Evaluation of B-Lite Light Weight Breast Implants

Clinical Performance of B-Lite® Light Weight Breast Implant

This study is testing how well B-Lite light weight breast implants work for women who want breast augmentation and checking how satisfied they are with the results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: G&G Biotechnology Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 5 sites (Heidelberg and 4 other locations)
• Trial ID: NCT02777476 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical performance of B-Lite® light weight breast implants in women seeking primary breast augmentation. It is a post-marketing study that includes participants who meet specific eligibility criteria, such as being between 18 and 60 years old and having no contraindications for MRI. All surgeries will be conducted following standard practices at designated study sites, with a focus on monitoring outcomes and patient satisfaction. Participants will be required to comply with follow-up visits and return the implant if necessary.

Who should consider this trial

Good fit: Ideal candidates are genetic women aged 18 to 60 seeking primary breast augmentation without any contraindications.

Not a fit: Patients with active infections, those who are pregnant or nursing, or those with silicone implants other than breast implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a safer and more comfortable option for breast augmentation.

How similar studies have performed: Other studies on breast implants have shown varying degrees of success, but the specific evaluation of B-Lite implants is relatively novel.

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

Where this trial is running

Heidelberg and 4 other locations

• Ethianum — Heidelberg, Germany (Recruiting)
• Herzelia Medical Center — Herzliya, Israel (Completed)
• Akademikliniken — Stockholm, Sweden (Active_not_recruiting)
• Concept-Clinic — Geneva, Switzerland (Withdrawn)
• London Bridge Plastic Surgery Ltd — London, United Kingdom (Withdrawn)

Study contacts

• Study coordinator: Dael Govreen-Segal

Conditions Breast Implants