TM J Implant Advisory I. Background
Questions posed by the committee during the hearing included why the National Institute for Dental Research has not provided more funding for TMJ research? should any TMJ surgery be done? are autografts better than allografts? what should be done for patients who have had a TMJ implant removed? who should determine whether a treatment is appropriate? The hearing raised serious questions about TMJ implant safety and may lead to further restrictions on the sale of the devices. Oral and maxillofacial surgeons who continue to place synthetic materials in the joint should carefully review all published data to determine whether the implant can be considered safe and effective. FDA, which had already published a safety alert and a public health notice and recall on Vitek implants, recently recalled devices made by Novamed Inc. and Oral Surgery Marketing Inc. These companies took over Vitek after its bankruptcy. It has been reported that FDA has issued written warnings to other TMJ implant manufacturers that they are to apply for FDA approval to continue selling devices.
Prompted by problems resulting from the Vitek Proplast Teflon TMJ implants, the House of Representatives Government Operations Human Resources and Intergovemmental Relations Subcommittee held a hearing on June 4, 1992, in Washington, D.C. The focus of the hearing was whether the Food and Drug Administration (FDA) and National Institutes of Health (NIH) have failed to act appropriately to protect the public from the inadequacies of TMJ implants. The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act require that medical devices be shown by their manufacturers to be safe and effective before they may be distributed and used. Devices already on the market were effectively “grandfathered” from the requirement, although those classified as Class III devices are supposed to eventually meet the same requirements as new devices. For post-1976 devices, if manufacturers claimed the device was similar to pre- 1976 devices already being marketed, FDA would review the submission to determine the substantial equivalence of a new device to the pre-1976 device. It is unclear whether all TMJ implants were submitted for FDA approval, or whether FDA reviewed manufacturers’ claims regarding safety and efficacy. Rep. Ted Weiss (D-NY), chairman of the subcommittee, cited this philosophy as how most “jaw” implants were allowed to be marketed and utilized. FDA testimony revealed that the TMJ implants sold by Vitek were cleared for marketing by FDA without data to show safety and effectiveness because the manufacturer’s applications stated that they were similar to other implants on the market that had supporting data. The committee questioned whether the other TMJ implants still on the market, including those manufactured by Techmedica and TMJ Implants, Inc., had submitted data showing safety and effectiveness. FDA has essentially replied in the negative. Testimony from patients illustrated the severity of the problem with various types of TMJ implants. The three patients, who each had 15- 19 operations, blamed the implant manufacturers and FDA. Testimony from a panel of doctors, including AAOMS fellows Drs. Daniel Laskin, Richmond, VA, and Larry Wolford, Dallas, TX, covered a range of issues. It was stated that the Vitek TMJ implants were in use for 5-10 years before much adverse data was published in the professional literature. One witness testified that DowCorning knew of potential problems with its Silastic Sheeting before the product was marketed, as with breast implants.
II. Current FDA Recommendations Among the recommendations in the FDA’s September 199 1 Public Health Advisory for health professionals with Vitek TMJ implants are: l It is vitally important that you make concerted efforts to reach your TMJ implant patients. l Conduct clinical follow-up of all your TMJ implant patients and monitor the results. All patients, symptomatic or asymptomatic, should undergo routine imaging evaluation annually for as long as the implant is in place. Screening radiography (plain films and tomograms) may be needed to evaluate any changes associated with the presence of metallic implants. For nonmetallic implants, Magnetic Resonance Imaging (MRI) is the most efficient method to detect signs of giant-cell reaction (the FDA Advisory inappropriately refers to a giant cell “tumor”), implant deterioration, and destruction of bone and/or soft tissue. A Computerized Tomography (CT) scan may be used under special circumstances or when an MRI is contraindicated. FDA recommendations relative to type and frequency of imaging in the September 199 1 public health notice differ from and supersede those in its December 1990 Safety Alert. It is the September 1991 recommendations that are referenced here. l Discuss the risk of device failure and alternative therapies with patients. Degeneration or resorption of the mandibular condyle can occur with the development of a giant cell reaction as a result of implant fragmentation. 1148
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TMJ IMPLANT ADVISORY
Bone degeneration may also occur in the glenoid fossa of some patients. l If evaluation reveals progressive bone degeneration or implant disruption, or if the patient has pain or occlusal changes for a period of 6 months or longer, the implanr s/tould be removed. Alternative therapies may include other, non-Proplast coated implants, autologous bone grafts, or management without replacement.* l Advise Vitek implant patients of the availability of the Medic Alert Foundation International Implant Registry. Medic Alert is a nonprofit organization that has set up the registry at FDA’s request. The registry, which at present is only available to Vitek implant patients, will enable FDA to locate the patients in the event future notifications are necessary and will provide patients with updates on their implants as soon as new information becomes available. The initial enrollment fee is $20, with a $10 annual renewal fee. The registry’s telephone number is 1-800554-5297. Copies of the FDA’s public health advisory on Vitek implants, along with question and answer sheets for patients and doctors, and clinical information are available from Medic Alert by calling I-800-554-5297.
III. AAOMS Recommended
OMS Procedures
Be prepared to document your attempts to reach patients via phone logs, registered mail receipts, etc. Patient allegations of doctor abandonment are taken very seriously by FDA and AAOMS. The MOMS Code of Professional Conduct, Section Three, Advisory Opinion 3.00, Termination of Services (Patient Abandonment) reads as follows: “Oral and maxillofacial surgeons are free to select whom they will treat. At the outset of the surgeon-patient relationship, the boundaries of the service that the surgeon intends to perform should be set forth clearly. The surgeon is responsible to perform with due care the surgery, post-operative care, treatment for any complications, discharge of the patient that is not premature and delivery of complete and adequate instructions to the patient upon discharge. Once services are commenced, the surgeon may discontinue such service only upon completion of care and is not entitled to withdraw from the case as long as the patient still requires his services, unless adequate notice is provided the patient to seek the services of another practitioner or upon discharge by the patient. Adequate notice is understood to be long enough to permit the patient, with reasonable diligence, to obtain the services of another to provide the necessary care. Failure of the patient to pay for services generally does not justify withholding further needed services, nor does lack of cooperation on the part of the patient justify such termination except in extreme cases. In situations of practitioner illness, withdrawal from the case is not justified without adequate notice to the patient.”
the discipline of counseling, censure, probation, suspension, or expulsion. Members are urged to closely review information contained in any notices regarding TMJ implants. Many issues are raised that may affect patient care and the rights and responsibilities of manufacturers, marketers, treating doctors, patients and liability insurance carriers. Members also are encouraged to monitor the professional literature for scientific data related to TMJ implants. Again, if you choose to continue to place synthetic materials in the joint, carefully review all published data to determine whether the implant can be considered safe and effective. Also, determine the legal status of the implant for marketing. AAOMS recognizes that this issue raises legal questions; however, because of the variety of federal and state laws that can apply to any particular case, AAOMS cannot offer specific legal advice as to how individual OMSs might be affected. Any questions regarding particular legal obligations should be referred to your attorney. IV.
What AAOMS Has Done and Is Currently Doing
AAOMS has assisted FDA in alerting members of the specialty to the problems associated with Vitek TMJ implants by the following actions: A special December 1990 notice to the membership on the Vitek bankruptcy filing and upcoming notices. Providing membership mailing labels to FDA for dissemination of its December 28, 1990 “Safety Alert-Serious Problems With Proplast-Coated TMJ Implants.” Publication in the January 199 1 JOMS of the bankruptcy notice to creditors, parties in interest, and all other recipients of the TMJ replacement devices manufactured by Vitek, Inc. Publication of the FDA’s September 199 1 public health notice in the October 199 1 issue of the AAOMS Digest.
The Commission on Professional Conduct, after thorough investigation of alleged code violations, may impose
AAOMS and FDA are currently discussing the issues of TMJ implant patient notification and abandonment, and how the two organizations might work together to best serve patients. AAOMS is continuing to monitor this clinical issue and is currently involved in developing further clinical advisories. Prospective and retrospective studies of TMJ implant patients, and other research related to this issue are also being considered. AAOMS will continue to notify members of pertinent developments as they occur.
* Although the FDA included the use of non-Proplast coated TMJ implants as an alternative therapy, OMS’s should be aware that the FDA may review these other TMJ implants and could determine to revoke or restrict the marketing of such devices.
(This TMJ Implant Advisory was distributed to US and Canadian AAOMS fellows, members, life and retired fellows/members, candidates, residents and afiliate members on August 10, 1992.)
Questions posed by the committee during the hearing included why the National Institute for Dental Research has not provided more funding for TMJ research? should any TMJ surgery be done? are autografts better than allografts? what should be done for patients who have had a TMJ implant removed? who should determine whether a treatment is appropriate? The hearing raised serious questions about TMJ implant safety and may lead to further restrictions on the sale of the devices. Oral and maxillofacial surgeons who continue to place synthetic materials in the joint should carefully review all published data to determine whether the implant can be considered safe and effective. FDA, which had already published a safety alert and a public health notice and recall on Vitek implants, recently recalled devices made by Novamed Inc. and Oral Surgery Marketing Inc. These companies took over Vitek after its bankruptcy. It has been reported that FDA has issued written warnings to other TMJ implant manufacturers that they are to apply for FDA approval to continue selling devices.
Prompted by problems resulting from the Vitek Proplast Teflon TMJ implants, the House of Representatives Government Operations Human Resources and Intergovemmental Relations Subcommittee held a hearing on June 4, 1992, in Washington, D.C. The focus of the hearing was whether the Food and Drug Administration (FDA) and National Institutes of Health (NIH) have failed to act appropriately to protect the public from the inadequacies of TMJ implants. The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act require that medical devices be shown by their manufacturers to be safe and effective before they may be distributed and used. Devices already on the market were effectively “grandfathered” from the requirement, although those classified as Class III devices are supposed to eventually meet the same requirements as new devices. For post-1976 devices, if manufacturers claimed the device was similar to pre- 1976 devices already being marketed, FDA would review the submission to determine the substantial equivalence of a new device to the pre-1976 device. It is unclear whether all TMJ implants were submitted for FDA approval, or whether FDA reviewed manufacturers’ claims regarding safety and efficacy. Rep. Ted Weiss (D-NY), chairman of the subcommittee, cited this philosophy as how most “jaw” implants were allowed to be marketed and utilized. FDA testimony revealed that the TMJ implants sold by Vitek were cleared for marketing by FDA without data to show safety and effectiveness because the manufacturer’s applications stated that they were similar to other implants on the market that had supporting data. The committee questioned whether the other TMJ implants still on the market, including those manufactured by Techmedica and TMJ Implants, Inc., had submitted data showing safety and effectiveness. FDA has essentially replied in the negative. Testimony from patients illustrated the severity of the problem with various types of TMJ implants. The three patients, who each had 15- 19 operations, blamed the implant manufacturers and FDA. Testimony from a panel of doctors, including AAOMS fellows Drs. Daniel Laskin, Richmond, VA, and Larry Wolford, Dallas, TX, covered a range of issues. It was stated that the Vitek TMJ implants were in use for 5-10 years before much adverse data was published in the professional literature. One witness testified that DowCorning knew of potential problems with its Silastic Sheeting before the product was marketed, as with breast implants.
II. Current FDA Recommendations Among the recommendations in the FDA’s September 199 1 Public Health Advisory for health professionals with Vitek TMJ implants are: l It is vitally important that you make concerted efforts to reach your TMJ implant patients. l Conduct clinical follow-up of all your TMJ implant patients and monitor the results. All patients, symptomatic or asymptomatic, should undergo routine imaging evaluation annually for as long as the implant is in place. Screening radiography (plain films and tomograms) may be needed to evaluate any changes associated with the presence of metallic implants. For nonmetallic implants, Magnetic Resonance Imaging (MRI) is the most efficient method to detect signs of giant-cell reaction (the FDA Advisory inappropriately refers to a giant cell “tumor”), implant deterioration, and destruction of bone and/or soft tissue. A Computerized Tomography (CT) scan may be used under special circumstances or when an MRI is contraindicated. FDA recommendations relative to type and frequency of imaging in the September 199 1 public health notice differ from and supersede those in its December 1990 Safety Alert. It is the September 1991 recommendations that are referenced here. l Discuss the risk of device failure and alternative therapies with patients. Degeneration or resorption of the mandibular condyle can occur with the development of a giant cell reaction as a result of implant fragmentation. 1148
1149
TMJ IMPLANT ADVISORY
Bone degeneration may also occur in the glenoid fossa of some patients. l If evaluation reveals progressive bone degeneration or implant disruption, or if the patient has pain or occlusal changes for a period of 6 months or longer, the implanr s/tould be removed. Alternative therapies may include other, non-Proplast coated implants, autologous bone grafts, or management without replacement.* l Advise Vitek implant patients of the availability of the Medic Alert Foundation International Implant Registry. Medic Alert is a nonprofit organization that has set up the registry at FDA’s request. The registry, which at present is only available to Vitek implant patients, will enable FDA to locate the patients in the event future notifications are necessary and will provide patients with updates on their implants as soon as new information becomes available. The initial enrollment fee is $20, with a $10 annual renewal fee. The registry’s telephone number is 1-800554-5297. Copies of the FDA’s public health advisory on Vitek implants, along with question and answer sheets for patients and doctors, and clinical information are available from Medic Alert by calling I-800-554-5297.
III. AAOMS Recommended
OMS Procedures
Be prepared to document your attempts to reach patients via phone logs, registered mail receipts, etc. Patient allegations of doctor abandonment are taken very seriously by FDA and AAOMS. The MOMS Code of Professional Conduct, Section Three, Advisory Opinion 3.00, Termination of Services (Patient Abandonment) reads as follows: “Oral and maxillofacial surgeons are free to select whom they will treat. At the outset of the surgeon-patient relationship, the boundaries of the service that the surgeon intends to perform should be set forth clearly. The surgeon is responsible to perform with due care the surgery, post-operative care, treatment for any complications, discharge of the patient that is not premature and delivery of complete and adequate instructions to the patient upon discharge. Once services are commenced, the surgeon may discontinue such service only upon completion of care and is not entitled to withdraw from the case as long as the patient still requires his services, unless adequate notice is provided the patient to seek the services of another practitioner or upon discharge by the patient. Adequate notice is understood to be long enough to permit the patient, with reasonable diligence, to obtain the services of another to provide the necessary care. Failure of the patient to pay for services generally does not justify withholding further needed services, nor does lack of cooperation on the part of the patient justify such termination except in extreme cases. In situations of practitioner illness, withdrawal from the case is not justified without adequate notice to the patient.”
the discipline of counseling, censure, probation, suspension, or expulsion. Members are urged to closely review information contained in any notices regarding TMJ implants. Many issues are raised that may affect patient care and the rights and responsibilities of manufacturers, marketers, treating doctors, patients and liability insurance carriers. Members also are encouraged to monitor the professional literature for scientific data related to TMJ implants. Again, if you choose to continue to place synthetic materials in the joint, carefully review all published data to determine whether the implant can be considered safe and effective. Also, determine the legal status of the implant for marketing. AAOMS recognizes that this issue raises legal questions; however, because of the variety of federal and state laws that can apply to any particular case, AAOMS cannot offer specific legal advice as to how individual OMSs might be affected. Any questions regarding particular legal obligations should be referred to your attorney. IV.
What AAOMS Has Done and Is Currently Doing
AAOMS has assisted FDA in alerting members of the specialty to the problems associated with Vitek TMJ implants by the following actions: A special December 1990 notice to the membership on the Vitek bankruptcy filing and upcoming notices. Providing membership mailing labels to FDA for dissemination of its December 28, 1990 “Safety Alert-Serious Problems With Proplast-Coated TMJ Implants.” Publication in the January 199 1 JOMS of the bankruptcy notice to creditors, parties in interest, and all other recipients of the TMJ replacement devices manufactured by Vitek, Inc. Publication of the FDA’s September 199 1 public health notice in the October 199 1 issue of the AAOMS Digest.
The Commission on Professional Conduct, after thorough investigation of alleged code violations, may impose
AAOMS and FDA are currently discussing the issues of TMJ implant patient notification and abandonment, and how the two organizations might work together to best serve patients. AAOMS is continuing to monitor this clinical issue and is currently involved in developing further clinical advisories. Prospective and retrospective studies of TMJ implant patients, and other research related to this issue are also being considered. AAOMS will continue to notify members of pertinent developments as they occur.
* Although the FDA included the use of non-Proplast coated TMJ implants as an alternative therapy, OMS’s should be aware that the FDA may review these other TMJ implants and could determine to revoke or restrict the marketing of such devices.
(This TMJ Implant Advisory was distributed to US and Canadian AAOMS fellows, members, life and retired fellows/members, candidates, residents and afiliate members on August 10, 1992.)
