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

NCT02132572 | Completed Results

• 1 other identifier: MAF-AGN-MED-BRE-003
• Study Type: observational
• Target: 201
• Locations: 5 countries
• Sites: 5

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)

Conditions

Breast Implantation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 to 10 years

Study Arms (1)

Natrelle BIOCELL™ Textured 410 Implant

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

Device: BIOCELL™ Textured 410 Implant

Interventions

BIOCELL™ Textured 410 Implant DEVICE

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

Natrelle BIOCELL™ Textured 410 Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects that have undergone a primary breast augmentation for aesthetic reasons with a Natrelle BIOCELL™ textured 410 cohesive implant

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allergan: lead

Study Sites (5)

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

East Grinstead, United Kingdom

Location

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 13, 2016
• Results First Posted: September 13, 2016

Record last verified: 2016-07

Locations

IL (1); DE (1); GB (1); FR (1); ES (1)