Clinical Trial Search

Primary: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. — 0; 0 Implanted breasts

Primary: Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant — 28 Percentage of Subjects

Primary: Number of Subjects With Breast Implant Rupture — 0; 0; 0; 0 participants

Primary: Post Surgical Complications and Reoperation Rate During Breast Augmentation — 1.85; 1.85 percentage of participants

Primary: Local Complications — 15.0; 21.6; 11.1; 10.7 Percentage by Patient

Primary: Local Complications — 18.9; 24.6; 28.7; 6.7 percentage by patient

Primary: Local Complications — 9.2; 14.5; 11.9; 26.8 Percentage of Patients

Primary: Reoperation Rates — 6 participants

Primary: Kaplan Meier Estimated Cumulative Incidence of Reported Complications — 0.0; 6.7; 10.8; 11.2 Cumulative Reoperation Events

Primary: Local Complications — 12; 7; 8; 2 Participants

Primary: Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M — 1.09; 1.22; 1.3; 1.87 score on a scale

Primary: Quality of Recovery Score — 165; 169 score on a scale

Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale

Primary: Number of Participants With Complications After Tissue Expander Replacement With Implant — 10; 10 participants

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

Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale

Primary: Breast Projection — 19.8205 percentage loss of projection

Primary: Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) — 37.3 percentage of projection vs baseline

Primary: Nipple to Fold Measurement on Stretch — 2.3; 2.5; 1.4; 1.4 centimeters

Primary: Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant — 8; 12 Participants

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

Primary: Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event — 149; 82 Breasts

Primary: Postoperative Duration of Drain Placements — 9.2; 10.8 days — p=0.15

Primary: Number of Participants With Areolar Dilation of up to 6mm at 12 Months — 13 Participants

Primary: Breast Q Augmentation Module — 494.5; 503.4; 420 units on a scale

Primary: Success Rate — 65.4 percentage of participants

Primary: Number of Adverse Events — 46 number of AE

Primary: Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement…

Primary: Volume Restoration — 33 Participants

Primary: Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180. — 11 Participants