title: Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study.
abstract: BACKGROUND
  Since their introduction, the safety of silicone breast implants has been under debate. Although an association with systemic diseases was never established, women continuously blamed implants for their unexplained systemic symptoms. In 2011, a pattern of symptoms caused by systemic reactions to adjuvants (e.g. vaccines, silicone) was identified: 'autoimmune syndrome induced by adjuvants' (ASIA). Our aim was to collect a cohort of women with silicone breast implants and unexplained systemic symptoms to identify a possible pattern and compare this with ASIA.
  
  
  METHODS
  Women with silicone breast implants and unexplained systemic symptoms were invited through national media to visit a special outpatient clinic in Amsterdam. All were examined by experienced consultant physicians and interviewed. Chest X-ray and laboratory tests were performed.
  
  
  RESULTS
  Between March 2012 and 2013, 80 women were included, of which 75% reported pre-existent allergies. After a symptom-free period of years, a pattern of systemic symptoms developed, which included fatique, neurasthenia, myalgia, arthralgia and morning stiffness in more than 65% of women. All had at least two major ASIA criteria and 79% fulfilled ≥ 3 typical clinical ASIA manifestations. After explantation, 36 out of 52 women experienced a significant reduction of symptoms.
  
  
  CONCLUSIONS
  After excluding alternative explanations, a clear pattern of signs and symptoms was recognised. Most women had pre-existent allergies, suggesting that intolerance to silicone or other substances in the implants might cause their symptoms. In 69% of women, explantation of implants reduced symptoms. Therefore, physicians should recognise this pattern and consider referring patients for explantation.
authors.affiliation: Department of Plastic and Reconstructive Surgery, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: M C
authors.initials: MC
authors.lastname: Maijers
authors.forename: C J M
authors.initials: CJ
authors.lastname: de Blok
authors.forename: F B
authors.initials: FB
authors.lastname: Niessen
authors.forename: A A M
authors.initials: AA
authors.lastname: van der Veldt
authors.forename: M J P F
authors.initials: MJ
authors.lastname: Ritt
authors.forename: H A H
authors.initials: HA
authors.lastname: Winters
authors.forename: M H H
authors.initials: MH
authors.lastname: Kramer
authors.forename: P W B
authors.initials: PW
authors.lastname: Nanayakkara
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000554:Ambulatory Care Facilities; D001327:Autoimmune Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000276:immunology; D018427:Breast Implants / Q000009:adverse effects* / Q000523:psychology; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D009426:Netherlands; D012008:Recurrence; D012086:Reoperation; D012307:Risk Factors; D057566:Self Report; D012828:Silicones / Q000009:adverse effects*; D013001:Somatoform Disorders / Q000175:diagnosis / Q000523:psychology; D013577:Syndrome; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D012828:Silicones