Foreign Body Giant Cell Reaction to a Proplast/Teflon Interpositional Implant: A Case Report and Literature Review.

After discectomy, interpositional implants (IPIs) are believed to provide temporomandibular joint stability and protect against degenerative joint space remodeling. Alloplastic IPIs gained popularity in the late 1970s because the practice showed early success without donor site morbidity. Unfortunately, these implants were subject to substantial fragmentation resulting in an exuberant foreign body giant cell response that progressively eroded adjacent structures. Most of these alloplastic implants were removed in the years following their recall by the US Food and Drug Administration in 1991, however some remained in circulation. This report describes a case of a failed Proplast/Teflon IPI 27 years after its placement. This case highlights the considerations for managing a patient with a Proplast/Teflon IPI and serves to remind providers that, although increasingly rare, these implants are still present and subject to delayed failure.

Large cell lymphoma associated with prosthetic joint debris.

Soft tissue reactions to materials in joint prostheses include discoloration, fibrosis, florid histiocytic reaction, and granulomatous inflammation with foreign body giant cell reaction. Clinical manifestations include pain and swelling. We report a case of temporomandibular joint Proplast-Teflon prosthesis, followed by the development of large cell lymphoma in the left parotid gland 10 years after joint replacement. While it is unclear whether the implant directly contributed to the development of lymphoma, this association has not been previously documented, prompting this report.

Temporomandibular joint reconstruction after failed teflon-proplast implant: case report and literature review.

Multiple reports document that a foreign-body giant cell reaction forms around Proplast-Teflon temporomandibular joint (TMJ) implants. This results in destruction of surrounding bone and instability of the implants. This case presents a patient whose Proplast-Teflon TMJ implants became displaced into her middle cranial fossa. The staged reconstruction of this patient is described, including removal of the TMJ implants, reconstruction of the defect, concomitant orthodontic treatment and final reconstruction with TMJ Concepts. This process involved a multidisciplinary approach between several medical and dental specialties. At her 3-year follow up, the patient had a stable postoperative result.

Long-term outcomes after total alloplastic temporomandibular joint reconstruction following exposure to failed materials.

PURPOSE: Total alloplastic temporomandibular joint (TMJ) reconstruction is often necessary because of the significant bony destruction resulting from failed Proplast-Teflon (Vitek, Houston, TX) and/or Silastic (Dow Corning, Arlington, TX) foreign body inflammatory reactions. Multiply operated and functionless, TMJ patients likewise have undergone total alloplastic reconstruction. Many of these patients were also exposed to failed TMJ implant materials. It was the purpose of this study to evaluate a population representative of both these groups of patients reconstructed with the Techmedica (now, TMJ Concepts, Ventura, CA) Total TMJ System to determine whether the long-term subjective and objective outcomes were affected by either the presence of the previously failed TMJ implant materials, the number of prior procedures, or both. PATIENTS AND METHODS: One hundred ninety-eight patients who had been implanted with 332 Techmedica System total joints between 1990 and 1994 where divided into 4 groups based on their prior exposure to failed TMJ implant materials: group I, Proplast-Teflon (82 patients, 135 joints); group II, Silastic (28 patients, 46 joints); group III, both Proplast-Teflon and Silastic (25 patients, 46 joints); and group IV, no prior exposure to Proplast-Teflon or Silastic (63 patients, 105 joints). The mean follow-up was 60.2 +/- 40.3 months (range, 2 to 120 months). To determine whether exposure to either or both failed implant materials affected the long-term subjective and objective outcome variables, the groups were compared statistically using multivariate mixed modeling with age, sex, number of prior operations, years with TMJ problem, prior implant type, and implant sides as independent variables, and the relevant baseline measure as covariates. RESULTS: For the subjective variables, patients exposed to Proplast-Teflon or Silastic had significantly higher mean pain scores long-term. The type of prior failed TMJ implant material was not statistically significant with regard to function. Patients exposed to Proplast-Teflon reported poorer diet consistency scores long-term. Objectively, patients with 5 or fewer prior TMJ surgeries exposed to neither failed implant or Silastic reported better long-term mean maximum interincisal opening than did those patients exposed to Proplast-Teflon or both failed materials. However, for patients with 6 or more prior TMJ surgeries, those exposed to Proplast-Teflon or both failed materials reported less decrease in mean maximum interincisal opening over time. CONCLUSION: These data confirm what has been observed clinically, that in the population studied, multiply operated patients previously exposed to failed Proplast-Teflon alone or both failed Proplast-Teflon and Silastic have poorer reported long-term outcomes with alloplastic reconstruction. However, the total alloplastic TMJ reconstruction devices used in this study remained functional.

Clinical evaluation of patients with temporomandibular joint implants.

PURPOSE: An undetermined number of patients with temporomandibular joint (TMJ) symptoms have been treated with intra-articular disc implants composed of Teflon ethylene/propylene or Teflon polytetrafluoroethylene and aluminum oxide (Proplast-Teflon; Vitek, Houston, TX). These implants have shown the potential to fragment in situ resulting in nonbiodegradable particles that stimulate a giant cell reaction and lead to degeneration of local structures, pain, and limitation of mandibular opening. We examined the possible relationship between TMJ implants and persistent pain, responses to sensory stimuli, quality of life, and systemic immune dysfunction. PATIENTS AND METHODS: This case series (32 patients) were referred from university-based orofacial pain centers and private practices from across the United States. Laboratory and clinical assessments evaluated orofacial pain symptoms, neurologic function, clinical signs and symptoms of rheumatologic disease, physical function, systemic measures of immune function, and behavioral measures. RESULTS: We found that TMJ implant patients appeared to have altered sensitivity to sensory stimuli, a higher number of tender points with a diagnosis of fibromyalgia, increased self-report of chemical sensitivity, higher psychologic distress and significantly lower functional ability. Systemic illness or autoimmune disease was not evident in this series of TMJ implant patients. CONCLUSIONS: Significant problems were noted on clinical assessment of TMJ implant patients. This is a US government work. There are no restrictions on its use.

Long-term study of temporomandibular joint surgery with alloplastic implants compared with nonimplant surgery and nonsurgical rehabilitation for painful temporomandibular joint disc displacement.

PURPOSE: The purpose of this study was to determine the long-term objective and subjective outcomes of temporomandibular joint (TMJ) implant surgery for the treatment of painful TMJ disc displacement using temporary Silastic (Dow Corning Corporation, Midland, MI), permanent Silastic, or Proplast (Vitek, Houston, TX) implants to replace the disc. These cases were compared with other cases of the same diagnosis treated with either nonsurgical rehabilitation or nonimplant surgery involving discectomy or disc repair procedures. MATERIALS AND METHODS: A cross-sectional study was conducted among 466 patients who received treatment for unilateral or bilateral TMJ disc displacement before January 1, 1990. The 5 treatment groups noted above were compared for long-term outcomes. Objective outcome measurements for jaw function were performed using a calibrated examiner and the Craniomandibular Index (CMI). Subjective (self-reported) outcomes were obtained relative to jaw function (Mandibular Function Impairment Questionnaire [MFIQ]), symptom severity (Symptom Severity Index [SSI]), and the impact of pain (Global Pain Impact [GPI] scale). RESULTS: The results, adjusted for gender, baseline tomogram score, and baseline symptom scores, showed that the nonsurgical rehabilitation group (n = 159) and the group having TMJ surgery without implants (n = 149) had statistically better results than the group who underwent surgery with a Proplast implant (n = 94). These between-group differences included both objective signs (CMI), and subjective reports of jaw function (MFIQ), symptom severity (SSI), and global pain impact (GPI). The MFIQ score associated with the nonsurgical rehabilitation group was also statistically better than for the Silastic implant groups, including both the temporary (n = 31) and permanent (n = 33) implants. Clinical differences between groups were slight. CONCLUSION: This study suggests that the use of interpositional disc implants in TMJ surgery is not associated with improved outcomes when compared with nonimplant surgery or nonsurgical rehabilitation.

Self-reported systemic, immune-mediated disorders in patients with and without proplast-teflon implants of the temporomandibular joint.

PURPOSE: This study investigates the self-reported immune-related health status of patients exposed to Proplast-Teflon (P/T) temporomandibular joint (TMJ) implants, comparing their health status with a group of patients who were not exposed to any alloplastic TMJ implants. It also compares those whose implants were removed with those in whom they were retained. PATIENTS AND METHODS: Patients seen in a single oral and maxillofacial surgical practice completed a detailed self-report questionnaire about physical symptoms and disorders. Sixty-four had received P/T implants, and 22 were unexposed to any TMJ alloplastic implant. Of the P/T-exposed group, 44 had removed and 20 had retained implants. RESULTS: In general, P/T-exposed patients did not differ from unexposed patients in rates of reported immune-mediated and somatization-related conditions, allergies, or symptoms of environmental sensitivity. However, patients with removed P/T implants reported significantly more problems in all categories of conditions than those with retained P/T implants. This difference was no longer statistically significant after controlling for pain severity and sex. CONCLUSIONS: Although P/T-exposed patients do not report more systemic health conditions than similar patients who were unexposed to alloplastic jaw implants, those with removed implants report more conditions and are more likely to be seen in clinical practice. This may lead to a bias in the general perception regarding the systemic health status of P/T-exposed patients. In addition, effects may be secondary to high levels of pain and dysfunction among patients with removed implants, rather than implant exposure itself. Future prospective research is needed to identify factors associated with implant failure.

Morphologic and immunohistochemical observation of explanted Proplast-Teflon temporomandibular joint interpositional implants.

PURPOSE: The objective of this study was to investigate the cellular tissue response to temporomandibular joint (TMJ) Proplast-Teflon disc material by morphologic and immunohistochemical means. PATIENTS AND METHODS: Twelve patients who had been subjected to TMJ discectomy combined with insertion of a Proplast-Teflon interpositional implant (PTIPI) were recalled for removal of the alloplastic disc. The time elapsed between the Proplast-Teflon disc implantation and its removal varied between 13 and 71 months (mean, 54.6 +/- 5.8 [SEM]) The implants and periimplant tissues were examined by light microscopy and immunohistochemically using a panel of monoclonal antibodies reactive with different subclasses of leukocytes. The sections were immunostained using the alkaline phosphatase-antialkaline phosphatase (APAAP) technique. RESULTS: Fibrosis and a massive foreign body giant cell reaction were seen inside the heavily disrupted alloplastic implants and in the periimplant tissues. CD68-positive monocyte-derived cells dominated the reactive infiltrate in the implants and surrounding tissue. The CD68-positive cells also were partly positive for lysozyme. The lymphocytic infiltration contained no B cells. CONCLUSIONS: This study of the PTIPI-induced tissue reaction gave no indication of a toxic or an immunologic pathogenesis. Mechanical stress seems important in the fragmentation of the implant and induction of the foreign body reaction. It is not yet known if this fragmentation is the major contributing factor.

A protocol for the management of failed alloplastic temporomandibular joint disc implants.

PURPOSE: This is a retrospective evaluation of a protocol for management of failed alloplastic temporomandibular joint (TMJ) disc implants. PATIENTS AND METHODS: The criteria for implant failure were defined as any one or combination of the following symptoms and signs: TMJ pain, jaw hypomobility, occlusal changes, and radiographic evidence of bone pathology related to the implant. The protocol consisted of removal of the implant, aggressive joint debridement, recontouring of the articulating surfaces, and placement of a pedicled temporalis muscle/fascia flap (TF) for joint lining. Arch bars and maxillomandibular guiding elastics were used if extensive condylar recontouring was necessary. No attempt was made to reconstruct the condyle or correct occlusal abnormalities at the time of implant removal. All 27 patients (42 joints) treated by this protocol during the study period were included for evaluation. There were 24 Proplast/Teflon (PTI) (Vitek, Inc, Houston, TX), 11 Silastic (SI) (Dow Corning, Midland, MI), and 7 Christensen Fossa implants (CFI) (TMJ Implants, Golden, CO) implants removed. RESULTS: The mean follow-up period was 38.3 months (range, 3 to 65 months). Pain was well controlled in 24 of 27 patients (88.9%). Preoperative and postoperative mean maximal incisal opening (MIO) was 32.1 mm and 39.8 mm, respectively. Two patients (7.4%) required a second TMJ operation for persistent pain and limitation of opening. To date, 7 patients (25.9%) have required a secondary procedure (unilateral vertical ramus osteotomy, n = 1; Le Fort I osteotomy, n = 6) to correct occlusal prematurity on the operated side or bilateral open bite. The remaining patients have required no additional surgical treatment. CONCLUSIONS: The results of this study indicate that a proposed protocol is an effective means of controlling pain and improving jaw motion in patients with failed alloplastic TMJ disc implants.

Surgical treatment of internal derangement of the temporomandibular joint: long-term evaluation of three techniques.

PURPOSE: The long-term outcomes of three different surgical treatments for internal derangement of the temporomandibular joint (TMJ), ie, discoplasty, discectomy without replacement, and discectomy with replacement of the disc with a Proplast-Teflon (Vitek Inc, Houston, TX) interpositional implant (PTIPI) are compared. MATERIALS AND METHODS: Forty-two cases of internal derangement of the TMJ were treated with disc repair and eminectomy (group A, n = 13), simple discectomy (group B, n = 17) and discectomy combined with insertion of a PTIPI (group C, n = 12). Preoperative and postoperative findings (more than 5-year follow-up) relating to pain, mouth opening, joint noise, and radiographic changes were compared. RESULTS: Decrease of symptoms after surgery was reported by 77%, 94%, and 83% of the patients (groups A, B, and C, respectively). The decrease in pain intensity ranged from 52% to 71%. Mouth opening increased in 50% to 60% of the patients. The percentage increase ranged from 15% to 26% in the respective groups. Development of osteoarthrosis after surgery was demonstrated in 93% and 100% of the cases in the discectomy and discectomy/disc implant group, respectively, but only in 62% of the discoplasty group. CONCLUSION: This study demonstrates the importance of a functioning disc in the TMJ. There was no significant difference between the groups concerning symptoms before and after surgery. The discoplasty group, however, showed a high frequency of relapse, which necessitated secondary discectomy. PTIPIs clearly accelerated the development of osteoarthrosis, which may be classified as iatrogenic damage. The need for further research to establish the long-term performance of autogenous grafts and the development of improved alloplastic disc replacement materials is discussed.

Sternoclavicular grafts for temporomandibular joint reconstruction.

This study evaluated the long-term outcomes of 52 sternoclavicular grafts for temporomandibular joint (TMJ) reconstruction in 38 patients. Patients were divided into three groups according to preoperative diagnosis and evaluated an average of 45 months (range, 10 to 84 months) postsurgery. Group 1 consisted of 14 patients (24 joints) with previous Proplast/Teflon implants (P/T; Vitek, Inc, Houston, TX;); successful reconstruction was achieved in only four patients (29%) and seven joints (29%). Group 2 included 10 patients (14 joints) with inflammatory TMJ pathology (non-P/T); success occurred in five patients (50%) and eight joints (57%). Group 3 consisted of 14 patients (14 joints) with non-P/T and noninflammatory TMJ pathology. Success in this group occurred in 13 patients (93%) and 13 joints (93%), with only one failure. The results of this study support the use of the sternoclavicular graft for TMJ reconstruction in a select group of patients and demonstrate a high failure rate in patients with previous P/T implants.