Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants (RANBI-I)

Allergan

Status

Completed

Conditions

Breast Implantation

Treatments

Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants

Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants

Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants

Study type

Observational

Funder types

Industry

Identifiers

NCT02438332

GMA-CAN-PLS-0337

Details and patient eligibility

About

This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.

Enrollment

330 patients

Sex

Female

Ages

22+ 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 smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device
Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection
Subfascial, 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 NATRELLE® INSPIRA® device implanted at initial breast augmentation
Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation
Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator
Axillary or peri-areolar approach
Mastopexy augmentation