TMJI patient-specific TM Joints.. rumors I've heard for months..

Hi - thanks for letting me know that I am not alone.  My implants were made specifically for me by a colorado company who makes the titanium jaw impants.  My whole jaw is an implant with many screws from the top of my scull down below my eyes and then again in the bottom part of my jaw.  Yes I still have an oral surgeon, but he is not giving me much help as he says - he has done what can be done and now I have to find a way to get the pain in control - I am trying to do that and lead a normal life - if that is possible.  I saw a neurologist and he had told me that the damage is done and cannot be reversed so lets hope the pain clinic can help.  They do want to schedule a cat scan to see if I am rejecting these implants?????  I wish you the best with what you are going thru too.  Keep in touch as I have found out it helps to talk with someone who has or is going thru the same thing.  My husband is wonderful and my kids try to understand,but they just want me to be back to being myself and cooking and eating the way I use too.  I still cook, but I myself eat very little - my weight is an issue and the meds make it hard as they affect me easily.  If you don't mind me asking what meds do you take and do they help?  They have just changed me to lyrica - kind of expensive - I have only been on this for 3 days and no big change - the other drug was neurontin - not really a help, but I did try and come off all the meds and it was so bad - i could not stand myself...  well again good luck and it seems like you do your homework on things like I do.  keep in touch.  Diane D
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Hey I am in the same boat as well and the meds that help me well for pain is the Duragesic patches helped me get my life back. And Soma for the muscles and ambien sometimes to help me sleep. I also use Norco for breakthrough pain. I would ask your pain clinic about trying the duragesic patches you change them either every 48 or 72 hrs. Beats taking pills 24/7 and hurting your tummy. Get rid of the Neurontin all it does is make you sleepy and makes you feel bad and gain weight trust me I was on it for 3 years. As soon as I got off of it I felt so much better. If you want to chat please send me an email angiharrover@gmail.com or find my share post Angi_H is me.


Angi

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Hi, Diane.  The meds I've been on for many years, are tylenol-4 and soma. Also, to prevent migraines and vomiting, I take phenergan.  My neuro tried Lyrica with me, too.  After more than a week, I ended up with severe chest pains (I had a heart condition as a kid and prolly should have not started on it). However, the Lyrica did help me to sleep and it seems to help a lot of people.  I don't think that this drug, alone, would be sufficient but, I am NOT a doctor;  and, everyone responds differently to pain. 

I would, like Angi said, go to a pain clinic and let them know what has helped in the past.  The lyica; you've got to take some time, usually at least a week, for it to start to work. 

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Additional information can be located at:

http://google.fda.gov/search?q=TMJ+Implants+Inc&entqr=0&restrict=%28medwatch%29%7C%28enforcement_report%29&getfields=*&sort=date%3AD%3AL%3Ad1&output=xml_no_dtd&ie=UTF-8&lr=&client=FDA&num=100&as=Search&ud=1&restrictBox=%28medwatch%29&restrictBox=%28enforcement_report%29&oe=&proxystylesheet=FDA

 <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />

 

 

 

<?xml:namespace prefix = v ns = "urn:schemas-microsoft-com:vml" />Department of Health and Human Services

Public Health Service
Food and Drug Administration

 

9200 Corporate Boulevard
Rockville, Maryland 20850

<!-- #EndEditable --><!-- #BeginEditable "body" -->

DEC 2 0 2006

WARNING LETTER

VIA FEDERAL EXPRESS

 

Robert W. Christensen, D.D.S.
President
TMJ Implants, Inc.
17301 W. Colfax Avenue
Suite 135
Golden, Colorado 80401

Dear Dr. Christensen:

On September 5, 2006, the Food and Drug Administration (FDA) obtained information from your Internet web site, http://www.tmj.com, that revealed you are promoting hemi and full mandibles without premarket clearance or approval from FDA.

According to your web site, TMJ Implants, Inc. "can design and deliver hemi and full mandibles to meet the most unique and unusual patient needs. These highly specific oral maxillofacial surgical (OMS) reconstruction solutions allow patients enhanced function and greater pain reduction." You further claim, for example, that:

·         TMJ Implants, Inc. has created solutions for such unusual conditions as Treacher- Collins and Goldenhar Syndromes"; and

·         Unusual cases involving trauma to the mandible and/or temporomandibular joint (TMJ), and disease states such as cancer or tumor have also been addressed."

Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), the hemi and full mandibles are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body, 21 U.S.C. 321(h). A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your products for sale, which is a violation of the law. We are aware that you have received marketing approval for the TMJ (Temporomandibular Joint) Metal-on-Metal Total Joint Replacement System TM, which is intended for reconstruction of the TMJ due to one or more of the following conditions:

·         Inflammatory arthritis involving the TMJ not responsive to other modalities of treatment

·         Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment

·         Failed tissue graft

·         Failed alloplastic joint reconstruction

·         Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion;

and for the Fossa-Eminence Prosthesis, which is intended for use to partially reconstruct the TMJ under the same conditions indicated for:

·         the total joint replacement except for the last condition listed above and

·         internal derangement confirmed to be pathological in origin by both clinical observation and radiographic findings, where the patient has moderate to severe pain and/or disabling dysfunction and has not responded to less invasive conventional therapy. You have not obtained approval for hemi and full mandibles that are intended for the uses described on your web site. You must obtain approval of either a new PMA or a supplement to one of your approved PMAs for these devices before they may be legally marketed.

The hemi and full mandibles are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k); is deemed satisfied when a PMA is pending before the agency (21 CFR 807.81(b)).

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. In addition we request that you submit to our office distribution information for these devices for the past two years. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to:

Mr. Ronald L. Swann
Chief
Dental, Ear, Nose Throat, and
Ophthalmic Devices Branch (HFZ-331)
Division of Enforcement A
Office of Compliance
Center for Devices and Radiological Health
U.S. Food and Drug Administration
2098 Gaither Road
Rockville, Maryland 20850
U.S.A.

If you have any questions about the content of this letter please contact Mr. Swann by phone at <?XML:NAMESPACE PREFIX = SKYPE />240-276-0115 or by fax at 240-276-0114.

Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under
the law.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

 

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WOW! Thanks for the information… but let’s be fair here… there was a posted reply to that letter and nothing has been decided. There is a PMA for patient specific devices in place. We all have different opinions about what it is best. What works for one, may or may not work for another!<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" ?>

 

I am so glad I caught this…..

 

December 28, 2006

 

Mr. Ronald L. Swann, Chief
Dental, Ear, Nose Throat, and Ophthalmic Devices Branch (HFZ-331)
Division of Enforcement A
Office of Compliance
Center for Devices and Radiological Health
U.S. Food and Drug Administration
2098 Gaither Road
Rockville, Maryland 20850

 

Re: Warning Letter for Information Appearing on TMJI's Website.

 

Dear Mr. Swann:

This is a reply to the Warning Letter sent to me by Mr. Timothy Ulatowski dated December 20, 2006, received by our office on December 26, 2006 concerning the referenced matter.

 

First of all, I want to state for the record that we feel we are in total compliance with the terms and conditions of the prior PMA approval for the use of our Metal-on-Metal Total TMJ Replacement System™ and for the Fossa-Eminence Prosthesis in this situation.

 

We are sorry if there is a misconception on our website concerning the promotion of our Patient-Specific™ devices, which give the impression that we are "promoting hemi and full mandibles without pre-market clearance or approval from the FDA"

 

In attempting to reach the public with the awareness of the ability of our Patient-Specific™ full and partial TMJ devices to address complicated conditions that have no other means of solution because of such things as developmental abnormalities which include the Treacher-Collins and Goldenhar Syndromes and other situations of pathological lesion or origin, we should have made it clear that these unusual TMJ conditions are adaptable to treatment with our uniquely designed Patient-Specific™ TMJ devices

 

Obviously, we do not want to give the impression that we are in the business of"promoting hemi and full mandibles" when our business is the manufacture of devices needed for solving problems with the TMJ.

 

We will accordingly correct our website to eliminate any doubt or confusion that our labeling reflected on our website is solely to indicate the use of our Patient-Specific™ TMJ devices to address the type of situations approved by the FDA in our PMA.

 

We hope that this explanation satisfactorily responds to your concerns, as we wish to be in full compliance with FDA's approval for these Patient-Specific™ situations. We will await your response to let us know of any further action which we need to take.

 

Sincerely yours,

 

TMJ IMPLANTS, INC.

 

 

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And, by this, for clearing up any misunderstandings.  I truly HOPE this has dispelled any rumors and that these rumor-mongers will cease!

Anne

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