company was quick to discount
adverse findings in animal experiments - all done after the
implant was in widespread use - and was slow to accept the
implications of early implant failures.
TMJ disorders can produce arthritis, jaw and facial pain,
headaches, earaches, clicking sounds in the jaw, and
restricted movement. The temporomandibular joints is
terribly complicated: It lets the lower jaw, or mandible,
move up and down, side to side, forward and back, and in
many combinations as a person speaks, bites, chews,
swallows, smiles, laughs, grimaces. It is an exquisite network
of nerves and muscles, and it isn't well understood. No one
knows, for instance, why TMJ disorders afflict women more
than men; 90% of the Vitek implant recipients are women.
Treatment of TMJ disorders has long occupied a medical
gray area. Orthopedic surgeons have stayed away from it,
fearful of slipping up in an area so close to the brain, ear
and facial nerves. But oral and maxillofacial surgeons have
been more aggressive in treating TMJD, and when the Vitek
implant came on the market, many turned to it
enthusiastically.
Compounding the tragedy, new research in the Netherlands
suggests that the best treatment for TMJD may be none at
all, because most TMJ disorders abate in a few years. Some
experts in the US also say there is no justification for surgical
intervention in TMJD cases. "The worst post-surgical cases
are far worse than the worst cases in their natural,
pre-surgical states," says Joseph Marbach of Columbia
University's school of public health.
Blaming Surgeons
Dr. Homsy, a chemical engineer who was president and
majority owner of now-defunct Vitek, blames surgeons for
putting his products in the wrong patients or for botching the
procedure. The implants, he asserts, "weren't at fault; poor
surgical judgement and technique were." If there were any
gaps in testing, he says, it is the fault of Dr. Kent.
Dr. Kent, head of oral and maxillofacial surgery at Louisiana
State University, blames Dr. Homsy for inadequate testing.
"The ultimate responsibility for testing is the manufacturer's,"
says Dr. Kent. Counters his erstwhile friend, who contends
that he urged Dr. Kent to conduct the appropriate tests: "I'm
a scientist. I can't operate on animals."
Ms. Ruggles, for one, has been on a "surgical
merry-go-round" ever since her implants came out in June
of 1989. Doctors have tried just about every option - a
dermal tissue implant, a silicone rubber implant, a pair of
Vitek total-joint implants - without any success. Her surgery
bills to date total $280,000, only partly covered by her
husband's medical insurance.
Thoughts of Suicide
In Tucson, Arizona, oral surgeon Stephen Harkins is treating
100 implant patients, 20 of whom he says are suicidal. "They
are barely functional, under heavy pain medication and
antidepressants," he says. "They have had significant
damage to the bones and muscles of the face and nerve
damage." Some have had to have their jaws rebuilt with ribs
and cartilage from their own bodies or from cadavers, with
mixed results. "These people aren't kooks," says Dr. Harkins.
"They look like they've spent 10 years in Auschwitz."
Thousands of patients already have had their failed implants
removed, and thousands more will have to have theirs
"explanted" as well. While many aren't showing any overt
symptoms of failure, x-rays and CT scans reveal the onset of
bone loss. Deborah Zeitler, an associate professor of oral
surgery at the University of Iowa, says more than 90% of her
patients with implants already have had them out. Douglas
Morgan, a surgeon in La Crescenta, California, reports
finding an implant had eroded a hole into a patient's brain.
An Oval Disk
Other surgical implants have failed, of course, but few so
completely. Silicone-gel breast implants are failing at a rate
of about 1%. But it now looks as if the failure rate of the
interpositional implant, or IPI, ultimately "could be 100%,"
says Daniel Laskin, editor in chief of the Journal of Oral and
Maxillofacial Surgery.
The IPI, Vitek's main product, was widely used to replace an
oval disk of cartilage that acts as a shock absorber between
the temporal and mandibular bones. The disk can easily be
dislocated by a blow to the jaw or irreparably damaged by
too much grinding or clenching of the teeth.
The IPI was nothing more than two layers of plastic
laminated together - a super-thin sheath of Teflon FEP,
which is a smooth DuPont Co. polymer, and a wafer of
highly porous Proplast, which is a biomaterial concocted by
Dr. Homsy out of another DuPont polymer, Teflon PTFE, and
carbon or aluminum oxide. A fundamental flaw doomed
the tiny implant: It simply couldn't withstand the wear and
tear of the lower jaw sliding on its Teflon surface. In some
cases, it disintegrated within a few months.
The IPI fiasco has been ruinous for everybody involved.
Vitek was forced into bankruptcy; Dr. Homsy is in
professional exile in Switzerland. DuPont, Vitek's Teflon
supplier and the only deep-pocketed entity in reach, has
been ensnared in litigation, despite a disclaimer about
medical complications caused by implanted Teflon-like
polymers.
The First Implant
Dr. Homsy is one of bioengineering's pioneers. After earning
a Ph.D. in chemical engineering at Massachusetts Institute
of Technology, he spend seven years at DuPont in sales and
as a Teflon researcher. In 1968 he developed Proplast, which
gained wide use in plastic surgery, including chin and
cheek implants.
In 1974, Dr. Kent began cutting implants out of sheets of
laminated Proplast/Teflon (then being sold by Vitek for
plastic surgery) and using them to cover the tips of
jawbones in TMJD patients. Other surgeons followed his lead
with good results, and some began using the sheeting to
replace perforated disks.
By 1979, sponge-like Proplast was being touted by the
American Association of Oral and Maxillofacial Surgeons as
the "living implant" because human tissue could grow into
its pores. At the group's annual meeting that year, Dr. Kent
reported on the results of 50 jaw implants, saying that
virtually all of the patients showed "marked pain relief and
restoration of jaw movement," according to a press release.
At a major meeting of TMJ specialists three years later, Dr.
Kent sensed booming demand for Proplast/Teflon. "We
anticipate numbers of procedures to rise to 10,000 or more
annually easily within the next year," he wrote to Dr. Homsy
in March 1982. In the letter, he suggested producing precut
disks in an "ovoid shape" so surgeons wouldn't have to do
the cutting at the operating table.
FDA's Imprimatur
One year later, Vitek had the go-ahead from the FDA to
market a precut disk, the IPI. To obtain FDA approval, Dr.
Homsy merely had to persuade a bureaucrat that a
Proplast/Teflon device was substantially equivalent" to a
product already on the market before the enactment of a
1976 law regulating medical devices. In this case, the
product was an implant made of Silastic, or silicone rubber.
Silastic implants have failed, too, but the consequences
generally have been less severe.
Once approved, the IPI took off commercially, thanks
largely to a timely boost from a trio of Tucson surgeons, one
of whom had been taught by Dr. Kent how to use
Proplast/Teflon in the TMJ. At an oral-surgery meeting in
Berlin, Tucson surgeon Theodore Kiersch reported a 93%
success rate - high for this kind of procedure.
This helped touch off what Dr. Kent later called "a
stampede" among oral and maxillofacial surgeons to
implant the IPI in TMJ patients. For them, it was a bona fide
business opportunity, a chance to do more than
wisdom-tooth extractions and root canals. "It became the
fashion," says John Westline, a Delray Beach, Florida, oral
surgeon. "Guys were putting them in and having success,
and so people were jumping on the bandwagon."
The 1983 class of implant recipients included Betty Jean
Meyer, a onetime real-estate broker in Tucson who readily
agreed to have an IPI put in for headache relief. She says
her surgeon told her, "We'll slip this little disk in, and you'll be
out of the hospital in two to three days." The attending
surgeon was Dr. Kiersch. It was the first of four major
operations for Ms. Meyer, all unsuccessful, including and
1985 procedure by Dr. Kent, who replaced two IPIs with
Vitek-made jaw joints.
Yet another surgeon has since removed these joints and
rebuilt her eroded jaw bones with grafts from her rib cage,
leaving her in perpetual pain. "There are days when my jaws
are so swollen and blue I can't open my mouth," she says. "I
have to pack my face in ice and stay in bed, with the
curtains drawn and the door closed. I need the quiet. I need
darkness."
Scant Testing
Dr. Kiersch, looking back, feels betrayed by the implant's
makers. "My duty was to find the best material possible," he
says. "I'm a clinician; I'm not a research person. We were
told the material had been released by the FDA. We
assumed it had been tested in the animal joint."
Today, many medical devices undergo lab tests, animal
experiments and human trials involving groups of closely
monitored patients. In those days, however, such testing
generally wasn't required of medical devices. Vitek never
tested the IPI in animal jaws before marketing it. Vitek took
the position that there was no way to reproduce in a lab
animal what happens in the human TMJ.
The company didn't do any human trials, either. It relied in
the early success that Dr. Kent and others had in implant
Proplast/Teflon in TMJ patients. While such limited,
unstructured testing would never pass FDA muster as a
clinical trial, Dr. Homsy contends it was an "effective" one.
Vitek did run tests on a mechanical simulator that imitates
the human jaw. But the company never did the most
obvious test of all: testing Proplast and Teflon together, as a
laminated product, to determine how long the IPI would
withstand the stresses from biting and chewing.
Stress Test
Mark Fontenot, a bioengineer who once consulted with
Vitek on a physical-therapy device and who has done
research with Dr. Kent, three years ago did such a test using
a simulator patterned after Vitek's. he found that the
machine, in sliding back and forth over the IPI with 20
pounds of force, wore through the Teflon surface into the
Proplast backing 100 to 200 times fasted than the wear-rate
reported by Dr. Homsy. It fractured the thin Teflon layer,
scattered microscopic Teflon particles all about and ate
into the underlying Proplast. At that rate, according to a
scientific paper Dr. Fontenot published last year with Dr.
Kent, the IPI would have a "service life" of only one to three
years.
How did Dr. Homsy err so badly? His wear-testing was of
Teflon with a metal backing that didn't give way under the
20-pound load, Dr. Fontenot says. Had the tested laminated
Teflon/Proplast, it would have been obvious that highly
porous Proplast isn't solid enough.
"It's like paper backed by a sponge," says Dr. Fontenot. "You
can take a pencil and punch a hole in the [Teflon] surface.
Almost anything would have been better than Proplast,
even papier-māché."
Dr. Homsy says Dr. Fontenot's simulator test isn't
representative because the implant was supposed to gain
strength after implantation as body tissue grow into the
pores of the Proplast. In most cases, however, "you don't get
in-growth," says Barry Sands, a biomedical engineer and
former FDA investigator who did a risk evaluation of the
Vitek implants. Once implanted, he says, the IPI gets
repeatedly compressed between the upper and lower jaws
"like a carpet that binds up under a door," and the pores in
the Proplast "get closed off."
Only after reports of IPI failure began rumbling in around
1984 were animal studies done. In 1984, a colleague of Dr.
Kent's implanted IPIs in dogs. The results were "essentially
catastrophic," according to a 1990 deposition that Dr. Kent
gave in and Arizona court case against Vitek in Tucson.
After just a few months, the Teflon layer was "completely
worn" and Teflon particles had triggered bone erosion in the
dogs. To Drs. Kent and Homsy, the test showed mainly that
the dog wasn't a good test animal to use.
Monkey Jaws
The dog study wasn't the only one to be disregarded. In May
1986, Mohamed El Deeb, a professor at the University of
Minnesota dental school, had Dr. Homsy come to
Minneapolis to see the results of his experiments on
monkeys. Both Proplast/Teflon and Silastic implants began
to fragment after a year, causing "severe degenerative joint
changes," but the reaction was more pronounced with
Proplast/Teflon, says Dr. El Deeb.
He says Dr. Homsy made no comment. Asked about the
study today, Dr. Homsy says that monkeys weren't a good
model.
Reports of Vitek implant failures continued to crop up. The
most alarming, published in 1986, involved a 37-year-old
woman who had an IPI put in after having her jaw broken by
her abusive husband. Teflon debris from the worn implant
had migrated through her lymphatic vessels into lymph
nodes in her neck, causing painful inflammation, according
to researchers in Chicago. The IPI failed, they concluded,
because it "couldn't withstand the loads generated" by
chewing.
For Dr. Kent, this case was something of a turning point.
Besides bringing it to Dr. Homsy's attention, he says he
began "blowing the whistle" on the IPI, albeit indirectly. As
chairman of scientific sessions at the Oral Surgeons
association's national meeting in 1986, he gave the IPI
critics a chance to present papers.
Warning Letter
In October of that year, Vitek had no choice but to notify
every member of the association about the increasingly
obvious complications. Among other things, it said the
prognosis for the IPI's success beyond three years was
unknown. But Vitek blunted the letter's warning by also
trumpeting the results of an oral surgeon survey: 91.5% of
5,070 implant cases showed "satisfactory" results, it said,
without defining "satisfactory."
By 1987, malpractice lawsuits against surgeons and
product-liability suits against Vitek were mounting.
Nonetheless, in July of that year, a Memphis surgeon
suggested to Marcie Grossberg, a school librarian who had
been hit in the jaw by a student, that she get IPIs. "The only
Teflon I knew about was in my skillet," says Ms. Grossberg, 40,
who says she trusted the doctor's assurances that the IPI was
"state-of-the-art" treatment.
She shouldn't have. Within a few months, her implants were
disintegrating and her chin was receding. "I couldn't get my
teeth together," she says. "Food would fall out of my mouth."
In October 1988, she found another surgeon to extract the
implants. Now she suffers from immune-system disorders
that doctors believe may be caused by unremoved Teflon
particles.
Today, Drs. Homsy and Kent are squabbling over the testing
issue. In a February 1990 letter, Dr. Kent says Dr. Homsy didn't
do the "appropriate" animal tests "in spite of my suggestion
on the early 1980's that they be performed." The next month,
Dr. Homsy retorted: "You have repeatedly informed us that
there were no appropriate animal models and that testing
performed by you and LSU substantiated that conclusion."
Ownership and Royalties
Dr. Kent, nationally known as an innovator in reconstructive
and oral surgery, is trying to distance himself from the entire
catastrophe. "My role in the IPI was essentially nothing," he
asserts, even though he advised Dr. Homsy on the implant's
shape. Dr. Kent also owned a 1% stake in Vitek, and from
1984 he got a 4% royalty on every TMJ product sold - about
$50,000 a year, he says (Dr. Homsy pegs it closer to $100,000
some years). He got additional royalties on Proplast facial
implants of his design.
As for Dr. Homsy, he sees the entire affair as a "holocaust" for
himself, his family and his company, as well as for
bioengineering and the medical-device industry. But the
doesn't concede that the IPI was a misapplication of his
beloved invention, Proplast, or that, as designed, it was
inherently flawed. "Unfortunately," he says, "the implant is a
set piece for scapegoating."
Instead, he blames not only surgeons but also patients, for
failing to follow their surgeons' post-operative admonitions
against opening their jaws wide or eating solid food until
they are fully healed.
Throughout all this, the FDA seems to have missed several
opportunities to intervene and head off the IPI disaster. The
initial inspections of Vitek's plants after the IPI was approved
in 1983 were limited and failed to uncover and significant
problems. It wasn't until July 1988 - one month after the
company pulled the product off the market - that the
agency conducted a comprehensive inspection of Vitek's
plant. That inspection, which included checking quality
controls and other manufacturing practices, turned up
numerous violations.
Red Flags Waved
FDA officials say Vitek wasn't relaying all of the reports it was
receiving of problems with the devices, as it was required to
do. But the FDA also was unaware of or failed to act on
several other signs that something was seriously amiss,
including the company's 1986 letter to surgeons and a 1987
report from the US Air Force about implant failures, severe
pain and bone erosion. Complaints from air bases
prompted a notice to every branch of the armed services
cautioning surgeons against using the IPI. But the
government didn't recall the product until December 1990.
Says Henry Wall, a Norcross, Georgia, oral surgeon: "The FDA
was asleep at the switch."
FDA officials contend that the agency acted as soon as the
problems came to the agency's attention.
For most patients who implants have failed, there are few
alternatives. Two companies - TMJ Implants Inc. of Golden,
Colorado, and the Northeast Dental Center of Los Angeles -
are marketing jaw implants, both of which were on the
market before 1976 when FDA approval wasn't required.
(They are different from the interpositional disks and are
made of metal, not Proplast or Teflon.) Both companies
claim good results with their implants. Some surgeons
recommend using patients' own tissue to reconstruct the
jaw joint, but such surgery often fails as well.
What's more, every medical option is very costly. Many IPI
patients are destitute, having lost their jobs and exhausted
their savings and insurance coverage. And other are
stymied by coverage limits.
Arlen Huber, 35, suffers from facial swelling and severe
headaches and want the IPI he received after a farming
accident taken out. The lowest surgeon's estimate the
Fingal, North Dakota, farmer can get for doing so is $25,000,
not counting anesthesia or hospitalization. But under a 1989
state law, insurance carriers can limit lifetime coverage for
surgical treatment of TMJ disorders to $8,000.
Mr. Huber says he has appealed to state officials in Bismarck
for help, but "they can't do anything for me."
******
charlie ruff
I just spent some time on the web site of bracesface.com and I really
don't see what all the fuss is. Sounds like pretty standard stuff. I
couldn't find the reference to only extracting in 1-2% or so of his
patients. Can you point me in the right direction?
CJR
Alex Maas
It is found at www.braceface/nonextraction.htm. The percentage was
1 to 5%, much lower than the orthodontists I have consulted, including
the one you recommended ,who estimated 10 to 20%. In consultation
with that orthodontist, immediate extraction was recommended.
Although I have no problem with extraction per se, I cannot undo the
possible consequences. Two other orthodontists I have seen did not
recommend immediate extraction, but they don't believe in tongue
thrust therapy, as does the orthodontist you recommended.
I am trying to make the best decision possible, something I am sorry I
did not do before.
I do have more of a problem with breaking of the jaw. This was
recommended to me as a course of action for myself over thirty years
ago, and I have to believe orthodontia has advanced since then. My
parent refused to go for it. Although I realize orthosurgery may be
the reality, I would like to do as much as possible to non-surgically
pull the lower jaw forward in line with the upper jaw. The
orthodontist you recommended only said surgery was an option, not a
necessity.
The orthodontist you recommended to me showed before and after
pictures of someone who looked like my son's cousin, due to the
retrusive lower jaw.But, in the end, the profile was unchanged. I was
not satisfied with this, although that may be the reality, without
surgery. I just want to confirm this.
Of the four orthodontists whom I have consulted, the one you
recommended has come closest to the treatment plan I am looking for.
But I want this confirmed. We will be seeing a very progressive
orthodontist on Monday, one who was doing
palatal expansion while other orthodontists were scoffing at him. I
believe he will confirm the treatment plan of the orthodontist you
recommended. But I have to know.
Thanks.
Alex Maas
Alex Maas
Thank you Dr. King. I appreciate the input, and I will try to
remember distraction osteogenesis. And, yes, I am a little frustrated,
but I know it is a result of my attidue. I cannot just blindly accept
what any orthodontist tells me, like most people do. My parents made
this mistake with me, and I won't repeat it. With six years of
orthodontia, I ended up with overlapping teeth, malocclusion, and the
suggestion from a dentist and another orthodontist that needed my jaw
broken or my teeth would wear out by time I was thirty. I am
forty-three and still have all my teeth.
Sabra Broock
On 3 May 2002 07:15:22 -0700, a.m...@att.net (Alex Maas) wrote:
>sa...@mesadrive.com (Sabra Broock) wrote in message news:<3cd1fdd6...@news.mesadrive.com>...
>> carabelli wrote:
[clip]
a.m...@att.net wrote:
...clip...
> Breaking the jaw is another matter. I cannot think of another
>part of the body that is broken to make it better by some other type
>of medical specialist.
>If jaw surgery must be done eventually, I can easily accept that.
[clip]
Dr. Dave King wrote that permanent complications occur in <3-4% of
cases operated (I think he was only referring to mandibular
advancement procedures but I don't really know for sure). I would
expect a parent to boldly ask to be told what types of permanent
complications that statistic would include. What percentage of the
people who are reading smd today know what those complications are,
why they exist, and what they might mean to the future of the person
affected?
If this procedure is being done for cosmetic purposes only, I suppose
the term "must be done" is the same as a facelift that "must be done"
for someone suffering from a little too much time on the planet --
treatment for the gravity effect ---
And then there is that range of need that has to do with all the
salesmanship by surgeons.... everyone knows it's out there and it
isn't just OMFS, and not only surgeons. It is prevalent throughtout
the healthcare industry. There is no need to deny its existence.
And then there is the small percentage of people who have terrible
problems for which surgery "must be done" in order to correct problems
that no one ever writes about here in this Usenet newsgroup. Go to a
Children's Hospital sometime and see what *real* problems exist ---
look at the faces of some of the children for whom surgery gives them
a chance for some sort of normal life both functionally and
cosmetically. For those children, "must be done" and the risks versus
benefit discussions will not be anything like what I think I'm reading
about in this thread. These cases operated by OMFS would be referred
to as "medically necessary" and of all the operated cases on a
national average... what percentage of the OMFS's practices do they
represent? -- Might it be somewhere in the neighborhood of <3-4% ? I
wouldn't be surprised to find that the statistic would be right about
that...
Anyone who is a parent or has been a parent long enough to have been
told by a surgeon, "your child needs surgery" probably knows about the
anguish of making a decision for a person whose safety depends upon
you, the parent. They cannot make such decisions for themselves yet.
It becomes a most humbling event in the lifetime of a parent. Just
the part about the risk of anesthetic death should be so sobering a
reality that parents take pause to think beyond blind acceptance of a
surgeon's advice.
The child we are reading about in this thread deserves to know that a
parent is already deciding that surgery is acceptable if it must be
done (later) but that child is not able to understand this or else he
would be allowed by law to make the decision for himself... but what
if that child when older (later) realizes that he never-ever would
have accepted surgery as part of an elective treatment plan along with
its known risks for complications. He may say it never would have
been worth "the risk of it all"...
This topic is one that is generally given very little attention by
anyone writing in smd. And because it is overlooked and because it is
so important ... it generally boils my blood and that is why I would
have preferred to stay out of the thread. But Nadine wrote words of
truth about my experiences with jaw surgery and my permanent
complications --- and had she not done that, I would likely not have
contributed further to the thread (except to point out carabelli's
double negative).
There aren't many reasons I am grateful about the events of my past
twenty-ish years as a "permanent complication" of jaw surgery. But I
am grateful that this happened to me and not one of my children. I
would have trusted the surgeon just the same had the advice been about
my children as it was for me. The risks and complications were not
told to me in their entirety. I was only told about the portions that
wouldn't scare me off. How was I to know if I had been told *all* or
*part of all*??? But I am here to tell anyone reading this that to
permanently complicate a person's life with a severe jaw function
disability is nothing to take lightly. Jaw disabilities are not
given the time of day by our society. No one understands it until it
happens to them. Then. Then the adaptation process begins.
Understanding "medical necessity" is a topic that could be discussed
in this newsgroup for a very long time before general understanding
took a giant step forward. The view from where I sit is that people
may complain a lot about the ailments of our health care system (and
IMO the system is seriously ailing) ... but until people seek to
understand the wisdom behind these words of Benjamin Franklin, almost
nothing will get better:
"Nothing is more fatal to health than overcare of it." (Benjamin
Franklin)
Sabra Broock
charlie ruff
> recommended has come closest to the treatment plan I am looking for.
> But I want this confirmed. We will be seeing a very progressive
> orthodontist on Monday, one who was doing
> palatal expansion while other orthodontists were scoffing at him. I
> believe he will confirm the treatment plan of the orthodontist you
> recommended. But I have to know.
> Thanks.
>
> Alex Maas
the one who is very progressive and doing palatal expansion when
others scoffed???
papatal expansion has been in the orthodontic repertoire for 50 years
as standard treatment. andy haas of cleveland did the research on
that as a grad student and most of us do that routinely. unless your
progressive orthodontist is older than 80 i can't understand what
palatal expansion has to do with being progressive.
good luck
cjr
charlie ruff
i again was on this web site and i really don't see what the magic is
other than braceface is trying to market his practice by seeming to do
something someone else is not doing. some medical professionals call
that quackery. that is claiming to have skills and abilities others
don't and yet you've never published or taught on your own technique.
we wish there was more science in ortho but to claim a different
technique and never to have published the results - let the consumer
beware.
cjr
Alex Maas
> others scoffed???
>
> papatal expansion has been in the orthodontic repertoire for 50 years
> as standard treatment. andy haas of cleveland did the research on
> that as a grad student and most of us do that routinely. unless your
> progressive orthodontist is older than 80 i can't understand what
> palatal expansion has to do with being progressive.
>
> good luck
>
> cjr
Thanks. I was told this by his office. I would have no way of
knowing this, but his office should know better.But this orthodontist
does believe in tongue thrust therapy. That is progressive, I think.
Some orthodontists don't see any connection between tongue thrust and
straight teeth or between tongue thrust and lower jaw retrusion.
Although perhaps the latter is debatable, I have to guess that there
is a direct connection between elimination of tongue thrust and
maintaining straight teeth. The orthodontist you suggested routinely
sends patients for tongue thrust therapy.
However, he also uses functional appliances, and I have also been
told by two other orthodontists that functional appliances are
becoming a thing of the past for most orthodontists. But one person
who told me this strongly believes in jaw-breaking as the final
solution. The orthodontist you recommended only mentioned this as an
option.
Functional appliances are certainly preferable than the
breaking of the jaw to me. On the other hand, my son is a severe
gagger, and I was originally advised he would have a hard time with
functionals, by the orthodontist who has the most experience dealing
with him.
What I really want to know is it quackery than to believe that you
can use
the final prepubertal growth period combined with "a bag of light-pull
elastics"
to bring the jaws in line?. (per www.braceface). This seems more
logical than trying to pull the teeth through bones.
And is it quackery to believe that you can get by without the use
of headbands in many cases? This is what was originally presented to
me--either extract or do non-extraction with a high-pull headband worn
at least 14 hours a day to make room for two upper teeth. Just
yesterday a saw in ad in a local family magazine that made a big deal
out of treatment without headbands.
I know I am in over my head, but I want the best results possible.
I know there are many variables involved that any orthodontist cannot
talk about to the patient, but there are a lot of variables for the
parent as well. Headbands and functional appliances are both
difficult for the parent of a gagger, but I am more than willing to do
whatever is necessary.
I am not looking for the easiest solution, only the best. And I
have to guess. But I believe so do orthodontists, even though I know
you are all the best of the best scholastically. But I also believe
there are variables such as tongue thrust, that some orthodontists
completely overlook.
Thanks
alex
Alex Maas
But as you said previously, there is nothing extraordinary here. It
is only a combination of approaches learned through practice, courses,
and trial-and-error.
Some orthodontists do not know about or do not believe in tongue
thrust therapy. But many do, as the one you suggested to me for my
son.
There are alternatives to functional appliances, but lots of
orthodontists still use them.
A few orthodontists limit the use of headgear, but I believe
that is an art as much as anything else. Of course, if you extract
all the time, that would probably help. (I don't know if that's
true). Some orthodontists extract much more than others, and
certainly extraction is less commonplace now than it was years ago.
And, of course, there is the question about timing. Orthodontists
seem to be all over the place on this. But I don't think waiting for
the last pre-pubertal growth spurt is anything radical.
And there is a lot of things on that website I don't understand,
particularly about when exactly to start treament, but I suspect it
isn't that radical. But some orthodontists may wait too long, I
believe, although this doesn't happen as much any more. Or the parents
wait too long.
And I also suspect that some orthodontists may do second-stage too
early also. I read one criticism by an orthodontist about some
orthodontists who treat second stage way too early for one reason--to
make as much money as possible in the fastest time. Although this
orthodontist didn't have a problem with it if the practitioners are
honest, I doubt that any orthodontist would tell his patients that.
(I do not suspect that from the person you recommended).
These are just a combination of approaches that works for this
orthodontist, and other combinations work for other orthodontists. I
am just trying to find a similar approach.
Thanks.
Alex
Sabra Broock
this information really?? Alex, what are your thoughts on my post
(below)?
SB
On Sat, 04 May 2002 16:52:24 GMT, sa...@mesadrive.com (Sabra Broock)
wrote:
>Somethings disturb me deeply about this thread.
Jeff Genecov
practitionaers standpoint is that there are very few absolutes. It
must be frustrating and confusing for the patients also, who are
trying hard to do the right thing. But here's the deal: When you can't
get 4 orthodontists to agree on the treatment plan for your son, how
in the world can you, as a layman, gather and process enough
information to make the right decision? You'd have to do a lot of
journal reviews, evaluate each of the studies, compare the group
studied to your son, and then decide who was right.
Ostensibly, that's why you go to the orthodontist in the first place,
so that his or her education can do those things for you. So then
you're back in the viscious cycle of trying to determine whose
education and diagnostic skills to trust.
But what makes it harder is that in a growing child, there may be more
than one right answer depending on how much growth is left and how
compliant your son might be. And then, if lower jaw growth is less
than estimated, no answer will give the desired results.
At nine, it's probably too early to decide for sure on extractions
and/or surgery. All you can do is try to create the room, if you are
willing to be patient and are willing to pay for it, for the next 18
months or so, and then reevaluate about the time the last growth spurt
will begin. If the orthodontist monitors your son readily after the
first phase is over, then he should be able to estimate the growth
spurt approximately. And there are ways, using a lateral head x ray to
determine that timing fairly well.
Finally - beware of anyone who brags about their non extraction rate.
They should be determining extractions based on predetermined
treatment goals and how extraction will or won't allow them to meet
those goals, not trying to fit all the teeth in to justify their
philosophies. In fact trying to fit all the teeth in is the way the
original founders of orthodontics practiced over a century ago. The
reason extractions became popular was because non extraction therapy
was very often unstable- the crowding came back.
Jeff Genecov, DDS, MSD
Dipolomate, American Board of Orthodontics
a.m...@att.net (Alex Maas) wrote in message news:<1c647bc3.02050...@posting.google.com>...
Alex Maas
> I keep seeing posts come through from Alex. What is the point of all
> this information really?? Alex, what are your thoughts on my post
> (below)?
>
understand what that post referred to originally. My father is a
doctor and my family members were taught to avoid surgery when
possible, as much for the risk of being anesthetized as anything else.
My father once got in a terrible argument with the most prominent
oral surgeon in my area as my father believes that oral surgeons
should have an anesthesiologist on their staffs.
I am trying to give my child the best chance to correct the
retrusion of his lower jaw without surgery. It is hard for me to sort
out different treatment plans. That is why I am posting. I am sorry
if it bothers you. I cannot just blindly trust what any one
orthodontist tells me. If I have one opinion seconded then perhaps
that is enough.
I just want to make the best guess I can and then move forward with
that treatment. In a complicated case, I understand that a roomful of
orthodontists would come up with a roomful of treatment plans. I am
using this group to try to sort out the information.
Thanks for your concern.
Dave King
Responding about orthognathic surgical complications and their treatment
requires alot of time and bandwidth if we are to discuss everything in its
entirety here. Unfortunately I have neither, but a few points can be added.
Dont start thinking that everything is a disaster.
Research the topic but dont pretend that you will know more. Be willing to
accept an expert opinion. Get additional opinions if you arent satisfied. If
you have problems listening to your mechanic, accountant or parents, forget
about doctors. If you think that you know it all, not only are you in for a
suprise but a very unhappy time. Unreasonable expectations always lead to
disaster. Listening to the media does not make you an expert nor does
surfing the web and infact, those sensationalized topics you feel so bad
about hearing today will be replaced tomorrow with something even more
sensational.
Ask questions. Read the damn consent form. If you are unsure of the
questions to ask, they are right in front of you. The American Board of OMFS
has standardized consent forms that list the most common, minor and major
complications. How many times have questions been answered here when the
doctor should have received that call? No question is really unreasonable.
If you dont understand something, ASK about that one. If you dont like the
risks then the surgery isnt all that necessary. With regards to corrective
jaw surgery, this is purely elective nearly 100% of the time. No one dies
from having a malocclusion or an over/underbite.
Speak with the anesthesiologist. Anesthesia related complications are much
more severe, common and life-threatening than 'breaking the jaws'.
Ask other patients that had the same or similiar procedure but realize that
a biological response cannot be predicted accurately 100% of the time.
Everyone is different and problems can and do arise.
Even if something hasnt worked out entirely to a plan, my proactive patients
are always the ones that are a pleasure to treat.
If anyone is interested in a complications text, 'Complications in Oral &
Maxillofacial Surgery' is an excellent choice.
DAK
--
~~~~~~~~~~~~~~~~~~~~~
Oral & Maxillofacial Surgeon
Diplomate, American Board of Oral & Maxillofacial Surgery
HTTP://WWW.DEOMFS.COM
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Dave King
Most common minor complications: generally resolve with time except the last
one
prolonged pain
numbness
limited mobility
infection
relapse
More severe:
tooth loss
permanent numbness cheek, lip, teeth or tongue
malunion of the bones
implant failure
ankylosis (joint immobility)
Treatment depends on the severity of the complication.
Numbness is seldom permanent but can be corrected. Although true, nerve
grafts only get you back to about 70%.
Infection is obviously treated with antibiotics and that is usually
curative.
Physical therapy helps with mobility.
Nonunion of the bones, implant failure, ankylosis and relapse require
retreatment. Get that done earlier than later.
Most important aspect of postsurgical healing is patient compliance.
--
~~~~~~~~~~~~~~~~~~~~~
Oral & Maxillofacial Surgeon
Diplomate, American Board of Oral & Maxillofacial Surgery
HTTP://WWW.DEOMFS.COM
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