Clinical Trial Search

Primary: Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment — 48 Breasts

Primary: Number of Adverse Events — 46 number of AE

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

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

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

Primary: Volume Restoration — 33 Participants

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

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

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

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

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

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

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

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

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

Primary: Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple) — 20.6 centimeters

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

Primary: Knowledge as Measured by Decision Quality Instrument — 66.7; 66.7 score on a scale — p=0.801

Primary: Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved — 13 days

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

Primary: Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS — 7 Participants

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

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

Primary: Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention — 6.64; 6.67; 4.62; 6.93 score on a scale

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

Primary: Reoperation Rates — 6 participants

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

Primary: Mammogram Recall for Additional Imaging — 11.3; 12.3; 9.8 percentage of women recalled

Primary: Patient Global Impression of Change (PGIC) — 55; 25 percentage of VMI/MI respondents