TMJ Device and Regulatory History

Regulatory History

Pre 1976

The FDA’s regulation of new medical devices entering the market began with the 1976 Medical Device Amendments. Temporomandibular Joint (TMJ) implants are pre-Amendments devices, meaning they entered the market before 1976.

May 28, 1976

The Medical Device Amendments were enacted giving FDA authority to regulate medical devices, such as TMJ implants, which were already on the market. This allowed sale of TMJ implants marketed before May 28, 1976 to continue without demonstrating safety and effectiveness. These devices introduced after this date required FDA clearance.

January 7, 1991

FDA issued a press release announcing a recall of Vitek, Inc.’s jaw implants, describing possible health hazard associated with the product.

June 4, 1992

Are FDA and NIH Ignoring the Danger of TMJ (Jaw) Implants? A Hearing before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations House of Representatives One Hundred Second Congress.

February 11, 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. TMJ implants were reclassified as Class III – the highest risk category. This means that all manufacturers of TMJ devices would be required to submit a Premarket Approval Application (PMA) –demonstrating safety and effectiveness – when called for by the FDA.

April 1995

Orthopedic Network News dedicated its feature article issue to TMJ implants.

December 30, 1998

The FDA published a final regulation in the Federal Register that requires manufacturers of TMJ implants to submit Pre Market Approvals (PMAs) with data showing the safety and effectiveness of the implants.

The FDA approved the TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052) – 1999
The FDA approved the Nexus CMF LLC (formerly TMJ Implants, Inc.), TMJ Fossa-Eminence/Condylar Prosthesis System (P000023). – 2001
The FDA approved the TMJ Implants, Inc., TMJ Fossa-Eminence Prosthesis (P000035). – 2001
The FDA approved the Biomet Microfixation, Inc., Total Temporomandibular Joint Replacement System device (P020016). – 2005

April 2001

FDA TMJ Implant Update booklet. Some of our information may be similar to the material they present.

September 2002

Medical Implant Information Performance & Policies Workshop Final Report

2007

Government Accountability Office (GAO) conducted an investigation looking at the FDA’s approval of four TMJ implant devices. The GAO investigation report is available online at: www.gao.gov/cgi-bin/getrpt?GAO-07-996.

November 28, 2010

An investigational article by John Fauber appeared in the M ilwaukee Journal Sentinel and MedPage Today on TMJ implant devices.

February 7, 2011

The Food and Drug Administration orders a postmarket surveillance of certain TMJ Implants. The FDA ordered all three manufacturers of the four FDA-approved TMJ implants to conduct post-market surveillance studies to better understand the events associated with the need to remove (explant) TMJ implants and replace (revise) TMJ implants.

Milwaukee Journal Sentinel article, FDA Orders Review of Jaw Joint Implants After Numerous Problems.

April 13, 2011

The U.S. Senate conducted a Congressional hearing on Medical Devices. The TMJ Association was asked to submit a written statement and summary and recommendations for this hearing.

July 29, 2011

The Institute of Medicine released its recommendations on the FDA’s 510(k) process for medical devices (including TMJ implant devices). In the report the IOM committee concluded that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one

June 16 2016 – Present

The TMJ Association, acting as the catalyst to advance the interest of TMJ patients, developed the first TMJ Patient-Led RoundTable conducted under the auspices of the Medical Device Epidemiology Network (MDEpiNet). The RoundTable was initiated by a need to find out why some TMJ patients improve with implant surgery, while others worsen. The RoundTable is conducting a comprehensive study of all aspects of TMD and how these aspects interact to affect patient outcomes. The RoundTable Working Groups continue to meet on a regular basis.

TMJ Implant Devices

The following is an alphabetical listing of TMJ implant devices currently and formerly on the market and their history.

Biomet Microfixation/ Zimmer Biomet (formerly Walter Lorenz Surgical, Inc.)

Present. This device is currently available and marketed to patients. https://www.zimmerbiomet.com/medical-professionals/cmf/total-joint-replacement-system.html

September 21, 2005. Approval Order, Summary of Safety and Effectiveness, and Labeling for Walter Lorenz Total Temporomandibular Joint Replacement System.

January 2003. The FDA has issued a warning letter to Dr. Douglas Sinn, a Walter Lorenz TMJ implant clinical investigator.

August 22, 2002. A dental products panel hearing to vote on a premarket approval application for the Walter Lorenz Surgical device occurred. The Panel unanimously voted that P020016 be found approvable with conditions. The FDA has posted the August 22, 2002 Dental Products Panel meeting transcript.

June 1995. An FDA-approved (IDE #G940177) clinical study utilizing a total temporomandibular joint prosthesis developed by Biomet-Lorenz began. The first patient was enrolled in June 1995 at the Hospital of the University of Pennsylvania. Peter D. Quinn, DMD, MD, Chairman of Oral and Maxillofacial Surgery at the University of Pennsylvania served as the clinical investigator. In April 1998, a second clinical site for this study was initiated at the University of Texas Southwestern Medical School with Douglas Sinn, DDS, Chairman of the Department of Oral and Maxillofacial Surgery serving as the clinical investigator at that institution.

To date, approximately 112 cases are being followed at intervals of 1|3|6 months, one year, one and a half years, and annually thereafter. The prosthesis is a stock prosthesis with a fossa component of ultra-high weight polyethylene and a condylar prosthesis made of cobalt-chrome alloy.

The most current three-year data on the implants placed at the University of Pennsylvania has been recently published in the February 2000 issue of the Oral and Maxillofacial Surgery Clinics of North America (pp. 93-103).

Hoffman-Pappas Temporomandibular Joint Replacement System)

Present. This device is no longer available.

October 6, 2006. The FDA seeks an injunction against Endotec Inc., maker of the Hoffman-Pappas device, for illegal distribution of unapproved total joint replacement devices.

July 2003. The FDA has issued a warning letter to Dr. James Yanney, a Hoffman-Pappas TMJ implant clinical investigator.

The Endotec or Hoffman-Pappas Temporomandibular Joint Replacement System is a custom TMJ prosthesis being used at approximately ten hospital centers in this country for clinical trials. The FDA has given the company an Investigational Device Exemption #G97OO92, as part of the approval process.

The Hoffman-Pappas prosthesis (“joint”) has been co-developed by an oral and maxillofacial surgeon, Dr. David Hoffman, and a well-known biomedical engineer, Dr. Michael Pappas. Dr. Pappas is responsible for the development of a number of other prosthetic joint replacement systems for the hips and knees used throughout the world.

The Hoffman-Pappas joint is a custom-made prosthesis that is built from data obtained from a CAT Scan of a patient’s skull. The joint is designed and fabricated on CAD CAM Systems and is fitted to a replica of the patient’s skull. Any changes in the patient’s occlusion, jaw position or abnormal anatomy can be accommodated at the design level and can be checked at the construction level.

The three basic materials used are titanium, high molecular weight polyethylene and titanium-nitride (a thin layer ceramic). These are the same materials used for prosthetic joints made for other parts of the body. The prosthesis is divided into three components as follows:

The condyle component which attaches to the lateral side of the mandible and forms the head or “bell” part of the joint.
The articulating surface which is a polyethylene insert.
The metallic fossa, which is a custom fit metal housing against the glenoid fossa or the roof of the joint that attaches to the polyethylene.

The condyle is made of titanium. Its outer surface is chemically changed to a coating of titanium nitride, a material that is extremely hard and has been tested extensively for its wear properties in prosthetic joints. The high molecular weight polyethylene insert is a standard material used in all articulating surfaces for joint reconstruction. The metal fossa is made of pure titanium.

The fossa and condylar components are screwed into position against the skull and the lateral side of the mandible respectively. The fossa component obtains most of its stability through its custom fit and is secured in place using three or four small 2mm screws. The condylar component obtains its stability from two types of screws, three of which are specialized microlocking screws that avoids any type of micromovement of the prosthesis or movement of the screw against the metal. This is a unique feature of this joint. The screw holes are all designed to be placed in the maximum amount of bone avoiding contact of underlying structures, such as nerves or blood vessels.

The prosthesis is placed through two incisions, one in front of the ear approximately one and a half to two inches long and the second incision along the lateral side of the neck below the angle of the jaw, approximately two inches long. The standard hospitalization for the procedure is usually two days.

Patients are seen on a routine outpatient basis after surgery and may regain function of their jaw within a short period of time after surgery. There is no intermaxillary fixation or wiring of the teeth together after surgery. Patients should allow approximately two weeks of nonworking and a two to three month period of continuous passive motion machines and/or physical therapy.

The study has been ongoing for one year. Long-term follow up studies lasting up to three years have been conducted with prototypes. Overall results are very promising. There have been no surgical failures to date.

Indications for this prosthesis follows guidelines presented by the American Association of Oral and Maxillofacial Surgeons and the American Academy of Orofacial Pain. The indications generally consist of previous failed surgeries, underlying rheumatological or severe osteoarthritic diseases, significant traumatic injuries or failed alloplastic implants.

Dow Corning (Silastic Disc Implant)

Present. The TMJ Association contacted the FDA regarding the use of Silastic in the TMJ after learning that some doctors are still implanting this material in the TMJ. We were told by the FDA that if a surgeon implants any silicone material into a jaw joint the surgeon is using it “off label” and according the “practice of Medicine.” This simply means, the surgeon is practicing without FDA or manufacturers recommendation for use.

February 2005. In the Dow Corning litigation, the deadline for opt out claimants to complete their fact sheet discovery was February 28, 2005.

March 2003. Those patients who had Dow Corning Silicone products, as well as Vitek, implanted into the temporomandibular joint have been eligible to be included in the Dow Corning Bankruptcy Settlement. Mr. Mitchell Toups, representing many TMJ implant patients, informed us the claim process has begun. Clients should get all their medical records that will be needed for processing the claims.

1991. The FDA called for PMAs (pre-market approvals) on all TMJ devices. Pre-market approval documents contain testing and clinical data on safety and efficacy of a product. Not one silicone manufacturer submitted a PMA on Silastic sheeting to be used in the TMJoint. Therefore, FDA has not approved any company’s silicone products for use in the TM joint.

January 1993. Dow Corning discontinued the sale of all Silastic TMJ implants. (Read letter from Dow Corning). Dow has since instructed customers to inform patients who received Silastic implants of the risks and benefits of removing the implant or leaving it in. If a patient decides to leave a Silastic disc in, he or she should be followed regularly with appropriate imaging and evaluation of symptoms. Dow further states that the temporary Silastic implant (Wilkes Design) should have been removed, and patients with silicone sheeting used in custom TMJ devices should be monitored regularly. Although Dow Corning has apparently bowed out of the TMJ device market, there are other silicone products manufacturers.

Dr. Lappe describes the development of Silastic and other implant materials for the TMJ as “marked by a pattern of haphazard development, entrepreneuralism, unverified assertions in the absence of animal testing, and a silent FDA. In 1992, he states, “we are left with no truly suitable implant material, in part because the most commonly used one – Silastic brand reinforced sheeting – was only belatedly subjected to testing. And then, it was found to be deficient for just the properties which were known to its manufacturer fully twenty years earlier.”

1991 Sheep studies were conducted and severe bony destruction and foreign body giant cell reaction were found. Finally, after 20 years of use, it was decided that Silastic isn’t appropriate for long-term use and that even short-term use is highly experimental.

As late as 1989, there was not one long-term study of the use of Silastic in animals or humans. As a matter of fact, a single study in 1965 “served as the principal impetus to encourage the marketing of Silastic sheeting for this new and untested purpose.”

A 1986 article reported “fragmentation, perforation, and deterioration of the (Silastic) material.” And another stated, “silicone may not be a totally inert material and that its biomechanical properties are not ideal for use in the TMJ.” By the end of the 1980s, enough failures had occurred for some researchers to call for strict limits on the use of Silastic.

The Wilkes Design, marketed in 1985, had “tabs” to allow for easy removal.

A 1982 study warned doctors that particle migration meant they should be alerted to possible systemic reactions and foreign body synovitis, speeding failure.

Short-term studies in the early Seventies looked good. Reports after one to five years, however, showed substantial problems, including ankylosis, arthritis, and lymph node swelling.

Introduced in the mid-Sixties, was a Silastic block, or silicone rubber, carved to shape. Another was Silastic HP Sheeting, which was reinforced with Dacron. Although designed for temporary use, many surgeons leave these implants in the joints for an indefinite period of time.

Nexus CMF (formerly TMJ Medical, TMJ Implants, Inc. and commonly referred to as the Christensen device)

Present. This device is no longer being marketed to patients.

July 2016. The following is a postmarket surveillance study approval letter. It is our understanding the FDA cease and desist order has been lifted.

June 30, 2015. The Food and Drug Administration’s Center of Devices & Radiological Health sent a warning letter to the President of Nexus CMF telling him that, “Nexus CMF has committed a prohibited act under section 301(q)(1)(c) of the Act by failing to comply with requirements under section 522 of the Act, and your P000023and P00035 devices are currently misbranded under section 502(t)(3) of the Act. It is also a prohibited act under section 301(a) of the Act to introduce or deliver for introduction a misbranded device into interstate commerce.” The TMJ Association verified with the FDA on November 11, 2015 that this letter is still in effect. Click here to view the warning letter. What this means for patients… Nexus CMF is currently prohibited from selling their TMJ total and partial joints to patients, surgeons and hospitals. If you or someone you know has received this implant after June 30, 2015 or is anticipating getting one in the near future, you should report this to the FDA’s MedWatch system. Please feel free to contact the TMJ Association at info@tmj.org if you need any assistance with completing a report or would like to file it anonymously.

January 31, 2012. 180-Day TMJ Fossa-Eminence Prosthesis SystemTMJ Medical, Golden, CO. Approval for labeling changes to update the owner and company name, manufacturing suite, standardization of the product names, and adverse events section related to completion of the post-approval study.

September 30, 2010. TMJ Implants, Inc. is acquired by Crocker Ventures.

October 27, 2009. FDA Wins Court Case Against TMJ Implants, Inc. — Manufacturer to Pay $340,000 in Civil Money Penalties. The United States Court of Appeals Tenth Circuit ruled in favor of the FDA in a civil money penalties case against TMJ implant device manufacturer, TMJ Implants, Inc. and President, Dr. Robert W. Christensen, for failure to submit 17 medical device reports. Click here to read the article that appeared in FDA Law Blog.

The following information is taken from the October 27, 2009 United States Court of Appeals document:

“FDA has explained the purpose of the reporting requirement and its broad scope: To carry out its responsibilities, the agency needs to be informed whenever a manufacturer or importer receives or otherwise becomes aware of information about device problems. Only if FDA is provided with such information will it be able to evaluate the risk, if any, associated with a device and take whatever action is necessary to reduce or eliminate the public’s exposure to this risk” (p. 4).
“Dr. Christensen contended that in each of the disputed events TMJI’s devices were not explanted because of any inherent problem with the device itself; rather, natural progression of the TMJ disease necessitated removal of the device” (p. 9).
“Dr. Christensen and his colleagues also expressed concern that filing medical device reports (MDRs) would expose TMJI to civil lawsuits and provide their competitors wih an unfair advantage” (p. 10).

Christensen offered to file the required MDRs if FDA promised to drop the Civil Money Penalties of $340,000. The judges state:

“offering to abide by the law only after being punished for not doing so does not mitigate the culcability of the initial unlawful conduct…” (p.26).

December 20, 2006. The FDA issued a warning letter to TMJ Implants, Inc. concerning the promotion of hemi and full mandibles without premarket clearance or approval from the FDA. TMJ Implants, Inc.’s response to the warning letter is also posted on the FDA’s site.

July 14, 2005. The Food and Drug Administration (FDA), along with the Center for Devices and Radiological Health (CDRH) and the United States Department of Health and Human Services, has filed an administrative complaint against TMJ Implants, Inc., manufacturer of the Christensen implant. Also named in the complaint are Robert Christensen, President of TMJ Implants, Inc., and Maureen Mooney, Regulatory Affairs and Quality Assurance Manager of TMJ Implants, Inc. The complaint alleges that TMJ Implants, Inc., violated an FDA regulation that requires “a medical device manufacturer file a medical device report (MDR) whenever the manufacturer becomes aware of deaths and serious injuries which the manufacturer’s device has caused or may have caused or to which the device has contributed or may have contributed.” According to the FDA, TMJ Implants, Inc., failed to file MDRs between October 22, 2002 and July 10, 2003. “[The] FDA routinely inspects medical device manufacturers to determine their compliance with Food, Drug and Cosmetic Act requirements and monitors adverse event reporting systems such as MedWatch, through which consumers and physicians report deaths, serious injuries, or other adverse effects which a medical device has caused or may have caused or to which the device has contributed or may have contributed.” During an inspection in July and August of 2003, the FDA collected complaint reports received by TMJ Implants, Inc., which “describe MDR reportable events.” The FDA is seeking a civil penalty of $10,000 for each of the twenty-one MDR violations listed in the complaint, $210,000 for TMJ Implants, Inc., and $210,000 each for Robert Christensen and Maureen Mooney. The complaint is currently in the discovery stage.

February 2004. The FDA has issued a warning letter to TMJ implants, Inc.

March 2002. The FDA has issued a warning letter to TMJ implants, Inc.

July 25, 2001. Revised Summary of Safety and Effectiveness (SSE) for TMJ Fossa-Eminence Prosthesis- P000035

June 28, 2001. TMJ Association’s FDA Petition Supplement regarding TMJ Implants, Inc. premarket approval (PMA) of the TMJ Fossa-Eminence Prosthesis, Application No. P000035

May 1, 2001. TMJ Association’s FDA Petition regarding TMJ Implants, Inc. premarket approval (PMA) of the TMJ Fossa-Eminence Prosthesis, Application No. P000035

March 2001. TMJ Implants, Inc. is asking our assistance in contacting patients lost to follow-up. It is only through information derived from a comprehensive database, that current and future TMJ implant patients can make informed health care decisions. If you have been lost to follow-up, please contact TMJ Implants, Inc., Registry/IDE Study, 17301 West Colfax Avenue, Suite 135, Golden, CO 80401. Email: info@tmj.com Telephone: 1-800-825-4TMJ.

February 27, 2001. The FDA approved the Christensen Fossa-Eminence partial temporomandibular joint. The FDA included product labeling which the patient and the surgeon will share the risk responsibility. This single step has led to the joints return to the market. According to Dickinson FDAWebview “… this approval is the first in 25 years where the agency (The FDA) stepped back from its “appropriate use” worries and left them to physicians and patients to decide, based on full disclosure in labeling of the device’s real-world limitations – including the availability of no-device alternative therapies”. An Editorial in the Journal of Oral Maxilofacial Surgery written by Dr. Daniel Laskin entitled “Shifting the Responsibility for Medical Decisions” references the February article posted on Dickinson’s FDA Webview. The FDA issued the Approval Order, Summary of Safety and Effectiveness, and Labeling for TMJ Implant Inc.’s (Christensen) Fossa-Eminence partial temporomandibular joint. Please view the FDA’s website to view these documents. http://www.accessdata.fda.gov/cdrh_docs/pdf/P000035b.pdf.

January 5, 2001. The FDA issued the Approval Order, Summary of Safety and Effectiveness, and Labeling for TMJ Implant Inc.’s (Christensen) all metal total joint device.

September 2000. The FDA has issued a warning letter to TMJ implants, Inc.

On October 6, 2000 at a meeting of the Dental Products Advisory Panel to the FDA, Panel members voted unanimously to “not approve” the partial joint prosthesis. The panel believed that the safety and effectiveness data for the device were inadequate. In addition, the panel believed that the indications for use needed to be clarified. (See p. 17).

As stated on p.18, “The FDA considered and concurred with the Panel’s concerns about the prospective and retrospective studies…. [The] FDA balanced the scientific concerns related to the limited clinical data with the knowledge that there appears to be a group of patients, albeit poorly defined, for whom this device seems to provide a reasonable treatment option.”

The following was presented by The TMJ Association at the October 6, 2000 panel hearing. FDA Dental Products Meeting of the Medical Device Advisory Committee – Open Session.

The TMJ Association is sufficiently concerned about the FDA’s approval of the device in spite of the unanimous opinion of its advisory panel that we have petitioned the agency to hold a public hearing to reconsider the FDA decision. On August 12, 2002, we received a letter from the FDA, denying the petition of The TMJ Association. Though disappointed, we were not surprised by FDA’s decision. We will continue to press for scientific evidence of safety and effectiveness of TMJ devices and other treatments that are recommended to TMJ patients.

On Friday, October 6, 2000 the Food and Drug Administration (FDA) Dental Products Panel voted unanimously that the TMJ Implants, Inc. (also known as the Christensen) Fossa-Eminence Prosthesis was not approvable. Concerns were raised regarding the indications for use. The applicant’s clinical study included over 81% of the patients with a diagnosis of internal derangement. The panel expressed concerns about this clinical study and requested further data to substantiate safety and efficacy. The sponsors did not provide any testing data demonstrating the effect of the metal eminence on the natural mandibular condyle. Final disposition of the recommendation awaits FDA’s decision.

The FDA has posted the October 6, 2000 Dental Products Panel Meeting transcript.

The FDA is proceeding with approval of the metal on metal total joint replacement system. Of interest is the fact that labeling states that the fatigue-limit is 130 pounds. Labeling further states that, surgeons who recommend this device should take into consideration the patient’s oral habits such as bruxing or grinding which may increase the joint loads.

We have been advised that as of May 8, 2000 there is no premarket approval document (PMA) on any device manufactured by TMJ Implants, Inc. (commonly referred to as the Christensen) under active review by the Food and Drug Administration. The devices include the stock or “off the self” TMJ condylar prosthesis with, either a cast cobalt chromium head or polymethylmethacrylate (PMMA) condylar head, the patient-specific all metal custom device and the fossa eminence prosthesis. These devices are not legally marketable. Some of these devices may be utilized under the rules of an investigational device exemption application.

On May 11, 1999 the Dental Products Advisory Panel evaluated the Pre-Market approval application (PMA) for temporomandibular joint implants manufactured by TMJ Implants, Inc. On August 10, 1999 the agency granted the company a public health need status for the TMJ Implants Inc. Fossa-Eminence Prosthesis for meniscal perforation only. This means the company may continue to market the Fossa-Eminence Prosthesis for this indication. At the present time, the portion of the PMA concerning the Fossa-Eminence for the above indication remains under review. The FDA has posted the May 11, 1999 Dental Products Panel meeting transcript on their website.

Further information from FDA regarding the status of TMJ Implants Inc.’s PMA is considered confidential.

The other devices included in TMJ Implants, Inc.’s PMA are: The TMJ Condylar prosthesis available with either a cast cobalt chromium head or a polymethylmethacrylate (PMMA) condylar head and a patient-specific (all metal custom) device.

According to FDA law when a PMA is past 180 days the device cannot be legally marketed.

Stryker/TMJ Concepts (formerly TMJ Solutions, Techmedica)

Present. This device is currently available and marketed to patients. http://tmjconcepts.com/
Material composition information on the TMJ Concepts device.

April 5, 2021. TMJ Concepts is acquired by Stryker.

December 2000. We have received a letter from Dr. Louis Mercuri, clinical scientist for TMJ Concepts, asking our assistance in contacting patients who have received the Techmedica total joint device. (The Techmedica Company manufactured TMJ total joint devices from January 1989 through September 1993 and TMJ Concepts has been producing them since December 1997.) Dr. Mercuri is attempting to contact as many Techmedica patients as possible, which have not reported for follow-up, in order to collect long-term data. If you are one of these patients, Dr. Mercuri asks that you contact your surgeon, TMJ Concepts (formerly Techmedica) at 800-504-9527 or Dr. Mercuri at 708-216-6907.

The TMJ Association is encouraged that TMJ Concepts is making an effort to retrieve the Techmedica patients lost to follow-up. It is only through information provided from a comprehensive database that current and future TMJ implant patients can make informed health care decisions. The Association will cooperate with other TMJ manufacturers in their attempts to contact patients who have been lost to follow-up.

July 2, 1999. Approval Order, Summary of Safety and Effectiveness, and Labeling for TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System.

The FDA has posted the May 10, 1999 Dental Products Panel meeting transcript on their website, https://www.fda.gov/advisory-committees/dental-products-panel/past-meeting-materials-dental-products-panel.

Present. This device is currently available and marketed to patients. http://tmjconcepts.com/

July 2, 1999. Approval Order, Summary of Safety and Effectiveness, and Labeling for TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System.

FDA posted the May 10, 1999 Dental Products Panel meeting.

Temporomandibular Research Foundation (Morgan Device)

Present. These devices have not been evaluated by the FDA and are not being marketed.

1999 No information has been received from this company. The Temporomandibular Research Foundation did not respond to the FDA request for premarket approvals (PMA) for all TMJ devices.

Vitek (VKI, VKII, VKII, IPI) Proplast Teflon

Present. These devices are no longer available.

September 12, 2007. An Ontario Superior Court judge allowed a class-action lawsuit to go-ahead against the Canadian federal government over jaw implants. The lawsuit specifically alleges the Health Canada employees negligently approved the Vitek TMJ Implants under the Food and Drugs Act, and that they failed to warn doctors and patients of the potential risks. The class action was certified by the Kathryn Taylor case.

January 2006. The U.S. Environmental Protection Agency (EPA) plans to list a toxic chemical, PFOA, used to make Teflon to its list of well-known pollutants. Over the years TMJ implant patients have received Vitek implants which contain Teflon and have reported many health problems to us. The TMJ Association is in communication with the EPA about this issue and will continue to keep patients updated via our website.

June 2005. The Food and Drug Administration (FDA) released a CD-ROM with over 800 pages of Vitek, Inc. implant-related documents, including FDA correspondence. You may request a copy of the CD-ROM through the Freedom of Information (FOI) Act by writing to: Mr. Patrick Kaelin, Food and Drug Administration, 4040 N. Central Expressway, Dallas, TX 75204. Please note there is a charge of $9.00 + shipping and handling.

Clinical Information on the Vitek TMJ Interposition (IPI) Implant and the Vitek-Kent (VK) and Vitek-Kent I (VK-I) TMJ Implants

2004 In the LSU/Kent litigation involving the Vitek, Inc. TMJ implant, the Court ruled in late 2004 that the class action could not proceed under various legal defenses raised by the defendants. Therefore, it appears that a class action approach is no longer a viable option for anyone who did not file an individual claim before 2001.
September, 1991 The FDA publishes the following safety alert letters.

On January 7, 1991 The FDA issued a class one recall of jaw implants manufactured by Vitek, Inc.

In December 1990 the FDA issued a “Public Health Advisory on Vitek Proplast TMJ Implants” to oral and maxiofacial surgeons warning of complications associated with Proplast-Teflon. The surgeons were advised to examine their patients every six months with an appropriate radiographic (imaging) exam, for as long as the implants remained in place. They were told that if the exam shows signs of deterioration, the implant should be removed as soon as possible.

In March 1990, because of an increasing number of reports of implant failure, the Food and Drug Administration (FDA) recalled Vitek’s Interpositional Implants (IPIs). Several months later Vitek declared bankruptcy. Subsequently, Dr. Charles Homsy, the president of Vitek, Inc. fled the United States. Vitek continued to market their TMJ implants under subsidiary companies. Surgeons still used them until eventually the FDA seized all products from Vitek as well as its subsidiaries.

At the 1986 meeting of the American Association of Oral and Maxillofacial Surgeons (AAOMS), several surgeons reported catastrophic biomechanical failure of the IPI that caused a giant cell reaction, leading to bone resorption and pain. A summary of the literature from 1986 to 1991 reported a failure rate of 10 to 25 percent. By 1992, a success rate of less than 20 percent was being reported.

Only after reports of failure began appearing in 1984, were animal studies conducted on dogs. The results were “essentially catastrophic,” according to a 1990 deposition that Dr. Jack Kent, a Vitek consultant who owned 21,000 shares in the company, gave in an Arizona court case against Vitek. After just a few months, the Teflon layer was “completely worn,” and Teflon particles had triggered bone erosion in the dogs. Dr. Kent wrote a letter to Dr. Homsy in early 1984 expressing his concern that, based on his experience with one of his patients, Vitek might have a “calamity of unbelievable proportions on our hands”. This did not, however, deter Dr. Kent from continuing to write articles praising the Vitek implants, and it certainly did not stop him from collecting his royalties.

In 1983 the FDA allowed Vitek to market a pre-cut disc. Under the law, the company’s president, Charles Homsy, merely had to convince the Food and Drug Administration (FDA) that the device was “substantially equivalent” to Dow Corning’s Silastic disc, marketed years earlier.

1970s. Vitek developed and sold Proplast Sheeting (Teflon FEP film, laminated to a porous composite material made from polytetrafluoroethylene (PTFE) and carbon). The implant was modified in the early Eighties, and Teflon film was then laminated to PTFE and aluminum oxide. These implants, usually no larger than a thumbnail, were manufactured individually or custom cut from sheets in the operating room by the surgeon and then sutured to the fossa or condyle. Many people with Silastic and Proplast-Teflon implants experienced problems shortly after implantation.