THE AFTERMATH

PART TWO

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.

 

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.

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?

Vitek the company and the man who owned Dr Charles Homsey who manufactured the implants after final FDA approval filed bankruptcy immediately upon hearing through the medical an d dental community that the implants were failing. he filed both corporate and personal bankruptcy from another country. Switzerland.

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,  we, were in fact damaged by those we were suing. 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 degree, which I had waited to go back to once my children were in school full-time to complete my 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 as just one example. Not to mention how this type of disease in the TM joints also affect a persons hearing. Mine was already compromised from live music speakers 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