Breast implant illness: scientific evidence of its existence

Figures & data

Figure 1. Breast implant illness (a form of autoimmune/autoinflammatory syndrome induced by adjuvants) presents with neurological/musculoskeletal, immunological, and/or vascular manifestations.

ANA, antinuclear antibodies; ANCA, anti-neutrophil cytoplasmic antibodies; SBI-ASIA, silicone breast implant-related autoimmune/autoinflammatory syndrome induced by adjuvants.

Table 1. Fibromyalgia 2016 criteria [13]

Criteria

A patient satisfies modified 2016 fibromyalgia criteria if the following 3 conditions are met:

[1] Widespread pain index (WPI) ≥ 7 and symptom severity scale (SSS) score ≥ 5 OR WPI of 4–6 and SSS score ≥ 9

[2] Generalized pain, defined as pain in at least 4 of 5 regions, must be present. Jaw, chest, and abdominal pain are not included in generalized pain definition

[3] Symptoms must have been present for at least 3 months

[4] A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses

Notes

[1] WPI: note the number of areas in which the patient has had pain over the last week. In how many areas has the patient had pain? Score will be between 0 and 19.

[2] Symptom severity scale (SSS) score.

Fatigue, Waking unrefreshed. Cognitive symptoms.

For the each of the 3 symptoms above, indicate the level of severity over the past week using the following scale:

0 =  No problem.

1 =  Slight or mild problems, generally mild or intermittent.

2 =  Moderate, considerable problems, often present and/or at a moderate level.

3 =  Severe: pervasive, continuous, life-disturbing problems.

The symptom severity scale (SSS) score: is the sum of the severity scores of the 3 symptoms (fatigue, waking unrefreshed, and cognitive symptoms) (0–9) plus the sum (0–3) of the number of the following symptoms the patient has been bothered by that occurred during the previous 6 months:

[1] Headaches (0–1, 2) Pain or cramps in lower abdomen (0–1, 3) Depression (0–1)

The final symptom severity score (SSS) is between 0 and 12

Table 2. Criteria for the diagnosis of autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA) [8,45]

Major criteria Exposure to an external stimulus (implants such as silicone and mesh are classic adjuvants) prior to clinical manifestations The appearance of ‘typical’ clinical manifestations such as Chronic fatigue, unrefreshing sleep, or sleep disturbances Myalgia, myositis, or muscle weakness Arthralgia and/or arthritis Cognitive impairment, memory loss Pyrexia Sicca (dry mouth, dry eyes) Neurological manifestations (especially associated with demyelination) 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, Raynaud’s phenomenon) Specific HLA associations (i.e. HLA DRB1, HLA DQB1) Evolvement of an autoimmune disease (i.e. multiple sclerosis, rheumatoid arthritis, Sjögren syndrome, systemic sclerosis) Patient are considered to have ASIA when either two major or one major and two minor criteria are present.

Table 3. Frequency of autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA) symptoms in unselected patients with breast implants, healthy controls, and patients who registered themselves as having breast implant illness (BII)

	Group 1: SBI patients (n = 84)	Group 2: Negative controls (HC)(n = 48)	Group 3: Positive controls (MKS)(n = 86)
Amount of ASIA symptoms	2.34 ± 1.5	1.8 ± 1.8	4.06 ± 1.5
ASIA (Tree 1)	44 (52%)	14 (29%)	67 (78%)
ASIA (Tree 2)	19 (23%)	3 (6%)	46 (53%)

Tree 1: Arthralgia and/or myalgia AND fatigue/sleep disturbances.

Tree 2: Arthralgia and/or myalgia AND fatigue/sleep disturbances

and/or cognitive impairment AND pyrexia and/or sicca.

Group 1: ‘Silicone breast implant (SBI) patients’: unselected patients were recruited from Dutch hospitals, where they had been augmented or reconstructed with SBIs. Group 2: ‘Negative controls’: healthy controls without breast implants were recruited from friends of subjects from group 1. Group 3: ‘Positive controls’: patients were recruited from the Dutch foundation for breast implant illness (‘Meldpunt Klachten Siliconen; MKS’).

Figure 2. Pathophysiology of breast implant illness (a form of autoimmuneinflammatory/autoimmunityinflammatory syndrome induced by adjuvants).

Implantation results in attraction of proteins and phagocytes, a process that is critically dependent on mast cell recruitment (1.2). Leakage and/or rupture of silicones from the breast implant results in increased apoptosis/necrosis of cells (1.1). Subsequently, antigen-presenting cells are activated [2], resulting in T cell activation and granuloma formation [3]. These cellular mechanisms result in lymphadenopathy [4], autoantibody production [5] and clinical manifestations such as fatigue and arthralgia/myalgia [6]. SBI-ASIA, silicone breast implant-related autoimmune/autoinflammatory syndrome induced by adjuvants.

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