Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02438332

Acronym

RANBI-I

Enrollment

330

Registered

2015-05-08

Start date

2014-12-31

Completion date

2016-06-30

Last updated

2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Implantation

Brief summary

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.

Interventions

DEVICESmooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants

Surgical implant

DEVICETextured NATRELLE® INSPIRA® TruForm® 1 Breast Implants

surgical implant

DEVICESmooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants

surgical implant

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants	4 Years

Secondary

Measure	Time frame
Reasons For Primary Augmentation	4 Years
Time From the Date of Implant Until First Reoperation	4 Years
Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants	4 Years
Incidences of Implant Removal With Replacement	4 Years
Incidences of Implant Removal Without Replacement	4 Years
Reasons For Reoperation Incidence	4 Years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026