Introduction
Materials and methods
Major criteria
|
• Exposure to an external stimulus (infection, vaccine, silicone, adjuvant) prior to clinical manifestations |
• The appearance of ‘typical’ clinical manifestations: |
- Myalgia, Myositis or muscle weakness |
- Arthralgia and/or arthritis |
- Chronic fatigue, un-refreshing sleep or sleep disturbances |
- Neurological manifestations (especially associated with demyelination) |
- Cognitive impairment, memory loss |
- Pyrexia, dry mouth |
• Removal of inciting agent induces improvement |
• Typical biopsy of involved organs |
Minor criteria
|
• The appearance of autoantibodies or antibodies directed at the suspected adjuvant |
• Other clinical manifestations (i.e. irritable bowel syndrome) |
• Specific HLA (i.e. HLA DRB1, HLA DQB1) |
• Evolvement of an autoimmune disease (i.e. multiple sclerosis, systemic sclerosis) |
Statistics
Review
Results
Patient demographics
Variable | 1994 | 2014 |
---|---|---|
Years (range) | Years (range) | |
Median age at time of evaluation | NA | 49 (27–72) |
Median age at time of implantation | 32 (19–52) | 33 (14–56) |
Median age at onset of symptoms | 38 (23–57) | 41 (20–68) |
Median age at time of diagnoses | NA | 49 (27–72) |
Median latency period | 6 (0–24) | 4 (1–39) |
Median time between implant and diagnosis | NA | 13 (2–43) |
Median age at time of removal | 44 (30–59) | 49 (31–68) |
Reasons for implantation | 1994 | 2014 |
---|---|---|
N (%) |
N (%) | |
Cosmetic purposes | 68 | 80 |
Malignant tumour | 4 | 14 |
Benign tumour | 28 | 3 |
BRCA positive | NA | 3 |
Local manifestations and complications
Clinical symptoms
Symptom | 1994 | 2014 |
P value |
---|---|---|---|
N (%) |
N (%) | ||
Myalgia, Myositis or muscle weakness | 91 | 54 | <.001 |
Arthralgia and/or arthritis | 81 | 91 | .04 |
Chronic fatigue, un-refreshing sleep or sleep disturbances | 95 | 98 | .25 |
Neurological manifestations (especially associated with demyelination) | 32 | 20 | .05 |
Cognitive impairment, memory loss | 81 | 78 | .60 |
Pyrexia | 52 | 64 | .09 |
Dry eyes and/or dry mouth (sicca) | 72 | 73 | .87 |
Symptom | 1994 | 2014 |
P value |
---|---|---|---|
N (%) |
N (%) | ||
Raynaud’s phenomenon | 58 | 30 | <.001 |
Irritable bowel syndrome | NA | 17 | – |
Recurrent respiratory tract infections | NA | 54 | – |
Recurrent cystitis | NA | 36 | – |
Livedo reticularis | 62 | 28 | <.001 |
Allergies | 52 | 52 | NS |
Laboratory findings
Measurement | 1994 | 2014 |
---|---|---|
N (%) |
N (%) | |
Increased immunoglobulins | 13/76 (17) | 14/98 (14) |
Decreased immunoglobulins | 24/76 (32) | 13/98 (13) |
ANA | 33/93 (36) | 5/100 (5) |
RF | 10/90 (11) | 4/92 (4) |
Presence of autoimmune diseases
Symptom |
N (%) |
---|---|
RA | 4 |
CTD | 18 |
Vasculitis | 5 |
Granulomatous disease | 3 |
Other | 7 |
Implant removal
Statistics
Discussion
Review of current literature
References | Cohort (N) | Fatigue | Arthralgia | Myalgia | Sicca | Pyrexia | Neurological symptoms | Memory/cognitive impairment | Other symptoms |
---|---|---|---|---|---|---|---|---|---|
Maijers [15] | 80 | X | X | X | NR | NR | NR | X | Dermatological problems, alopecia, night sweats, depression, GI-symptoms |
Cohen Tervaert [3] | 32 | X | X | X | NR | X | NR | NR | Asthenie |
Contant [23] | 57 | NR | X | NR | X | NR | NR | NR | Raynaud, headache, dizziness, palpitations, diarrhoea transpiration |
Contant [24] | 63 | NR | X | NR | X | NR | X | X | Raynaud, headache, palpitations, diarrhoea, transpiration, night sweats, rashes |
Shoaib [25] | 26 | NR | X | X | X | X | X | NR | Headache, skin rash, Raynaud’s, hair loss, allergies, sensitivity to sunlight and lymph-adenopathy |
Cuellar [26] | 300 | X | X | NR | X | X | X | X | Headache, night sweats, diarrhoea, recurrent infections, dyspnoea, angio-oedema and shoulder pain |
Gaubitz [27] | 90 | X | X | X | X | NR | NR | NR | Night sweats, Raynaud, tingling, photosensitivity, headache, dyspnoea, depression, hoarseness |
Giltay [28] | 235 | NR | X | NR | NR | NR | NR | NR | Skin abnormalities, burning eyes |
De Jong [29] | 42 | X | X | X | X | X | NR | NR | Rashes, oral ulcers |
Englert [30] | 458 | NR | NR | X | NR | NR | NR | X | Night sweats, breast pain, reflux, paraesthesiae, lethargy |
Vasey [31] | 50 | X | X | X | NR | NR | NR | NR | Lymphadenopathy |
Vermeulen [32] | 319 | X | X | X | NR | NR | NR | X | Headache, lymphadenopathy, sore throat |
Bridges [33] | 156 | X | X | X | X | X | NR | X | Pulmonary symptoms, alopecia, ulcers, lymphadenopathy |
Freundlich [34] | 50 | X | X | NR | X | NR | NR | NR | Raynaud, alopecia, lymphadenopathy, night sweats, sore throats |
Solomon [35] | 176 | X | X | NR | X | NR | NR | X | Skin abnormalities, gland enlargement, dysphagia, carpel tunnel syndrome, alopecia |
Peters [22] | 100 | X | X | X | NR | NR | NR | X | Gastrointestinal symptoms, breast pain, rashes |
Mehmed [36] | 240 | X | X | NR | NR | X | X | X | Dysphagia, hair loss, depression, skin rash, headache |
Wells [37] | 52 | X | X | X | NR | X | NR | X | Headaches, swollen glands, back pain, rashes |