Chronology of the Vitek Proplast Implant ~ The Aftermath

THE AFTERMATH

PART TWO

Temporal Mandibular Joint (Jaw Joint)

1992, 6/4 – Congressional Hearings on TMJ implants

June 29 1992 – FDA/CDRH staff met with representatives of AAOMS to discuss patient abandonment, reimbursement issues, and recommendations for patient follow-up and future research efforts. AAOMS agreed to distribute a “TMJ Implant Advisory” to more than 6,000 AAOMS members and to publish the “Advisory” in their Journal.

July 7 1992 – FDA/CDRH staff met with representatives of the Health Insurance Association of America to discuss insurance coverage for TMJ-related disorders.

September 1 1992 – FDA published a proposed regulation classifying the IPI, condylar and fossa prostheses into Class III.

September 18 1992 – FDA published a proposal in the Federal Register to reclassify TMJ Implants and components including interpositional use, from Class II to Class III devices.

1992 Oct – OSOMOP SPAGNOLI/KENT report that of 465 patients with IPI, 86% of implants were still in placeafter an average of 32 months. 92.4% were a-symptomatic, however 249 showed some degree of CONDYLE RESORPTION….PROJECT that 54% may fail.

October 1992 – At FDA’s request, the Medic Alert International Implant Registry established an 800 number for patients and physicians to request information about Vitek TMJ implants and to join a registry.

October 30 1992 – FDA participated in NIDR workshop to develop a surveillance instrument for assessing the frequency, cost, and effects of TMJ surgery in the U.S.

1992 November – AAOMS AAOMS workshop on TMJ implants. “Recommend removal of Teflon/Proplast implant and Affected soft tissues.”

November 28 1992 – “FDA Needs Your Help” was exhibited at the Greater New York Dental Meeting. This exhibit alerted doctors to the need to notify patients with Vitek implants to call Medic Alert and enroll in the registry.

December 2 1992 – FDA notified Dr. Christensen that the Christensen Fossa and Condylal prostheses have pre-Amendment status.

December 7 1992 – FDA Inspection of Dow was requested due to consumer reports of problems associated with the Wilkes design and Silastic sheeting (35 MDR/PRP reports).

December 29 1992 – FDA notified all six TMJ manufacturers that two TMJ devices are pre-Amendments devices, which allows the other four companies to market their devices through the pre-market notification [510(k)] process instead of the more rigorous pre-market approval (PMA) process.

 

Vitekl Proplast Teflon Silas-tic Implants

1993- FDA sends letters to Dow Corning, The Temporomandibular Research Foundation (Morgan), Osteomed Corporation, Techmedica Incorporated, TiMesh Incorporated, TMJ Implants Incorporated (Christensen).

1993 1/26- ONN DOW CORNING EXITS THE TMJ BUSINESS.

February 11 1993 – The Dental Devices Panel met and reaffirmed FDA’s position to reclassify TMJ implants as Class III devices.

1993 April – JOMS WOLFORD reports revision surgery after Proplast/Teflon failure 88% of 163 joints showed significant Osseous Changes after 2 to 126 months.

April 4 1993 – FDA issued a warning letter to Dow citing the need for the submission of 510 (k)s for the Silastic HP sheeting, Medical Grade Sheeting and Wilkes design. Dow responds that effective March 31 1993, they discontinued marketing all implant-grade silicone.

1993 April 4 – FDA  issued a WARNING LETTER to DOW CORNING citing the need for submission of 510(K)s for the Silastic HP sheeting, Medical Grade Sheeting and Wilkes design. Dow Corning responds that, effective March 31 1993, they DISCONTINUED MARKETING ALL IMPLANT-GRADE SILICONE.

1993 4/26 – ONN Class Action lawsuit filed AGAINST DOW CORNING AND DUPONT ON BEHALF OF BOTH VITEK AND DOW CORNING SILASTIC TMJ RECIPIENTS.

June 9 1993 – FDA notified Dr. Morgan that his TMJ implants have pre-Amendments status.

June 15 1993 – Dow Corning discontinued the marketing of H.P. sheeting, Silastic TMJ implants, and medical grade sheeting and block material.

June 18 1993 – A 510(k) for a TMJ implant was received from Osteomed.

Summer 1993 – FDA’s Office of Compliance authorized “urgent use” of the Techmedica TMJ implant in 12 patients

August 29 1993 – Tracking requirements of the Safe Medical Devices Act became effective. Manufacturers of certain devices, including TMJ implants, must establish tracking systems, which will enable them to promptly locate devices in distribution. Newly marketed devices subject to tracking are also subject to post-market surveillance studies.

1993 Aug 31 – WSJ WSJ article about TMJ patients.

1993 Sept-Oct – Television programming airs coverage regarding Implants: 20/20, American Journal, Current Affair segments aired on ABC TV.

September 10 1993 – FDA learned that Dr. Homsey was attempting to market Proplast TMJ products in Europe and FDA wrote a letter to WHO citing Agency concerns.

The Immune Systems Giant Cell Response to the Implant Material

October 12 1993 – FDA staff met with representatives of Dow to discuss an increase in the number of problem reports associated with the Wilkes IPI and Silastic sheeting used in TMJ. Dow agreed to send an advisory to its consignees.

October 29 1993 – FDA developed a 510(k) guidance document for manufacturers of TMJ implants advising them how to set up protocols for evaluations of their products. The guidance addressed the length of time required to conduct studies and follow-up of their products.

October 29 1993 – FDA sent letters to Techmedica and Osteomed requesting additional information on their TMJ implants. This resulted in withdrawal of both 510(k)s. FDA would expedite the processing of new applications received.

December 8 1993 – Dow issues letter to consignees regarding Silastic sheeting and the Wilkes IPI.

February 14 1994 – A draft classification regulation to re-propose the fossa and condylar prostheses into Class III was published.

April 17 – 20 1994 – FDA co-sponsored a conference with National Institute of Dental Research entitled, “Management Requirements for a National Implant Data System.” The planning conference served to accelerate the process of producing a unified approach to the study of biological host and implant response performances of various biomaterials and devices in HUMAN CLINICAL USE.

1994 July 15 – FDA sent a “Dear Doctor” letter to all U.S. plastic and reconstructive surgeons, oral surgeons, orthopedic surgeons, and otolaryngologists concerning problems with Proplast TMJ Implants.

1994 September – Remainder of products removed from the market except the grand fathered Christensen and Morgan.

1994, September – FDA FDA revised its “TMJ Implants: A Consumer Information Update.” September 12-13 1994 – FDA sponsored an “International Satellite Workshop on the TMJ and Related Pain Conditions.”

September 14 1994 – FDA sent a letter to Japan, Italy, Switzerland, Canada, Mexico, Australia, New Zealand and the Director General of EC in Belgium to inform regulatory bodies about the Proplast TMJ experience in the U.S and Dr Charles Homsey’s attempt to market the devices.

November 17 1994 – FDA sent a letter to all TMJ implant patients in the Medic Alert International Implant Registry (IIR) informing them that the IIR will no longer continue its operation. FDA will continue to inform the medical and dental community and TMJ resource organizations of any problems related to Vitek TMJ implants.

1994 12/20 – ONN, FDA reclassified TMJ implants as Class III.

December 20 1994 – A final rule to classify the IPI, total joint, fossa, and condylar prostheses into Class III devices was published in the Federal Register.

October 16-17 1995 – FDA participated in the NIH Workshop “Bio- Materials and Medical Implant Science: Present and Future Perspectives.”

1995 4/1 – ONN Claims against Vitek EXCEED 2,200, EXCLUDING ABOUT 500 PATIENTS WHO RECEIVED …$1,000…TOTAL REIMBURSEMENTS.

April 29-May 1, 1996 – NIH convened the Technology Assessment Conference: “Management of Temporomandibular Disorders.”

July 17 1996 – The Anspach Total Temporomandibular Implant (formerly known as the Techmedica Implant, and now distributed through TMJ Concepts) received pre-market notification 510(k) clearance which will require device tracking and post – market surveillance.

August 2 1996 – FDA issued letters stating the agency’s intention to rescind the determinations of substantial equivalence (SE) for nine 510(k)s Proplast devices which are used in loaded situations, (for example in joints).

July 1997 – Bankruptcy Court awards to over 2500 litigants based on point system:  All awards less than $10,000.

July 1997 – Dental Research of National Institutes of Health (NIH) Meeting with funding for research into chronic problems of Alloplastic Disc replacement. FDA approves the marketing of Techmedica Total Joint Prostheses again; the first models to be ready in 1997 (new name is TMJ Concepts)

June 19 1998 – FDA rescinded the determinations of SE for four of the nine 510(k)s and the remaining five are being reviewed.

December 30 1998 – FDA published a final 515(b) regulation in the Federal Register that requires manufacturers of TMJ implants to submit PMAs with data showing the safety and effectiveness of the implants.

HEALTH LEADERS IN CONGRESS INTRODUCE LEGISLATION REVERSING SUPREME COURT’S MEDICAL DEVICE DECISION Legislation will Protect Patients from Dangerous & Defective Devices.

Personal Note from the Baroness:

I have lived through every minute of this timeline.  obviously not always aware of the goings on behind the scenes. Such as what was known prior to my first surgery for the implantation of the Proplast’s. I went through a period of real anger. Anger at my country, anger at my doctors, and anger at myself. I was part of the first class action litigation and received some settlement monies. There is not enough monies that could ever reimburse me for the damages. And that is all that can be reimbursed for. Sure pain is part of the damages, but how much is every day, every hour pain worth? Or how about reimbursement for the lifestyle I lost?

Vitek the company, and the man who owned Vitek, Dr Charles Homsey manufactured the implants  filed bankruptcy immediately upon hearing through the medical and dental community that the implants were failing. he filed both corporate and personal bankruptcy from another country. Switzerland. The USA FDA had to recall the implants.

The most surreal thing is I am grateful I accepted the settlement monies and did not try to hold out for a trial and more damages awarded. Of which I also signed a confidential clause stating I would not divulge my awards. I filed my Torte suit in 1992, the first offer of settlement came in 1994. The others just as slow, if not slower. Had I gone to trial I would still be waiting now.

Why not go to trial? First you and your attorney’s must find a court that will hear a summary motion. In this motion we asked the court to agree with us, the plaintiffs,  that we, were in fact damaged by those we were suing and have a case. There were many agency’s involved from hospitals, to universities, to private businesses with public stock holders. In the cases against DuPont and Dow Corning amazingly the judge found that we ,the plaintiffs, did not have standing (cause) to sue the two monster companies DuPont & Dow Corning. (makes me very suspicious still today, as these two corporations have a big lobbying industry on Capitol Hill.) I was once again grateful I had decided the trial would be too much and took the settlement.

DuPont and Dow Corning Settle With Some Plaintiffs.

The courts however took pity on some of the plaintiffs by offering miniscule settlements if we would just agree to go away. The two Biggies knew that they would no doubt succeed, but the time and money wrapped up in the litigation  and not to mention the media attention inspired them to offer what is known in the litigation industry as nuisance settlements. I promise you it did not even come close to enough to live on for one year for a family of four. I lost my employment and income because i was unable to work which meant I also lost my profit-sharing. I also had to stop going to school to complete my master degree, This was severely a detriment to myself as well as my family.

What was painful to my spirit was that  I could no longer sing like I had all my life. It had become impossible to open my mouth more than 3 cm on my good days because of the damage to my TM joints. Think holding a note as one example where you need to be able to have full range of motion of the mouth; Not to mention how this type of disease in the TM joints also affect a persons hearing. Mine was already compromised from live music-  I did not need anymore help.

These assaults by medical devices are not the first of their kind. Nor will they be the last. I recall in horror what the IUD devices did to so many women of my generation. And now we are dealing with Hip & Knee Joint replacement Implants being recalled.

I just wonder when we will ever learn.

There has to be a better way. This cannot be rocket science, can it?

Please feel free to contact me if you have any questions or comments. And thank you so much for taking the time to become familiar what this business is all about.

http://kennedy. senate.gov/ newsroom/ press_release. cfm?id=86739FE7- B6C1-4C2F- 9BF3-409D6348BED 0

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35 Comments

35 thoughts on “Chronology of the Vitek Proplast Implant ~ The Aftermath

  1. I know that they were using them in Canada & the government went into Dentists office & removed them. the also compensated the patients. I don’t know why I never was notified or received anything here in Indiana. Since I lost my job due to this proble, I have developed diabetes, a knee transplant, brittle bone disease, salivary cancer & now this heating in my head is driving me crazy. I live in Indianapolis, if anyone knows a good pain clinic or Doctor please let me know. Thank you for this group.

    • Hi Donna,
      I am happy that you have shared your experience here with all of us. I have been advocating for myself and other Vitek Proplast recipients since 1990 when the FDA declared the implants as failures and recalled them. Since my bi-lateral implants were placed in 1986 I, like you and thousands it was too late for. I don’t know how many of us are surviving the onslaught of immune disorders and other over-lapping illnesses but I do know that we are still coming out of the wood work of the dentists and oral surgeons charts.
      On being notified. Mine came by way of a ting one paragraph blip buried in the back pages of the business section of my local Sunday paper. It was a Sunday and I didn’t know if the implants I’d had placed in 986 were Vitek Proplast or not. The following morning I phoned the surgeon to earn that yes, these were the implants I had, and yes the fact that I had remained symptomatic and became progressively more ill likely had to with the Teflon and Silastic my body was rejecting. I believed my surgeon acted n good faith when he used the implants based on the information he had as a physician and consumer of medical implants. That faith died with the first copy of the letter I received that had been sent out in 1984 to doctors warning them of the potential risks. As part of the investigation by my class action attorney’s we discovered memos from Dr Kent to Dr Homsey warning him of the potential problem with the implants in load bearing joints like the jaws, knees and hips. Kent’s warnings were ignored.
      The class action suit was more for principle in my case than anything else. The settlements we agreed on could never compensate any one of us for the losses experienced as a result, but holding those involved accountable was. Sadly Homsey was ahead of the feds and fled the USA jurisdiction after filing professional and personal bankruptcy and last I heard was a Switzerland resident.
      We as a class action suit were able to do one very powerful act though, we petitioned the World Health Organization to prevent the sale off Vitek Proplast in 3rd world countries where he was trying to unload the inventory he couldn’t sell else where.

      I am sorry that your joints had suffered so much degeneration as well. In 1991 when another surgeon attempted to remove my implants he as faced with complete fragmentation of the implant, and progressed bone degeneration. My articular disks were both gone of course which had been the purpose for the implants which resulted in bone rubbing on bone, which sets all the protective connective tissue into war. = muscle spasms for one type of warfare. My surgeon after cleaning up the condyles as best he could he then harvested cartilage from the back of my ears, and some bone from my hip and fashioned articular discs bi-laterally It dumbfounded me then why that had not been the appropriate treatment in the first place. I mention this to you Donna because I now that although there is always gong to be pain, muscle spasms, and range of motion problems with our TMJ’s, but bone rubbing on bone cane be alleviated, and should be. It exasperates bone loss which we cannot afford.
      I know I wrote a lot here to take in. I also realized I should write a thorough persona update.
      I cope completely different today.
      I am happy we connected and I look forward to more sharing.

    • Hi! My name is Kathy, and I had the proplast implants in 1987 and 1988. Not only do I have the implants, but I have jaw extensions and a chin implant. To this day, I still have these horrible implants! Back in the mid 1993-1994 I saw a huge add in a Minneapolis Newspaper about the “Warning to Proplast Patients” that scared me like no other!
      I had the implants through a very reputable maxillofacial surgeon, in Tulsa, Oklahoma. I was told by this surgeon that he would be the main surgeon performing my surgeries, along with his partner, and a very well known surgeon from the Houston area, that was flying in ( Tulsa, Oklahoma ) who in fact was bringing my implants, that would be assisting in my surgery as well. I had to have so much reconstruction of my jaw, face and chin, that it would take two surgeries, exactly 1 year to the date apart because there were also two Orthodontics who were involved in my case as well. Alot of reconstruction!
      What a big mess!!!!
      To make my long story short, one of the maxillofacial surgeons, that performed the surgeries, has been deceased for a very long time however, his partner is still in practice, so years ago, around the time the class action suit was going on, I went back to this doctor and expressed my concern about the proplast implants. He looked right at me, and very rudely said; “You do not have the Proplast Implants, your mistaken!” He quickly left the room. I left his office and went straight to the hospital where I had my surgeries, and retrieved my Medical Records on both of my surgeries, As I suspected, there in my medical records, in black and white, Proplast Implants, along with their serial numbers! Of coarse I went back to that surgeons office to show him I do in fact remember what was implanted in me, and that doctor would not see me and I was asked to leave his office! What was he afraid of??
      I did turn those medical records over to the Attorney who was representing me in the class action law suit, which I received very little, considering what all I had gone through. ( I now wish I had made a copy for myself ) All I have is my word, that I do have these implants, all my medical records have been destroyed now because its been so long.
      I’ve had some severe ear pains, and headaches over time. My entire body, all joints, muscles, etc…hurt all the time, and now I’m seeing a physician once a month just to control my pain throughout my body.
      I’m at odds! I have no idea where to turn and what to do! I would love some advice please.
      Now I know “I’m not crazy!” That I’m not the only one out there going through all this!
      Sincerely,
      Kathy Johnson
      eyesonu24seven@gmail.com

      • Hi Kathy,
        Your ending paragraph brought tears to my eyes because I remember feeling that exact thing. I began in 1995 searching for other survivors and I began writing about the nightmare that changed our lives forever.
        The outright deceit and lack of acknowledgments from the medical community is still ongoing.
        I would suggest that you begin giving your primary physician any documentation about the implants you had. Such as the chronological list of events. (I have created one if you need it)
        I also recommend a blood test for polymers. I have developed a rejection disease called Giant Cell Response because when another surgeon attempted to remove my implants (bi-lateral) they’d already fragmented.
        Please feel welcome to contact me again. We need each other to be a collective voice.
        – Toni aka Barefoot Baroness

    • Well it has been over a year since I last wrote to you Baroness. I was never notified by the oral surgeon Dr. Robert Sexton and Dr. Craig Cooper who “sold me on this implant.” I did not learn until I went to a different oral surgeon Dr. Bussard (who has retired.) he told me they had been recalled and I was furious as I was a Dental Assistant and neither of the above two Dr.s notified me and I felt we had a friendship. It took twelve hours to clean out the joints. Dr. Buzzard said he got as much as possible. But not all, I did not get a dime in compensation. I assume because I was not notified in time. I developed salivary gland cancer within two months of removing the implants. Dr. Buzzard cut it out and it came back huge under my tongue, he sent to me an Ear, Nose, Throat, Dr. I was given the choice of cleaning out the inside of my mouth and removing half of the salivary glands or radiation. He did not advise radiation, due to my age. So I got dry mouth, all my beautiful teeth decayed. Then I started getting joint pain everywhere. My mate thinks that is because of pain pills.My knee went bad, and I got another terrible Dr. He removed the joint, then the next day I was vomiting, and running a fever. So they did a “scrub.” Then I had a heart attack, the sepsis. He then left right after the second surgery and moved to Peru. Now my eyes are light sensitive, muscle pains, brittle bone disease, diabetes, rheumatoid arthritis and a stroke. And God only knows what else. may I ask how does everyone deal with the pain? I have tried biofeedback, acupuncture, meditation. No one in my family understands the severity of the pain. Any help of pain clinics good ones) in Indiana would be appreciated. I am 65 now and never thought it would let me live this long. Best wishes to all, Sleddog.

  2. I have had so many problems since this was told to me it had to be removed in 1989, it had been in there for 6 years, the surgery took 12 hours to clean up, they had nothing to put in it’s place back then. The oral surgeon who put it in never told me anything. I believe it was 4-6 weeks after they removed as much as they could. Then i got salivary gland cancer. I never received any compensation , I talked to a lawyer & he said in Indiana you only have 2 years to sue. have tried for disability 4 times & been denied. Lost my management job. my muscles swell up in my face, the only thing that ever helped was the duragesic patches, but the government has cracked down on med icon for pain. I have been to 37 Dentists & oral surgeons. i feel it is in my head now. I was told simply I would have really bad days & some fair days. That’s all for now.

  3. I am going back reading all the comments again and I am appalled that doctors are still using them!! Mine are cheek implants and the surgeon who has agreed to do the surgery was shocked that I was never told of the recall and that they are still in 29 years later. I have bone erosion even on the side that is non symptomatic! I sent you an email! Do you still have your other blog up?

  4. Hi, well, it’s been almost 2 1/2 years since I have been in touch with you. I would love to be able to communicate with you via private email a little more if possible! ~Bethina

  5. My mother in law received these implants in 1982 on both sides and still has the implants in. She didn’t have any issues until recently she has tried to contact her implant Dr he is nowhere to be found. We are trying to find her a Dr to just look at them and hopefully give her some advice but all the drs we call refuse to see her. I’m hoping someone on here knows of a doctor somewhere in the USA to help her. She is having chewing issues, and pinched nerve feelings in her jaw. she does not want any lawsuit just a doctor to help her.

    • Hi Amanda,
      It always breaks my heart to have to acknowledge yet another Proplast victim. I’m so sorry.
      As you can read by the others who comment that the medical community runs when they see us coming.
      Today I focus on pain and symptom management versus trying to find absolute answers to my future prognosis. No one knows, we are the test subjects.

  6. Just found your site. I have Proplast cheek implants and have been avoiding the need to have them removed for about 2 years. I know they are probably causing a few of my health issues but I am terrified to have this surgery! They were placed in 1986.

    • Hello Bethina, thank you so much for writing. I understand your fear.
      My jaw implants were implanted in 1986 as well and the attempt to remove them in 1991 after the recall notification in 1990. I had to wait a year to change insurance providers for overage because my diagnosis was TMJ disease which back then most medical insurance companies would not touch.
      In just those 5 years my implants had fragmented completely, my surgeon believes they had done so immediately because I had been symptomatic from the beginning.
      My belief is that your implants will have done the same, which means to me a patient with the same implants that the damage is done. When the surgeon attempted to remove mine all that could be done was to debris my TM joints (jaws) There were no implants intact to remove.
      Since then my medical issues have been extensive and overlapping. From rejection of the implants which is called a Giant Cell Reaction to mysterious skin rashes and swelling of my face, head, and neck.. The list of muscle-skeletal diseases are vast.
      I hope that you have a doctor, or team of doctors who takes you serious.I’ve had too many look at me with the blank stare of a deer caught in headlights to believe the medical community as a whole wants to admit this man created disaster happened and affects so many people world-wide.
      I get furious every time I think of the inventor Charles Hosmey trying to hawk his failed medical implants to 3rd world countries now.
      Please stay in touch, letting me(us) know how you are doing.

    • Hello Bethina,
      I’m so sorry I missed your comment. You and I had the original surgery the same year, please know I am not convinced another surgery would be of any benefit. To you. See my replies below please.
      In my humble experiences this last 30 years have revolved around navigating illnesses and pain management due to these implants I today live an active and happy life. I wish that you also can find your way. Please write again and I promise to not be so tardy in my reply.

  7. I had the Vitek condile implant removed in the summer of 2012 as I have stated before, And I am still a mess from all the complications that came from having it,The shingels pain in my mouth and jaw is ongoing and the depression caused by this mess is unbearable.I had no insurance and can not get any medicaid help at all,I was denied any help at all from my state and country. I hope no one else ever has to go thru this again.

    • Hi Grant, please forgive my tardiness in responding.
      I completely relate to your symptoms and the greatest disappointment in being shunned by the medical community. I have been blessed to have had great medical coverage throughout what has now been 30 years of being significantly impacted by these implants, but even so as soon as I mention Vitek Proplast I am also quickly shown the door.
      My implants were in 1986 and in 1991 only through my local newspaper did I discover the FDA had recalled the implants, and why I had remained symptomatic after the original surgery. Although another surgeon tried to remove my implants in 91 they had completely fragmented and my immune system set about fighting the toxins, but to no avail. I have Giant Cell Response and a couple other over-lapping illnesses because of being poisoned by the Teflon & Silastic. The second surgery also pointless.
      I tell you this only to serve as a point that I doubt having surgery again even to debris the TM joints probably won’t alter your medical condition. Sad but true.

      Today I focus on removing all toxins from my life and my body I can and I look at my health today as something I can only try to maintain at a level of function. Living with chronic pain almost did me in, so I know how important it is to find a way to manage the pain adequately so that I can have a life, albeit certainly is different from what I expected 30 years ago, I accept that today and that has helped me in ways I can only hope might be a light for you. It can happen. Don’t give up please.

  8. This is my first time writing on my severe problems with proplast teflon since
    April 2004 suggested by my maxillofacial facial surgeon in San Diego. I had
    surgery for sleep apnea with the poorly advised proplast teflon ($1,500 by me)
    for cheek implants by my surgeon. Initally, I was told he would use graft from
    my hip for the cheek area of concern during the surgery. He made a very poor
    choice using proplast teflon knowing of FDA concerns from the 1980′s/1990′s. I
    went from being a past marathoner (26.2 miles and one ultra marathon 50 miles in
    1983) before this ill fated surgery in 2004. I was jogging 30/40 miles a week
    before the surgery in 2004 to constant infections, coughing, burning and facial
    pain, swollen left cheek compromised hearing loss with popping in the ears,
    feeling of fatigue, pins and needles sensation in my face, head and neck. When
    it is at it worse, (once every 3/4 weeks) now, I will sleep 8/12 hours from the
    infection and unable to get up or work. I did have the cheek implants removed in
    2006 and improvement about sixty percent. Then was upon three written letters of
    concern given by two other maxillofacial surgeon, ears, nose and throat and
    orthodontist specilist. I convinced the surgeon to remove the implants upon his
    statement of not getting paid to remove them and not admitting or believing me
    about my pain. His bedside manners was less than appropiate with unwilling to
    admit to the botched surgery. He remarked of “why I don’t go back to work and
    concentrate on my job” among other things. He made an incorrect statement that
    the implant removal didn’t show any infection issues. Very wrong statement
    since the pain subsided by sixty percent and swelling went down in my left
    cheek after the
    removal.

    I would appreciate any advise to start my research with the microscopic pieces
    still imbedded in my cheeks or suggestions for removal, class action lawsuit
    time frame, etc. Unfortunately, FDA still approved proplast teflon in 2004 for
    cheek implants after knowing of this material having severe problems with TMJ
    patients. I will do the necessary reading with joining this forum.

    Thank you, Run 2 pb

    • Hello Mike,
      So nice to meet you but sad it is under these circumstances. I am proud and honored that chose to speak out here on my blog. My belief is Mike that we all must talk about this, we have to lend our credible histories in disagreement with that which is perpetrated by Vitek and its vendors; that it is a safe product, we know that is hogwash. Now lets tell the world.
      I am appalled by your story and even more deeply saddened that this Proplast product is even available for any implantation in humans.
      This also frustrates and angers me something fierce.

      The doctors attitude that you speak to is a perfect example of deflection. No decent surgeon should be using these materials anywhere in the body but its even more ludicrous to use them facially or in load bearing joints, As far as the FDA’s approval and what that means to me we could you & I together not manage to throw in a bucket and make it, Not only is the approval process aligned with great misnomers the administration is just as corrupt as most US Govt, administrations,
      The lobbyist are too powerful and we as consumers are too powerless.

      My suggestion is a lot of research. Please do as you mentioned reading what is here. I also have another blog which i a trying to maintain strictly for living with a chronic illness and pain which includes implant information. http://fullcircledme.wordpress.com/
      There is also a brand new web site that I am co-moderator on that we just began for Vitek Implant Survivors.Though it is very early in its birth we hope it to become our home where we all can share information and find support
      You might want to check it out anyway.
      https://plus.google.com/communities/118400029449049537436

      My first concern would be seeking legal advice. It would seem that medical advice would be the first level of concern, but to be honest I would not trust just any medical providers word. even today my experience and that of others I have been privy to is most doctor’s and their agents refuse still to admit there is an open & ongoing issue with our immune systems.
      So I advice legal council first. You may find that a good attorney specializing in medial implant failures has great referrals to credible physicians. There is a specific group of attorneys who specialize in medical implant failures and your fair city should have some very fine options.
      My attorney Michael Morey Esq in Portland Oregon may even be a source of referrals for you.
      Please keep in touch, feel free to contact me anytime via my blogs. I welcome the connection with another survivor.
      Hang in there, one note of encouragement is that finding ways to cope helps smooth the rough edges and it can get better.

      Take Care ~ BB

    • hi Mike I had a similar idea…can these fragments of the proplast vitek tmj implants remain in our bodies forever and move about pricking dangerous holes where they don;t need to be? Can an MRI or other magnetic scanning have the ability to cause these fragments to move around causing more pain and problems?

  9. Hello everybody. My proplast II implants were put in January 1984 and removed with severe bone loss April 1985. Baroness my story is similar to yours. I think I may know your attorney too. I was from Arizona. My story was a tad different with my doctors that supported me and their offices burned to the ground. My records were already in a vault by my team of attorneys. I cried daily trying to get them to stop the production of these implants. It took years. I wish it could have stopped in 1985 when they knew and stopped with me. God bless each of you for I know the daily struggle and now the medical needs of the long term affect.

    • Hello Janice,
      Welcome to FullCircledMe. I cannot tell you how grateful I am that you found those of us who like you are looking to connect with others who have been and are still going through what you are. I had hoped upon reading that you had your implants removed in a year after you would not have been as affected. can read the pain between your sentences taht you are living the same life. This goes pointedly to just how dangerous to our immune systems.

      it took a very soulless individual in my mind who could take what knew to be an unsafe medical device and try to market it to other lesser known the know countries, and 3rd world countries. It took us moving mountains to get the World Health Organization on board to stop him because so many people lied.

      I do hope you will come back and share more. share with how you are doing today. This is valuable to each of us The medical community still does not want to talk about. We are an embarrassment.

  10. Dear Baroness, I am hoping all is well with you. I ” Broke down” the other day and decided to be “proactive” with my situation. I have definite “red flags” in regard to my
    doctor/surgeon. Several years ago ( I was working at Sak’s in Chevy Chase), and was
    approached by a woman who was picketing the Senate and showed me disturbing
    photos of people who were disfigured by Proplast. I was startled and did not admit that
    I had surgery and the implants. At that time I telephoned my surgeon and he assured
    me that “only people who had prior health issues” we subject to any problems with
    the proplast implants. On this past tuesday I telephoned my surgeon and spoke
    with his secretary, asking for my surgical records and I.D. numbers of the implants.
    I was calm and kind, ( I always feel we gain more benefit)- I mentioned I was concerned
    that the Proplast material had been “recalled”. Today, I received a call from my Doctors
    surgical nurse, who had a bit of an “attitude” and informed me that I indeed did have
    the Proplast implants in my face, but there were no “I.D.” numbers. I that point, I requested a copy of the complete surgical report sent to me. I assume the next step
    for me is to find a Lawyer ( hopefully one who will accept a Pro-Bono case) and take
    action. This seems to be a “Win-Win” situation. I feel certain that the best course
    of action is to acquire financial compensation to cover medical costs to have this
    material removed from my face. I assume the expense will be vast and finding a
    surgeon will be “a bit of a treat”. If you have any suggestions for me, I will appreciate
    any input, ( it will be much appreciated).
    All the best, and Warm Regards, Richard Ransom Beman

    • Hello again Richard,
      I am so grateful to hear that you are taking the fight into your own hands.
      My two biggest suggestions to you are:
      ( see your implant surgeon yes, get documented anything he/she says.In fact I would take a family member or close friend so you have a witness as to what is said. I would not share with any doctor your intent to seek legal advice just yet Definitely seek it,
      My 2nd suggestion. Seek legal council.ASAP! If you need a referral for you area I can give you my attorney’s name here in Oregon who I am sure would know who to refer you to. There is such thing as statue of limitations where you only have so long to file litigation. i have no clue when that might apply to your case so it is imperative you see an attorney and find out your rights.

      Good luck and please stay in touch I am very interested to know how you are doing physically as well ~ BB

    • when they tried 7 times to remove all the fragments in the TMJ area it was found that the fragments were already traveling throughout my body….so it seemed the more surgeries(performed in Philadelphia) the worse things got….I was included in that class action suit years ago because a friend read about it in the Philadelphia Inquirer.At that time 1995 I had been working as a high risk labor and delivery R.N.at Kapiolani hospital, H.I.. I was conned into the implants by Dr Lonnie Tiner ( This is after the FDA had recalled the devilish devices.So please Watch Out he put those proplast vitek implants in both TMJ’s and I found out he is out of hiding from Switzerland or wherever and is in the Yucca Valley, California.Good thing I don;t have a newer car or I would make an appointment just to give him a chance to apologize and share some of the cash that he took from all of us…..would a sincere apology erase the pain and physical limitations?????…hahaha Well I do not know. Maybe the government should make these doctors and inventors of dangerous implants be put in a” research jail” until they find us a cure for the pain and physical limitations that these proplast vitek implants have caused. PS. Remember when we are in severe pain.. its so easy for doctors to scam and con us……….sincerely, Anna Piper

  11. Had my implant out 1994 left side. And now having some swelling and slight clicking not able to open my mouth very big, I did have dental work a couple weeks ago alittle avasive but i kept my mouth open not a block. I dont have blocks put in my mouth for dental at all. but I am hoping its just from the dental work. anyone know how long does the reconstructive surgery last. They did the old fashion way no other device in its place. Thanks TT

    • Hello tt.
      I am assuming that you had your implants since the mid 1980’s or before? I had mine removed almost immediately upon learning of the recall because I had remained symptomatic even post op of the implants. In fact became quite ill. It is my assertion this was from the Teflon & Silastic that the body is not able to absorb or create into waste. This would be my concern with your implant remaining. Do you know if it was intact still or had fragmented?

      I also believe there is an absolute connection to your dental work I don’t know what your range of motion is for your jaws but I can barely get two fingers stacked upon another in between my teeth. That is on a good day. So even though no blocks were used (very wise) your TM joints were still traumatized and stretched to long, too far.

      Thanks for coming by and taking the time to comment. Means a lot to me. I have long been looking for this community of other TMJ implant patients. I’d love to know how you are doing over-all, and what your thoughts are on the circumstances of being a Proplast recipient. How has it impacted your life.

      Please take care and keep an eye here I have posts I am planning on moving from my primary blog to here that are all implant related.
      Best of everything to you ~ BB

      • Barefoot Baroness,

        This is my first time writing on my severe problems with proplast teflon since April 2004 suggested by my maxillofacial facial surgeon in San Diego. I had surgery for sleep apnea with the poorly advised proplast teflon ($1,500 by me) for cheek implants by my surgeon. Initally, I was told he would use graft from my hip for the cheek area of concern during the surgery. He made a very poor choice using proplast teflon knowing of FDA concerns from the 1980’s/1990’s. I went from being a past marathoner (26.2 miles and one ultra marathon 50 miles in 1983) before this ill fated surgery in 2004. I was jogging 30/40 miles a week before the surgery in 2004 to constant infections, coughing, burning and facial pain, swollen left cheek compromised hearing loss with popping in the ears, feeling of fatigue, pins and needles sensation in my face, head and neck. When it is at it worse, (once every 3/4 weeks) now, I will sleep 8/12 hours from the infection and unable to get up or work. I did have the cheek implants removed in 2006 and improvement about sixty percent. Then was upon three written letters of concern given by two other maxillofacial surgeon, ears, nose and throat and orthodontist specilist. I convinced the surgeon to remove the implants upon his statement of not getting paid to remove them and not admitting or believing me about my pain. His bedside manners was less than appropiate with unwilling to admit to the botched surgery. He remarked of “why I don’t go back to work and concentrate on my job” among other things. He made an incorrect statement that the implant removal didn’t show any infection issues. Very wrong statement
        since the pain subsided by sixty percent and swelling went down in my left cheek after the
        removal.

        I would appreciate any advise to start my research with the microscopic pieces still imbedded in my cheeks or suggestions for removal, class action lawsuit time frame, etc. Unfortunately, FDA still approved proplast teflon in 2004 for cheek implants after knowing of this material having severe problems with TMJ patients. I will do the necessary reading with joining this forum.

        Thank you, Run 2 pb

  12. I had the Vitek implant removed this summer, I was a mess from shingles,and Giant Cell Granuloma.They were worried about my brain sack being in trouble from my body going after the teflon granules. It was in there twenty six years and I just dealt with the pain until I was almost dead from all the pain cause by that Fu$^#ng Implant.

    • Hello grant! I am so sorry to hear that the implant was left is so long. You were wronged! You did not say whether it bi-lateral or lateral. I am most curious to talk wit you further about this. It has been my hope all along that by posting my story and my details I would meet others who have been affected by the Vitek Proplast Implants.

      People think we are joking when we say we are in rejection of Teflon & Silastic. I am assuming them since your implants remained so long in the joints, or what was left of them that you did not get in on the class action law suit against DuPont & Dow Corning?
      Those are the two most well known named defendants in my law suit, there were others like Texas Methodist Hospital, Louisiana State University,. & Dr. Kent from LSU University,

      I do hope Grant you will come back and e can compare some notes .~

      • i had the teflon implants in from nov 1983 toll july 28 2011 i did not get the recall notice i have been waiting on my disability hearing i can not work my anixety is always high

        • I can understand your anxiety. I had mine only from 1986 to 1991 and it was enough to cause damage . So my heart extends to what you are going through. I do hope you will stay in touch, all this who are coming here because of implants want to know.

          Take care ~

  13. Hello, this is a note to the Baroness. I am quite concerned, due to the fact that I had
    Proplast implants placed in my face many years ago and I am now wondering what
    possible physical damage they have caused me. My plastic surgeon assured me
    several years ago that the only persons who could become affected are people
    who had a previous physical problem. I found this hard to believe and I am wondering
    what recourse I now have. As well, we both know all of this is financially costly.
    My plastic surgeries alone were costly, and the thought of needing extensive
    surgery to remove this material from my face (chin and cheek implants) is frighting.
    Thank you in advance…. Regards, Richard Ransom Beman

    • Dear Richard, I am grateful beyond that you have contacted me. I have spent the better part of the last 15 yrs looking for others who have been impacted by the Proplast implanrs. There are so many questions I have and am not sure you would want that done on such a public platform.

      Let me start here with that I know what damage there is. I am medically affected by the implants. As I suspect you may be. Do you have any symptoms that something is a miss?

      I have remained symptomatic the entire time and after the implant surgery became very ill, my pain level for my head, jaws, ears and face went from a number 5 to 6 on a pain scale all the way up to 10.

      Today despite the fact that after my implants were recalled by the FDA I have contracted Giant Cell Response, Connective Tissue Disease, Chronic pain and migraines, Fibromyaglia, am tested for Lupus and MS every year with brain scans. And just have new credible information that people like who have symptoms still should be tested for Lyme disease. I and possibl;y youu have a foriegn subsatnce that your body canot assimilate so rejection srates. The cenetral nervous system is involved completely.

      There is much more written about my case, and about Vitek Proplast Implants on this blog (see pages_ and I have a fairly new blog which will contain all this kind of genre for discussion at fullcircledme.com/

      Rird may I suggest that you not trust your plastic surgeon, Get your implant ID numbers, each piece has to come with an identifying number. Lets start there and see what we first can learn about your particular implants. You do understand too that my implant were bi-lateral TM joints (jaw) I have literature highly suggestive that the proplast should never have been used in load weight loading joints… hmm like the jaws maybe?

      Be in touch, we can find an answer and maybe these implants are perfectly safe. Have you had are call? Or maybe how would you know if your doctor is not forth coming. In 1990-100991 when the FDA recalled mine and millions of other implants there were about 87% of the doctor never notified their patient. And they were obligated to do so.

      I have so much more of course so I’ll stop because I will be repetitive to what is both blogs.

      Stay in touch, let me know what is next.
      Feel free to write me any time and I pray that you are doing well and that you are being cautious. ~ BB

      • hello i had teflon implants in 1983 were never notifyed i didnt find out till feb 2011 i had no jaw joints that were distroyed by the implants i had a hole in my scull repaired teflon particals were floating on my brain sack now i have 2 titainum jaw joints and am a nervouse wreck my counclor tells me get over it i cant work im waiting for disability hearing i call fda trying to find updated information an im unable to thanx for listening!!!~ LaVaughn

You are most welcome to share your thoughts, comments, and/or complaints here. Know though complaints are only handled on the 2nd Tuesday of the week.~ The Management

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