Clinical trial · Observational
Association of Silicone Breast Implants With Overall Wellbeingand Auto-immune Diseases
Association of Silicone Breast Implant Reconstruction and -Enlargement With Overall Wellbeing, Lymphoma and Auto-immune Disease - Breast Implant Illness
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of breast implants in the development of so called 'breast implant illness' and autoimmune diseases in breast cancer survivors with a silicone breast implant-based reconstruction. Breast implant illness is a constellation of non-specific symptoms reported by a small group of women with silicone breast implants. Methods/Design: The Areola study is a multi-centre historic cohort study with prospective follow-up aiming to assess the risk of 'breast implant illness' and autoimmune diseases in female breast cancer survivors with and without silicone breast implants. The cohort consists of breast cancer survivors who received surgical treatment with silicone implant-based reconstruction in six major hospitals across the Netherlands in the period between 2000 and 2015. As comparison group, a frequency-matched sample of breast cancer survivors without breast implants will be selected. An additional group of women who received breast augmentation surgery in the same years will be selected to compare their characteristics and health outcomes with those of breast cancer patients with implants. All women still alive will be invited to complete a web-based questionnaire covering various health related topics. The entire cohort including deceased women will be linked to the population based computerized databases of Statistics Netherlands. These databases include a registry of diagnostic codes, a pharmacotherapeutic prescriptions registry and a cause-of-death registry in which diagnoses of autoimmune diseases will be identified. Outcomes of interest are the prevalence and incidence of BII and the prevalence and incidence of autoimmune diseases. In addition, risk factors for the development of BII and autoimmune disorders will be assessed among women with implants. Discussion: The Areola study will contribute to the availability of reliable information on the risks of breast implant illness and autoimmune diseases in Dutch breast cancer survivors with silicone breast implants. This will inform breast cancer survivors and aid future breast cancer patients and their treating physicians to make informed decisions about reconstructive strategies after mastectomy. Keywords: Silicone breast implants, Breast reconstruction, Breast cancer, Breast Implant Illness, Autoimmune disease
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Diseases | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Implant; Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Augmentation | Procedure | — | UNRESOLVED |
| Breast conserving surgery/Mastectomy/Autologous reconstruction | Procedure | — | UNRESOLVED |
| Breast reconstruction with silicone breast implant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Reconstruction with silicone breast implant
- description
- The cohort will be composed of women who underwent surgery for first invasive breast cancer or ductal carcinoma in situ (DCIS) in the years 2000 to 2015 in the collaborating centres. Eligible for inclusion in the exposed group are all women who underwent (i) mastectomy followed by immediate implant-based reconstruction, (ii) mastectomy followed by implant-based reconstruction at a later stage and (iii) latissimus dorsi flap reconstruction with a silicone breast implant
- interventionNames
- Procedure: Breast reconstruction with silicone breast implant
- label
- Breast cancer surgery without silicone breast implant
- description
- . Eligible for inclusion in the comparison group are women who underwent (i) simple mastectomy without reconstruction, (ii) autologous reconstruction and (iii) breast conserving surgery. From the latter group a frequency-matched sample will be selected based on age at breast cancer diagnosis and calendar year of diagnosis.
- interventionNames
- Procedure: Breast conserving surgery/Mastectomy/Autologous reconstruction
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * surgery for first invasive breast cancer or ductal carcinoma in situ (DCIS) in the years 2000 to 2015 in the collaborating centres Exclusion Criteria: * above the age of 60 at breast cancer diagnosis * above the age of 80 years at time of inclusion * Not residing in Netherlands
References
Publications (6)
- BACKGROUNDSpoor J, de Jong D, van Leeuwen FE. [Silicone breast implants: the importance of nuanced reporting]. Ned Tijdschr Geneeskd. 2022 Mar 21;166:D6515. Dutch. PMID 35499539
- BACKGROUNDSpoor J, de Jong D, van Leeuwen FE. Silicone Particle Migration: A Misleading Report. Aesthet Surg J. 2022 Mar 15;42(4):NP261-NP262. doi: 10.1093/asj/sjab377. No abstract available. PMID 34695179
- DERIVEDSpoor J, Mureau MAM, de Jong D, Tissier RLM, Vis M, Rakhorst H, Hommes J, de Boer M, Oldenburg HSA, Heuts EM, Vissers YLJ, Dassen AE, Evers DJ, Koppert LB, Zaal LH, van der Hulst RRWJ, Vrancken Peeters MTFD, Bleiker EMA, van Leeuwen FE. Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants. J Natl Cancer Inst. 2026 Apr 19:djag115. doi: 10.1093/jnci/djag115. Online ahead of print. PMID 42001600
- DERIVEDSpoor J, van Leeuwen FE, de Jong D, Zaal LH, Rakhorst H, de Boer M, Vissers YLJ, Bleiker EMA, Vrancken Peeters MTFD, Mureau MAM; AREOLA Collaboration. A comparison of Breast Implant Illness-related symptoms between breast cancer survivors and breast augmentation recipients. Plast Reconstr Surg. 2026 Mar 27. doi: 10.1097/PRS.0000000000013061. Online ahead of print. PMID 41891787
- DERIVEDSpoor J, Mureau MAM, Tissier RLM, Hommes J, Rakhorst H, de Boer M, Oldenburg HSA, Heuts EM, Vissers YLJ, Dassen AE, Evers DJ, Koppert LB, Zaal LH, Linn SC, de Jong D, van der Hulst RRWJ, Vrancken Peeters MTFD, Bleiker EMA, van Leeuwen FE. Breast implant illness after reconstruction with silicone breast implants. J Natl Cancer Inst. 2025 Aug 1;117(8):1717-1728. doi: 10.1093/jnci/djaf136. PMID 40605595
- DERIVEDSpoor J, Mureau MAM, Hommes J, Rakhorst H, Dassen AE, Oldenburg HSA, Vissers YLJ, Heuts EM, Koppert LB, Zaal LH, van der Hulst RRWJ, Vrancken Peeters MTFD, Bleiker EMA, van Leeuwen FE; AREOLA Collaboration. The Areola study: design and rationale of a cohort study on long-term health outcomes in women with implant-based breast reconstructions. Ann Epidemiol. 2023 Jun;82:16-25. doi: 10.1016/j.annepidem.2023.04.001. Epub 2023 Apr 6.