Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants (RANBI)

Allergan

Status: Completed

Conditions: Breast Implantation

Treatments: Device: BIOCELL™ Textured 410 Implant

Study type: Observational

Funder types: Industry

Identifiers

NCT02132572

MAF-AGN-MED-BRE-003

Details and patient eligibility

About

Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

Enrollment: 201 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 & 3 only) has been implanted
• Primary breast augmentation 3 to 10 years prior to data collection
• Submuscular/dual plane or subglandular implant placement

Exclusion criteria

• Breast augmentation for Poland Syndrome or amastia
• Breast reconstruction following mastectomy
• Revision or secondary breast reconstruction
• Non 410 device at initial breast augmentation
• Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant
• Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions)
• Axillary or peri-areolar approach
• Glandular mastopexy augmentation (skin excision only)

Trial design

201 participants in 1 patient group

Natrelle BIOCELL™ Textured 410 Implant

Description:

Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.

Treatment:

Device: BIOCELL™ Textured 410 Implant