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

Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02132572
Acronym
RANBI
Enrollment
201
Registered
2014-05-07
Start date
2014-05-31
Completion date
2014-10-31
Last updated
2016-09-13

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

Conditions

Breast Implantation

Brief summary

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

Interventions

DEVICEBIOCELL™ Textured 410 Implant

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

Sponsors

Allergan
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant3 to 10 yearsData were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.

Countries

France, Germany, Israel, Spain, United Kingdom

Participant flow

Participants by arm

ArmCount
Natrelle BIOCELL™ Textured 410 Implant
Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
201
Total201

Baseline characteristics

CharacteristicNatrelle BIOCELL™ Textured 410 Implant
Age, Customized
17 to 30 years
67 Participants
Age, Customized
31 to 40 years
74 Participants
Age, Customized
41 to 50 years
36 Participants
Age, Customized
51 to 60 years
18 Participants
Age, Customized
61 to 70 years
3 Participants
Age, Customized
Missing age data
3 Participants
Sex: Female, Male
Female
201 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 201
serious
Total, serious adverse events
30 / 201

Outcome results

Primary

Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant

Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.

Time frame: 3 to 10 years

Population: Per Protocol: Subjects who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants 3 to 10 years prior to data collection

ArmMeasureValue (NUMBER)
Natrelle BIOCELL™ Textured 410 ImplantPercentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant28 Percentage of Subjects

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