Clinical Performance of B-Lite® Light Weight Breast Implant

Inclusion Criteria:

• Genetic women between the ages of 18 and 60 seeking primary breast augmentation
• Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, nohistory of severe claustrophobia)
• Patient provides signed informed consent
• Patient agrees to comply with the study protocol and complete all required follow upvisits, including to undergo MRI
• Patient agrees to return the device to the Sponsor should the implant have to beexplanted
• The patient has realistic expectations of surgical results after discussion withinvestigator and is an acceptable candidate for breast augmentation.

Exclusion Criteria:

• Patients with active infection anywhere in their body
• Patient is pregnant or nursing at the time of recruitment, or has been in the 6 monthspreceding recruitment date, or not willing to use reliable means of contraceptionduring the first year after surgery
• Patient was implanted with any silicone implant other than breast implants (e.g.,silicone artificial joints or facial implants)
• Patient breast tissue is clinically incompatible for the procedure (e.g., tissuedamage resulting from radiation, insufficient tissue coverage or compromisedvascularity)
• Patient has a condition, or is under treatment for any condition, which, in theopinion of the investigator and/or consulting physician(s), may constitute anunwarranted surgical risk (e.g., unstable cardiac or pulmonary problems, possibleallergies and/or extraordinary immune response to implant)
• The patient has a history of mental instability and/or history of pharmaceuticalpsychiatric treatment
• Patient unable to understand the scope of the study and/or surgery
• The patient has any disease, including uncontrolled diabetes (e.g., HbA1c > 8%), thatis clinically known to impact wound healing ability
• Patient has existing costal injuries
• Patient has abscesses, malignant tumors (cancer or recurrent metastases), clinicallyrelevant cysts or advanced fibrotic disease or patient with BIRAD ≥3
• Are not willing to undergo further surgery for revision, if medically required
• The patient has a confirmed rheumatic disease or syndrome (e.g., SLE, Sjogren'ssyndrome, scleroderma, polymyositis or any connective tissue disorder, rheumatoidarthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, anyother inflammatory arthritis, fibromyalgia or chronic fatigue syndrome)
• The patient has a severe breast and upper trunk deformity
• The patient participated in an investigational trial within 90 days of enrollment
• The patient has undergone an invasive medical procedure within 90 days of enrollment.
• Aesthetic addiction, drug abuse, alcohol abuse