30 closest matches · ranked by relevance
Breast Augmentation · Breast Reconstruction
Primary: Reoperation Rates — 6 participants
Hypomastia · Primary Breast Augmentation
Primary: Breast Q Augmentation Module — 494.5; 503.4; 420 units on a scale
Mastopexy
Primary: Number of Participants With Areolar Dilation of up to 6mm at 12 Months — 13 Participants
Surgical Incision
Primary: Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M — 1.09; 1.22; 1.3; 1.87 score on a scale
Macromastia
Primary: Postoperative Pain — 4.47; 4.66 units on a scale — p=0.4697
Labia Enlarged · Labium; Hypertrophy
Primary: Evaluation of Change Between Baseline and Follow-up Images as Determined by a Masked, Qualitative Assessment of Photographs at 90-days and 180-days Post-treatment…
Subjects Requiring Revision Breast Augmentation Surgery
Primary: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. — 0; 0 Implanted breasts
Breast Enhancement
Primary: Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment — 48 Breasts
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
Breast Cancer Female
Primary: Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention — 6.64; 6.67; 4.62; 6.93 score on a scale
Breast Cancer
Primary: Number of Participants With Complications After Tissue Expander Replacement With Implant — 10; 10 participants
Recurrent Ptosis of the Breast
Primary: Nipple to Fold Measurement on Stretch — 2.3; 2.5; 1.4; 1.4 centimeters
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
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
Breast Cancer · LCIS · DCIS
Primary: Quality of Life as Measured by the Breast Q — 61.9; 57.6; 74.2; 64.2 score on a scale
Breast Cancer
Primary: Rate of Breast Related Adverse Events — 12 Reconstructed breasts affected
Women Who Have Had Breast Enhancement With Macrolane VRF
Primary: Number of Adverse Events — 46 number of AE
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
Breast-Conserving Surgery
Primary: Volume Restoration — 33 Participants
Breast Ptosis
Primary: Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180. — 11 Participants
Breast Reconstruction
Primary: Local Complications — 15.0; 21.6; 11.1; 10.7 Percentage by Patient
Breast Augmentation · Breast Reconstruction · Revision of Augmentation or Reconstruction
Primary: Local Complications — 9.2; 14.5; 11.9; 26.8 Percentage of Patients
Breast Lift
Primary: Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple) — 20.6 centimeters
Breast Cancer
Primary: Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix — 0; 82.8; 17.2; 0 percentage of breasts
Breast Augmentation · Breast Reconstruction · Breast Revision
Primary: Local Complications — 12; 7; 8; 2 Participants
Breast Implantation
Primary: Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant — 28 Percentage of Subjects
Breast Augmentation
Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale
Breast Cancer
Primary: Quality of Recovery Score — 165; 169 score on a scale
Efficiency of Surgical Incision Closure · Post-operative Scar
Primary: Operative Time to Closure of Final Skin Layer — 58.38; 444.76 seconds
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