NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study

July 16, 2015 updated by: Allergan
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3811

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts.

  • Female, age 18 or older
  • Present with one or more of the following conditions:
  • Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction, with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
  • Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when permanent implants are placed in the reconstructed breast)
  • Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants
  • Has adequate tissue available to cover implants
  • Willing to undergo MRI at the specified follow-up visit for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)

Exclusion Criteria:

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the exclusion criteria listed below but not received any NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled 410 X- or L-Style Breast Implants

  • Does not have advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
  • Does not have existing carcinoma of the breast, without mastectomy
  • Does not have abscess or infection in the body at the time of enrollment
  • Is not pregnant or nursing
  • Does not have any disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability
  • Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration
  • Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
  • Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
  • Is not willing to undergo further surgery for revision, if medically required

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmentation
Women undergoing breast augmentation.
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Names:
  • NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Reconstruction
Women undergoing breast reconstruction.
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Names:
  • NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Revision-Augmentation
Women undergoing revision of previous breast augmentation.
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Names:
  • NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Revision-Reconstruction
Women undergoing revision of previous breast reconstruction.
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Names:
  • NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Satisfaction With Breast Implants on a 5-Point Scale
Time Frame: 5 years
Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.
5 years
Investigator Satisfaction With Breast Implants on a 5-Point Scale
Time Frame: 5 years
Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.
5 years
Local Complications
Time Frame: 5 years
Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Medical Director, Allergan Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 410CA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Augmentation

Clinical Trials on Anatomically shaped silicone gel-filled breast implants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe