THE 1992 CONGRESSIONAL HEARINGS!

Date: February 1, 1990
To: The Record
Through: Lillian Yin, Ph.D. Director, Division of OB-GYN, ENT, Dental Devices (DOED), Office of Device Evaluation HFZ-470___ Louis Hlavinka, Chief ENT and Dental Devices Branch, DOED HFZ-470___
Subject: Procode Designation for Vitek 510(k) K823549/Proplast TMJ Interpositional Implant
From: Jane Yurawecz

The Vitek Proplast TMJ Interpositional Implant was found substantially equivalent to rubber sheeting laminated to polyester cloth. The predicate device is an unclassified pre-Amendments device, and when K823549 was reviewed, had not had a procode assigned. The procode ELE, assigned to subperiosteal implants, was used for K823549 because at the time it seemed to be the most appropriate procode assignment available.
The Dental Products Panel met April 21, 1989 for the purpose of making classification recommendations for TMJ implants. Prior to this meeting, a procode assignment for TMJ implants was established. The procode for TMJ implants is LZD.
Jane Yurawecz (121)
Mr. Levitt. I would ask Mr. Barry Sands to respond to that, please.
Mr. Sands. The basis for equivalence, the Vitek IPI in that 510(k) was based on the use of Silastic sheeting for the treatment of what they refer to as "trismus." That indication interpreted at that time, and the manner in which the literature reflected how that pathology was treated, demonstrated that Silastic sheeting could be used in the TMJ joint.
So, in he 510(k) for the Vitek IPI, there was a published article comparing Silastic sheeting to that of the Vitek IPI device, with the conclusions that the results were equal or better than the Silastic device.
Mr. Sanders. Mr. Benson, at the FDA panel meeting on TMJ implants in 1989, an FDA official suggested any manufacturer that made a TMJ implant of any material could market their device as substantially equivalent to preamendment devices. Is that still the position of the FDA today?
Mr. Sands. At present, if a manufacturer intends to market a device, they do have the avenue of premarket notification. In today's review of the 510(k), as Mr. Levitt referred to, the battery of information is much more intensive in what we require and would also include lengthy clinical studies to demonstrate equivalence.
Mr. Sanders. Mr. Benson, given the disaster with Teflon TMJ implants, I would hope at least FDA has learned something about the dangers of Teflon from this experience. How has the information from the Vitek implants influenced FDA's regulation of other Teflon implants?
Mr. Benson. I think that is a very good question and I think that we need to continue to emphasize internally what we learn from one set of products to another. I think this lesson has been going out in the last year or so, vividly, at least it has in my mind. I think that we have a number of strategies in place. I will just mention one concept. If you would like to go into more detail, I would ask Mr. Levitt to do that.
Simply put, I think what we have learned is that Teflon, silicone, same principle, when it is in a load-bearing situation, it may break down into particles. Those particles are likely to cause foreign body reaction. This is not a good thing.
Therefore, we have to systematically look at the performance characteristics of products that are made of these materials or these kinds of materials. It doesn't mean if they are in nonload bearing for other uses that they would be inappropriate. They may well be appropriate. But where there is clear information, then we will act to remove these products from the market with whatever vehicle is appropriate.
We can go further with this if you like.
Mr. Sanders. Mr. Levitt.
Mr. Levitt. If I could add one additional point, speaking specifically to the TMJ use. At the panel meeting that you referred to, the panel recommended that these kinds of products for TMJ, IPI, interpositional use, and so forth, be put in class III, which would require full extensive premarket testing under investigational device exemption and premarket approval application.
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We need to act of that recommendation and move that process forward.
Mr. Sanders. Mr. Benson, the FDA is currently considering approval of Polytef, an injectable Teflon product for use in the bladder to correct incontinence and related problems. Polytef is already on the market for treatment for vocal cords.
When the FDA advisory panel met to discuss this product, were they given the dangers of other Teflon products, such as the TMJ implants?
Mr. Benson. I don't know the answer. Perhaps Barry does. He is saying he doesn't either.
Mr. Sands. As far as specific to the TMJ use, no, they were not.
Mr. Sanders. They were not given that.
Mr. Sands. No.
Mr. Sanders. Given the history of problems with the Vitek implants, Mr. Benson, why isn't the FDA reconsidering the use of Teflon injections for any purpose and why would you consider a new kind of treatment that could potentially harm millions of people?
Mr. Benson. The answer to the first question is that I think it fits under the answer I gave you a few minutes ago, that we are going to look--I didn't want to get into great detail, but we need to look at, in the case of the vocal cords, what would not be a load-bearing use. The potential problem with this use of Teflon is that the particles are already there to start with. It is a paste and they have very small particles embedded in the paste.
The concern that is being shown is those articles can drift off and cause the foreign body reaction that we have been talking about. We have to look at that and have to see if there are foreign body reactions in that case. Let me make it hypothetical: The vocal cord case--if there is a better way of solving the problem, if the benefit of that use outweighs the risk of those foreign bodies, we will look at that.
In the case of load bearing, as I said, with load-bearing use, we already know, I think, that it is inappropriate.
In the case of the bladder use, I would only say that it really is inappropriate for us to discuss an open application publicly, but we are obviously considering what to do about that.
Mr. Sanders. Mr. Benson. Polytef is currently available for treating vocal cords which means it can be used for "off label" treatments that are not approved by the FDA. According to Dr. Nir Kossovsky, a professor at UCLA several years ago a 2-year -old girl had half her bladder removed as a result of problems of Teflon injections with this product.
Since that is not an approved use, would such adverse reactions be likely to come to the attention of the FDA?
Mr. Benson. We would hope they would. It is the only vehicle really that have to warn people. We take that information and we have really taken it upon ourselves to get out and issue alerts or issue warnings of one kind or another when this happens.
There is an obligation now, as a result of the new amendments, the law passed in November for users--that if such a procedure were done in a hospital, that hospital must report that reaction to the manufacturer and in certain cases, report to us.
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We have longstanding voluntary program where we encourage physicians, and Dr. Kessler is presently trying to beef up that program, agencywide, to get more adverse reactions reported to the agency.
At the same time, I am very anxious within our center to do a better job of focusing in on problems when things like that come to our attention so we can take action.
Mr. Sanders. Would it be fair to say most adverse reactions really are not reported? Would that be a fair statement?
Mr. Benson. We have a saying--not a saying, but an observation, that it is hard for us to know what the denominator is to things. That is the answer I would have to give to you. We don't know how many adverse reactions occur, so it is hard to know what the percentage is.
Mr. Sanders. Dr. Nir Kossovsky has published an article describing the severe persistent chronic inflammation, swelling, and pus resulting from Teflon injections. I know Dr. Kossovsky is on an FDA advisory panel for other devices, so I assume you are familiar with his work.
How has this article influenced FDA's position on Polytef Teflon injections?
Mr. Benson. I am not familiar with that work. I am afraid--I have to check, maybe some of our people are.
Mr. Sanders. Is there anybody on the panel who is familiar with that article?
[A summary of that article follows:}
(page 124)
In vivo characterization of the inflammatory properties of poly (tetrafluorethylene) particles
Nir Kossovsky,* David Millett, Saad Juma, ** Nancy LIttle, *** Preston C. Briggs, Schlomo Raz,**** and Eric Berg*****
Biomatetials Bioreactivity Characterization Laboratory, Department of Pathology and Laboratory Medicine, and +Division of Urology, Department of Surgery, UCLA Medical Center, Los Angeles, California and *American Medical Systems, Minnestonka, Minnesota

Suburothelial injections of particulate poly(tetrafluoroethylene) (PTFE) is becoming a widely accepted treatment for a number of urological disorders. Because little is known about the long-term histologic morphology of the injection site, this animal study was performed. Three populations, each consisting of two mongrel dogs, five New Zealand White rabbits, and 10 BALB/c mice, were injected with poly(tetrafluoroethylene) particulate in a glycerine carrier (Polytef Paste) and were followed for a period of 1 week, 3 months, 6 months, and 1 year. Mice received one subcutaneous dorsal injection each, rabbits received two subareolar injections each, and dogs received three subareolar injections each in addition to two periurethral injections. Histologic examination of the biopsy sites revealed a persistent chronic inflammatory reaction with progressive growth of the involved tissue volume. In addition to giant cells and macrophages, lymphocytes became apparent at 3 months and constituted up to 40% of the cellular infiltrate by 1 year. Plasma cells were also noted at the 1-year period in the rabbit model. The progressive growth of the inflammatory pseudo-tumors evoked by injected PTFE may compromise the long-term safety of certain urological procedures involving particulate PTFE.

INTRODUCTION

Periurethral injections of materials have been used to treat urinary incontinence since the 1930s. Over the last 20 years, dispersed particulate poly-(tetrafluoroethylene) under the trade name of Polytef** has become a material of choice for this procedure. Although this product generates a grossly satisfactory suburothelial mound, little is known about the long-term histologic
*To whom correspondences should be addressed at Biomaterials Bioreactivity Characterization Laboratory, Department of Pathology and Laboratory Medicine, UCLA Medical Center, 10833 Le Conte Avenue, Los Angeles, Ca 90024-1732.
**Present address: Division of Urology, University of California San Diego Medical Center, 225 Dickinson Street, H-897, San Diego, CA 92103.
***Present address: University of Texas, Health Science Center at San Antonio, Division of Urology, 7703 Floyd Curl Drive, San Antonio, TX 78284-7845.
** Mentor O&O, Hingham, MA, presently distributed by Mentor Corp., Goleta, CA
Journal of Biomedical Materials Research, Vol. 25, 1287-1301 (1991)
(C) 1991 John Wiley & Sons CCC 0021-9304/91/101287-15$4.00
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Mr. Benson. No. We will collect and get back to you if you will like.
Mr. Sanders. You will provide us with that information?
Mr. Benson. Yes, we will.
[The information requested had not been provided a the time of printing]
Mr. Sanders. Mr. Hobson.
Mr. Hobson. I would like to ask one question. Some years ago as a young businessman, I realized I was having great pain. I didn't know why. My oral surgeon told me--and my jaw drops out, still does. I won't do it for you here.
I went to a couple of oral surgeons and they told me that somehow-now, the best I can remember, the explanation was that somehow my jaw, one side is off from the other side--and they could do certain things but they weren't sure that would be effective and alleviate the pain; or I could live with it.
I could live with it dropping out and I have always been able to get it back in except for a couple times it scared the hell out of me when it didn't go back in--especially one time when the dentist couldn't get it in and I got it back in. It is rather frightening. I didn't have anything done.
My pain, either I live with it and I don't know it is there or it went away, but I didn't have anything done because he told me at the time what was going to happen, and they weren't sure that it would do any good.
We talk about the materials, but do we talk about who does the protocols? I am looking through some of the data. Fifteen to twenty percent, they are going to use, whatever, in this one position here. Where is the protocol and who says to the patient--who designs that? Is this something that comes out periodically?
FDA obviously has some stuff--these are the things you use when you decide that you are going to do it. But does the dental society? The dental schools? Who makes this decision and how does the patient know? When you are in pain, you will do almost anything to get rid of that pain or even if you think it will, because you--there is an excruciating pain that you just want to stop--it just drives you--it is really difficult.
I guess what I am concerned about is making sure that the patient gets the information and that the physician--the oral surgeon or whoever, or even the general practitioner looking at these people--where do they get the data that says, hey, these things are only used in extreme cases.
Who does that and whose responsibility is that for the ordinary patient?
Mr. Benson. I--let me try to address at least part of it.
Mr. Hobson. If you can't answer it, who should we ask?
Mr. Benson. Let me address part of it and perhaps Dr. Loe or someone from NIH would like to pick it up. I think what doesn't exist here and what we want to push are the proper experiments and clinical trials that will give us information about the appropriate use of these devices. That information hasn't been collected and hasn't been evaluated by the FDA. We need to do that.
That is what Mr. Levitt was referring to a few minutes ago when he said we have to get on with the classification and call for data
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processing. That hasn't happened. It needs to happen. I want to make it happen. That is a part of getting the answers to specific practioners and, in turn to specific patients so that they will know when a given therapy is appropriate and when it isn't.
That experimentation hasn't been done, at least not in a way that has been presented to the FDA. I should hake that caveat. I would defer to Dr. Loe.
Dr. Loe. What you are talking about, Congressman, are standards of care. I believe there are many channels of communication for the concept of standard of care in various areas of therapy. However, when it comes to questions of practice or malpractice, decisions remain with the States and the licensing boards.
In terms of communicating to professionals the optimal care for various diseases and disorders, that comes through the dental schools, through the curricula and the teaching and education program. Graduates learn new concepts and standards through continuing education courses, and through the professional societies. I believe that the American Association of Oral and Maxillofacial Surgeons have criteria for standard of care.
We at NIDR or NIH do not have the authority and do not try to encompass expertise in every area of dentistry. In the case of TMD's, we have recommended conservative approaches and reversible procedures whenever possible.
Mr. Hobson. Let me ask you this. I was chairman of health for 4 years in the State of Ohio. I was on the Health Committee for the full 8 years I was in the legislature. I can tell you from my experience, the dental boards and medical boards are not truly effective, in my opinion, at getting at this type of issue, because peer review, in my opinion, is very lax and it is not the best result.
Do you have any dialog with--and do you need assistance through legislative authority or through other types of things, to talk to the people that are making the curriculums, that are making the protocols that go across these countries to various States and say "Hey, we don't have enough data on this or we don't have he authority to talk to these people."
Is there not a dialog?
Dr. Loe. Sir, I think there is a dialog. I thin the NIDR and the American Association of Dental Schools, for instance, have excellent communications, so that dental schools are very much aware of the current frontiers in oral health research and science. That information is incorporated into both the predoctoral and postdoctoral curricula.
With regard to the practicing profession, there is less structured and probably a less controlled type of information that flows from us and from others into the professional societies and the specialties and into continuing education channels.
Mr. Hobson. Let me ask you one other question. This was some data I had trouble getting when I was in the State legislature, not in just this particular field. And so I am not just picking on this area.
But you can't find out very readily in a State, for example, how many of these procedures are being done--you may find out where there is public money involved, how many are being done. But in the private sector where there are private funds, it is very difficult
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to find out the number of these procedures that are being done, whether it be this procedure or some other procedure.
I don't care if it is an OB/GYN or whatever you are talking about. The data that comes back doesn't tell you how many in Cleveland, OH, are being done, or how many in Cincinnati, or wherever. And you try to get that data to find out who is utilizing this, who may be over utilizing. You can't find that stuff out.
Dr.Loe. There is no complete system. There are other areas probably more important than the ones we are talking about, like genetic diseases.
Mr. Hobson. That to me is something our Chair here ought to be, in my opinion, looking at--the collection of data, not just on this issue, but other issues so we know where there is overutilization. You can't find out who is improperly doing things very well.
Mr. Sanders. Mr. Hobson, if I could jump in.
Dr. Loe. Mr. Hobson, could I add one more source. It could at least get a partial solution to these problems of reporting.
We can obtain data from the National Center for Health Statistics on hospital discharges. Most of these procedures are done in hospitals, so at least we get a sense of how many open surgeries of the TMJ have been done in a particular hospital. What is happening out in the practices, in the outpatient environment, there is no systematic way of knowing.
Mr. Hobson. OK.
Mr. Sanders. I think Mr. Hobson raises perhaps one of the crucial issues of this whole discussion. Perhaps if you had gone to another oral surgeon, you might have been treated very, very differently and there is not a base of information for those physicians to make a decision.
Mr. Hobson. That is not only true in this area. To me, that is one of the basic difficulties we have in the whole health care arena in looking at data and looking at utilization and trying to now what works and what doesn't work. What particular groups of specialties are effective--I mean, I happened to get into some of this stuff in the State.
In one part of Ohio, if you appeared to look like a woman, there was a certain procedure you were going to get in that part of Ohio. There was tremendous overutilization in that part of the State where it appeared. Again it was only where public money was involved and we could get the data. To me, that is a real health care problem in this country. We don't know enough about what is happening and who is establishing the protocols.
When you go into some physicians' offices, they are so inundated with papers that come in the door on not only procedures, but on types of medications and other stuff to use, that you don't know--they don't know many times to keep up. It is very difficult.
Mr. Sanders. I would agree with you. I don't know if you remember, last week, in approving the NIH authorization, we passed a national cancer registry effort, which, in fact, I introduced into the House just for that reason. We don't have the national statistics, I think you are exactly right.
Mr. Benson, let's continue if we might.
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The FDA first heard reports with problems with Teflon TMJ implants through medical device reporting [MDR] systems in 1986, but according to FDA memos, the first reports were ignored. It took 2 years for the FDA to take these reports seriously. Meanwhile, thousands of patients had these devices implanted.
Why did it take so long?
{A memo describing the MDR's follows:]
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I N T E R O F F I C E M E M O R A N D UM

Date: 13-DEC-1988 09:01 am EST
From: Segerson, David A. DAS
Dept: ODE-DOED
Tel No: 301-427-8185
TO: See Below
Subject: Vitek Proplast TMJ Implants

Dr. Yin asked me to send you a brief overview of the problems we are encountering regarding the subject device.
By TMJ implants, I am referring to any of three devices implanted in the
temporomandibular joint (TMJ). These three are (1) an interpositional
implant, (2) a prosthetic condyle, and (3) a prosthetic glenoid fossa. The
latter two represent artificial replacements for either side of the TMJ. The
interpositional implant is a pad used as an insert by itself or in conjunction
with the other two.
Vitek submitted a 510(k) (K823549) for an interpositional implant made of
Proplast, claiming substantial equivalence to silicone rubber sheeting
laminated to polyester cloth. Although such a device had not been classified.
Vitek demonstrated that the silicone product was indeed a pre-Amendments
device and had been used for the same indication. No 510(k) has been submitted for the condylar or glenoid fossa implants.
Proplast is Vitek's trade name for teflon, impregnated with carbon fibers or aluminum oxide. Data submitted with the 510(k) included a small clinical
study which showed that the Proplast device was better than the silicone device, so we determined the Vitek interpositional implant to be
substantially equivalent.
Problems first came to our attention in an MDR in April 1986. The initial
report contained no details and was dismissed. However, subsequent MDRs and PRPs provided evidence that there were serious problems -- problems
that are now appearing in the literature.
These reported problems all involve disintegration of the implants, foreign
body reactions, and resorption of the underlying bone. Physicians, with whom we have spoken, tell us that these adverse effects are asymptomatic
until they have progressed significantly and that many implant patients will
have to be explanted. Some physicians say all patients will have to be
explanted.
The Office of Compliance ordered a directed inspection of Vitek and DOED/ODE provided several specific questions to be asked. The EIR
resulting from that inspection has been reviewed by our staff and we have
sent our comments and a request for additional information back to O. C.
In addition, yesterday we asked O.C. to arrange a risk
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assessment meeting to plan follow-up action. We are recommending that
Vitek cease distribution of all TMJ implants and that Vitek notify physicians
that patients should be recalled for examination. We have heard
unofficially that Vitek has already ceased distribution of the interpositional
implant, but continues to distribute the glenoid fossa and condylar implants.
Please let Dr. Yin or me know if you have additional questions.
Dave
Distribution:
TO: Barnett, Mark ( MXB)
CC: Yin, Lillian ( LLY )
CC: Sheridan, Robert L. ( RLS )
CC: West, David L. ( DLW )
CC: Singleton, Darryl G. ( DGS )
CC: Yurawecz, Jane ( JFY )
CC: Sands, Barry E. ( BES )
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Mr. Benson. I am not aware when the first MDR reports came in. Maybe Mr. Niedelman is. As I looked over the background for this hearing, what hit me was that it was a study that was done, I think in Ohio--Iowa, I am sorry--that really brought it to our attention and caused us to focus on the problem.
Do you have any information on the MDR reports, Steve?
Mr. Niedelman. The MDR reports you are referring to were received in April 1986 and we understood them to be malfunctions at that time of the device. They were not high priority problems, although a directed inspection at the firm did follow, several months thereafter, that captured MDR as well as other issues at the plant.
Mr. Sanders. Is it fair to say this information was quite public?
Mr. Niedelman. MDR reports are, yes.
Mr. Benson. If I may make a further point on that. In retrospect, I wish we could have acted more swiftly, but you can say that, you know, for just about any problem that emerges. As it first comes to your attention, you only see limited data and that data has to be reinforced for you to realize you have a problem. Retrospectively, I wish we had acted more swiftly.
Mr. Sanders. In November 1986, the company acknowledged problems when they sent a "Dear Doctor" letter regarding bone loss caused by the implants. Moreover, in November 1987, the company revised their failure rate from 8 percent to 17 percent. Do you agree with that?
Mr. Levitt. That is correct.
Mr. Sanders. Eventually, Vitek's Teflon implants were removed from the market, primarily because of an avalanche of lawsuits. Last fall, the FDA finally published a public health notice warning about the problems with Teflon implants, and yet we have heard testimony that many patients and doctors still know little about the dangers. This is the point Mr. Hobson was making.
In some cases, people with these implants may not realize that an immune reaction might be creating a hole in their skulls, leaving the brain unprotected. What is FDA planning to do to help notify patients?
Mr. Levitt: First, it is important to point out that the FDA has made a number of attempts and very good faith attempts to try to notify as many patients as possible. This includes a safety alert to health professionals that was issued near the end of 1990, followed by a press release which would go to lay press, as well, in January 1991.
We initiated, as has been acknowledged, a widespread patient notification program, and without belaboring it, let me say in that program, in the fall of 1991, we used publications that reached over 50,000 health care practitioners. We utilized 40 professional organizations, 8 TMJ support groups, and over 500 consumer groups to try and reach as many patients as possible.
We tried to use this multiplier effect which we felt was the most advantageous way to reach people. Clearly, it has not been enough. We are undertaking additional steps as well. We are going to be sending notifications to dentists across the country and are developing a strategy to deal with that.
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Mr. Sanders. Would it be fair to say at this point, despite all your efforts, they have not worked?
Mr. Levitt. They have not worked as much as we would like.
Mr. Sanders. Do you want to be more specific on exactly what you will be doing to make sure they do work?
Mr. Levitt. The specifics we are preparing to undertake are still in the final stages
of development but they include, for example, a direct mailing to over 100,000 dentists in the country.
Mr. Sanders. These, presumably, are all the dentists that would be performing these procedures.
Mr. Levitt. All the dentist in the country, so we don't have to try to figure out which ones are using it and which ones are not.
Mr. Hobson. What about hospitals?
Mr. Levitt. Yes, hospitals have been part of that already.
It has been, I think, frustrating for us also that the response has not been as great. As I said, we have tried to utilize a number of mechanisms and are going to keep upgrading that until we achieve an acceptable level.
Mr. Sanders. Can we agree we have a serious problem, that efforts up to now have not yet succeeded, and our goal is to make sure every patient has all available information to understand the risks involved?
Mr. Levitt. I think we can certainly agree the efforts taken so far have not achieved the degree of success we need to. We need to do much more-we can have a goal to reach every single patient. I am not sure, realistically, that will ever be achieved. We will make every effort possible toward that goal.
Mr. Sanders. Patients have to pay to enroll in the TMJ implant registry and very few have done so. I think we can all agree this registry has not been a success thus far. If the FDA wants to provide information to implant patients in the future, there is no way to contact them directly; isn't that correct?
{An FDA document describing TMJ implants and the registry follows:]
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Vitek Patient Notification Program - Patient Q & A page 1
SAMPLE QUESTIONS and ANSWERS
about TMJ IMPLANTS

How can I find out Contact your implanting surgeon and/or hospital for the
what kind of name of the implant. If you were reimbursed by your
implant I have? health insurance company, they should also have the
information.

What should I do Contact your implanting surgeon or another oral maxillo-
if I have a Vitek facial surgeon to schedule a clinical examination and
TMJ implant? have an MRI or CT examination if you have not had one with in the last six months.

What is the Vitek implants are composed of Proplast and other
problem with the materials. These materials have been shown to break
Vitek TMJ apart or fail to function because of the forces caused by
implants? chewing.

Because the materials break apart (fragment), it may be
very difficult to remove all particles and some symptoms
may persist after surgical removal of the implant.
Additional medical treatment may be required.

What are the Symptoms may vary widely, and in some cases, may
common mimic sinus infections, ear infections, an/or loss of
symptoms hearing. In some cases there are no symptoms even
associated though the implant is failing.
the Vitek TMJ
implants? The most common symptoms are:
*pains near the ear on the side where the implant has
been placed and/or headaches; *limited lower jaw movement alone with a change in the bite or the way the teeth meet;
*joint noises in the jaw;
*nausea, dizziness, or ringing in the ear; and,
*increased sensitivity in the head, neck and shoulder.
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Vitek Patient Notification Program - Q & A page 2
If I don't have any Yes, Changes, such as bone loss, can occur even
problems with the without symptoms. These changes can only be found
implant, should I through careful medical evaluation.
still make an
appointment?

What should I do Contact your implanting surgeon or the surgeon who
if I have the now treats you. Schedule an appointment for a
symptoms clinical examination and a CT or MRI examination.
described earlier? Screening radiography (limited skull radiography and
tomograms) may be needed to determine if metal was used with some of the implants. For nonmetallic
implants (those without metal), MRI will help to discover
if there are signs of foreign body giant cell tumor
responses, implant break down, and/or destruction in
bone and/or soft tissue. A CT scan may be used under
special circumstances or when an MRI is not
advisable. Depending on the results of these
examinations, it may be necessary to remove the
implant as soon as possible. Speedy removal will
prevent further damage.

What if I'm not Not necessarily, but you should be followed routinely.
having However, if there is evidence that the implant is
symptoms, breaking up, the implant should be removed if possible,
should I have the even if you have no symptoms. If you are experiencing
implants removed pain or a change in your bite, this may be a sign that
now to avoid the implant is breaking up and removal should be
future problems? considered. Contact your implanting surgeon or the
surgeon who now treats you.

What alternatives The use of the patient's own bone grafts have shown
to the Vitek TMJ success in certain cases. There are other options
implants are available, but for the best option for you, please consult
currently with your implanting or oral maxillofacial surgeon.
available?

If I've had my No, but if you experience any of the symptoms, make
implant removed, an appointment.
should I still make
an appointment
with my
physician?
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Vitek Patient Notification Program - Patient Q & A page 3

If I've had my Yes, enroll in the registry. There may be situations
implant removed where because of the difficulty in removing all the
do I need to enroll particles, soft or bone tissue changes may occur.
in the registry? The registry will allow you to receive additional
information should it become available.

What is the cost There is an enrollment fee of $20. On your enrollment
of joining the anniversary date (12 months after you first join the
registry? registry), there is an a $10 renewal charge to maintain
your records.

Why do I have to Ordinarily, Vitek, the manufacturer of these TMJ
pay the registry devices, would be responsible for the patient notifica-
fee? tion program. However, the company has declared
bankruptcy and has been unable to finance this
program.


How can I find an Call your local or State dental society or a major
oral surgeon for medical or dental school in your area.
consultation?

Where do I sign There are two places for your signature on the form:
on the enrollment
form? *To grant permission to Medic Alert to release your
name to the FDA, sign in the box at the bottom of the
registry form.
*To enroll in the International Implant Registry (IIR),
sign in the space under item number 7.

You should know that granting permission to Medic
Alert to provide the FDA with your name and address does not automatically enroll you in the International
Implant Registry (IIR).
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Mr. Levitt: That is correct.
Mr. Sanders. In April 1989, an FDA advisory panel recommended that TMJ disc replacements should be a class III device, which would require manufacturers to submit proof that their implants are safe and effective. The panel was unanimous that the FDA consider this a high priority, because of the damage that patients were experiencing. This would have applied to all TMJ disc replacements made of silicone, Teflon, or other materials.
How is it that more than 3 years later, the FDA has not yet published a proposed rule in the Federal Register?
Mr. Levitt. First let me say, as you referenced earlier, that we fully recognize the need to move forward and move forward swiftly on that.
I think that in retrospect there are a number of factors that have gone into the time. One is that, of course, the particular Vitek IV (a) product was withdrawn from the market by the company.
Second, we have a large number of regulatory steps vis-a-vis the company involving multiple inspections, multiple seizures, the patient notification programs that we have talked about briefly, and so on. We also, of course, in addition to this particular product within the center, deal with, of course, a wide variety of products. We receive over 10,000--between 10,000 and 16,000 applications per year that all need to be dealt with.
And we need to balance all the different functions, and responsibilities that we have. We try to balance them as best we can. Often, in retrospect, it is clear that some actions should have been readjusted on the priority list.
Mr. Sanders. The fact remains, 3 years have come and gone and we still do not have a proposal for the Federal Register.
Mr. Benson. I think this hearing has focused attention on this issue. It certainly has focused my attention. We will get that out as rapidly as we can. I can't control it once it gets out of the center, but we will have it out of the center by the end of this month.
Mr. Sanders. Thank you. I have a copy of the draft of this proposed rule, which is apparently not ready for publication in the Federal Register. For at least 5 years, FDA has known how badly some patients have suffered from the Vitek implants and there have also been similar concerns about the Dow Corning silicone implants, about titanium implants, and other implants for many years.
Why is it taking so long to get a proposed rule?
Mr. Levitt. Is that a different one than the one you just referred?
Mr. Sanders. It broadened the questions a little bit.
Mr. Levitt. I believe it was the same document, the same answer would apply.
Mr. Sanders. I guess the point is, there is concern about all these implants.
Mr. Benson. It may be worth it, for the record, just to reference the classification process itself. The FDA faces roughly 70,000 manufactured products, 70,000. Back when the device amendments were passed, there were roughly 1,700 or 1,800 product types, individual product types. Each of these needed to be classified, going
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through a rather rigorous and drawn out classification process that included panel discussions, proposals, final regulations, and so on.
That process has taken us a long time. I think that we are in the final stages now of collecting, if you will, some of the products that were not earlier classified. I think your question refers to a collection of those.
Mr. Sanders. Just out of curiosity, do you feel you have the staffing to respond as rapidly as you should be responding?
Mr. Benson. That is always a difficult question to answer. I think that when you think about having--and I feel overwhelmed sometimes--70,000 products out there, each of which has potential for doing harm, and our job is clearly to protect the public and that is what we want to do--we have got to sharpen our ability to be able to collect information as it comes to us, as we were talking about earlier.
We have to be able to focus attention of that information, analyze it, figure out whether there is a problem, that there is some kind of corrective action that can work. We get it out there. Is it enforcement action? Do we need to take a product off the market? Do we need to warn physicians or patients? If we had more resources, we could do better at that. There is no question in my mind. We are trying to do the best we can within the constraints we have.
Mr. Sanders. The problem here is that new technology is exploding. For somebody suffering who is in pain, it doesn't do them any good to hear you have 70,000 devices to look at. The question is, we, as the U.S. Government have a responsibility to deal with these problems. I am not sure I have gotten a clear answer other than we all know there are a lot of devices out there.
Can we respond as rapidly as we should be responding to protect the public?
Mr. Benson. I think we constantly try to improve what we do within the resource constraints that we have. If we had more resources, we could do more, there is no question about that.
Mr. Sanders. Even if the proposed rule that we were talking about was published tomorrow it would take months for that rule to be final; and then, by law, the FDA would have to wait at least 30 months to require the manufacturers to submit their safety data. So we have to wait at least 4 to 5 years before the FDA actually reviews safety data; isn't that correct?
Mr. Benson. If we follow the procedure--you have accurately portrayed, the law requires us to go through from classification to calling for data for class III preamendments devices.
For some of the products contained in that recommendation, it might be possible to go more swiftly. If we determine that a product was not on the market prior to 1976, then we could make a determination that a PMA [premarket approval application] was required right away. But if a manufacturer, the sponsor, hasn't collected the data on that product, they are not going to be able to submit it to us. It is going to be, at best, many months.
Mr. Sanders. In the meantime, the most commonly used TMJ implants are probably the ones made of silicone by Dow Corning. These are grandfathered devices as well. Has the company ever
(138)
provided research evidence to FDA that these devices are safe and effective?
Mr. Benson. Mr. Sands should answer that.
Mr. Sands. Since the Silastic implant was out there prior to 1976, and demonstration of that device was out there prior to 1976, it has legal status to be marketed. Subsequently, we did receive premarket notification for a modification of that device, but the only modification of that device was a small geometrical change in that device and, thus, did not require extensive clinical studies to demonstrate the safety and effectiveness.
Mr. Sanders. Just for the record, then, what we are saying is that the company has never provided research evidence to the FDA that the most commonly used TMJ implants are safe and effective. Is that a fair statement?
Mr. Sands. Within the context of the applications I have seen, they have not.
Mr. Benson. In fairness, they have never been required to.
Mr. Sanders. We understand that. In fairness, also, I think for most lay people, this would indicate a real problem.
We heard this morning that during the 1980's there were many published studies showing these silicone TMJ devices cause many of the same problems as the breast implants and Teflon TMJ implants, especially the giant cell foreign body immune response.
Dow Corning responded by recommending their Wilkes implant as a temporary device for only 1 to 2 months; is that correct?
Mr. Sands. In the 510(k), is that what you are referring to within the application.
Mr. Sanders. In general.
Mr. Sands. In the application, they notified us that is was limited to 4 months of implantation. Currently, it is 1 to 2 months.
Mr. Sanders. Currently, they are recommending 1 to 2 months.
Mr. Sands. Yes.
Mr. Sanders. However, their silicone sheeting, which is sometimes also used for TMJ implants, has no such warning and may still be used permanently; isn't that correct?
[The instructions for the Wilkes TMJ implant and the silicone sheeting follow;]
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`

Subj: CH#16

SILASTIC (R)
brand
Temporomandibular
Joint Implant H. P.
(Wilkes Design)

INSTRUCTIONS FOR USE
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DESCRIPTION
The SILASTIC (R) Temporomandibular Joint Implant H. P. (Wilkes Design) is a temporary implant developed for use in treating internal derangements of the temporomandibular joint. The implant was designed to be used in disc removal procedures. Its principal purpose is to prevent formation of postoperative adhesions by maintaining joint recesses. Additionally, it can be used to protect exposed bearing surface cartilage and encourage resurfacing of eroded cartilage. In such procedures, the implant is placed interpositionally in the joint. A small stem on the implant is allowed to extend through the joint capsule and is secured just beneath the skin to facilitate easy removal. The implant should be removed from one to two months postoperatively in meniscectomy procedures. Removal is accomplished during a simple out patient procedure under local anesthesia.
The SILASTIC (R) Temporomandibular Joint Implant H. P. (Wilkes Design) is fabricated from implant-grade high performance silicone elastomer and is available in three sized to adequately meet various operative requirements.
HP
The letters HP in the product nomenclature indicate that the implant is fabricated from implant-grade, high performance silicone elastomer. This elastomer shows greater resistance to tear propagation than conventional silicone elastomer. In addition, this elastomer has excellent biodurability and biocompatibility.
Diagnosis and Staging
Experience has shown that most cases of internal derangement can be categorized into five groups according to disease stage. Moreover, the categories are equally applicable from the standpoint of clinical, arthrographic and surgical/pathological diagnoses. The descriptions of each stage are as follows:
1. Early stage
a. Clinical: No significant mechanical symptoms other than reciprocal clicking (early in opening movement); no pain or limitation of motion.
b. Arthrographic: Slight forward displacement, good anatomical
*Clyde H. Wilkes, M.D., Minneapolis, Minnesota
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SILASTIC (R) H.P. SHEETING

DESCRIPTION
SILASTIC (R) H.P. Sheeting (Reinforced, Radiopaque is a flexible, medical-grade H.P. silicone elastomer sheeting designed for implant applications, surgical repair procedures and laboratory uses. SILASTIC (R) H.P. Sheeting is fabricated from a Dacron (R) reinforced, medium durometer(R) H.P. silicone elastomer, that is visible upon X-ray evaluation.
ADVANTAGE
*Made from medical grade H. P. silicone elastomer, a material highly resistant to tearing and suture pull-out
*Dacron-reinforced sheet eliminates stretch and permits suture attachment.
*Easily cut to modified shape
*Adaptable to combined use with autogenous, homogenous and preserved tissue
*Highly permeable to gases
*Will not adhere to adjacent tissues, permitting easy removal is desired, with minimal trauma
*Autoclaveble without change in consistency, softness or other inherent properties
*Excellent biocompatibility

HOW SUPPLIED
Silastic(R) H.P. Sheeting (Reinforced, Radiopaque) is supplied non-sterile and individually packaged as follows:
Cat. No. Description
2403-0020 One ea. 6" x 8" x.020" Thick (non-sterile)
2403-0030 One ea. 6" x 8" x .030" Thick (non-sterile)
2403-0040 One ea. 6" x 8" x .040" Thick (non-sterile)
2403-0080 One ea. 6" x 8" x .080 Thick (non-sterile)

*Dacron is a registered trademark of E. I. DuPont De Nemours Co.
**Shore A durometer of approximately 50.
SILASTIC(R) The registered trademark is the brand name for Dow Corning's silicone elastomer products and materials. Only Dow Corning may identify its products with the trademark SILASTIC(R). The word is not a synonym for silicone elastomer and it is improper to use it without capitalization or to use it to identify another manufacturer's material. Since it may no be used by others, the appearance of the word SILASTIC(R) on a medical product assures that it is of the highest quality and comes only from Dow Corning.

INSERT PICTURE

APPLICATIONS
*For surgical repair of fractured orbital floors.
*As a protective sheathing to help facilitate neural-regeneration and tendon healing
*As an anchoring device for hemodialysis shunts.
*For various laboratory uses (E.G. gaskets and stoppers for microbiological closures and septa in gas-liquid chromatography)
*As a protective sheathing to help facilitate osteogenesis.
*For surgical repair of urethral strictures and duramater.
*To prevent synostosis following corrective surgery for cranial fusions and forearm fractures.
*To prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus or related TMJ dysfunctions such as meniscus displacement. (Note: It is recommended that SILASTIC(R) H.P. Sheeting not be used as a permanent interface in the presence of degenerative bone changes or chronic bruxism.)
*For fabricating components in artificial hearts.
DOW CORNING WRIGHT
5677 Airline Road
Arlington TN 38002
(901) 867-9971 (142)

SILASTIC (R) H. P. SHEETING
Radiopaque Implant Material
Silastic(R) H.P. Sheeting is fabricated from medical-grade high performance silicone elastomer and contains BaSO4, to provide radio-opacity. This material is one of the most inert implant materials available. However, dust, lint, talc, skin oil deposited in handling, and other surface contaminants can evoke foreign body reactions. Extreme care must, therefore, be taken to prevent recontamination once these deposits are removed
HIGH PERFORMANCE SILICONE ELASTOMER
The letters H. P. is the product nomenclature indicate the implant material is fabricated from medical-grade high performance silicone elastomer. This elastomer shows greater resistance to tear propagation than conventional silicone elastomer.
STERILIZATION
The Silastic(R) HP Sheeting is supplied non-sterile.
The following sequential steps are recommended to clean and sterilize
1. Scrub thoroughly with a clean, soft-bristled brush in hot water-soap solution to remove possible surface contaminants. Use a non-oily mild soap such as Ivory Flakes or Ivory bar soap. Do not use synthetic detergents or oil based soaps, as these may be absorbed and subsequently leached out to cause a tissue reaction.
2. Rinse thoroughly with distilled water.
3. Wrap in a lint-free cloth or place on a clean open tray, and autoclave by one of the following methods
a. High speed instrument sterilization 10 minutes at 270 deg F (132degC)
b. Standard gravity sterilization-30 minutes at 250deg F (121degC)
c. Prevacuum high temperature sterilization--either 10 minutes at 270 deg F (132degC), or 30 minutes at 250deg F (121degC).
NOTE
Gas sterilization is not recommended for silicone elastomers. Should this be the only available method of sterilization, it is essential to avoid inserting the implant material within 10 days of gas sterilization; otherwise severe tissue reaction might ensue from the in vivo release of the ethylene oxide and validation of safety is the user's responsibility.
Caution
Federal (United States) law limits this device to sale by or on the order of a physician.
Note
The purchaser should thoroughly test products made in part or otherwise incorporating Silastic(R) H. P. Sheeting to determine the acceptability of the product's performance in a specific application.

CAUTION -- WEAR PARTICLES
In some patients, wear particles from silicone elastomer implants used in bone and joint reconstruction may participate in, or exacerbate synovitis or bone cyst complications in contiguous bone. These complications have been reported to occur more frequently with scaphoid and lunate replacement implants. Contributing factors have been reported to include the use of implants in physically over-active patients, associated preoperative pathology such as cysts and degenerative changes, intraoperative temporary stabilization with K-wires, uncorrected associate carpal collapse or instability, subluxated implants, implant over or undersizing and uncorrected or recurrent deformity. Synovitis and bone cyst complications seldom occur with flexible hinge implants such as the finger, wrist, hammertoe and flexible hinge toe implants.
WARNING
POTENTIAL FOR COMPLICATIONS
A thorough discussion of all potential complications that may be associated with implant reconstructive procedures is not possible in product labeling. It is the responsibility of each surgeon using implants to consider the clinical and medical status of each patient and to be knowledgeable about all aspects of implant procedures and the potential complications that may occur in each specific case.
Implants are mechanical devices that can be worn away, fatigued, or broken. An implant site may become infected, painful, swollen, or inflamed. Strenuous implant loading, excessive mobility, the presence of articular instability, implant oversizing, and patient over-activity or misuse increase the complications including wear or fracture of the implant and particle formation. Excessively mobile joints are generally less stable and an implant alone cannot provide long-term stability in a joint that lacks functional stability: complications necessitating revision surgeries are thus more frequent in unstable joints. The status of the adjacent bone and soft tissue may be inadequate to support the implant, or may deteriorate in time resulting in instability, deformity, or both. The benefits from implant surgery may not meet the patient's expectations or may deteriorate in time, necessitating revision surgery to replace the implant or to carry out alternative procedures. Revision surgeries with implants are not uncommon. Therefore, surgeons must balance many considerations to achieve the best result in individual patients. Providing each patient scheduled for implant surgery with documented counseling of potential complications is required.
ADVERSE REACTIONS
There have been reports in literature suggesting a relationship between silicone implants and a broad spectrum of connective tissue disease, systemic illness, and auto-immune phenomena, suggesting immunological responses to silicone implants. If any of these possible reactions are suspected and the response persists, removal of the implant should be considered.
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DOW CORNING MEDICAL
SILASTIC(R) MEDICAL GRADE SHEETING
(CAT. #500, 501, 502)
DESCRIPTION
SILASTIC(R) Medical Grade Sheeting is a flexible, translucent, silicone elastomer sheeting material designed for medical and laboratory applications.
Three types of sheeting are available in a variety of thicknesses and flexibilities, including:
*Nonreinforced - made from a medium-durometer (50 Shore A) silicone elastomer in five thicknesses
(0.005, 0.010, 0.020, 0.040, and 0.060 inch)
*Reinforced - made from a medium-durometer (50 Shore A) silicone elastomer in four thicknesses -reinforced with Dacron(R) plain weave fabric (0.007-inch sheeting thickness). and Dacron tricot fabric (0.020-, 0.030-, and 0.040-inch sheeting thickness)
*Nonreinforced extra film - made from a high-durometer (70 Shore A) silicone elastomer in three thicknesses (0.050, 0.080, and 0.120 inch)
Advantages of SILASTIC Medical Grade Sheeting include:
*Body tissue and fluids are minimally reactive to sheeting
*Dacron-reinforced sheet minimizes stretch and permits suture attachment
*Easily cut to size and shape
*May be bonded to itself or synthetics (Dacron, tricot) with silicone adhesive (SILASTIC(R) Medical Adhesive Type A)
*Highly permeable to gases
*Will not adhere to adjacent tissue, permitting easy removal with minimal trauma
*Autoclavable without significant change in physical properties
APPLICATIONS
The purchaser should thoroughly test products made in part or otherwise incorporating SILASTIC Rx Medical Grade Sheeting to determine the acceptability of the product's performance in a specific application.

SILASTIC Medical Grade Sheeting has been used for the following applications:
*Protective sheathing to help facilitate neutral regeneration and tendon healing
*Anchoring device for hemodialysis shunts
*Various Laboratory uses, such as gaskets, and stoppers for microbiological closures, and septa in gas liquid chromatography
*To prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus
*Insulating material for electrostimulation devices
*Temporary covering for a prenatally ruptured omphalocele during staged repair
CAUTION
There have been case reports of thickened neomembranes encapsulation of silicone sheeting used in dural repair, with delayed subdural hemorrhage and brain and spinal cord compression.2
INSTRUCTIONS FOR USE
Cleaning
Scrub thoroughly with a clean, soft sponge or soft bristled brush in a hot water and soap solution to remove sodium bicarbonate (which is dusted on the sheeting surface to facilitate handling), skin oils deposited in handling and other possible surface contaminants. Use a nonoily cleaner or mild soap. Do not use synthetic detergents or oil-based soaps, as these soaps may be absorbed and may subsequently leach out to cause tissue reaction. Rinse copiously in hot water and follow with a thorough rinse in distilled water.
STERILIZATION
Steam
Wrap in nonlinting material or place in a clean, open tray. Autoclave by one of the following methods:
*High-speed instrument (flash) sterilizer - 10 minutes at 132 deg C (270degF) and 30 psi (2kg.cm-2) *Standard gravity sterilizer - 30 minutes at 121 degC (250degF) and 15 psi (1 kg/cm2)

1-REGISTERED TRADEMARK OF E. I. du Pont de Nemours & Co.
*1992 Dow Corning Corporation. All rights reserved
2-Reference Ng. T.H.K., et al. An Unusual Complication of SILASTIC(R) Dural Substitute: Case report 1990 Neurosurgery 27 (3):491-493
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RADIATION
Post-radiation testing of sheeting and elastomer reveals minimal physical property changes at 2.5 megarads exposure level, with tensile strength and elongation essentially unchanged. Minimal but measurable increases were seen in durometer and tensile modules at 200 percent elongation. Such property changes are similar to those seen when the sheeting is subjected to additional oven post-curing.
ETHYLENE OXIDE
Ethylene oxide (ETO) will not deteriorate SILASTIC(R) Medical Grade Sheeting. However, sterilization by ethylene oxide is not recommended unless sufficient data is available regarding the time required for complete outgassing of residual ethylene oxide and other ETO by-products from the specific system employed.

BIOCOMPATIBILITY
Biocompatibility tests, which meet or exceed UPS Class VI Plastics Tests, have been performed on the elastomer from which SILASTIC Medical Grade Sheeting is made and shown in Table 1.
Every production lot of elastomer is tested for levels of trace metals, and for absence of cytopathic effects using a tissue cell culture test (direct contact method).

TABLE 1: Biocompatibility of SILASTIC Medical Grade Sheeting

Test Results
Hemolysis, percent.................................................................<1
Pyrogenicity...........................................................................Nonpyrogenic1
Intracutaneous Injection...........................................................Nonirritating1
Systemic Injection...................................................................Nontoxic1
Skin Sensitization...................................................................Nonsensitizing1
Intramuscular Implant
10 days............................................................................Nonreactive1
30 days............................................................................Nonreactive1
90 days............................................................................Nonreactive1
Cell Tissue Culture..................................................................No Cytopathic Effect
*Based on comparison with defined USP negative controls

SHIPPING LIMITATIONS
None

The information and data contained herein are based on information we believe reliable. You should thoroughly test any application and independently conclude satisfactory performance before commercialization. Suggestions of uses should not be taken as inducements to infringe any particular patent.

STORAGE AND SHELF LIFE
When stored at room temperature, SILASTIC Medical Grade Sheeting has a shelf life of 60 months from date of shipment.
PACKAGING
Each piece of SILASTIC Medical Grade Sheeting measures 6 inches by 8 inches and is individually packaged in a resealable, nonsterile plastic bag.
Description Catalog Number
Nonreinforced
0.005-inch-thick sheet................................................500-1
0.010-inch-thick sheet................................................500-3
0.020-inch-thick sheet................................................500-5
0.040-inch-thick sheet................................................500-7
0.060-inch-thick sheet................................................500-9
Reinforced
0.007-inch-thick-sheet
(with Dacron plain weave)............................................501-1
0.020-inch-thick-sheet
(with Dacron tricot).....................................................501.3
0.030-inch-thick-sheet
(with Dacron tricot).....................................................501.5
0.040-inch-thick-sheet
(with Dacron tricot)......................................................501.7
Nonreinforced (extra-firm grade)
0.040-inch-thick sheet.................................................502.1
0.080-inch-thick sheet.................................................502.3
0.120-inch-thick sheet.................................................502.5
ORDERING
These products are sold only through distributors. To obtain the telephone number of a Dow Corning authorized distributor in you area, call a Medical Products customer service representative at 1-800-248-2481.

SILASTIC-This registered trademark is the brand name for Dow Corning's silicone elastomer products and materials. Only Dow Corning may identify its product with the trademark SILASTIC (R). The word is not a synonym for silicone elastomer and it is improper to use it without capitalization or to use it to identify another manufacturer's material. Since it may not be used by others, the appearance of the word SILASTIC(R) on a medical product assures that it is of the highest quality and comes only from Dow Corning.

Medical Material
Dow Corning Corporation
Midland, Michigan 48686-0994

SILASTIC(R) is a registered trademark of Dow Corning Corporation
Printed in U.S.A. Form no 51-049E-91
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Mr. Sands. With labeling that has been provided to us recently, that is correct.
Mr. Sanders. In addition, Dow Corning changed their silicone TMJ implant in several ways, including adding a material that would make it show up in x rays. However, Dow did not ask for FDA approval for that change as required by law. What has the FDA done about that?
Mr. Sands. We have recently become aware of some of the changes that you are outlining and that has been passed on to our Office of Compliance and Surveillance for followup.
Mr. Niedelman. An inspection request has been initiated to follow up.
Mr. Sanders. Do you think we should have moved earlier, faster?
[An undated draft memorandum regarding these changes follows;]
(146)

DRAFT
TO: William Damaska, Division Director, DCO, OCS HFZ-320
FROM: Biomedical Engineer, DEDB, DGRD, ODE
Through: Philip Phillips, Division Director, DGRD, ODE HFZ-410
Thomas Callhan, Associate Director, ADRD, DGRD HFZ-410
Louis Hlavinka, Branch Chief, DEDB, ADRD, DGRD HFZ-410

SUBJECT: Significant Changes to TMJ Interpositional Implant Manufactured by Dow Corning

It has come to our attention that significant changes have occurred to the material composition and labeling of the Wilkes
Interpositional Implant (marketed by Dow Corning. In addition, significant concerns exist with respect to the mechanical integrity and performance of the preamendment Silastic TMJ implant (Silastic sheeting).
Dow Corning has or is marketing two types of TMJ Interpositional Implants. The first type is considered a preamendments device (marketed prior to 1976). The second TMJ implant is referred to as the Wilkes design. The material composition
and intended use of these devices are listed below.

Silastic sheeting elastomer not specified To prevent soft
(preamendments TMJ implant) (radioopaque material not tissue fibrosis
included) of bony ankylosis
following surgical
three grades available correction of
*nonreinforced trismus
extra firm grade
*reinforced medium (No restriction on
grade length of
*nonreinforced implantation)
medium grade

Wilkes design same material composition same as above
(K834379) as above (However, the
actual labeling
section of 510(k)
states that
implant is for
temporary use
only - 4 months)

Three sets of labeling are attached to this memo. Attachment one represents the 1973 labeling for Silastic sheeting implant. Attachment two represents 1991 labeling for the Silastic sheeting implant. Attachment three represents April 1985 labeling for the Silastic HP sheeting implant, Attachment four represents September 1985 labeling for the Silastic HP sheeting implant. Lastly, attachment
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five represents labeling for the Wilkes design that I believe is current (no data on labeling)

Several changes have occurred to the Wilkes version of the TMJ implant. The implant now contains a radiopaque substance (Barium Sulphate). This was not described in the 1983 510(k). The labeling has also significantly changed. The implant was originally intended to be implanted for no longer that four months. Today, labeling states that the implantation period should not exceed one to two months. During this labeling evolution, Dow Corning significantly strengthened the warning of implantation fragmentation, wear particulate production, and other significant adverse events that occur with this type of implant.

The Silastic HP sheeting does not have a 510(k) for use in the treatment of trismus. In addition, the labeling associated with this sheeting does not provide any limitation on the length of implantation in the TMJ. They do caution the reader that significant wear particulate and implant failure can occur.

Although Silastic sheeting does not appear to have changed in material composition, significant concerns still exist. This material is still indicated to be used in the treatment of trismus. However, there is no limitation on the length of implantation, nor is there the significant caution statements that relate to the wear and mechanical breakdown of the implant itself.

The final point to make is that silastic sheeting (all of the above configurations) has very poor wear properties. It has been estimated that silastic sheeting wears 100 times faster than teflon. A Article published in the Journal of Biomedical Materials Research (Vol. 22, 475-484, 1988) entitled "Silicone rubber temporomandibular joint (TMJ) meniscal replacements: Postimplant histopathologic and material evaluation" documents the poor wear properties experienced in-vivo. Other articles exist that document silastic TMJ implant failures. In addition, the MDR database contains four MDRs that relate to Silastic TMJ implant failures.

Due to the above concerns, we request that you inspect Dow Corning to document the device changes, including labeling, that have occurred to Silastic sheeting and the Wilkes design over the past 16 years. The complaint files of Dow Corning relating to these devices should also be investigated to determine if all complaints that meet the MDR requirements have been reported to the Center. Lastly, Dow Corning should be informed that the Silastic HP sheeting does not appear to have clearance for marketing, the Wilkes design implant has changed significantly such that a premarket notification is necessary, and that the labeling for the preamendments Silastic sheeting indicated for TMJ use does not have adequate labeling reflecting the recognized (recognized by Dow Corning in the other TMJ implant labeling) device failures that occur when this implant is placed beyond one to two months.

Barry E. Sands
(148)
Mr. Niedelman. We just became aware of it in the center.
Mr. Hobson. Do you know when those changes were made? Six months, a year?
Mr. Sands. As far as can be seen from the labeling that we have presently, I would say it has been more than 6 months or 1 year. I could not give you, today, the exact time period. I would have to go back and review that labeling.
Mr. Hobson. But you received no documentation until you saw the labeling?
Mr. Sands. That is correct.
Mr. Hobson. When did you receive the labeling?
Mr. Sands. We received this labeling approximately 2 months ago, I believe.
Mr. Hobson. May I ask how you received it? Do you have a protocol for receiving it?
Mr. Sands. What--I won't say commonly--happened, out of concern or just out of advice from the surgeon, someone will sometimes send labeling to us and ask is this current labeling, is this approved? And that is basically---
Mr. Hobson. It came from the company?
Mr. Sands. No, it did not. It came from a public citizen.
Mr. Hobson. Did it come from the company?
Mr. Sands. No, from a public citizen.
Mr. Hobson. Has anyone asked the company why they didn't send it too you?
Mr. Levitt. That is what part of our investigation will look at. The company is supposed to send in what I will call an "amended application" if there are changes in the materials, in the labeling, and so on and so forth. One of the things we are looking at with this product, as well as other products, and letters were just sent out recently, is whether companies involved in these kinds of products submitted the kind of updated applications with new information justifying any changes that they needed.
Mr. Hobson. Could I ask one more question?
Mr. Sanders. Sure.
Mr. Hobson. This brings me to a general statement. Is there a flaw in the reporting procedures that does not get this information to you, or in your surveillance ability to get this kind of information on this products or any other product out there and that you are 6 months--I am not suggesting that you are at fault for this, don't get me wrong.
Is there a problem in the system, either from the private sector or from your own sector, that doesn't get you this information in a more timely fashion on various types of changes that may occur in the marketplace?
Mr. Levitt. There is, I believe a clear requirement that manufacturers of products update or amend a 510(k) application when they have changes that affect safety and effectiveness.
Sometimes there is a little room for interpretation and some of that may be going on here, but we believe that the system is in place and we are constantly involved in trying to enforce that system and make sure it is working as it is supposed to. It clearly appears here it has perhaps not worked and we are notifying companies and following up to make sure.
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Mr. Hobson. Can I ask you a practical question?
When this happens, does anybody pick up the phone or do you have to write an official letter signed by six people and approved by seven? Can you call up on the phone and say "Hey, what are you guys doing? Has anyone looked at this? Come down and talk to me about this." There may be a logical reason, or what happens?
Does it have to be so documented it never gets done for 4 months?
Mr. Benson. I would like to take a shot at that. I think you are referring to the bureaucracy and is there a simpler way to do things. We have tried to streamline the process in a lot of different ways. We give exemptions to people when we feel information isn't needed for safety reasons or effectiveness reasons.
We take a lot of potential information off the table to prevent that. If a company we have--I don't know 7,000 manufacturers that report to us, many--you know 70,000 products, you get a sense of the magnitude here. I have no objection to asking people to report in a situation where there is a genuine oversight or it didn't come to their attention.
I think a very difficult issue the FDA faces constantly is a little bit analogous to how you deal with speeders on the street. If we set a precedent of being too lax about our requirements, then I think we are going to encourage speeding, if you will.
I think what we have to do in this case, is with our 17 district offices, about 150 resident posts throughout the country, something like this will trigger an inspection so we will get the data. We will get the information necessary.
If there is a violation of the law that we think was an oversight, the agency will give the company the chance to make a correction. But if it looks like a pattern or something intentional, we will bring the full pressure of the law on them. Sometimes we make the phone call, but not always.
Mr. Hobson. Can I ask you, in this case, has anybody made a phone call?
Mr. Benson. My guess with the history of Dow Corning, we would not use that approach, appropriately so.
Mr. Hobson. OK.
Mr. Sanders. Thank you. Some of us don't quite understand why the FDA has ignored the changes in Dow's implants and the mounting scientific evidence against them. Even today, your testimony does not accurately describe concerns of TMJ researchers regarding the dangers of solid silicone in joint implants.
The bottom line is: The FDA has done nothing in the more than 3 years since the FDA advisory panel recommended that the FDA require safety data. How do you explain that?
Mr. Benson. This is the third time you have addressed this question.
Mr. Sanders. It is an important question.
Mr. Benson. I agree it is an important question. We are going to act o it as swiftly as we can. I can say that again. We are going to act on it as swiftly as we can.
Mr. Sanders. Let me ask about another manufacturer called TMJ Implants, Inc. A few months ago, the FDA notified TMJ Implants, Inc., that they have changes in their total joint re-
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placement, called the Christensen device, that required a 510(k) application. The company has protested, saying that the FDA was wrong. A few days ago FDA sent the company a warning letter.
What is the next step?
[Warning letters to several manufacturers are in app. 3, p. 224]
Mr. Niedelman. Denver district was, in fact, to meet with the firm regarding this letter that they issued to TMJ Implants, Inc. The firm was given 15 days to respond to the letter demanding the submission of a new 510(k) and was being requested they discontinue further distribution of the device until such time as a 510(k) is found substantially equivalent, if that is possible, in contrast to going through the investigational device PMA approval process.
Mr. Sanders. Dr. Christensen, the president of TMJ Implants, Inc., has contacted this subcommittee to inform us about the quality of his implants, and he has asked several surgeons to do so as well. I appreciate their providing this information. However, when the subcommittee requested research data indicating the safety and effectiveness of the implants, Dr. Christensen sent 30-year-old articles describing short-term success in a handful of patients.
Don't you think it is time that the FDA asked for research data regarding this device?
[Documents provided by several implant manufacturers are in app. 4, p. 243]
Mr. Benson. It is included in the panel, is it not?
Mr. Sanders. Yes.
Mr. Benson. It will be part of that classification procedure we were just talking about. The answer is yes.
Mr. Sanders. Do you think we will get better information than 30-year-old articles?
Mr. Benson. Ultimately, if we don't, the product won't be on the market.
Mr. Sanders. You appreciate the problem here is that this is a widely disseminated device and what this subcommittee has received is short-term success stories of 30 years ago, which some might think is a little bit out of date and not quite up to par.
Are we in agreement on that?
Mr. Benson. That is-yes, we are in agreement.
Mr. Sanders. The FDA has also contacted another manufacturer, Techmedica, regarding their TMJ devices. We had witnesses this morning who are optimistic that this device will succeed where others have failed, but unfortunately, again, there are no long-term studies. If FDA classified TMJ implants as class III devices, companies like Techmedica would have to conduct safety studies and submit them to the FDA. What are you waiting for?
Mr. Benson. For the fifth time, sir, we are going to get the classification regulation out as swiftly as we can. I want to get that done, and that will resolve those issues.
Mr. Sanders. Will you forgive the impatience of the subcommittee, but you have heard this morning about the pain and suffering that exists. There is a widespread feeling that the FDA has not moved as swiftly as it could.
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The subcommittee invited the manufacturers to provide written testimony and copies of research data for inclusion in the hearing record. Based on their responses, none have any long-term studies.
In addition, Dr. Homsy, the former president of Vitek, who wrote from Switzerland, is still claiming he has research evidence showing his products are safe. He is apparently still selling them despite the overwhelming evidence that they are dangerous. This is a good example of how biased manufacturers' safety claims can be.
What can the FDA do to ensure that the research provided to the FDA is less biased and of better quality than some of the research evidence you have received in the past?
Mr. Benson. One thing that we are doing is beefing up our bioresearch monitoring group within the center. This has not functioned in as strong a way in that past as it should.
Ultimately, I think the way to assure that we get good data is to make sure that manufacturers understand the importance of that. We need to be very clear that we can't allow fraudulent data, poor data, inadequate date, in support of approval for a product.
That is a step that I think we are doing our best to make clear. As far as this particular example is concerned, we have an import alert on these products, we have notified foreign governments about the problem, and so we are trying to make sure that others, as we heard this morning from the first panel, are not subject to the same problems.
Mr. Sanders. Mr. Hobson.
Mr. Hobson. I want to ask something for the record here. Is it fair to say that this Homsy Vitek IPI is not an effective product, that it is not sold in this country currently, but that it is sold in other parts of the world, and people might be going outside the country to get this products, and do we have the ability--I want to get this on record--do we have the ability to protect our citizens from this type of product?
Mr. Benson. All the systems that the FDA has at its disposal are in place to prevent your concerns from reaching a realization. We work with the Customs Department, we have an import alert out, which means that in conjunction with customs, we will prevent or attempt to prevent any shipments into this country.
We have warned, again, as I mentioned, other countries about the problem. As far as your first question goes, we certainly have enough evidence that has caused us to act against the product and rescind the 510(k) for the product. That doesn't preclude additional studies or additional proof. We have reached the conclusion that the product is not functioning properly.
Mr. Levitt. If I might add for my record, we do not have any information that they are selling or distributing the IPI products anywhere, although we do believe he is selling a hip product to other countries. But there is no evidence that we know of that he is distributing the IPI product anywhere in the world.
Mr. Hobson. Thank you.
Mr. Sanders. Dr. Loe, we will address the next question to you. Dr. Loe, this year the NIDR plans to spend about $3 million on TMJ. That amounts to 30 cents per year per patient using your estimate of 10 million patients who experience relatively serious pain.
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Why do we have so little funding available to study a problem that affects so many millions of Americans and costs the Federal Government billions of dollars in medical bills, lost productivity, et cetera?
Dr. Loe. First of all, I am not sure the mathematics you are giving me here has any relevance to the operation of the NIDR. We spend approximately 2 percent of out budget for TMJ research. That is very comparable with some of the diseases that we study.
Paget's disease, diabetes, cleft palate, they are all in the same category of $3 to $4 million per year.
We have a budget of about $159 million in fiscal year 1992. We have commitments to study an array of problems, from dental materials to genetic diseases. And so there are plenty of diseases and disorders to go around.
I should add that I don't think that we are funding less quality research in the area of TMD's. You have to realize that over these 10 or 15 years, we have built up capability in this area, and we are funding quality research. We have been very conservative in trying to establish diagnostic criteria and good classifications of these diseases, so that we know what we are doing. But we are not haphazardly funding any kind of treatment approach that may develop here or there.
Investigators have to submit applications for peer review, and we try to fund them in due course relative to the quality of their application. That is the process we use at the NIH.
Mr. Sanders. Do you think serious and worthwhile applications being submitted to you are not being acted on because of inadequate funding?
Dr. Loe: I can tell you that over the last 10 years we have had seven applications in the area of joint implants. We have funded four of them. Now, that is higher than we usually are able to fund in an area. Typically, we fund only out of five applications. So in this particular area, I think we have been generous.
Mr. Sanders. Is that response because of lack of funding or because you felt that the applications were not of high enough quality?
Dr. Loe. No, we funded them because they were quality applications.
Mr. Sanders. The NIDR has not funded any clinical studies of the effectiveness of TMJ implants or their short-term or long-term dangers. It has funded very few studies of treatment of any kind for TMJ. However, after this hearing was announced, the NIDR apparently decided it would fund a meta-analysis of treatment studies.
Dr. Loe. That is not true. That is a strong statement from me, but that it is the truth. We have been in negotiation with the individual who is going to do the meta-analysis for a long time, and it has absolutely nothing to do with this hearing. The contract was negotiated prior to my knowledge of any hearing coming up in the particular area.
Mr. Sanders. Dr. Loe, a meta-analysis is a statistical analysis of previously conducted studies. It is a good way to consolidate information from lots of well-conducted small studies. Unfortunately, in
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this case experts have advised our staff that there are very few well-conducted studies to consolidate.
Why hasn't the NIDR been willing to to support any studies of implants and why have you supported so few studies of treatment outcome?
Dr. Loe. I don't agree with the assessment of meta-analysis as a deficient method for studying the problem we are talking about. I think there is published material that is worth looking at; these are scientific papers published in peer-reviewed journals. We expect that something will come out of this type of analysis and that it will guide us to where we should be going next. Meta-analysis is a legitimate approach to the problem, as far as I am concerned.
In response to the second part of your question: Why have we funded so few grants in this area? The answer is simply that we haven't had any grant applications. We have taken several steps to try to inspire researchers out there, both in terms of workshops, and symposia, and also requests for applications.
I mentioned in my opening statement that I have a chronology of some of these activities, and I am going to submit it for the record. It will show that we have been trying to push this area for a long time.
[The chronology is presented on p. 100]
Mr. Sanders. So you have been active in requesting studies on implants?
[Requests for proposals and a summary of the Meta-analysis are in app. 5, p. 334]
Dr. Loe. That is right.
Mr. Hobson. This hearing may serve a function, too, to encourage some people to come forward.
Dr. Loe. Absolutely.
Mr. Hobson. I know these things are laborious to go through, but sometimes this can help.
Dr. Loe. The other part of the problem, though, Congressman, is there is only so much money to go around; 20 to 25 percent of the applications can be funded, and 75 percent cannot.
Mr. Hobson. Maybe this will get you some good quality ones.
Mr. Sanders. Dr. Pinn, this is the second hearing that the subcommittee has held regarding implants that are widely used without any safety data. The other hearing, of course, was on breast implants.
In both cases, the FDA did not require manufacturers to conduct safety research and NIH did not either.
What is NIH's position on research on medical devices?
Dr. Pinn. NIH believes that it does have an obligation to look at the scientific data surrounding anything affecting health. I should tell you, I cannot give you too many specifics under development.
But, at the present time there is consideration being given to establishing a medical and biological engineering center at NIH which would have as its major function to look at both the basic and applied research as well as clinical evaluation of the new technologies, including bio-I just lost my word. Thank you, biomaterials.
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So, that is under consideration right now. I cannot say more about that, but just to let you know we are thinking about that. The second thing is that a the present time, as you are probably aware, there is a Public Health Servicewide task force that has been appointed by Dr. Mason which includes both--which is cochaired by the FDA as well as the NIH and requires the participants throughout the Public Health Service to take another look for example, at the breast implant issue, and we are progressing with that right now.
The first meeting was held on March 23. We just held another meeting this week at which we had consume advocacy groups speak to us and present us with their concerns.
And I think this may serve as a model as to how we can in the future address some of the concerns jointly about implants.
Mr. Sanders. Dr. Loe, if I might, NIDR also hasn't funded studies of bone grafts or other tissue grafts used for TMJ disorders. Why is that?
Dr. Loe. As I said in my opening statement, the one big problem in this area has been to define the different aspects of this disease and subclasses, so that we know which can be approached through conservative treatment and which can be approached by a surgical method. May I also correct any misunderstandings about whether we are not funding anything in the clinical area. As you heard this morning, several of the scientists who testified have been funded by us. There are others who are also conducting clinical studies. There is one at Minnesota, for instance, comparing surgical versus nonsurgical treatments.
What I am trying to say is that we have worked hard and long over the past years to arrive at a point where we are ready to go forward. This is an important change that has taken place. We now have enough data to pursue clinical trials in the various areas we are talking about, and also to advise the professions and the public. So I think that things are now developing rapidly.
Mr. Sanders. Would it be true to say that grafts and implant studies are not funded?
Dr. Loe. Yes, I think that is probably true. I can't categorically say that we might not have funded some of these over the past few years, but we have not--we have thought that that would be somewhat peripheral to the priorities of the institute.
We have had long-range research plans for these issues published in the 1980's and in the 1990's. We have described in very fine detail what we would like to do in the next few years in order to arrive at certain endpoints, and we are acting according to that plan.
Mr. Sanders. The bells going off means there is a vote, but I think we can finish up the questions and still have enough time on that vote.
Dr. Pinn, we heard testimony this morning that these grafts and implants might be worse than nothing at all. In cases where products are widely used and apparently harming patients, don't you think NIH has some responsibility to conduct research comparing what happens to patients who have implants to what happens to those who don't?
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Dr. Pinn. The answer to that is yes, with qualification. Dr. Loe has addressed part of that question, and that is all I want to say to that at this point.
Mr. Sanders. We have documents indicating that one of the major researchers who was a proponent of Vitek's Teflon TMJ implants, Dr. John Kent, owned 21,000 shares of stock in the company. He published medical journal articles praising the implants until the evidence against the implants was overwhelming.
Even if the FDA did require manufacturers to conduct research, NIH could still play an important role by funding researchers who do not have a financial interest in the outcome of the research.
Dr. Pinn, does NIH have a policy regarding the need for such unbiased research for medical devices, drugs, and other products?
Dr. Pinn. We certainly do, and it certainly applies to my office, the Office of Research on Women's Health. Although TMD's are not conditions that affect only women, it is women who predominate among those who are receiving therapy or who are exposed to the procedures, and therefore it does become a women's health issue.
As a result of testimony that NIH sponsored several years ago, we have developed a research agenda on women's health for the next decade. I have suggested in testimony before this hearing, and certainly following what we heard this morning, that my office, working with the National Institute of Dental Research and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, intends to meet with concerned individuals, especially some of those you heard this morning, to see what we can do to generate the research needed to address the kinds of problems you have heard presented today. We are committed to doing that.
Mr. Sanders. Dr. Pinn, it seems to me this is another example where women may be getting unnecessary surgery and even dangerous surgery. And research on women is getting shortchanged. I know that Chairman Ted Weiss is very concerned that the National Cancer Institute is planning to conduct a major study for breast implants that completely excludes cancer patients, a decision that the Congressional Women's Caucus, Representative Henry Waxman, and Mr. Weiss have written to Dr. Healy about, to no avail.
So my question is, what is your office planning to do to remedy this situation regarding implants generally and TMJ and breast implants specifically?
Dr. Pinn. In terms of breast implants, we are working as part of a Public Health Service task force to look at the issue and get more information to guide us. We need scientific data as well as input from women who have breast cancer and who are concerned about how all the studies that NIH conducts will affect them or others with similar conditions.
I have also state to you that we plan to do to help address and redress the concerns of those who are suffering from TMJ disorders. Our office is concerned about how women are treated medically and how applications of scientific knowledge are applied to women.
You have heard this morning that it is primarily men who are treating TMD's and that their patients are mostly women. Let me tell you
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that our office is working to increase participation of women in biomedical careers.
We certainly appreciate the cooperation and efforts of our male colleagues, but we feel that if can increase the number of women participating in biomedical careers, we can increase the sensitivity of those who hear the concerns of women and address them seriously and scientifically.
Mr. Sanders. Chairman Weiss has returned. Let me give the Chair back to him.
Mr. Weiss [presiding]. Thank you very much, Mr. Sanders, and my apologies. The Foreign Affairs Committee took longer than I expected.
I know that you have gone through your testimony and oral responses to the questions, and I simply want to express my appreciation to you for the commitments that I understand you have made regarding how the situation is going to be improved.
I think that for whatever reason, between NIH and FDA, there has been sort of a juggling act, and the people who have been hurt by that are those who have this very serious problem, and find that there has been no real research done on some aspects of it. For reasons which are really hard to follow, it seems that research on implants isn't being done because it seems that by doing the research, NIH believed they would be encouraging their use.
But I think that is illogical, since these implants are already being used on thousands and thousands of patients. And I hope that the situation changes, because the research just got lost between the cracks, and neither FDA or NIH did it. As a result, there is limited knowledge.
We will be following it closely. I am very appreciative of your participation here today, and I look forward to some positive actions from the agencies in the near future.
Thank you very, very much. The hearing is adjourned subject to the call of the Chair.
[Whereupon, at 1:25p.m., the subcommittee adjourned, to reconvene subject call to the Chair.]

THE 1992 CONGRESSIONAL HEARINGS! PART 3! JUNE 4, 1992

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WE ARE ANGELS UNITED ON TMJ! TMJD_SAFE_HAVEN_4_LIFE_ISSUES · TMJ SUPPORT GROUP This TMJD Support Group is intended to be a Safe Haven and provide a place where people with TMJ pain can come and offer and receive support from people who know what they are going through. This is not a medical group and we do not have medical degrees or medical backgrounds. However, with the variety of members in here, there is bound to be someone who has been there and done that and can answer your questions. This group is in memory of Debbie Ward whom suffered from TMJD & died of unknown causes. There are many types of members with TMJD. Some have been treated medically, some treated with various splint therapies and physical therapies as well as some with surgical treatments ranging from Arthroscopy to full jaw joint replacements. Everyone with any degree of TMJD or has a family member that deals with it is welcome to join and offer and receive support that we all so badly need to get through each day with the pain we have to live with. It is YOUR place to cry, scream or vent on the pain you are dealing with and how it is affecting your life and the lives of your loved ones. The group is MODERATED to avoid the unsolicited advertisements and spam. We are all in pain and do not need to have to deal with that too. TMJ SURGERY FAMILY!. A Great Place to Share Information! This site is for sharing and is not a substitute for the advise of your physician/oral surgeon. Please consult with your health care professional. !

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