[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-implant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-implant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100588207","motiva-implants-post-approval-study-100588207",false,"NCT06938399","Motiva Implants® Post-Approval Study","Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures","Motiva PAS","Inclusion Criteria Motiva Implants®:\n\n* Female\n* Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation\n* Patient has adequate tissue available to cover implant(s)\n* Willingness to follow all study requirements\n* Signs an Informed Consent\n* Agrees to have device returned to the Sponsor, if explanted\n* Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised\n\nInclusion Criteria Control group:\n\n* Is 22 years of age or older\n* Female\n* Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift)\n* Signs an Informed Consent\n* Willingness to follow all study requirements\n\nExclusion Criteria Motiva Implants®:\n\n* Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2\n* Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing)\n* Has an active infection anywhere in their body\n* Is pregnant or nursing, or has had a full-term pregnancy or lactated within 6 months of enrollment\n* Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and\u002For significant postoperative complications\n* Has any medical condition such as obesity (BMI \\>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and\u002For significant postoperative complications\n* Has any connective tissue\u002Fautoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others\n* Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure\n* Has been implanted with any non-FDA approved breast implant\n* Has been implanted with any silicone implant other than breast implants\n* HIV positive (based on medical history)\n* Has been diagnosed with Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)\n\nExclusion Criteria Control group:\n\n* Has a history of silicone implants (anywhere in the body)\n* Plans to undergo silicone breast implant surgery during the course of the study\n* Has an active infection anywhere in their body\n* Has a history of cancer (except skin cancer)\n* Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and\u002For significant postoperative complications\n* Has any medical condition such as obesity (BMI \\>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and\u002For significant postoperative complications\n* Has any connective tissue\u002Fautoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others",true,"FEMALE","22 Years",{"count":21,"type":22},2400,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.",[28],"Breast Implant",[30,31,32,33,34],"Breast Implants","Breast Surgery","Breast Augmentation","Breast Revision","Silicone Implants","RECRUITING","2026-06-02",{"date":38,"type":39},"2026-06-03","ACTUAL",{"date":41,"type":39},"2025-05-01",{"date":43,"type":22},"2037-07-31",{"name":45,"class":46},"Motiva USA LLC","INDUSTRY",30,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100597485","implant-based-breast-reconstruction-in-post-bariatric-women---a-registry-based-national-study-100597485","NCT07059104","Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study","Implant-based Breast Surgery and Reconstruction Following Bariatric Surgery: an Observational Register-based Study on Prevalence and Risk Factors for Surgical Complications","Inclusion Criteria:\n\nInclusion in Soreg and thereafter inclusion in either BRIMP or NKBC\n\nExclusion Criteria:\n\n\\-",{"count":56,"type":22},20000,"10 Years","OBSERVATIONAL","The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously. The main questions it aims to answer are:\n\n1. What is the perceived need for breast implants after weight loss surgery, described as the proportion who have breast implants, and what characteristics, in terms of demographics and surgical details, do the operated women have?\n2. In women who have breast enlargement or breast enlargement combined with a lift, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example skin incision and choice of implant (for example texture, shape, size)?\n3. In women who have delayed breast reconstruction after breast cancer, that is have had their breast\u002Fs reconstructed in a separate operation, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation.\n4. In women who have immediate breast reconstruction after breast cancer?, that is have a breast reconstruction at the same time as the mastectomy, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation.\n5. In women who have risk reducing mastectomies, are there any differences between he women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation.\n6. Are there any identifiable risk factors for complications after breast reconstructive surgery, specific to the women who have had weight loss surgery and other women?\n\nResearchers will compare the patients to women who have the same type of reconstructive breast surgery but have not had bariatric surgery previously.\n\nThe study will use prospectively collected data from seven registers: The Scandinavian Obesity Surgery Register (SOReg), The Swedish Breast Implant Register (BRIMP), the Swedish National Quality Register for Breast Cancer (NKBC), the Swedish National Diabetes Register (NDR), Statistics Sweden (SCB), the Swedish inpatient register, and the Swedish National Prescribed Drug Register.",[61,62,63,28,64,65,66,67],"Breast Cancer","Breast Reconstruction","Bariatric Surgery","Breast Implant Infection","Surgical Complication","Mastopexy","Weight Loss",[69,70,71,72,73,74],"plastic surgery","breast augmentation","breast implant","augmentation mastopexy","complications","post-bariatric reconstruction","2025-07-10",{"date":77,"type":39},"2025-07-16",{"date":79,"type":39},"2025-01-01",{"date":81,"type":22},"2028-12-31",{"name":83,"class":84},"Vastra Gotaland Region","OTHER_GOV",1]