| Eligibility |
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, no
history of severe claustrophobia)
- Patient provides signed informed consent
- Patient agrees to comply with the study protocol and complete all required follow up
visits, including to undergo MRI
- Patient agrees to return the device to the Sponsor should the implant have to be
explanted
- The patient has realistic expectations of surgical results after discussion with
investigator 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 months
preceding recruitment date, or not willing to use reliable means of contraception
during 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., tissue
damage resulting from radiation, insufficient tissue coverage or compromised
vascularity)
- Patient has a condition, or is under treatment for any condition, which, in the
opinion of the investigator and/or consulting physician(s), may constitute an
unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems, possible
allergies and/or extraordinary immune response to implant)
- The patient has a history of mental instability and/or history of pharmaceutical
psychiatric 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%), that
is clinically known to impact wound healing ability
- Patient has existing costal injuries
- Patient has abscesses, malignant tumors (cancer or recurrent metastases), clinically
relevant 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's
syndrome, scleroderma, polymyositis or any connective tissue disorder, rheumatoid
arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any
other 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
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