[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-implant-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-implant-complications":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,74,99,126,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100495834","molecular-mechanisms-associated-with-breast-implant-complications-100495834",false,"NCT05736354","Molecular Mechanisms Associated With Breast Implant Complications","MMABIC","Inclusion Criteria for breast implant subjects:\n\n* Age greater than or equal to 18 years\n* Undergoing removal of breast implant\n* Willing and able to comply with protocol instructions\n\nInclusion Criteria for subjects undergoing breast surgeries (other than implant removal)\n\n* Age greater than or equal to 18 years\n* Undergoing breast surgery\n* Willing and able to comply with protocol instructions\n\nExclusion Criteria:\n\n* Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent)\n* Pregnant females\n* Immunodeficiency (HIV\u002FAIDS, SCID)\n* Currently on immunosuppressive medications\n* Prisoners","FEMALE","18 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.",[24,25],"Breast Implant; Complications","Infection or Inflammation","RECRUITING","2026-06-09",{"date":29,"type":30},"2026-06-11","ACTUAL",{"date":32,"type":30},"2021-01-03",{"date":34,"type":20},"2028-06-30",{"name":36,"class":37},"Indiana University","OTHER",3,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100465830","an-analysis-of-adverse-events-and-satisfaction-outcomes-of-women-who-underwent-primary-and-secondary-breast-augmentation-using-silimed-breast-implants-with-smooth-surface-100465830","NCT05345821","An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface","Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)","STEPS S","Inclusion Criteria:\n\n* Provide written informed consent\n* Female at birth\n* Be 18 years of age or older\n* Have a complaint of hypomastia\n* Have an indication for breast augmentation with silicone implants\n* Ability to comply with the protocol throughout the follow-up period.\n\nExclusion Criteria:\n\n* Replacement of breast implants due to a complication\n* Breast reconstruction in at least one breast\n* Informed pregnancy or breastfeeding at the time of inclusion\n* Sequelae of mastopexy\n* Ptosis requiring mastopexy\n* Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms\n* Advanced fibrocystic disease at the time of implantation\n* Neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - Active infection not yet treated or undergoing treatment at any site at the time of implantation\n* Report or record of adverse reactions or intolerance to silicone prior to implantation\n* Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation\n* Signs of inflammation of the breast or implant site at the time of implantation\n* Increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use\n* Having participated in another clinical trial within 6 months prior to implant placement\n* Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives",true,{"count":49,"type":20},384,"The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk\u002Fadverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.",[24,52,53,54],"Quality of Life","Satisfaction","Safety and Performance",[56,57,58,59,60,61,62],"Breast Implant","satisfaction","qualify of life","smooth surface","post-market","safety","efficacy","2026-03-12",{"date":65,"type":30},"2026-03-16",{"date":67,"type":30},"2022-10-05",{"date":69,"type":20},"2036-08",{"name":71,"class":72},"Silimed Industria de Implantes Ltda","INDUSTRY",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":73},"100313106","an-analysis-of-adverse-events-and-satisfaction-outcomes-of-women-who-underwent-primary-and-secondary-breast-augmentation-using-silimed-breast-implants-100313106","NCT03356132","An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants","Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface","STEPS A","Inclusion Criteria:\n\n* provide written informed consent.\n* female at birth\n* be 18 years of age or older\n* have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)\n* having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam\n* ability to comply with the protocol throughout the follow-up period.\n\nExclusion Criteria:\n\n* mammary reconstruction in at least one breast or augmentation after previous reconstruction,\n* pregnancy informed or breastfeeding at the inclusion moment,\n* advanced fibrocystic disease at the time of implantation,\n* neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,\n* reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,\n* immune diseases affecting active connective tissue or (eg, lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation,\n* signs of inflammation of the breast or implant site at the time of implantation,\n* Increased risk of immediate postoperative complications due to use of illicit drugs or medications,\n* Increased risk of immediate post-surgical complications caused by illicit drug use or medication use,\n* have participated in another clinical study up to 6 months prior to the placement of the implant,\n* any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.",{"count":83,"type":20},632,"The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk \u002F adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.",[24,52,53],[87,88,57,89,90,91,92],"breast implant","complication","quality of life","augmentation","textured","polyurethane",{"date":65,"type":30},{"date":95,"type":30},"2018-07-31",{"date":97,"type":20},"2036-12",{"name":71,"class":72},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":73},"100508359","seroma-of-the-mammary-gland-100508359","NCT05899387","Seroma of the Mammary Gland","Prospective, International, Multicenter Minimal Interventional Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Mastectomy with or Without Implant-based Breast Reconstruction","SerMa","Inclusion criteria study group and control group 1:\n\n* Written informed consent\n* Age ≥ 18 years\n* all stages of DCIS or primary breast cancer (T1-T4, N0 or N+, M0) including all histopathological subtypes (ER\u002FPR positive, ER positive\u002FPR negative, Her-2\u002Fneu positive and triple negative)\n* Surgical procedure planned including ablatio or subcutaneous mastectomy with implant or expander insertion\n\nInclusion criteria control group 2 and 3:\n\n* Written informed consent\n* Age ≥ 18 years\n* Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy\n\nExclusion criteria:\n\n* Age \\\u003C18 years\n* Male sex\n* Breast cancer patients planned for breast conserving therapy\n* Recurrent breast cancer disease\n* History of breast surgery\n* Diagnosis of LCIS only\n* Pregnancy at time of diagnosis\n* Patients with a known immunodeficiency",{"count":108,"type":20},2000,"INTERVENTIONAL",[111],"NA","The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.",[114,115,116,24],"Seroma","Breast Cancer","Mastectomy","2025-02-25",{"date":119,"type":30},"2025-02-28",{"date":121,"type":30},"2024-04-01",{"date":123,"type":20},"2027-07-01",{"name":125,"class":37},"University Hospital Augsburg",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":109,"phases":135,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100341848","delayed-immediate-versus-delayed-breast-reconstruction-in-breast-cancer-patients-with-mastectomy-and-radiation-therapy-100341848","NCT03730922","Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy","The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial","Inclusion Criteria:\n\n* Woman \\>18 years who are offered a mastectomy for invasive breast can-cer pT1-3, pN0-N3, M0 and wish reconstruction. The patient can be inclu-ded no matter the status of estrogen receptor, progesterone receptor, malignancy grade, and HER2 status.\n* The patient is a candidate for loco-regional radiation therapy according to national or institutional guidelines.\n* Highly selected patients with inflammatory breast cancer, namely those with complete or near complete response to neoadjuvant systemic thera-py judged by imaging and clinical examination before surgery. Any skin edema and clinical signs of skin involvement must have disappeared during systemic therapy. It is highly recommended that the decision to offer an inflammatory breast cancer patient inclusion in the DBCG RT Recon trial is made during a multidisciplinary team conference.\n* Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either as new standard or as part of a trial during the course of the trial is accepted.\n* Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted.\n* Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist esti-mates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinoma of the skin.\n* Life expectancy minimum 10 years.\n\nExclusion Criteria:\n\n* Pregnant or lactating.\n* Previous breast cancer or Ductal carcinoma in Situ (DCIS).\n* Bilateral breast cancer.\n* Previous radiation therapy to the chest region.\n* Previous non-breast malignancy (not including carcinoma in situ of the cervix or colon, melanoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin) within 5 years.\n* Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up.\n* Not being able to participate due to language or other personal issues.\n* Life expectancy less than 10 years.",{"count":134,"type":20},590,[111],"In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.",[138,139,24],"Breast Neoplasm Female","Complication of Radiation Therapy",[141,142,143],"Breast cancer","Reconstruction","Post mastectomy radiotherapy","2025-02-04",{"date":146,"type":30},"2025-02-06",{"date":148,"type":30},"2020-01-01",{"date":150,"type":20},"2035-11",{"name":152,"class":37},"Danish Breast Cancer Cooperative Group",8,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":73},"100515128","prospective-observational-clinical-follow-up-of-euromi-biosciences-pre-filled-silicone-gel-breast-implants-100515128","NCT05987475","Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants","ELEGANT","Inclusion Criteria:\n\n* Female;\n* 18 years old and above, and under 60 years old;\n* has approved and signed the informed consent form;\n* eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;\n* Willing to be followed up for a period of 10 years.\n\nExclusion Criteria:\n\n* Informed pregnancy or breastfeeding at the time of inclusion\n* Known hypersensitivity and \u002F or allergy to silicone;\n* Not understanding or not accepting the risks of further surgeries during follow-up;\n* Body mass index \\> 40 kg\u002Fm²;\n* Diabetes\n* HbA1c levels \\> 7,5%;\n* History of repeated failure with the implantation of similar implants;\n* Tissue or fat insufficiency;\n* Progressive breast cancer large tumours (\\>5 cm), late cancer stage and deep tumours;\n* Grossly positive axillary involvement \u002F or chest wall involvement;\n* High risk of cancer recurrence;\n* Tissue damage in the implant area due to irradiation of the thoracic wall;\n* Pre-existing pathology in the implant area;\n* General infection or infection in the implant area;\n* Medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) Which may, according to the judgement of the surgeon, entail excessive risk and\u002For post-surgical complications;\n* History or presence of an autoimmune disease;\n* Immunocompromised;\n* History or current treatment using radiation with lower-pole scarring and thin, poorly vascularized skin\u002Ftissue \u002F microwave diathermy \u002F or steroids;\n* Medical condition likely to interfere with her capacity to understand the follow-up requirements, to participate in the follow-up or to give her informed consent;\n* Concomitantly part of another interventional clinical trial.\n* Under supervision or legal guardianship\n* Deprived of liberty by a judicial or administrative decision\n* Not affiliated to health insurance system or is a beneficiary of such coverage","60 Years",{"count":163,"type":20},177,"Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT",[166,24],"Breast Implant Rupture","2023-11-28",{"date":169,"type":30},"2023-11-29",{"date":171,"type":30},"2023-10-18",{"date":173,"type":20},"2034-09",{"name":175,"class":72},"Euromi Biosciences"]