Clinical Performance of B-Lite® Light Weight Breast Implant
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
This is a post-marketing study for B-Lite® implants that carry the EC certificate for marketing in Europe and AMAR certificate for marketing in Israel. To date, hundreds of implants have already been implanted in women. The study is open for primary augmentation patients only. All surgeries will be performed as per standard practice at the given study site. No parallel surgical procedures will be performed at the same session.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.