23 closest matches · ranked by relevance
Breast Enhancement
Primary: Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment — 48 Breasts
Women Who Have Had Breast Enhancement With Macrolane VRF
Primary: Number of Adverse Events — 46 number of AE
Cellulite of the Buttocks
Primary: Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS — 7 Participants
Breast Augmentation
Primary: To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation — 4 participants with remaining product
Subjects Requiring Revision Breast Augmentation Surgery
Primary: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. — 0; 0 Implanted breasts
Mastopexy
Primary: Number of Participants With Areolar Dilation of up to 6mm at 12 Months — 13 Participants
Breast Cancer
Primary: Rate of Breast Related Adverse Events — 12 Reconstructed breasts affected
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 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 Augmentation · Breast Reconstruction
Primary: Reoperation Rates — 6 participants
Breast-Conserving Surgery
Primary: Volume Restoration — 33 Participants
Recurrent Ptosis of the Breast
Primary: Nipple to Fold Measurement on Stretch — 2.3; 2.5; 1.4; 1.4 centimeters
Breast Cancer
Primary: Number of Participants With Complications After Tissue Expander Replacement With Implant — 10; 10 participants
Breast Cancer
Primary: BreastQ Quality of Life and Satisfaction Questionnaire — 65.32; 67.07 score on a scale — p=0.05
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
Breast Cancer · Ductal Carcinoma in Situ
Primary: Ipsilateral Recurrence Rate — 0 participants
Postoperative Pain
Primary: Number of Subjects With Breast Implant Rupture — 0; 0; 0; 0 participants
Breast Cancer
Primary: Size Error in Millimeters — 0 milimeters
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
Atrophy
Primary: Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting — -28.1 mm
Breast Cancer
Primary: Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix — 0; 82.8; 17.2; 0 percentage of breasts
Volume Restoration and Shaping of the Buttocks
Primary: Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6 — 80.4 percentage of participants
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