[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"safety-and-performance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:safety-and-performance":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100591519","post-marketing-clinical-monitoring-of-safety-and-performance-of-breast-tissue-expander-for-breast-reconstruction-100591519",false,"NCT06981481","Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction","Post-marketing Clinical Monitoring of Safety and Performance of the Silimed® Brand Breast Tissue Expander for Breast Reconstruction","STEPS-R","Inclusion Criteria:\n\n1. provide written informed consent\n2. female sex at birth;\n3. be 18 years of age or older;\n4. have an indication for reconstruction with breast expander + breast implant(s);\n5. have a plan to receive an expander with a textured surface from the Silimed® brand + implant breast with textured surface from the Silimed® brand;\n6. ability to comply with the protocol throughout the follow-up period.\n\nExclusion Criteria:\n\n1. breast augmentation without reconstruction in at least one breast;\n2. neoplasia of any type (except breast neoplasia), not yet treated or under treatment, or requiring surgical removal at the time of implantation;\n3. pregnancy or breastfeeding at the time of implantation;\n4. smoking, uncontrolled diabetes, obesity (from grade 2) and ASA III\u002FIV;\n5. active infection not yet treated or being treated at any site at the time of implantation;\n6. report or record of adverse reactions or intolerance to silicone prior to implantation;\n7. immune diseases that affect connective tissue in activity or under treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation;\n8. record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (eg, medications that interfere with coagulation);\n9. high surgical risk or complications in the immediate post-surgery period, estimated before the implantation;\n10. evidence or report of tissue characteristics that are clinically inconsistent with a successful implantation (eg tissues with excessive fibrosis or compromised vascularization);\n11. may not have participated in another clinical study up to 6 months before placement of the expander, unless the researcher deems it to be good for the participant and not impact the study;\n12. previous treatment with radiotherapy;\n13. any other condition that, based on the opinion of the researcher or designee, may prevent the provision of informed consent, make study participation unsafe, compromise adherence to the protocol, complicate the interpretation of study outcome data or otherwise interfere with the achievement of the study objectives.",true,"FEMALE","18 Years",{"count":21,"type":22},152,"ESTIMATED","OBSERVATIONAL","The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction. The safety of the breast tissue expander will be evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physician after implantation.",[26,27],"Safety and Performance","Breast Tissue Expander",[29,30,31,32,33],"post-market","safety","performance","Breast tissue expander","breast reconstruction","RECRUITING","2026-03-12",{"date":37,"type":38},"2026-03-13","ACTUAL",{"date":40,"type":38},"2025-08-06",{"date":42,"type":22},"2027-11-30",{"name":44,"class":45},"Silimed Industria de Implantes Ltda","INDUSTRY",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"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",{"count":56,"type":22},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.",[59,60,61,26],"Breast Implant; Complications","Quality of Life","Satisfaction",[63,64,65,66,29,30,67],"Breast Implant","satisfaction","qualify of life","smooth surface","efficacy",{"date":69,"type":38},"2026-03-16",{"date":71,"type":38},"2022-10-05",{"date":73,"type":22},"2036-08",{"name":44,"class":45},1]