Evidence map›Paper›PMID 40605595›Full record

ArticleJournal of the National Cancer Institute2025

Breast implant illness after reconstruction with silicone breast implants.

Jonathan Spoor, Marc A M Mureau, Renaud L M Tissier, Juliëtte Hommes, Hinne Rakhorst, Mintsje de Boer, Hester S A Oldenburg, Esther M Heuts, Yvonne L J Vissers, Anneriet E Dassen and 9 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Journal of the National Cancer Institute, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05400954 (Association of Silicone Breast Implant Reconstruction and -Enlargement With Overall Wellbeing, Lymphoma and Auto-immune Disease - Breast Implant Illness), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT05400954 unknown statusnot on this map

Association of Silicone Breast Implant Reconstruction and -Enlargement With Overall Wellbeing, Lymphoma and Auto-immune Disease - Breast Implant Illness

TypeobservationalSponsorThe Netherlands Cancer InstituteRan2022 to 2025Enrolled15,000ConditionsBreast Cancer, Breast Implant, Complications, Autoimmune DiseasesArmsBreast reconstruction with silicone breast implant, Breast conserving surgery/Mastectomy/Autologous reconstruction, Breast Augmentation
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Observational
  3. Article
  4. Article
  5. Breast implant illness and the power of national mandatory reporting.Journal of the National Cancer Institute · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Jonathan SpoorDepartment of Epidemiology, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0002-6553-3452
Marc A M MureauDepartment of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.ORCID 0000-0001-6941-7734
Renaud L M TissierBiostatistics Unit, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0002-9665-883X
Juliëtte HommesDepartment of Plastic and Reconstructive Surgery, Zuyderland Medical Center, Heerlen, The Netherlands.ORCID 0000-0002-9122-2869
Hinne RakhorstDepartment of Plastic, Reconstructive and Hand Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.ORCID 0000-0002-1663-6092
Mintsje de BoerDepartment of Plastic and Reconstructive Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Hester S A OldenburgDepartment of Surgical Oncology, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0001-8626-1401
Esther M HeutsDepartment of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Yvonne L J VissersDepartment of Surgery, Zuyderland Medical Center, Heerlen, The Netherlands.
Anneriet E DassenDepartment of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.
Daniel J EversDepartment of Surgery, Ziekenhuisgroep Twente, Hengelo, The Netherlands.ORCID 0009-0007-9973-0618
Linetta B KoppertDepartment of Surgical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Laura H ZaalDepartment of Plastic Surgery, Velthuis Kliniek, Hilversum, The Netherlands.
Sabine C LinnDepartment of Medical Oncology, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0001-5541-0347
Daphne de JongDepartment of Pathology, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0002-9725-4060
Rene R W J van der HulstDepartment of Plastic and Reconstructive Surgery, Zuyderland Medical Center, Heerlen, The Netherlands.ORCID 0000-0002-3904-118X
Marie-Jeanne T F D Vrancken PeetersDepartment of Surgical Oncology, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0003-4472-4257
Eveline M A BleikerDivision of Psychosocial Research and Epidemiology, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0003-4357-949X
Flora E van LeeuwenDepartment of Epidemiology, Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.ORCID 0000-0002-5871-1484

Funding

Dutch Ministry of Health, Welfare and SportNational Institute for Public Health and the Environment
6 · The paper itself

Abstract

background"Breast implant illness" (BII) is a constellation of non-specific constitutional, rheumatologic, mental, and cognitive symptoms reported increasingly by women carrying silicone breast implants (SBIs). The impact of BII on the well-being of breast cancer patients with SBI-based breast reconstructions is a subject of debate.

methodsIn a multicenter cohort of breast cancer survivors (n = 9590) treated between 2000 and 2015 in 6 major regional hospitals in the Netherlands, we performed a health survey (response rate 64.7%). The presence of 18 BII-associated symptoms was compared between patients with and without SBIs in multivariable logistic regression models. In a latent class analysis (LCA), distinct symptom patterns were identified in the study population.

resultsMedian follow-up time was 13.7 (IQR, 6.8) years. Of all SBI-exposed patients (n = 1821), 20.7% reported ≥4 BII-associated symptoms vs 21.2% of non-exposed patients (risk ratio 0.98; 95% CI = 0.88 to 1.09). Joint pain, sicca, sleep impairment, morning stiffness, and shoulder pain were reported most frequently. Patients with SBIs did not have a significantly increased risk of any of the individual BII-associated symptoms. The LCA identified 5 distinct symptom clusters. Patients with SBI-exposure had a lower risk of falling in the most severe symptom cluster (odds ratio 0.64; 95% CI = 0.43 to 0.96). The other symptom clusters were not significantly associated with SBI-exposure.

conclusionsOur results indicate that breast cancer survivors with SBI-based reconstructions do not experience more BII-associated symptoms than breast cancer survivors without SBIs, challenging the notion of BII as a distinct clinical entity based on a generic silicone-induced biomechanical pathophysiological mechanism.

trial registrationThis study was preregistered at ClinicalTrials.gov on June 2, 2022 (NCT05400954).

Indexed as

Breast ImplantsBreast NeoplasmsMammaplastySilicone GelsAdultAgedBreast ImplantationCancer SurvivorsFemaleFollow-Up StudiesHumansMiddle AgedNetherlandsSiliconesSilicone GelsSilicones

Identifiers

PMID40605595
PMCPMC12342748

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Registered trials

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.