N/A N=18 European New Texture Implant Clinical Experience With Round Breast Implants
Breast Augmentation
Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=715 Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Breast Augmentation · Breast Reconstruction · Revision of Augmentation or Reconstruction
Primary: Local Complications — 18.9; 24.6; 28.7; 6.7 percentage by patient
Phase 4 N=19 European New Texture Implant Clinical Experience With Shaped Breast Implants
Breast Augmentation
Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale
N/A N=1,788 Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Breast Augmentation · Breast Reconstruction · Breast Revision
Primary: Local Complications — 12; 7; 8; 2 Participants
N/A N=84,329 Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Breast Reconstruction
Primary: Local Complications — 15.0; 21.6; 11.1; 10.7 Percentage by Patient
N/A N=941 Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Breast Augmentation · Breast Reconstruction · Revision of Augmentation or Reconstruction
Primary: Local Complications — 9.2; 14.5; 11.9; 26.8 Percentage of Patients
N/A N=42,491 Mentor MemoryGel Post-Approval Study
Breast Reconstruction · Breast Augmentation · Breast Revision
Primary: Kaplan Meier Estimated Cumulative Incidence of Reported Complications — 0.0; 6.7; 10.8; 11.2 Cumulative Reoperation Events
N/A N=94 Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects
Postoperative Pain
Primary: Number of Subjects With Breast Implant Rupture — 0; 0; 0; 0 participants
N/A N=100 3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
Hypomastia · Primary Breast Augmentation
Primary: Breast Q Augmentation Module — 494.5; 503.4; 420 units on a scale
N/A N=34 SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
Subjects Requiring Revision Breast Augmentation Surgery
Primary: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. — 0; 0 Implanted breasts
N/A N=104 Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
Pain
Primary: Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. — 20; 37 participants — p=<0.0001
N/A N=207 TiLoop® Bra for Breast Reconstruction
Patient and Surgical Related Risk Factors for Complications
Primary: Participants Who Received TiLOOP Mesh Reconstruction — 207 Patients with TiLOOP mesh reconstruction
Phase 4 N=150 Breastfeeding Etonogestrel Implant Study
Contraception
Primary: Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum — 54; 45; 48; 43 Participants
N/A N=201 Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Breast Implantation
Primary: Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant — 28 Percentage of Subjects
Phase 3 N=955 Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
Breast Augmentation · Breast Reconstruction · Breast Revision
Primary: 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation — 22.3; 52.7; 35.0; 59.7 percentage of subjects
Phase 3 N=1,008 Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
Breast Reconstruction · Breast Augmentation · Breast Revision
Primary: 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation — 25.5; 49.0; 43.6; 50.7 percentage of subjects
N/A N=142 A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Breast Augmentation · Breast Reconstruction
Primary: Reoperation Rates — 6 participants
Phase 3 N=95 Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Postpartum Contraception · Family Planning
Primary: Time to Lactogenesis Stage II [Questionnaire] — 65; 67.5 hours
N/A N=155 Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Contraception · Breastfeeding · Postpartum Contraception
Primary: Number of Participants Breastfeeding at 6 Months — 6; 4; 6 Participants
N/A N=62 The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Breast Reconstruction
Primary: Postoperative Duration of Drain Placements — 9.2; 10.8 days — p=0.15
N/A N=162 Asian Outcomes of Primary Breast Augmentation
Breast Augmentation
Primary: Post Surgical Complications and Reoperation Rate During Breast Augmentation — 1.85; 1.85 percentage of participants
Phase 2 N=66 Study to Evaluate EB-001 in Reducing Musculoskeletal Pain
Musculoskeletal Pain
Primary: Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h) — 289.18; 341.78; 401.75; 290.55 units on a Scale*hours
Phase 4 N=19 Study of EXPAREL in Patients Undergoing Breast Augmentation
Mammoplasty · Postoperative Pain
Primary: Duration of Analgesia — 0.07; 0.3; 4.28; 4.82 hours
Phase 2 N=100 Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
Breast Cancer
Primary: Incidence of Implant Failure — 8; 17; 34; 41 Number of Participants with Implant Fail
N/A N=158 Patient Controlled Tissue Expansion for Breast Reconstruction
Breast Cancer
Primary: Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event — 149; 82 Breasts
N/A N=90 Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
Breast Cancer
Primary: Number of Participants With Complications After Tissue Expander Replacement With Implant — 10; 10 participants
N/A N=396 Implementing BREASTChoice Into Practice
Breast Reconstruction · Breast Cancer
Primary: Knowledge as Measured by Decision Quality Instrument — 66.7; 66.7 score on a scale — p=0.801
N/A N=40 Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
Breast-Conserving Surgery
Primary: Volume Restoration — 33 Participants
N/A N=24 Macrolane for Enhancement of the Shape and Fullness of the Female Breast
Breast Enhancement
Primary: Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment — 48 Breasts
N/A N=50 Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Breast Cancer · Breast Reconstruction · Nipple Reconstruction
Primary: Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) — 37.3 percentage of projection vs baseline