The Temporomandibular Joint Implant Controversy.
REVIEW
Fourteen patients with temporomandibular joint (TM J) alloplastic implants who exhibit chronic signs and symptoms of chemical sensitivity are discussed. These patients were well before their implantation. Memory loss, confusion, imbalance, dizziness, non-immune vasculitis, petechiae, spontaneous bruising, edema, Raynaud's phenomenon, pain and autoimmune dysfunction are some of the symptoms and signs seen. Laboratory data show immunological abnormalities, including positive autoantibodies and altered T and B lymphocyte function. Provocation skin testing shows reaction to their implant material. The symptoms of patients with jaw implants are similar to those patients who experience complications from their breast implants. Similar abnormalities are seen with SPECT brain scan, in the autonomic nervous system, as well as laboratory data. All patients were sensitive to a wide variety of substances including toxic and in some cases to non-toxic chemicals (foods, pollens and molds). These same parameters were also similar in the patient with a known toxic chemical exposure without implants. A comparative discussion of the different parameters in all three types of patient is presented. A successful therapeutic intervention was developed using a massive pollutant avoidance program, nutritional supplementation and injection therapy for biological inhalants, foods and some chemicals. When indicated, intravenous therapy with antioxidants and heat depuration was added to their treatment regimen.
Keywords: temporomandibular joint, polytetrafluoroethylene, SPECT brain scan, Rhomberg, iriscorder, short-term memory loss, end organ disorders, implants.
INTRODUCTION
In most patients, silastic and Proplast alloplastic joint prostheses have caused severe pain, malocclusion, foreign body giant cell (FBGC) reaction, severe osteoarthritis with bone destruction, and, in some, erosion of the glenoid fossa causing a leakage of cerebrospinal fluid (CSF). In many, there has been migration of particles via lymphatics to distant sites. All these problems are inflammatory in nature.
In October 1991, the Center for Device and Radiological Health (FDA) [1] issued notice to the American Association of Oral and Maxillofacial Surgeons (AAOMS) to recall all their patients with Polytetrafluoroethylene (PTFE) and silastic sheeting for continuous monitoring. A timetable of events has unfolded which has led to the many complications we are now seeing in jaw implant patients (Table 1).
The purpose of this study was to develop demographics of jaw implant patients and compare them with both chemically sensitive breast implant patients and chemically sensitive patients without implants in order to develop a rational and successful diagnostic and theraputic program. Jaw implant patients, to date, have been difficult to treat successfully because the implant material must remain in situ.
MATERIALS AND METHODS
The signs and symptoms of fourteen chronically ill jaw implant patients who were exhibiting some signs of chemical sensitivity were recorded and compared with both a series of chemically sensitive patients with breast implants and chemically sensitive patients without implants.
Objective neurological tests of jaw implant patients (n=14) were performed, and then compared with chemically sensitive breast implant patients (n=75) and chemically sensitive patients without implants (n=72). The tests performed were the triple camera SPECT scan (Single Photon Emission Computed Tomography) of the brain by the method described by Fincher et al. [2], and perfected by Simon and Hickey [2]. The autonomic nervous system was objectively measured using the Iriscorder (a binocular infrared videopupillograph for detecting autonomic dysfunction of the eye; HTV Type C 2515, Hamamatsu Photonics K.K., Mamamatsu-City, Japan), using the method of Ishikawa [3].
T and B lymphocytes were measured using the Coulter Elite Flow Cytometer, while autoantibodies were measured by Antibody Assay Laboratories, Santa Ana, CA. Several patients' laboratory data were obtained from their oral surgeon: Larry Wolford, DDS, Dallas, TX. Toxic chemical analysis was accomplished by Acu-Chem Laboratories, Richardson, TX. These parameters were compared with known normal controls of these instruments.
Standard intradermal skin tests were performed under environmentally controlled conditions using standards advocated by the American Academy of Environmental Medicine [4].
Treatment was standardized to the following:
(1) Massive avoidance of pollutants in air, food, and water, creating a safe home oasis, and using non-polluting products.
(2) Nutritional therapy, including intravenous and oral supplements of vitamins, minerals and amino acids.
(3) Injection therapy for not only the implant material, but for secondary offenders such as food, biological inhalants and other chemicals such as perfumes, ethanol and newsprint.
(4) Heat depuration and physical therapy (sauna, massage and exercise, under environmentally controlled conditions).
RESULTS
Table 2 compares the symptoms and physical findings in our group of temporomandibular joint (TMJ) implant patients with those of chemically sensitive breast implant patients and chemically sensitive patients without implants. Severe pain and limited jaw opening are the most prominent signs and symptoms. The musculoskeletal system, including symptoms and signs such as fibromyalgia (100%) and arthralgia (32%), was the major end organ targeted. Neurological signs and symptoms, such as short-term memory, fatigue, balance problems (+Rhomberg) in 86%, depression in 57% and seizures in 21% were observed. Both musculoskeletal and neurological signs and symptoms were also the main area of concern among the breast implant patients as well as the chief complaint in 94% of the chemically sensitive patients without implants evaluated by Pan et al. [5] presenting at the Environmental Health Center, Dallas (EHC-D). Gastrointestinal (GI) upset (92%) consisting of bloating, indigestion, irritable bowel, and genitourinary (GU) symptoms of dysuria, recurrent cystitis and some incontinence occurred in 71% of TMJ patients. Gastrointestinal symptoms of 21% and genitourinary complaints of only 5% were noted in breast implant patients. Both gastrointestinal (29%) and genitourinary (7%) symptoms and signs were similarly low in chemically sensitive patients with no implants. Cardiovascular (36%) and tinnitus/otologic (42%) were again more prevalent in TMJ patients than in breast implant or chemically sensitive patients without implants. Recurrent sinus infections were prevalent in over one half of the TMJ implant patients studied.
Table 3 shows the immunological system of the TMJ implant patients to be abnormal, as well as reacting to their specific implanted alloplastic material. There is also widespread sensitivity to other inhaled chemicals and biological inhalants similar to those seen in the chemically sensitive breast implant patients and chemically sensitive patients without implants. Jaw implant patients reacted to other chemicals (83%) as well as biological inhalants (92%).
One hundred percent (4/4) PTFE implant patients tested with Proplast developed systemic symptoms and signs (controls do not). One patient developed syncope within 5 min of an intradermal injection of 0.01 ml antigen. Another patient developed nausea, weakness in her arms, feelings of unreality and headache. The other two reactions are discussed in cases I and 2. A specific skin test for titanium was reactive in 80% of patients tested, and silicone in 50% of patients tested. The same response to silicone in breast implant patients was 70% while our chemically sensitive patients without implants tested positive in only 37% [5]. Both TMJ implant and breast implant patients have shown positive skin tests to chemicals such as phenols, formaldehyde, newsprint, perfumes and ethanol. This is similar to the chemically sensitive patients without implants. No differences were found in the type of toxic chemicals seen in the blood of TMJ implant, breast implant or chemically sensitive patients without implants [3].
Table 4 notes that significant immunological changes have been found in TMJ implant patients. Of the 14 patients seen, 5 out of 7 (71%) were tested and exhibited positive autoantibodies. Also 8 out of 14 (73%) had abnormalities in their T and B lymphocytes. Silicone antibodies tested positive in only 1 out of 3 (33%) of 10 patients with silicone implants. Two had both silicone and Proplast implants and subsequent placement of titanium total joints. Another 6 patients had initial Proplast implants with subsequent placement of titanium total joint implants.
In comparison, Higuchi et al. [3] at EHC-D reported breast implant patients with 71% anti-smooth muscle antibodies, 55% antinuclear-antibodies (ANA), 41% myelin antibodies and anti-basement membrane antibodies of 49%. Abnormalities of T and B lymphocytes occurred in 8 out of 11 (73%) of TMJ patients with evidence of 5 out of 12 (42%) in breast implant patients. Abnormalities of T and B lymphocytes in the chemically sensitive patient without implants were prevalent in 71%, but only 17% had autoantibodies.
The cell-mediated immunity (CMI) testing measures T-cell function may be evaluated by the placement of seven recall antigens and one control on the surface of the skin (similar to the TB tine). The diameters of each wheal are measured after 48 h, added together and compared to known norms. Five out of six (83%) of the TMJ patients tested, exhibited a depressed CMI.
Table 5 gives us two excellent measurements for both central nervous system (CNS) and autonomic nervous system (ANS) dysfunction in the implant patient and the chemically sensitive patient without implants. The Iriscorder revealed 100% abnormalities in 6 out of 6 TMJ patients tested, with 92% (69/75) seen in breast implant patients. In our experience at EHC-D, chemically sensitive patients show an abnormality in only 65% (15 out of 23). Triple camera SPECT brain scans [2], which have proved useful in demonstrating specific areas of the brain affected with various organic solvent exposures, have also shown similar pathology in TMJ implant patients in virtually 100% or 5 out of 5 tested. Most of the neurotoxicity has been mild in these patients except for case 1. There is a strong correlation between positive SPECT scan findings of neurotoxicity and a positive Rhomberg. Ninety percent (35 out of 38) of SPECT brain scans were positive for neurotoxicity in severely ill breast implant patients studied at EHC-D [3], and 390 out of 400 (98%) of chemically sensitive patients without implants showed neurotoxicity [6].
Table 6 demonstrates an overview of their responses to treatment. Treatment in 12 out of 14 patients evaluated, who chose to pursue treatment, was oriented to decreasing the total daily load of pollutants to which a patient is subjected. Improvement occurred in 10 out of 12 (83%) of the patients treated. One patient remained the same after only a short duration of treatment and one patient became worse because of an unwillingness to undergo more than one modality.
To date, a total of fourteen patients with jaw implants have been evaluated and twelve have undergone treatment at the EHC-D. The presenting complaint for all except one was severe chronic pain. However, end organ disease was also a part of their clinical picture as well as immunological disorders that were not evident before TMJ alloplastic implantation. A multisystem disease complex is evident and consistent with immunological and nonimmunological detoxification and deregulation problems similar to patients with other types of implants who have presented at EHC-D. The clinical pattern is also similar to patients with chemical sensitivity without implants. Treatment patterns were also similar.
CASE PRESENTATIONS
Case 1
A 55-year-old self-referred female physician was first seen at EHC-D in April 1994 with the chief complaint of severe chronic pain in her head, face, left side of neck, shoulder, arm and back. A burning type of pain was also noted in her neck, shoulder and back. Three different types of pain had been diagnosed previously at a pain management center and consisted of myofacial, cervical radiculopathy and sympathetic mediated pain. Various pain medications including Phenoxybenzamone hydrochloride, Mexilitine hydrochloride, tricyclic antidepressants and anti-epileptics as well as short doses of steroids were used in an attempt to control her pain with little success, and the side effects of medication necessitated their discontinuation. Her present medications were Lorazapam, Acetaminophen with caffeine and butalbitai, occasional Meperidine hydrochloride, Lisinopril and Estradiol. Six months before evaluation, labile hypertension, pedal edema, petechiae, decreased renal output, ataxia, short-term memory loss and problems concentrating had developed.
The patient had been in good health until 1981 when she had a traumatic dislocation of her right TMJ. Arthroplastic surgery resulted in fibrous ankylosis and dislocation of her left TMJ. Bilateral disc replacements with Vitek/Proplast II were implanted in 1983. Symptoms of pain continued with increasing tinnitus in her right ear. Other problems of renal calculus, hypertonic esophageal sphincter, fibrocystic breast disease, and a hysterectomy for a rapidly growing fibroid occurred in the intervening 7.5 years. During the same time, treatment modalities also consisted of full orthodontics, splint equilibrations, physical therapy, transcutaneous electrical nerve stimulation (TENS) and non-steroid anti-inflammatory drugs (NSAIDS). In September 1990, a sudden and painful change in bite occurred. Tomographic, MRI and CT scans revealed destruction of both TM joints with severe condylar destruction by osteoarthritis, FBGC reaction and a left-sided perforation through the glenoid fossa into the middle cranial fossa. Bilateral fragmented PTFEs were removed and Techmedica CAD/CAM (Titanium and Ultra High Molecular Weight Polyethylene) total joint prostheses were implanted in February 1991.
Physical exam revealed a patient in chronic pain, normotensive, with numerous petechiae noted over her chest and upper extremities. A 1+ pitting edema was noted on her lower extremities and she had a positive Rhomberg. Her interincisal opening was 33 mm (n=40-55 mm) with the inability of any forward or lateral movement. Tenderness was noted in her temporalis muscles, TMJs, with multiple trigger points noted in her trapezius.
Laboratory data indicated a dysfunctional immune system. Her total lymphocytes were low with a high T11 of 94% (c-62-86%), a T8 of 37% (c-17-35%) and a low B4 of 2% (c-5-18%). A slightly low IgG of 796 (c-800-1800) was noted, but a normal IgE. Her C3 was slightly elevated and a positive antismooth muscle antibody was noted. An ANA initially negative became positive (1:160; homogenous pattern). Her sed rate (3) has remained normal. The Iriscorder of her eyes gave objective measurement of autonomic dysfunction. A triple camera SPECT brain scan was consistent with severe neurotoxicity (Fig. 1). Multiple food and inhalant sensitivities were diagnosed by intradermal, oral and inhaled challenge for the first time. She also had a positive intradermal provocation test to titanium (dizziness). Her intradermal provocation to Proplast reproduced symptoms of facial and left shoulder pain, light headedness and mild bronchospasm. She received intradermal injections for titanium but not Proplast.
Treatment consisted of massive avoidance of pollutants in air, food and water, creating a safe home oasis, antigen therapy for food, inhalants, and perfume, and supplemental vitamins, minerals and amino acids. Further improvement was obtained when twelve scars were injected with 1% carbocaine on four separate occasions (neural therapy). This was immediately followed by electromagnetic equalization using a manipulative physical therapy technique. These treatment modalities had a dramatic effect, eliminating most of her pain. Two months into treatment, extreme odor sensitivity to chemicals ensued. Treatment has left her often pain free, normotensive, with estrogen replacement as her only medication. An exacerbation of symptoms was noted when her 4th metacarpal fracture required three stainless steel screws but improved rapidly when these implants were removed. Long-term follow-up is still successful at five years. Her antismooth muscle antibody and ANA are now non-reactive, and her presbyopia/hyperopia has significantly improved in the past 1.5 years (contrary to the norm).
Case 2
A 34-year-old female referred by her oral surgeon presented at EHC-D in 1996 with the chief complaint of temporomandibular dysfunction (TMD), lack of energy, generalized pain, skin rash with blisters, muscle fatigue, symptoms of arthritis and Raynaud's phenomenon. Her symptoms started in 1986 and she underwent placement of bilateral PTFE joint implants in 1987. Severe pain and systemic symptoms ensued. In 1989 her implants were removed and no other alloplastic material implanted.
Other symptoms elicited were bloating with constipation, incontinence, menstrual irregularities, pedal edema with cold feet, memory loss and difficulty concentrating. A pregnancy in 1991 resulted in the birth of a child with significant allergies. Medications were Morphine sulfate, Paroxetine hydrochloride, Nabumetone, Tramadol hydrochloride and medication for sleep.
Physical examination revealed an interincisal opening of 12 mm, a positive Rhomberg, blisters on her fingertips, and cold feet, hands and face.
Triple camera SPECT brain scan showed minimal neurotoxicity with temporal lobe asymmetry. The Iriscorder objectively measured autonomic dysfunction. Her total T lymphocytes were depressed, and B lymphocytes were 4% (c-5-18%).
Intradermal skin testing was positive for dust and dust mites, molds, formaldehyde, cigarette smoke and nickel. She tested negative to most foods. Intradermal skin testing to Proplast caused burning, itching, coldness, jaw pain and headache. Treatment consisted of heat depuration with physical therapy (an environmentally controlled sauna, exercise and massage), non-polluted water and antigen therapy. Intravenous therapy consisting of 15 g vitamin C, 40 mEq MgSO[sub 4], 2 cc trace multiminerals (Zn 1 mg, Cu 0.4 mg, Mn 0.1 mg, Cr 4 mg, Se 20 ug), 2 g taurine, 600 mg glutathione, and B complex vitamins were also administered. This was followed by an oral antioxidant regimen.
She improved dramatically and since returning home has stopped all medications. Her balance and memory are now normal, and her depression is minimal. She continues to have some pain in her hips, back and right hand and arm. She does not have to rotate her foods. She remains much improved after three years of therapy.
Case 3
A 32-year-old female referred by her ear, nose and throat (ENT) surgeon presented at EHC-D in May 1990 with complaints of chronic pain in her left TMJ and the entire left side of her body. Intermittently, she suffered pain on the right side of her body as well. Left TMJ surgery was performed in November 1985 for adhesive capsulitis and an interincisal opening of 20 mm resulted post-operatively. Silastic sheeting was placed as a substitute for her left disc and later removed in 1987. She had a history of bilateral disc dislocation. Subsequently, trigeminal neuralgia, dizziness and tinnitus developed in her left ear. Acrylic splints caused mouth ulcerations. Fluromethane spray/stretch, ionophoresis with lidocaine, and solumedrol had been tried with no improvement. The patient was exhibiting symptoms of fibromyalgia, tendinitis, tenosynovitis and chronic fatigue. Weather changes caused headaches, arthritis flares and sinus pain. She has a history of endometritis, cystitis and recurrent upper respiratory tract infections. She is odor sensitive to chemicals. She had a lot of childhood allergies. Medications included Pseudoephedrine and Guaifenesin, Azetemizole, Cromolyn sodium nasal solution, Ranitidine hydrochloride, Diclofenac sodium, Fluoxetine hydrochloride, Oxycodone and Acetaminophen, Evening Primrose and Terfenadine.
Physical examination revealed a frail female, appearing to be in chronic distress. Atrophy of her masseters was noted with multiple facial scars. An interincisal opening of 20 mm was noted. Tenderness was noted along the distribution of the trigeminal nerve and multiple tenderness also noted in her facial muscles. With hyperextension of her head, neck pain was noted. Numbness was also noted along the ulnar distribution of her left arm and hand. A decrease in her pulse was noted with her left arm raised to a 45 Degrees to 90 Degrees angle. Her hand tingled as well. There was loss of grip strength in her left hand. A positive Rhomberg was noted.
Laboratory data showed vitamin deficiencies of B[sub 1], B[sub 6], C and D. A generalized amino acid deficiency was consistent with malnutrition. Sub-toxic blood levels of 2-Methylpentane, n-Hexane, Toluene, Trimethylbenzene, 1-1-1-Trichloroethane and Tetrachloroethylene were detected. IgG subtypes of IgG[sub 1], 3.0 g/l (c-4.22-12.92) and IgG[sub 3] 0.29 g/l (c-0.41-1.29) and a low IgA of 70 (c-90-450) were noted.
Skin testing revealed sensitivities to various foods and chemicals. Treatment again consisted of avoidance of pollutants in air, food and water, creation of a safe home environment and vitamin, mineral and amino acid supplements.
In 1992 she returned to the clinic for severe neck pain with a gradual onset of difficulty in speech and dysphagia. A partial left hyoidectomy was performed with relief of most of her pain. The patient then returned home and continued her present regimen. More TMJ surgery was contemplated, but was unnecessary because of the improvement in her symptoms.
DISCUSSION
Though small in number (n = 14), this series of chronically ill patients with TMJ alloplastic implants exhibit similar multisystem complexes to breast implant patients seen at EHC-D [6]. Jaw implant patients are similar to breast implant patients in that they exhibit a dysfunction of their immune system as well as dysfunction of the autonomic nervous and central nervous systems. Once a total joint xenobiotic prosthesis has been placed, the structural integrity of the TMJ has been destroyed and the patient must continue to have an artificial joint of some type. This makes treatment more difficult since historically, as has been shown at EHC-D, removal of the implant material aids in recovery. The patient will always have a permanent handicap: a persistent toxic chemical irritant (synthetic jaw implant) that cannot be eliminated.
A symptom complex of severe pain, short-term memory, fatigue, fibromyalgia, a positive Rhomberg, petechiae, GI disturbances, GU dysfunction, recurrent sinusitis, increased cardiovascular dysfunction, tinnitus, and seizures, is evident. This picture is in many respects similar to breast implant patients at EHC-D [3]. However, symptoms and signs seem to be universally more diverse than in either the breast implant or chemically sensitive patient without implants. There is evidence that the jaw implant materials are not the "inert" material that they are touted to be, with the body reacting accordingly with inflammatory responses causing the aforementioned symptom complex. More sinusitis and other symptoms surrounding the jaw are seen in these patients.
Even with this small series, it has become evident that alloplastic jaw implants (PTFE, silicone and titanium) have caused immune dysfunction as well as inflammatory responses similar to other implant patients who develop chemical sensitivity. For example, autoantibodies occurred in 71% of our jaw implant patients. Autoantibodies occurred in 94% (44/47) of the breast implant patients with only 17% (13/75) occurring in the chemically sensitive patients without implants at EHC-D [3]. Autoantibodies seem to be more prevalent in the silicone breast implant patients than our TMJ implant patients, but we must note our small number (14). There may, however, be other reasons for fewer autoantibodies in jaw implant patients. This could be in part a simple matter of the total surface area of the jaw implant being smaller than the total surface area of breast implants. Total time in situ is also shorter as many TMJ implants failed quickly. However, our small number of jaw implant patients correlated well with a group of 72 PTFE implants, which showed an increase of 2-3 autoantibodies in a significant percentage when compared to known norms (author's personal communication).
Other systems were found to be dysfunctional in the 14 jaw implant patients such as: GI, GU, cardiovascular and ENT, and have been found as well in other TMJ patients. For example, Wolford [7] reported an increased incidence of hysterectomies (40%), with oophorectomies (31%), endometriosis or uterine fibroids (26%), fibrocystic breast disease (49%), low grade fever (35%), and sensitivity to non-precious metals (51%). These findings are much higher than in the normal female population. Hysterectomies occurred in only 21% of the TMJ implant patients, oophorectomies in only 14%, fibroids in only 21%, and fibrocystic breast disease in 2 out of 14 (14%). These findings in these patients did not show any significant increase over known norms, bearing in mind that our small series of jaw implant patients may be skewed because of the small number.
Wolford [7] also reported findings in 37 of his patients studied by Namey who performed human leucocyte antigens (HLA) typing. Thirty percent had HLA-B locus typing (only 17.6% in controls), and 65% demonstrated antigens associated with a variety of other autoimmune diseases. Immunophenotyping [7] in 12 PTFE patients' peripheral blood lymphocytes (IA, CD2, CD3, CD4, CD8, CD4/CD8 ratio, CD20, CD56) found IA subset to be below controls in 73% of patients, and CD4/CD8 ratio decreased significantly below normal range. On the other hand, CD56 subset was elevated in 60% of 12 PTFE patients thus assessed. These tests were not done in our patients because of cost, but should be noted because they may be significant.
The CMI in 6 out of 6 of our patients was abnormal, showing T-cell dysfunction. Ryan [8, 9] alludes to a lack of cell mediated immunity in his investigation of primary granulomas with PTFE implants. Though a FBGC reaction of massive proportion is initially noted, a depressed CMI is noted in our patients, suggesting multiple insults to their immune system resulting in ultimate dysfunction and depression. The CMI improved when retested after therapy. CMIs were not tested in the breast implant patients. When the CMI was tested in a significant number of chemically sensitive patients without implants, it was also initially depressed, but improved after treatment at EHC-D [6].
Wolford [7] noted lymphocyte activation in 4 out of 6 severely ill patients with PTFE implants. In his series an improvement was noted within a year after reconstruction with a total joint prosthesis replacing the Proplast. This finding would not correlate with our series, probably because our criteria for selection involved only patients who were still chronically ill after reconstruction.
The spreading of PTFE to adjacent lymphatics can be found [10]. Wolford [7] states that FBGC granulomas have been reported in not only the TM J, but the muscles of mastication, parotid and submandibular glands, the roof of the orbit as well as within the orbit itself, in lung, and in breast biopsy specimens. One can only speculate that similar granulomatous formations are possible within the CNS of those patients exhibiting glenoid fossa perforation. Thus, inflammation in distant sites from the jaw implant occurs, with further sensitization and immune dysfunction, and alteration of the non-immune detoxification system. Findings similar to these suggest why our patients have both local and distant signs and symptoms.
Dissemination of Teflon (PTFE) to distant sites is not just limited to TMJ patients. There is already precedence and also much data available on the local granuloma (FBGC) reaction at the site of injection as well as dissemination of PTFE to the lungs, spleen, liver and brain following the Sting procedure (the periurethral injection of Teflon paste for urinary incontinence or vesicourethral reflux) [11-15]. A stroke occurring one year after a six-year-old girl had a Sting procedure resulted in debilitation and mental retardation [16]. This procedure is not recommended for use in children or young adults [11, 13, 17]. The use of Teflon fluff for cranial nerve vascular compression syndromes resulted in granulomatous formation mimicking an acoustic neuroma with severe sensorineural hearing loss [18]. The injection of Teflon into paralyzed vocal cords has also resulted in granulomas [19], and heart valves with Teflon causing emboli to the spleen, liver and brain [20] have been reported. Similar findings of dissemination have been discussed with silicone [3]. Since six of our patients had PTFE and 10 patients had silicone implants, we speculate that some of these had similar metastatic seeding (lymphatics and other routes) causing more metabolic disruption with signs and symptoms occurring away from the area of the jaw.
One wonders what the link is between plastic and metallic prostheses causing similar syndromes. Various cytokines are released by the histiocytes causing loss of bone, probably by osteoclast regulation, not only with PTFE [8] but also to a lesser degree silicone. These cytokines are interleukin-1, interleukin-6, tumor necrosis factor (TNF), collagenase, and prostaglandin PGE2. However, it has now become apparent that a change in homeostasis will occur as well in the metallic joint replacement resulting in metallic "wear debris" between the bone and implant interface with loosening of the prosthetic joint [21]. We have spoken to many metal total joint implant patients who have had this problem causing more surgery. Saffar et al. [21] note that loosening has been reported in titanium, cobalt chrome, and even ultra high molecular weight polyethylene, emphasizing local metabolic dysfunction. One can see that, with release of metal implant material, similar cytokines might be triggered, producing symptoms and signs of an implant syndrome.
The main entrance of pollutants into the body is via the respiratory system (inhalants), gastrointestinal tract (foods, drug, etc.), and skin (absorption). Then, the body's function is to alter and detoxify these incitants without having adverse reactions. Implants appear to modify the immunological and non-immunological detoxification systems, allowing the development of pathologic inflammatory responses to occur, apparently from these unwanted, undetoxified, pollutants triggering dys-homeostasis. Environmental pollutants along with implant seeding appear to be significant perpetuating factors of this syndrome. Further proof of an implant syndrome becomes evident when we perform intradermal skin testing with our jaw implant patients for foods, molds, pollens and unrelated chemicals, which can easily provoke their initial signs and symptoms. Thus, treatment with a rotation diet, and drinking non-polluted water will decrease the total body pollutant load. In our patients, the body's immune and non-immune detoxification mechanisms then work more effectively. This reduction in load results in a decrease in signs and symptoms. Creating a less polluted home environment, and the use of organic foods and natural products are done for the same reason. With these avoidances, fewer daily insults to these implant patients appear to allow their detoxification systems to improve with the normalizing of their body functions in spite of a constant low level seeding from implants that by necessity must remain in place. Leaving implants in situ, though necessary, can be hazardous; for example, we have observed jaw implant patients with severe and life-threatening reactions to petrochemical-based products similar to the chemically sensitive patients without implants.
Detoxification is further accomplished by decreasing the total toxic load by supplementation with the necessary catalysts, enzymes, cofactors, etc. Supplemental vitamins, minerals and amino acids are made available for effective metabolic functions. These nutrients are given to patients in supplemental form either orally or parenterally. Intravenous nutrient supplementation appeared necessary to rapidly elevate the low levels of deficient nutritional elements in some of our jaw implant patients. Previous studies have also shown low levels of nutrients in virtually every chemically sensitive patient [22]. Intravenous therapy allows the patient to improve his/her nutrient deficiencies expeditiously, and also helps to bypass the GI tract, which shows evidence of malabsorption. In addition, intravenous therapy can rapidly counteract the diuretic effect that allows for a rapid excretion of nutrients seen in many chemically sensitive patients. Intravenous therapy for the severely ill patient also helps in supplying the nutrient fuels for immediate and long-term GI healing. Long-term oral supplementation enhances the patient's ability to detoxify and is necessary because of his/her malabsorption.
In many chronic pain patients, supplemental magnesium appears to play an integral part in improvement of their pain. Patients are then often able to decrease the amount of pain medication they are taking. Initially, with avoidance of external pollutants only, their pain did not improve with just a non-nutritive and/or oral supplementation approach, and intravenous supplementation was necessary.
Though a small number of jaw implant patients had nutrition levels measured, it appears that their clinical course was similar to breast implant patients and the chemically sensitive patients without implants. When nutrient substances were measured, they were shown to be deficient. All three groups of patients responded favorably and similarly to intravenous nutrients, thus suggesting similar nutritional deficiencies. Increased metabolism, malabsorption, and urinary nutrient loss are apparent, necessitating initial intravenous nutrient replacement and continued long-term oral supplementation.
It has been found that in chemically sensitive breast implant patients and chemically sensitive patients without implants, a "spreading phenomenon" of new sensitivities occurs. These new sensitivities result in adverse reactions to yet other toxic substances and even non-toxic substances such as minerals, vitamins and foods. This phenomenon was seen in all the patients (Table 3). Adverse reactions are further triggered, which in turn seem to cause new symptoms. It has been observed in the past that failure to recognize and treat these secondary triggering agents will result in an overall failure of therapy. In many of the jaw implant patients, it was necessary to reduce the patient's total load not only by avoidance, but also by heat/exercise therapy and antigen injection therapy (secondary offending incitants). The case reports are good examples of the use of antigen injection therapy in obtaining improvement and positive response to treatment.
Heat, exercise and massage (heat depuration) are more rapid ways of releasing many primary and secondary offending incitants that have already been stored in fat. Treatment should only be under the direct supervision of a physician since initial complications can be severe. This technique has been found to be efficacious in other implant patients. Neurological symptoms are prevalent simply on the basis of many chemicals being lipid soluble and having an affinity with the lipid rich tissues of the nervous system. Heat depuration seems to be the most rapid method of reducing the total CNS and fat pollutant load. We must caution against too rapid a release, as this may temporarily exacerbate symptoms.
Though basic, in combination these methods are effective. It takes a patient, though, who is diligent, dedicated and willing to make changes in his/her life style, including modification of diet and the immediate environment. This treatment is also cost effective in that it decreases the number of medications, lost work days, hospitalizations and surgeries in this type of chronically ill patient. From previous studies, multiple treatment modalities are important and necessary in the successful outcome also of the jaw implant patient. For example, when only one treatment option was utilized by one patient (heat depuration), she became worse with the development of diarrhea. In spite of urging, all other modalities were refused, and improvement was not observed. It thus appears important to do several different treatment modalities simultaneously to reduce the patient's total load. This treatment takes time, and is not always an immediate panacea. In the long term, improvement in overall health appears highly successful in our small number of TMJ implant patients. The philosophy of this type of treatment modification is well proven in chemically sensitive patients, and, when ignored in the severely compromised patient, may lead to disaster. For example, one jaw implant patient chose not to pursue treatment. One year later she developed severe and rapid weight gain, uncontrollable electrolyte imbalance, seizures, cardiac arrest and death at age 34. We cannot say whether our treatment regimen would have aided in an improved outcome. However, we can speculate that improvement probably would have occurred, as a fatal outcome has been noted in other non-treated implant patients.
CONCLUSION
We have presented a small series of chronically ill, chemically sensitive TMJ implant patients (n = 14). Though limited in number, they can be compared with other implant patients as well as chemically sensitive patients without implants. We may place emphasis on several observations. Severe complications from TMJ alloplastic implants have resulted in seriously ill patients with multi-system end organ diseases in significant numbers. To date, treatment has been addressed by more and more medications and repeated surgeries. These patients are becoming debilitated, and morbidity and mortality have become a prominent concern. There are definite similarities in symptoms and signs between all fourteen patients (Table 2), as well as similarities to breast implant patients and to chemically sensitive patients without implants at EHC-D. Though severe pain was the presenting complaint, many other signs and symptoms were indeed common to the jaw implant patients as a whole, thus an "implant syndrome complex" is evident.
Excellent and objective diagnostic tools are useful, such as T and B lymphocyte measurements, the measurement of autoantibodies, CMI, SPECT brain scan, and the use of the Iriscorder for autonomic dysfunction. An excellent diagnostic tool is the various intradermal provocation skin testing for foods, pollens, molds, and chemicals, and the actual implant materials. When these patients receive injection neutralization for their offending incitants, eat organic food, breathe clean air, drink less polluted water, have a safe chemical-free environment, use supplemental vitamins, minerals, and amino acids, they improve. Before treatment, ongoing debilitation was evident. Intravenous therapy was also an integral part for some patients. Therapy does not work for all, but 10 out of 12 patients (71.4%) improved. It is recommended by the authors that this treatment be considered as another management option in a group of very difficult patients who, to date, have been treated with repeated surgeries or polypharmacy with minimal success. Further study is needed.
A
B
1960-1970s
Christensen and Morgan Implants
1970s
Silastic Sheeting (Dow Coming, Midland, MI)
1976
Medical Device Amendment
1976-1983
Proplast I (Vitek, Houston, TX)
1983
Proplast II (Polytetrafluoroethylene) pre-cut discs
1983-1990
Proplast IPI inserted in approximately 25 000 to 30 000
patients
1985
Reports started to surface of problems with Proplast and
Silicone
March 1990
Vitek issues safety alert and cessation of manufacturing
1990
Bankruptcy of Vitek secondary to Malpractice Claims
October 1990
FDA (Center for Devices and Radiological Health)
identification program to find all implant patients
October 1990
FDA seizes all articles and devices composed of all or
part of Proplast including Vitek/Kent (VK I & II) Total
Joints
1991
Media campaign launched
1991
Letters to all members of American Association of Oral
and Maxillofacial Surgeons (AAOMS) to recall their patients
with PTFE or Silastic Sheeting for continuous monitoring
1991
FDA declares all implants Class III
June 1992
FDA warns Novamed (subsidiary of Vitek) to cease
distribution of all materials
June 1992
Hearing of Subcommittee on Human Resources and
Intergovernmental Relations and recommendations for
investigation
November 1992
AAOMS Workshop to determine treatment and follow-up of
patients
1992-1997
FDA sends letters to Dow Coming, The Temporomandibular
Research Foundation (Morgan), Osteomed Corporation,
Techmedica Incorporated, TiMesh Incorporated, TMJ
Implants Incorporated (Christensen)
1993
Remainder of products removed from the market except
the grandfathered Christensen and Morgan
1993
Bankruptcy Court awards to over 2500 litigants based on
point system: all awards less than $10 000
September 1994
Dental Research of National Institutes of Health (NIH)
Meeting with funding for research into chronic problems
of Alloplastic Disc replacement
July 1997
FDA approves the marketing of Techmedica Total Joint
Prostheses again; the first models to be ready in 1997
(new name is TMJ Concepts)
TABLE 2. Symptoms and physical findings between TMJ, breast implant patients and chemically sensitive patients without implants
Legend for Chart:
B - TMJ
C - Breast
D - CS/no implants[a]
A
B C D
Number
14 75 72
Sex
F F F (45) M (27)
Age (years)
30-55 24-67 16-79
Mean age
41.5 45.3 43.4
Severe jaw pain
13/14 (93%) 0 0
Decrease in mouth opening
13/14 (93%) 0 0
Musculoskeletal
-- 65/75 (87%) 16/72 (22%)
Fibromyalgia
14/14 (100%) -- --
Arthritis
5/14 (36%) -- --
Neurological
-- 49/75 (65%) 68/72 (94%)
Fatigue
10/14 (71%) 49/75 (65%) --
+Rhomberg
12/14 (86%) 68/75 (91%) --
Short-term memory loss
12/14 (86%) 49/75 (65%) --
Depression
8/14 (57%) 65% --
Seizures
3/14 (21%) 0 --
Gastrointestinal (bloating, constipation irritability)
13/14 (92%) 16/75 (21%) 21/72 (29%)
Genitourinary (dysuria, cystitis, incontinence)
10/14 (71%) 4/75 (5%) 5/72 (7%)
Dermatological (petechiae, rash)
6/14 (43%) 10/75 (13%) 10/72 (14%)
Cardiovascular (arrhythmia, PACs)
5/14 (36%) 15/75 (20%) 10/72 (14%)
Tinnitus/otologic
6/14 (43%) 17/75 (23%) No data
Recurrent sinus infections
7/14 (50%) No data --
[a] See reference [5].
Legend for Chart:
B - TMJ
C - Breast
D - CS/no implants
A
B C D
Silicone implants
10/14 (71%) 75/75 (100%) 0
Proplast implants
6/14 (43%) 0 0
Titanium/total joint (some with more than one implant)
8/14 (57%) 0 0
Proplast intradermal skin test
4/4 (100%) 0 0
Titanium intradermal skin test
4/5 (80%) 0 0
Silicone intradermal skin test
4/8 (50%) 46/77 (70%) 10/27 (37%)
Intradermal skin tests to chemical
10/12 (83%) 32/32 (100%) 75/75 (100%)
Intradermal skin test to inhalant
12/13 (92%) 45/45 (100%) 75/75 (100%)
Intradermal skin test to foods
12/13 (92%) 45/45 (100%) 75/75 (100%)
Legend for Chart:
B - TMJ
C - Breast
D - CS/no implants[a]
A
B C D
Depression of CMI
5/6 (83%) n.t. 6/7 (86%)
Abnormalities oft and B lymphocytes
8/11 (73%) 5/12 (42%) 12/17 (71%)
Autoantibodies
5/7 (71%) 44/47 (94%) 13/75 (17%)
Silicone antibodies
1/3 (33%) 5/12 (42%) n.t.
[a] Source: Rea, William J. A study of 30 patients with
vasculitis: unpublished data.
Legend for Chart:
B - TMJ
C - Breast
D - CS/no implants
A
B C D
Iriscorder: (ANS dysfunction)
6/6 (100%) 69/75 (92%) 15/23 (65%)
SPECT brain scan: (CNS dysfunction)
5/5 (100%) 35/38 (92%) 390/400 (98%)
Legend for Chart:
B - Number
C - %
A B C
Number entering therapy 12/14 86
Number refusing treatment[a] 2/14 14
Improved 10/12 83
Same[b] 1/12 8.3
Worse[c] 1/12 8.3
[a] One refused treatment, subsequently died. [b] Patient
desired immediate results, stopped after two weeks.
[c] Patient completed one modality only; heat depuration
and developed diarrhea.
PHOTO (BLACK & WHITE): FIG. 1. A triple SPECT brain scan of case I patient. Some increased activity is seen in thc basal ganglia -both the flow and functional phases. The functional phase (larger image) shows significantly more activity than the flow phase. There are multiple hot and cold foci distributed throughout the cortex. Temporal lobe indicates mismatch indicating short-term memory loss. These findings are consistent with severe neurotoxicity.
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[19] Boedt D, Rolls H, Ghent PK. Laryngeal tissue responses to Teflon. Arc Otolaryng 1967; 86: 562-7.
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By S-Deborah N. Baird, MD FAAP and William J. Rea, MD FACS FAAEM
Adapted by MD FAAP and MD FACS FAAEM