{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T18:47:27Z","timestamp":1785523647137,"version":"3.56.0"},"reference-count":42,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2024,7,27]],"date-time":"2024-07-27T00:00:00Z","timestamp":1722038400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Institute of Public Health and the Environment on behalf of the Ministry of Health, Welfare, and Sport"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: This study aims to describe a prospective clinical cohort of patients with silicone breast implants and suspected Breast Implant Illness (BII). Methods: Women were included in a specialized silicone outpatient clinic at Amsterdam UMC, the Netherlands. Baseline characteristics were collected including medical history, implant details, and symptoms. Experienced physicians categorized BII suspicion as high, moderate, or low, based on symptoms and after exclusion of other probable causes. Additionally, participants completed questionnaires assessing symptoms and daily life impact at baseline, 6 months, 1, 2, and 5 years. For this initial analysis, the results from the first three years of inclusions were collected. Results: Data from 353 women were collected from December 2020\u2013December 2023. At baseline, the most reported symptoms were fatigue, arthralgia, myalgia, and morning stiffness, accompanied by local symptoms in 83.3% of patients. At the clinic, 112 women were categorized as having high suspicion of BII, 147 women as moderate, and 94 women as low. At follow-up, 182 women (51.6%) opted for explantation. Following explantation, women with a high or moderate suspicion of BII experienced more significant symptom improvement, accompanied by a decrease in anxiety and a greater sense of control over their illness, compared to women with a low suspicion of BII. Conclusions: Our study highlights a distinct interplay of systemic and local symptoms among women with suspicion of BII. Women with a high or moderate BII suspicion benefit significantly more from explantation than women with low suspicion. Experienced physicians are pivotal in effectively assessing and guiding this patient group, highlighting the need for tailored clinical approaches.<\/jats:p>","DOI":"10.3390\/jcm13154394","type":"journal-article","created":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T09:50:05Z","timestamp":1722246605000},"page":"4394","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A Prospective Observational Clinical Cohort of Women with Suspected Breast Implant Illness"],"prefix":"10.3390","volume":"13","author":[{"given":"Karlinde A.","family":"Spit","sequence":"first","affiliation":[{"name":"Section General Internal Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centres, Location VUmc, 1081 HZ Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-5016-4712","authenticated-orcid":false,"given":"Siham","family":"Azahaf","sequence":"additional","affiliation":[{"name":"Section General Internal Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centres, Location VUmc, 1081 HZ Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christel J. M.","family":"de Blok","sequence":"additional","affiliation":[{"name":"Section General Internal Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centres, Location VUmc, 1081 HZ Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prabath W. B.","family":"Nanayakkara","sequence":"additional","affiliation":[{"name":"Section General Internal Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centres, Location VUmc, 1081 HZ Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,7,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2638","DOI":"10.1001\/archinte.1993.00410230048007","article-title":"Silicone breast implants. History, safety, and potential complications","volume":"153","author":"Bridges","year":"1993","journal-title":"Arch. Intern. Med."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1007\/BF02788777","article-title":"The immunopathology of siliconosis. History, clinical presentation, and relation to silicosis and the chemistry of silicon and silicone","volume":"18","author":"Shanklin","year":"1998","journal-title":"Immunol. Res."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1016\/j.cps.2008.07.007","article-title":"History of breast implants and the food and drug administration","volume":"36","author":"Spear","year":"2009","journal-title":"Clin. Plast. Surg."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1080\/1744666X.2022.2010546","article-title":"Breast implant illness: Scientific evidence of its existence","volume":"18","author":"Mohazab","year":"2022","journal-title":"Expert. Rev. Clin. Immunol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1097\/SLA.0000000000002990","article-title":"US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients","volume":"269","author":"Coroneos","year":"2019","journal-title":"Ann. Surg."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1846","DOI":"10.1093\/ije\/dyy217","article-title":"Silicone breast implants and the risk of autoimmune\/rheumatic disorders: A real-world analysis","volume":"47","author":"Watad","year":"2018","journal-title":"Int. J. Epidemiol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"616","DOI":"10.1001\/jama.1996.03530320040032","article-title":"Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study","volume":"275","author":"Hennekens","year":"1996","journal-title":"JAMA"},{"key":"ref_8","first-page":"534","article-title":"Women with silicone breast implants and unexplained systemic symptoms: A descriptive cohort study","volume":"71","author":"Maijers","year":"2013","journal-title":"Neth. J. Med."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"e057159","DOI":"10.1136\/bmjopen-2021-057159","article-title":"Patient-reported systemic symptoms in women with silicone breast implants: A descriptive cohort study","volume":"12","author":"Spit","year":"2022","journal-title":"BMJ Open"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"S82","DOI":"10.1097\/SAP.0000000000002446","article-title":"Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study","volume":"85","author":"Wee","year":"2020","journal-title":"Ann. Plast. Surg."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1007\/s12026-016-8813-y","article-title":"Is explantation of silicone breast implants useful in patients with complaints?","volume":"65","author":"Colaris","year":"2017","journal-title":"Immunol. Res."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"327e","DOI":"10.1097\/PRS.0b013e31823aeacf","article-title":"T regulatory cells and TH17 cells in peri-silicone implant capsular fibrosis","volume":"129","author":"Wolfram","year":"2012","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1423","DOI":"10.1007\/s00266-020-01663-9","article-title":"Breast Prosthesis Syndrome: Pathophysiology and Management Algorithm","volume":"44","year":"2020","journal-title":"Aesthetic Plast. Surg."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"801","DOI":"10.1001\/archsurg.138.7.801","article-title":"Incidence of silicone breast implant rupture","volume":"138","author":"Friis","year":"2003","journal-title":"Arch. Surg."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"163","DOI":"10.21037\/gs.2016.09.12","article-title":"Silicone breast implant rupture: A review","volume":"6","author":"Hillard","year":"2017","journal-title":"Gland. Surg."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1401","DOI":"10.1097\/01.prs.0000279374.99503.89","article-title":"Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity","volume":"120","author":"Collis","year":"2007","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"2268","DOI":"10.1007\/s00266-023-03535-4","article-title":"The Incidence and Outcomes of Breast Implants Among 1696 Women over more than 50 Years","volume":"47","author":"Peterson","year":"2023","journal-title":"Aesthetic Plast. Surg."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1148\/rg.2017160086","article-title":"Multimodality Imaging-based Evaluation of Single-Lumen Silicone Breast Implants for Rupture","volume":"37","author":"Seiler","year":"2017","journal-title":"Radiographics"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"e221290","DOI":"10.7326\/aimcc.2022.1290","article-title":"A Rare Observation of Silicone-Associated Scleroderma-Like Syndrome: How to Recognize and Diagnose Similar Cases","volume":"2","author":"Spit","year":"2023","journal-title":"Ann. Intern. Med. Clin. Cases"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"e2125381","DOI":"10.1001\/jamanetworkopen.2021.25381","article-title":"Assessment of Silicone Particle Migration Among Women Undergoing Removal or Revision of Silicone Breast Implants in the Netherlands","volume":"4","author":"Dijkman","year":"2021","journal-title":"JAMA Netw. Open"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"370","DOI":"10.1093\/asj\/sjab197","article-title":"Understanding Breast Implant Illness: Etiology is the Key","volume":"42","author":"Yang","year":"2022","journal-title":"Aesthetic Surg. J."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"765e","DOI":"10.1097\/PRS.0000000000003785","article-title":"Breast Implant Illness: Symptoms, Patient Concerns, and the Power of Social Media","volume":"140","author":"Tang","year":"2017","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Lieffering, A.S., Ramerman, L., Verheij, R.A., Rakhorst, H.A., Mureau, M.A.M., van der Hulst, R., and Hommes, J.E. (2024). Medical Specialist Care Utilization Prior to the Explantation of Cosmetic Silicone Breast Implants: A Nationwide Retrospective Data Linkage Study. Aesthetic Plast. Surg.","DOI":"10.1007\/s00266-024-04047-5"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1016\/j.jpsychores.2005.10.020","article-title":"The Brief Illness Perception Questionnaire","volume":"60","author":"Broadbent","year":"2006","journal-title":"J. Psychosom. Res."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1661","DOI":"10.1007\/s10067-015-2931-0","article-title":"Autoimmune\/inflammatory syndrome induced by adjuvant (ASIA) evolution after silicone implants. Who is at risk?","volume":"34","author":"Goren","year":"2015","journal-title":"Clin. Rheumatol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"440","DOI":"10.1016\/j.autrev.2017.11.037","article-title":"The value of Autoimmune Syndrome Induced by Adjuvant (ASIA)\u2014Shedding light on orphan diseases in autoimmunity","volume":"17","author":"Segal","year":"2018","journal-title":"Autoimmun. Rev."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"302","DOI":"10.1080\/03630242.2022.2068734","article-title":"Silicone breast implants and connective tissue diseases: How does current evidence add to the no-association consensus? Systematic review and meta-analysis","volume":"62","year":"2022","journal-title":"Women Health"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1097\/00006534-200101000-00034","article-title":"Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery","volume":"107","author":"Fryzek","year":"2001","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1097\/01.PRS.0000041442.53735.F8","article-title":"Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants","volume":"111","author":"Fryzek","year":"2003","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1097\/01.sap.0000101930.75241.55","article-title":"Self-reported musculoskeletal symptoms among Danish women with cosmetic breast implants","volume":"52","author":"Fryzek","year":"2004","journal-title":"Ann. Plast. Surg."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"397","DOI":"10.1093\/asj\/sjab375","article-title":"A Practical Guide to Managing Patients With Systemic Symptoms and Breast Implants","volume":"42","author":"McGuire","year":"2022","journal-title":"Aesthetic Surg. J."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"g3253","DOI":"10.1136\/bmj.g3253","article-title":"Use of placebo controls in the evaluation of surgery: Systematic review","volume":"348","author":"Wartolowska","year":"2014","journal-title":"BMJ"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"e4373","DOI":"10.1097\/GOX.0000000000004373","article-title":"Measuring Platinum Levels in Hair in Women with Silicone Breast Implants and Systemic Symptoms","volume":"10","author":"Spit","year":"2022","journal-title":"Plast Reconstr. Surg. Glob. Open"},{"key":"ref_34","unstructured":"FDA (2024, June 10). Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants\u2014FDA Safety Communication, Available online: https:\/\/www.fda.gov\/medical-devices\/safety-communications\/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"563","DOI":"10.1007\/s00238-018-1427-y","article-title":"Poly Implant Proth\u00e8se silicone breast implants: Implant dynamics and capsular contracture","volume":"41","author":"Bachour","year":"2018","journal-title":"Eur. J. Plast Surg."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"250","DOI":"10.1007\/s00266-017-0776-4","article-title":"Mechanical Performance of Poly Implant Prosthesis (PIP) Breast Implants: A Comparative Study","volume":"41","author":"Martins","year":"2017","journal-title":"Aesthetic Plast Surg."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1097\/PRS.0000000000003654","article-title":"Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk","volume":"140","author":"Beath","year":"2017","journal-title":"Plast Reconstr. Surg."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"335","DOI":"10.1001\/jamaoncol.2017.4510","article-title":"Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast","volume":"4","author":"Hauptmann","year":"2018","journal-title":"JAMA Oncol."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"841","DOI":"10.1016\/j.bjps.2019.11.064","article-title":"Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants","volume":"73","author":"Cordeiro","year":"2020","journal-title":"J. Plast Reconstr. Aesthetic Surg."},{"key":"ref_40","unstructured":"FDA (2023, March 08). May FDA Provides Update on Breast Implant Associated-Squamous Cell Carcinoma (BIA-SCC). Available online: https:\/\/associationofbreastsurgery.org.uk\/media\/584370\/may-fda-provides-update-on-breast-implant-associated.pdf."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/j.rxeng.2020.10.011","article-title":"Is breast ultrasound a good alternative to magnetic resonance imaging for evaluating implant integrity?","volume":"64","author":"Secco","year":"2022","journal-title":"Radiologia (Engl. Ed.)"},{"key":"ref_42","doi-asserted-by":"crossref","unstructured":"Dymek, P., B\u0142aszkowski, T., Sienkiewicz, S., Kie\u0142bowski, K., Mruk, H., Lewandowska, M., Kipczak, A., Szyld, M., and K\u0142adny, J. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in axillary lymph nodes\u2014A case report and review of 29 other cases from world literature. Nowotwory J. Oncol., 2020. 70, 244\u2013249.","DOI":"10.5603\/NJO.a2020.0044"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/15\/4394\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T15:24:49Z","timestamp":1760109889000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/15\/4394"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,27]]},"references-count":42,"journal-issue":{"issue":"15","published-online":{"date-parts":[[2024,8]]}},"alternative-id":["jcm13154394"],"URL":"https:\/\/doi.org\/10.3390\/jcm13154394","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,27]]}}}