Clinical Performance of B-Lite® Light Weight Breast Implant

Launched by G&G BIOTECHNOLOGY LTD. · May 17, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the B-Lite® Light Weight Breast Implant, which has already been used in thousands of surgeries. The goal of this study is to gather more information about how well these implants work for women who are getting breast augmentation for the first time. The trial is currently recruiting women aged 18 to 60 who are in good health and meet certain criteria, such as being able to undergo an MRI and having realistic expectations about the surgery results.

Participants can expect to have their surgery performed according to standard medical practices at the study site. They will be required to attend follow-up visits and may need to undergo an MRI as part of the study. It’s important for potential participants to know that there are specific reasons they might not be eligible, such as having an active infection, being pregnant or nursing, or having certain medical conditions that could pose risks during surgery. Overall, this trial aims to provide valuable insights into the safety and effectiveness of B-Lite® implants for breast augmentation.

Gender

FEMALE

Eligibility criteria

• 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