Evidence map›Paper›PMID 35680258›Full record

Observational studyBMJ open2022

Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study.

Karlinde Amber Spit, Miranda Scharff, Christel Jm de Blok, Frank B Niessen, Yara Bachour, Prabath W Nanayakkara

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
8.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Observational
  5. Exploring Silicone-Induced Lupus Through a Case Report.Mediterranean journal of rheumatology · 2025
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. The Role of Positron Emission Tomography Imaging in Breast Implant Illness.Plastic and reconstructive surgery. Global open · 2025
    Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Silicone Migration from Intact Saline Breast Implants.Plastic and reconstructive surgery. Global open · 2024
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Karlinde Amber Spit *Internal Medicine, Amsterdam UMC, Locatie VUmc, Amsterdam, Noord-Holland, The Netherlands.
Miranda Scharff *Internal Medicine, Amsterdam UMC, Locatie VUmc, Amsterdam, Noord-Holland, The Netherlands.
Christel Jm de BlokDepartment of Endocrinology, Amsterdam UMC, VUMC Location, Amsterdam, Noord-Holland, The Netherlands.
Frank B NiessenDepartment of Plastic Surgery, Amsterdam UMC Locatie VUmc, Amsterdam, Noord-Holland, The Netherlands.
Yara BachourInternal Medicine, Amsterdam UMC, Locatie VUmc, Amsterdam, Noord-Holland, The Netherlands.
Prabath W NanayakkaraInternal Medicine, Amsterdam UMC, Locatie VUmc, Amsterdam, Noord-Holland, The Netherlands p.nanayakkara@vumc.nl.ORCID 0000-0002-1555-3682
Amsterdam UMC Location Vrije Universiteit Amsterdam · NLGGD Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAn unknown portion of women with silicone breast implants (SBI) report development of systemic symptoms, recently named as 'breast implant illness (BII)'. We aim to describe the symptoms and characteristics of women with SBI reporting these systemic symptoms and compare the clinical course of women who chose to keep their implants, to women who had their implants removed.

designObservational cohort study.

settingSpecialised BII out-patient clinic at Amsterdam UMC, the Netherlands, from 2011 to 2020.

participantsAll women presenting to the BII clinic with SBI and systemic symptoms.

results467 women were included for baseline analyses and 398 women for follow-up. Most frequently reported systemic symptoms at baseline included fatigue (88%), arthralgia (71%), morning stiffness (59%), myalgia (48%), cognitive impairment (33%), peripheral neurological symptoms (30%) and lymphadenopathy (22%). Furthermore, 56% reported pre-existing allergies at baseline and positive antinuclear antibodies were observed in 23%. At follow-up with a median of 3.3 years (IQR 2-4), 152 women had their implants removed on clinical grounds. Symptoms improved significantly in 65 women (43%), improved moderately in 37 women (24%), did not change in 37 women (24%) and deteriorated in 13 women (9%). Women who underwent explantation showed more improvement of their systemic symptoms compared with women who did not (OR 2.9, 95% CI 1.3 to 6.2). Additionally, women who underwent explantation within 10 years after implantation improved significantly better than women who got the implants removed after 10 years (p=0.007). Lastly, local symptoms decreased from 75% to 34% after implant removal (p<0.0001).

conclusionMost women with SBI who developed systemic symptoms experienced improvement after explantation, especially when removed within 10 years after implantation. Early recognition of the pattern of systemic symptoms in women with SBI is important and implant removal should be considered.

Indexed as

Breast ImplantationBreast ImplantsCohort StudiesFemaleHumansPatient Reported Outcome MeasuresSiliconesSiliconesbreast surgeryplastic & reconstructive surgeryrheumatology

Identifiers

PMID35680258
PMCPMC9185500
OpenAlexW4281750059

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.