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Section III - Pathology Table 2



TABLE 2 - OTHER SILICONE IMPLANTABLE DEVICES

YEAR

AUTHOR

TYPE OF

EXPOSURE

RESULTS

1974 Aptekar

[Record No. 7234]

Silicone finger joint implants Three years after bilateral implantation of silicone finger joint implants, the right prosthesis was found to be broken. Pathology revealed chronic inflammation, fibroblastic proliferation and fibrinoid necrosis with occasional foreign body giant cells. Shards of colorless, refractile material were also found. Some of these were surrounded by acute and chronic inflammatory cells and occasional foreign body giant cells.
4/4/77 Christie

[Record No. 0971]

Silicone elastomer finger joints Complications following implantation of silicone elastomer finger joints - including migration of silicone particles up to 65 um in diameter. In Case 1, implant removal due to breakage. Histology revealed a granulomatous reaction in response to refractile foreign bodies with the material lying freely and within multinucleated foreign-body giant cells. In Case 2, the patient developed an enlarged axillary lymph node which was excised. Histology revealed follicular hyperplasia and multinucleated foreign body giant cells, many of which contained irregular particles of refractile material. The authors note, "[t]he clinical significance of detritic synovitis . . .is that it may stimulate recurrence of active rheumatoid arthritis."
1980 Kircher

[Record No. 1033]

Silicone elastomer finger joint implants Case 1 - The patient noted the presence of a left axillary mass 5 years after implantation. This was noted by the patient for one month without change. Because of a 24 lb. weight loss the patient sought medical attention. Physical examination revealed a 2 by 3 cm., nontender, mobile, firm but not hard lymph node in the left axilla. Hand x-ray views revealed fractures in both the left metacarpophalangeal Silastic prostheses. Axillary lymph node biopsy was performed. The specimen consisted of a lymph node, 26 by 21 by 14 mm., with a light tan appearance and a homogeneous consistency. The lymph node contained prominent lymphoid follicles with active germinal centers. The most striking feature was the presence of numerous multinucleated foreign body giant cells within sinusoids. Many of these giant cells contained irregular, light yellow, refractile particles of foreign material. Within some cells the microgranular foreign material was arranged in small clusters, giving the appearance of asteroid bodies. Polarized light failed to illuminate the substance.

Case 2 - The patient noted a mass in the left breast 5 years after implantation. Because the mass persisted, she sought medical attention one month later. Physical examination revealed a firm mass, 4 cm. in diameter, in the upper outer

1981 Bommer

[Record No. 2443]

7 hemodialysis patients with silicone tubing dialyzed for up to 53 months Silicone was found in the liver. There were varying amounts of foreign material in macrophages or giant cells of the lung, liver, spleen and thoracic and abdominal lymph nodes. Particles were observed in isolated macrophages. True granulomas were rare but some were seen.
1981 Bommer

[Record No. 2693]

Autopsy results from 47 patients who underwent hemodialysis with silicone tubing for 69-80 months. Bommer also examined 10 patients from 2 other centers where silicone tubing was used In 7 patients dialyzed for 52-165 months, varying amounts of foreign material was seen in macrophages and giant cells in the lung, liver, spleen, bone marrow, skin, thoracic and abdominal lymph nodes. There was a foreign body reaction seen in the lung, liver, spleen and mediastinal or abdominal lymph nodes as well as in the bone marrow of patients.

In the lung, there were single or clustered macrophages or multinucleated giant cells found in interstitium and occasionally in intra alveolar space.

1981 Christie

[Record No. 1045]

Ipsilateral silicone elastomer finger joint prostheses The original adenopathy was seen five years after implantation of ipsilateral silicone elastomer finger joint prostheses.
1981 Groff

[Record No. 1055]

Silicone metacarpophalangeal joint arthroplasty Report on patient who, eight years after metacarpophalangeal arthroplasty, developed nontender fullness in his right axilla. The pathologic findings were as follows:

"[m]icroscopically, the nodal architecture was intact, with active germinal centers and a prominent interfollicular component of plasma cells. Each lymph node contained one or more typical large rheumatoid necrobiotic nodules, with a central area of fibrinoid necrosis, surrounded by a layer of radially oriented palisaded histiocytes, and an outer zone of chronic inflammation and early granulation tissue. An additional striking feature was the presence of numerous widely scattered multinucleated giant cells. These occurred singly in the sinusoids of parafollicular areas, as well as prominently in the wall and central areas of the necrobiotic nodules. Virtually all these cells contained irregular, serpentine, refractile masses of pale yellow foreign material which was not evidence under polarized light. This finding is similar to what has been described microscopically with filings from new silicone elastomer prostheses (1) and identical to that recorded in the three previously described cases of silicone lymphadenopathy."

1981 Parfrey

[Record No. 5270]

Dialysis with silicone tubing in 15 patients Liver biopsy revealed refractile particles similar to those described by Leong (silicone). Parfrey believes the material is morphologically similar to silicone elastomer. Particles were seen in the portal tracts of the liver in all cases. There were refractile particles in the lobules, centrilobular situation in all 15 patients. This was consistently associated with some degree of perivenular fibrosis and sinusoidal dilation.

Epithelioid granulomas related to the particles were present in 5 cases. Groups of macrophages containing particles were seen in every case in association with focal hepatocyte necrosis. Parfrey agrees with Leong that the material may contribute to chronic liver damage in some hemodialysis patients.

1982 Benjamin

[Record No. 1060]

Silastic metacarpophalangeal joint implants Axillary lymphadenopathy with foreign body giant cell reaction to silicone particles, in patients with long-standing arthritis and silastic finger joint arthroplasties. One of these patients also had a lymphoma in the same node.
1982 Corrin

[Record No. 0713]

Silicone joint prostheses A 60-year-old-man complaining of chest pain was found to have enlarged axillary lymph nodes and an opacity on chest radiography. Lung cancer with lymph node metastases was diagnosed and an enlarged axillary lymph node was biopsied. This showed numerous epithelioid and giant cell granulomata with refractile nonbirefringent particles in many of the giant cells. Enquiries about previous injections and operations on the arm revealed that the patient had prosthetic finger and wrist joints inserted seven years previously because of rheumatoid arthritis. The prostheses were made of Silastic brand silicone rubber.
1982 Digby

[Record No. 1059]

Metacarpophalangeal joint implants A 56-year old woman received bilateral finger joint prostheses because of rheumatoid arthritis. Approximately 4 years later it was discovered that the right implant had fractured. Approximately 5 years after that she developed a painless lump in her right axilla. A lymph node was removed. Paraffin sections showed large tumour cells of the lymphoid series. Varying and occasionally large amounts of reticulin and collagen were present. Intermingled with the tumour cells were multinucleated giant cells containing refractile foreign material which was confirmed to be silicone by non-dispersive X-ray fluorescence analysis. The woman died less than one year later. At post mortem, metastases were found in the liver, spleen, spine and cervical lymph nodes.
1982 Gordon

[Record No. 1067]

Orthopedic silicone elastomer implants Authors acknowledge that ". . . it is now well-recognized in the field of plastic surgery that after the use of various types of silicone-polymer prostheses, severe inflammatory reactions to the implanted materials may be observed." Report on six patients with reactive synovitis and foreign-body giant-cell reaction to particulate silicone rubber. Implants involved were metacarpophalangeal joint, trapezium, trapezoid, wrist, elbow, and great toe. In all specimens, particulate foreign-body material was present in the synovial tissue. Of particular interest are the following microscopic findings: "[i]nflammation that was characteristically mononuclear and included lymphocytes and plasma cells was present in all but one patient and was moderate in four. In addition eosinophia was seen in three patients and was pronounced in one. In one patient, particles of foreign-body material were seen within the synovial lining cells."
1982 Leong

[Record No. 1064]

Hemodialysis with silicone tubing Spalled particles of silicone observed in patients with chronic renal failure by hemodialysis. Eighteen of the 38 had liver biopsies. The refractile particles of silicone were associated with various degrees of hepatic inflammation and fibrosis and granulomatous hepatitis was evident in 9 cases.

31 autopsies of patients who underwent hemodialysis revealed that 22 had silicone in the liver. Silicone was also present in the spleen in all cases, in the marrow of 9 persons, the lungs of 8 persons, and in the nodes in some patients. Giant cells containing silicone were also observed in these organs. Granulomatous inflammation was seen in association with the particles of silicone.

Silicone was present 6 weeks - 84 months after hemodialysis. The silicone was traced to the silicone tubing located in the roller pump of the dialysis machine.

In 9 cases there were granulomas with multinucleated giant cells containing silicone in the liver. In 2 cases, fibrosis sufficiently extensive to encircle nodules of hepatocytes was observed. Silicone in the spleen and bone marrow was present in macrophages and in scattered giant cells. In the lungs, silicone was

4/1/82 Worsing

[Record No. 1656]

Particulate silicone elastomer implanted in New Zealand white rabbits The authors implanted NZW rabbits with particulate silicone elastomer, silastic pellets, and a sham. They did not observe any inflammatory response to either the pellets or the sham, but their findings as to the particulate elastomer were as follows:

"[t]he development of a reactive synovitis with foreign-body giant cells in response to particulate silicone elastomer appears to be a potential complication of implantation of Silastic prostheses. The histologic response to particulate silicone elastomer appears to be consistent with the foreign-body response to Silastic implants reported in the surgical literature, specifically in the capsules surrounding Silastic mammary implants. The exact mechanism for this inflammatory response is unknown. Barker et al. believed that the silicone-elastomer gel "bleeds" through the wall of the Silastic bag, and they documented such leakage as occurring in vitro. Vistnes et al. showed a similar histological pattern after rupture of Silastic bag-gel mammary prostheses. Rigdon and Dricks demonstrated that the use of an improperly catalyzed silicone gel also caused an inflammatory tissue reaction."

They concluded: "[o]ur results indicate that silicone elastomer in particulate form has a

1983 Nalbandian

[Record No. 2836]

Silicone implant arthroplasty An examination of host tissue response to implanted material was performed on animals and in a long-term human clinical evaluation. Autopsy material on three dogs was obtained more than ten years after silicone implants were placed in their limbs, and in one human arthritic patient it was obtained 12 years after hand reconstruction with implants. Tissue from the augmentation stump capsule was smooth, shiny, uninflamed, and contained scattered foci of lymphocytes, macrophages, and multinucleated giant cells within the connective-tissue stroma. The macrophages and giant cells were contiguous to silicone material. In addition to the tissue response in the capsule, a similar reaction was noted in the medullary cavity of the bone adjacent to the implant. The spectrum of histological patterns associated with silicone particles in synovial tissues shows a histiocytic synovitis with foreign-body giant cell reaction provoked by silicone.
1984 Harvey

[Record No. 7235]

Silicone elastomer finger joint prostheses She noticed progressive swelling of the lymph nodes in both axillae. Examination revealed bilateral axillary lymphadenopathy. The largest node in the right axilla measured 3 cm in diameter, in the left axilla 3.5 cm in diameter. Biopsy of a node in the left axilla showed reactive changes, with follicles containing large germinal centres. The subcapsular and medullary sinuses contained many histiocytes and foreign body giant cells, with large vacuoles containing amorphous refractile material consistent in appearance with silicone. Six months after biopsy she was well.
1985 Dolwick

[Record No. 0572]

8 patients with silicone TMJ implants All specimens reveled granulomatous inflammation, multinucleated giant cells associated with silicone material, fragmented amorphous refractile irregularly spherical foreign material consistent with fragmented silicone. Multinucleated giant cells of the foreign body type were also observed. In all cases, the silicone material shared essentially the same histology features and was invariably accompanied by a foreign body giant cell response. Granulation tissue and areas of telangiectasia noted in areas of reaction of silicone.

Dolwick concluded that, "Granulomatous inflammation with foreign body giant cells usually originates as an immune reaction to an offending agent which is nondegradable or difficult to process and destroy. This distinctive pattern of inflammation is easily recognized in histologic sections.... Two factors appear to determine the formation of granulomas: (1) the presence of an indigestible foreign material or organisms and (2) the presence of cell-mediated immunity to the inciting agent."

1985 Eiken

[Record No. 2472]

Silastic H.P. implant arthroplasty in 48 patients "[t]he results of the present follow-up study show that severe silicone foreign body reactions should be considered the rule and not the exception in situations of compressive implant loading and shearing. The severity of the reactions seems to depend on the quantity and the size of the abraded particles, i.e. the total exposed surface area as suggested by Worsing et al. (1982). The principal reactions have been erosive synovitis, disseminated osteolysis and distant lymph node involvement.

In clinical practice proximal carpal implants, properly positioned and well functioning, are the most likely debris producers, particularly when articulating with incongruous and rough joint surfaces. In our series the clinical incidence of severe foreign body reactions following lunate and scaphoid Silastic H.P. implant replacement exceeded 50% within an observation period of 33 months.

In regard to these results and also in consideration of the unknown long-term biological effects, continued use of Silastic H.P. implants in proximal carpal arthroplasty, at least in younger patients, should at present be seriously questioned."

1985 Kaufman

[Record No. 1124]

Silastic and polyethylene orthopaedic implants Study of 20 patients correlates the clinical picture of each with the pathology of synovial tissue obtained at the time of revision arthroplasty. Report includes both silastic and polyethylene implants. The authors note similar findings for both products including a finding that, although larger pieces are relatively inert, particles produce an inflammatory and foreign body giant cell reaction.
1985 Manes

[Record No. 1128]

Navicular silicone elastomer prosthesis Foreign body granuloma in a bone articulating with a silicone rubber prothesis. There was mild swelling on the dorsal aspect directly over the prosthesis, tenderness in the area of Lister's tubercle. Gross exam revealed a lesion. Silicone particles were seen, along with giant cells and necrotic material. Synovial tissue also showed evidence of silicone globules.
1/85 Smith

[Record No. 1387]

Silicone rubber implants in 9 patients Nine patients developed foreign body synovitis after implantation with silicone rubber to replace corpus, wrist joint, and ulnar head. All required secondary surgery. Their post-surgical findings included the following:

"Histologic studies of the wrist synovium of all patients by standard and polarized microscopy (other than case 1 where no report was available) revealed particulate foreign body material in the synovial tissue. This material was always refractile under polarized light microscopy, but not birefringent. Particulate material was seen both intracellulary and extracellulary. The particles ranged in size from 20 to 100 u.m. The synovium showed evidence of chronic inflammation that was characterized by lymphocytes and plasma cells and foreign body giant cell reaction surrounding areas where silicone debris was found. Cortial erosions of the carpal bones and radial styloid as well as cyst-like lucent interosseous defects were present on roentgenograms of six of the seven cases of carpal replacement arthroplasty."

1986 Shiel

[Record No. 7237]

Silicone elastomer metatarsophalangeal joint implants Four years after placement of bilateral first metatarsophalangeal silicone prostheses, a man developed bilateral inguinal and right femoral lymphadenopathy. Pathology of an excised left femoral lymph node revealed noncaseating granulomatous reaction with scattered multinucleated giant cells. Within many of the granulomas an amorphous, pale yellow, refractile material was present. X-rays of the feet revealed gross deformity of the left prosthesis with cystic and erosive changes.
1987 Jasim

[Record No. 7238]

Silicone elastomer metatarsophalangeal joint implants Case 1 - enlarged groin lymph node shown to contain foreign body giant cell reaction and epithelioid granulomatous lesion in the lymph nodes.

Case 2, 3, 4 - after implants removed, histological changes consisted of hyperplastic synovial membrane due to chronic inflammation and granulomatous lesions. The inflammatory granulomatous reaction extended into the skin and subcutaneous tissue in some cases, and bone was involved in all 3 cases. Inflammatory cells, histiocytes, fibroblastic reaction and multinucleate foreign body giant cells were seen in the cancellous bone of the medulla. Large and small silicone particles were seen in the cytoplasm of giant cells and extracellularly in the stroma.

1987 Peimer

[Record No. 1845]

Silicone trapeziometacarpal implant "[t]he generation of silicone microparticles leading to secondary synovitis and joint changes is now recognized as a serious problem, but it is still not widely perceived as a predictable and direct consequence of the normal use of these implants. The underlying microparticulate pathophysiology has only recently been described. Physiologically wear-induced implant surface deformation generates free microparticles, which prompt a proliferative and inflammatory cellular response. The importance of particle size in determining the host's response to any nontoxic material (including implants) has recognized human and experimental models."

They noted: "[i]mplant surface deterioration, microfragmentation, and wearing are found if these prostheses are subjected to cyclic bearing, shear, and compression stresses, singly and in combination. Although large pieces of silicone (implants and 'fractured' prostheses) are generally well tolerated by the tissues, microparticulate silicone is poorly tolerated and incites a significant inflammatory, destructive, foreign body reaction. The pathologic changes are shed particle dose-related, secondary to the invasive reactive synovitis.

12/89 Christie

[Record No. 2514]

Trapezium resection implant Case report of silicone synovitis occurring in the wrist following insertion of a trapezium resection implant. Severe pain developed between 5 and 6 years post-operatively and the implant was replaced. Pathology at time of replacement revealed:

". . . a hypertrophic villous synovitis with marked thickening of synovial membrane, induced by a chronic foreign-body-type inflammatory cell reaction to silicone rubber, with a varying number of macrophages and multinucleate giant cells . . . . There is erosion of articular cartilage by pannus which contains refractile but nonbirefringent silicone particles both intracellularly and extracellularly. Synovial invasion of bony structures adjacent to the prosthesis, with destruction of cortical and trabecular bone by inflamed synovium, occurs. There may be "cysts" within bones that are not filled with fluid, as may be seen in degenerative arthritis, but are more like intraosseous synovial tumors, histologically similar to the pannus. These cysts may result from direct ingrowth of pannus from joint margins and/or be a local intraosseous response to abraded silicone detritus that has migrated into bone through lymphatic or vascular channels; distant migration of these particles has already been well documented. The removed implant is often discolored, may be

1990 Alexander

[Record No. 7239]

Lunate silicone arthroplasty Three of five patients with radiographs averaging 57 months after operation had evidence of particulate synovitis. It was concluded that the success rate for silicone replacement arthroplasty and the incidence of particulate synovitis do not warrant the continued use of silicone replacement arthroplasty as a primary treatment modality for Kienb�ck's disease.

In our study, radiographic evidence of particle-wear synovitis was present in three of the five patients who obtained long-term x-ray follow-up. One of the three patients manifested clinical symptoms of moderate-to-severe pain and swelling. Another patient has pain and chronic instability with subluxation of the prosthesis. The third patient with x-ray evidence of particle-wear synovitis received satisfactory rating and reported no pain, swelling, or physical limitations.

1990 Perlman

[Record No. 5274]

Swanson angled Hemi-implant A patient who had received a Swanson angled hemi-implant presented with complaints of pain in the first metatarsophalangeal joint. A diagnosis of implant failure and possible silicone particulate synovitis was made based on radiographic and clinical presentation. The pathologic analysis revealed the following:

"[b]oth soft tissue and bone were sent for pathologic examination. Gross examination revealed soft tissue to be firm and white to yellow in appearance. The cartilage of the metatarsal head was eroded and pitted. Underlying bone was yellow and porotic. Areas of the cartilage were detached from the underlying bone. Microscopic examination of the soft tissue revealed necrotic material with unidentifiable foreign material (silastic) present in abundance of fibrotic granulation tissue. A foreign body giant cell response was noted with foreign material present within many of the giant cells. Microscopic examination of the metatarsal head revealed bone and bone marrow almost completely replaced by unidentifiable foreign material, and foreign body giant cell response with extreme fibrosis. The articular surface revealed degeneration and focal disappearance of cartilage and replacement by granulation tissue."

1990 Smith

[Record No. 2518]

Silicone carpal prostheses This study investigated whether a cellular or a humoral-mediated immunologic response to silicone carpal prostheses could be detected in animals previously sensitized to silicone. The authors summarized their findings as follows:

". . . our study has demonstrated antibody formation to implanted silicone prostheses as well as a cellular immune response. This, in conjunction with the data accumulated by numerous previous investigators strongly suggests that the formation and contracture of periprosthetic capsules and synovitis are mediated by the body's immunological systems, both humoral and cellular, and that silicones are the antigenic determinants."

1990 Tabatowski

[Record No. 1205]

Double-stemmed silastic prosthetic arthroplasty of the left hallux metatarsal joint The patient developed a mobile, tender nodule in the left side of the groin, and fine needle aspiration was performed. The failed prosthesis was subsequently removed and a iliac bone graft was inserted. The microscopic picture was dominated by giant multinucleate macrophages. The nuclei were round and 'mirror image" and had bland chromatin; they varied widely in number, from 3 to 4 to >100 in a single cell. Some of the multinucleate macrophages contained one or two asteroid bodies, often located peripherally in the cell cytoplasm and, rarely, extracellularly. The multinucleate cells also contained irregular, faintly yellow particles, morphologically consistent with silicone microfragments as described in the literature. These particles were also present extracellularly. In the background was a spectrum of reactive lymphocytes most compatible with chronic lymphadenitis, including occasional plasma cells, eosinophils and a small but distinctive population of mast cells.
1991 Kalicharan

[Record No. 7078]

Silicone plombe implanted in the sclera 8 years later after implantation, the patient developed an inflammation of the tissue and partial protrusion of the sclera. A large portion of the silicone pores were filled with cellular material including macrophages, giant cells and erythrocytes indicating a foreign body granuloma. The external surface of the pores had granular osmiophilic dense amorphous layer including extracellular debris. Engulfing of silicone particles by macrophages and the evidence of long-term tissue response suggest partial biodegradation of the silicone.

Kalicharan states, "The growth of macrophages, red blood cell accumulation, a few giant cells, the invasion of the lymphocytes through the pores of the plombe and a fibrin network formed by preclotting........ The present study gives insight into how the cell is biologically influenced by the preserve of a silicone biomaterial used as a buckle and how this affects the tissue response after 8 years in situ....."

He concludes that the silicone plombe induced a moderate foreign body granuloma. The presence of many lymphocytes in and on the surface of the pores indicate that silicone elicits an immunoresponse in the category of chronic inflammation. The giant cells are associated with the final stage of biodegradation. Here the plombe had reached a preliminary stage of biodegradation.

"Our observation of granular membrane-coated vesicles engulfed by the lamellopodia may be associated with protein and polymer digestion in the giant cells and macrophages. We therefore believe on account of the abundant presence of lysosomes in the cytoplasm of the macrophages, that the implanted foreign (silicone) body was being further metabolized by hydrolysis, not into crystalline forms like poly-L-lactide as described by Rozema, but into a more rounded granular form."

"The persistence of macrophages on the polymer surface seen in this study may be attributed to the probable immunological chemotactic properties exerted on the surface of the plombe."

1991 Ognibene

[Record No. 7240]

Silicone Hemi-Silastic implant These implant failures are being manifested by extremely unusual pathology. Although silicone has not been shown to be carcinogenic, the florid reaction seen in this case demonstrated a degree of "malignancy" that may have incapacitated the patient. The gross specimen of the periarticular tissue obtained from the most recent surgery had the appearance of a villonodular synovitis with the characteristic golden-yellow to red-brown color, and significant synovial hyperplasia. The initial pathology report corroborated this diagnosis. It was not until a second report was filed that the silicone crystals were identified, and the diagnosis became a detritic synovitis. Radiographs taken 12 months after the second surgery revealed osteoblastic activity with regeneration of the bone stock. This reossification process further rules out conditions such as fibrous dysplasia and substantiates a reactive synovitis.
1991 Peimer

[Record No. 1445]

Silicone wrist and trapezial arthroplasty in 7 persons The fracture was attributed to the end stage of untreated microparticulate synovitis as a consequence of implant wear. In Case No. 2, the authors curetted reactive synovium from that metacarpal and found chronic inflammation and giant cells with ingested and free silicone microparticles. In all cases there was evidence of bone deterioration. They concluded:

"[o]ur cases illustrate an additional complication in the natural course that is precipitated by continued microparticle dosing in untreated (silicone) synovitis. Fractures developed in these patients more than 2 years later than the reported average onset of microparticle synovitis and from silicone formulations not previously associated with the process. The generation of silicone microparticles is a predictable, direct consequence of normal use of these implants and, if significant, may result in extensive secondary pathologic conditions, including fractures, since all microparticles are known to be poorly tolerated."

1992 Ford

[Record No. 7075]

Silastic Dow Corning silicone buttock implants Implants ruptured 9 years post implantation. There was massive silicone extravasation, migration and silicone granuloma. The patient presented with a painful right groin mass which was present for one year. There was a very firm subcutaneous mass containing nodules from 1-5cm in diameter which traversed from the right buttock anteriorly into the right labia majora. Nodules also extended superiorly to the inguinal ligament and inferiorly over the entire femoral triangle. Silicone granuloma and free silicone were encountered during surgery. Tissue reaction was quite advanced.
1992 Sammacro

[Record No. 3038]

Silicone 1st metatarsophalangeal joint Anteroposterior, lateral, and oblique x-rays of the left foot revealed a fragmented bipolar prosthesis in the left metatarsophalangeal joint. Soft tissue swelling was noted at the metatarsophalangeal joint. A diagnosis of failed prosthesis of the left first metatarsophalangeal joint and inguinal lymphadenopathy was made. The left femoral lymph node was mobile, nontender, and measured 2 cm in greatest dimension. Fine needle aspiration was performed. Microscopic fields were dominated by giant multinucleated macrophages. The nuclei were round, "mirror image," and had bland chromatin; they varied widely in number, from three or four to over 100 nuclei per single cell. Some of the multinucleated macrophages contained one or two asteroid bodies often located peripherally in the cell cytoplasm and rarely extracellularly. The multinucleated cells also contained irregular, faintly yellow particles, which were nonbirefringent under polarized light and morphologically consistent with silicone microfragments. These particles were also present extracellularly. In the background was a spectrum of reactive lymphocytes most compatible with a chronic lymphadenitis, including occasional plasma cells, eosinophils, and a small but distinctive population of mast cells. Tingible body macrophages, transformed lymphocytes, lymphohistiocytic aggregates, and
1993 Rahman

[Record No. 3035]

55 patients who underwent silicone hemiarthroplasty of the first metatarsophalangeal (MP) joint Mean implantation of 4.5 years. 56/78 feet had radiologic evidence of silicone granulomatous disease. Histology from 3 confirmed the presence of silicone granulomata characterized by numerous multinucleated giant cells, some with silicone intracellular silicone particles. Rahman recommends abandoning hemiarthroplasty because of these complications.
1994 Senn

[Record No. 7077]

Molteno Implant for bilateral glaucoma surgery - underwent pars plana vitrectomy and silicone oil tamponade Histology showed numerous foreign body granulomas occasionally containing multinucleated giant cells coating the inner surface of the bleb as well as intracellular and extracellular deposits of emulsified silicone oil in the wall of the bleb. The inner surface lined was with a monolayer of macrophages containing droplets of silicone oil.
1995 Matsumoto

[Record No. 7049]

Silicone plate 8 years 9 months after implantation, the patient developed a silicone granuloma in the sellar and suprasellar region. Granuloma and hematoma around the silicone plate were observed. Clinical symptoms included severe headaches, vomiting, polyuria and usual disturbance of both eyes. A firm mass was located below the optic chiasm adhering to the optic nerve. The mass consisted of a mixture of firm fibrous tissue, silicone plate and hematoma. The symptoms resolved after removal. Pathology showed a dense fibrous connective tissue, capillary vessels, inflammatory cell infiltrates, macrophages, and multinucleated giant cells. Diagnosis: delayed immune response to fibrous body. Breakdown of materials with aging may trigger delayed immune response.
1996 Hirakawa

[Record No. 7076]

Silicone orthopaedic devices 10 cases of silicone granuloma reported. Light microscopic histology showed particles of foreign material in the connective and synovial tissue of all cases. All 10 had foreign body giant cells as well as numerous mononuclear histiocytes. Reaction was marked in 2 patients. Lymphocytes and plasma cells common in all samples.
1996 Roux

[Record No. 7241]

Silicone wrist implant This examination revealed asymmetrically enlarged axillary lymph nodes with dense, thickened cortical tissue; a residual fatty hilum could be seen, indicating incomplete replacement. Ultrasound (US)-guided fine-needle aspiration biopsy of the largest node demonstrated foreign body giant cells containing an abundance of partially refractile granular material. Most of the giant cells contained large irregular fragments of ingested foreign material and had an appearance typical of those from nodes that drain prosthetic implant sites.


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TMJD_SAFE_HAVEN_4_LIFE_ISSUES · TMJ SUPPORT GROUP

This TMJD Support Group is intended to be a Safe Haven and provide a place where people with TMJ pain can come and offer and receive support from people who know what they are going through. This is not a medical group and we do not have medical degrees or medical backgrounds. However, with the variety of members in here, there is bound to be someone who has been there and done that and can answer your questions.

This group is in memory of Debbie Ward whom suffered from TMJD & died of unknown causes.

There are many types of members with TMJD. Some have been treated medically, some treated with various splint therapies and physical therapies as well as some with surgical treatments ranging from Arthroscopy to full jaw joint replacements. Everyone with any degree of TMJD or has a family member that deals with it is welcome to join and offer and receive support that we all so badly need to get through each day with the pain we have to live with.

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