[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Silimed Industria de Implantes Ltda\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,74,102],{"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":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100629880","clinical-evaluation-of-neorepair-acellular-matrix-in-immediate-implant-based-breast-reconstruction-100629880",false,"NCT07480421","Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction","Neo-Matrix","Inclusion Criteria:\n\n* Provide written informed consent;\n* Female sex at birth;\n* Be 18 years of age or older;\n* Have an indication for reconstructive surgeries requiring reinforcement, repair, regeneration, and reconstruction of tissues in the breast region;\n* Have well-vascularized tissue, according to the physician's clinical assessment, for better cell infiltration, revascularization, and incorporation;\n* Have an indication for breast reconstruction with Silimed acellular matrix intended for subcutaneous or submuscular implantation;\n* Have an indication for breast reconstruction with Silimed breast implants;\n* Have the ability to comply with the protocol for the entire follow-up period.\n\nExclusion Criteria:\n\n* Breast augmentation without reconstruction in at least one breast;\n* Neoplasia of any type that is not yet treated, or is under treatment, or requires surgical removal at the time of implantation\\*;\n* Pregnancy or breastfeeding at the time of implantation;\n* Smoking, uncontrolled diabetes, obesity (grade 2 or higher) or ASA (American Society of Anesthesiology) pre-surgical classification III\u002FIV (ANNEX I);\n* Active infection that is not yet treated or is under treatment at any site at the time of implantation;\n* Active inflammation that is not yet treated or is under treatment at the implantation site;\n* Report or record of adverse reactions or intolerance or known history of hypersensitivity to collagen or bovine products at the time of implantation;\n* Report or record of adverse reactions or intolerance to silicone;\n* Any immune disorder or disease at the time of implantation;\n* Depressed immune system at the time of implantation;\n* Report or record of atopy at the time of implantation;\n* Record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (e.g., medications that interfere with coagulation);\n* High surgical risk or risk of complications in the immediate post-surgical period estimated before implantation;\n* Evidence or report of tissue characteristics that are clinically incompatible with successful implantation (e.g., tissues with excessive fibrosis or compromised vascularization);\n* Having participated in another clinical study up to 6 months before matrix placement, unless the investigator judges it to be beneficial for the participant and not impacting the study;\n* Any other condition that, based on the opinion of the investigator or designated individual, may prevent the provision of informed consent, make participation in the study unsafe, compromise adherence to the protocol, complicate the interpretation of outcome data, or otherwise interfere with the achievement of the study objectives.\n\n  * Breast neoplasia where part of the treatment involves an initial surgical approach does not constitute an exclusion criterion, provided that this treatment decision is reported and that the patient is followed by an oncologist.","FEMALE","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction. The safety of the acellular matriz will be evaluated by estimating known and unexpected adverse event rates assessed by clinical evaluations and patient reports of adverse events after implantation in addition to monitoring integration by Magnetic Resonance Imaging (MRI). The performance of Silimed® brand acellular matriz will be evaluated by clinical effectiveness of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Secondary performance outcomes include: assessment of body image-related quality of life, self-esteem assessment, aesthetic and functional breast assessment, and participant satisfaction level.",[26],"Breast Reconstruction",[28,29,30,31,32],"post-market","safety","performance","breast reconstruction","acellular matrix","NOT_YET_RECRUITING","2026-03-18",{"date":36,"type":37},"2026-03-20","ACTUAL",{"date":39,"type":20},"2026-07-01",{"date":41,"type":20},"2029-06-30",{"name":43,"class":44},"Silimed Industria de Implantes Ltda","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100591519","post-marketing-clinical-monitoring-of-safety-and-performance-of-breast-tissue-expander-for-breast-reconstruction-100591519","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,{"count":56,"type":20},152,"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.",[60,61],"Safety and Performance","Breast Tissue Expander",[28,29,30,63,31],"Breast tissue expander","RECRUITING","2026-03-12",{"date":67,"type":37},"2026-03-13",{"date":69,"type":37},"2025-08-06",{"date":71,"type":20},"2027-11-30",{"name":43,"class":44},3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":54,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":45},"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":83,"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.",[86,87,88,60],"Breast Implant; Complications","Quality of Life","Satisfaction",[90,91,92,93,28,29,94],"Breast Implant","satisfaction","qualify of life","smooth surface","efficacy",{"date":96,"type":37},"2026-03-16",{"date":98,"type":37},"2022-10-05",{"date":100,"type":20},"2036-08",{"name":43,"class":44},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":54,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":45},"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":111,"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.",[86,87,88],[115,116,91,117,118,119,120],"breast implant","complication","quality of life","augmentation","textured","polyurethane",{"date":96,"type":37},{"date":123,"type":37},"2018-07-31",{"date":125,"type":20},"2036-12",{"name":43,"class":44},""]