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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02132572
• Collaborator: (none)
• Enrollment: 201
• Locations: 5
• Duration (Months): 5
• Patients Per Site: 40.2
• Patients Per Site Per Month: 8

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Breast Implantation	Device: BIOCELL™ Textured 410 Implant

Study Design

• Study Type: Observational
• Actual Enrollment: 201 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Natrelle BIOCELL™ Textured 410 Implant Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.	Device: BIOCELL™ Textured 410 Implant; Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant [3 to 10 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Bordeaux		France
2		Düsseldorf		Germany
3		Tel Aviv		Israel
4		Madrid		Spain
5		East Grinstead		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02132572
• Other Study ID Numbers: MAF-AGN-MED-BRE-003
• First Posted: May 7, 2014
• Last Update Posted: Sep 13, 2016
• Last Verified: Jul 1, 2016

Study Results

Participant Flow

Arm/Group Title	Natrelle BIOCELL™ Textured 410 Implant
Arm/Group Description	Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
Period Title: Overall Study
STARTED	201
COMPLETED	201
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Natrelle BIOCELL™ Textured 410 Implant
Arm/Group Description	Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
Overall Participants	201
Age, Customized (Number) [Number]
17 to 30 years	67 33.3%
31 to 40 years	74 36.8%
41 to 50 years	36 17.9%
51 to 60 years	18 9%
61 to 70 years	3 1.5%
Missing age data	3 1.5%
Sex: Female, Male (Count of Participants)
Female	201 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Natrelle BIOCELL™ Textured 410 Implant
Arm/Group Description	Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
Measure Participants	175
Number [Percentage of Subjects]	28

Adverse Events

Adverse Event Reporting Description	The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
Arm/Group Title	Natrelle BIOCELL™ Textured 410 Implant
Arm/Group Description	Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
All Cause Mortality
	Natrelle BIOCELL™ Textured 410 Implant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Natrelle BIOCELL™ Textured 410 Implant
	Affected / at Risk (%)	# Events
Total	30/201 (14.9%)
General disorders
Device Breakage	7/201 (3.5%)
Device Dislocation	8/201 (4%)
Capsular Contracture Associated with Breast Implant	7/201 (3.5%)
Device Optical Issue	6/201 (3%)
Device Damage	2/201 (1%)
Device Deployment Issue	1/201 (0.5%)
Device Expulsion	1/201 (0.5%)
Impaired Healing	1/201 (0.5%)
Implant Site Reaction	2/201 (1%)
Device Issue	1/201 (0.5%)
Injury, poisoning and procedural complications
Post Procedural Haematoma	5/201 (2.5%)
Seroma	4/201 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Female	3/201 (1.5%)
Reproductive system and breast disorders
Nipple Disorder	1/201 (0.5%)
Breast Pain	1/201 (0.5%)
Surgical and medical procedures
Scar Excision	1/201 (0.5%)
Surgery	1/201 (0.5%)
Other (Not Including Serious) Adverse Events
	Natrelle BIOCELL™ Textured 410 Implant
	Affected / at Risk (%)	# Events
Total	0/201 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.