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

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

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

Primary: Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting — -28.1 mm

Primary: Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6 — 80.4 percentage of participants

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

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

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

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

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

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

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

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

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

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

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

Primary: Volume Restoration — 33 Participants

Primary: Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day…

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

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

Primary: Performance at 1 Month Investigator Overall VISCOL Range — 77 Participants — p=<0.0001

Primary: NLF-SRS Grade of Nasolabial Folds Change — -1.50 score on a scale

Primary: Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) — 1.8; 1.7; 1.8; 1.8 Change in MLFS score from baseline

Primary: Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial…