Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

October 6, 2014 updated by: Allergan Medical
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

715

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

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States

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:

  • Female, age 18 years or older
  • Seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia, asymmetry, ptosis, or aplasia
  • Seeking primary breast reconstruction
  • Seeking breast revision-augmentation
  • Seeking breast revision-reconstruction
  • Adequate tissue available to cover implants
  • Patients at MRI designated sites must be willing to undergo MRI at their 1,3, 5, 7 and 9-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).

Exclusion Criteria:

  • Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
  • Existing carcinoma of the breast, without mastectomy
  • Abscess or infection in the body at the time of enrollment
  • Pregnant or nursing
  • Have any disease, including uncontrolled diabetes (e.g., HbAIc > 8%), that is clinically known to impact wound healing ability
  • Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration
  • Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
  • 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)
  • Are 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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Primary augmentation
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
Experimental: 2
Primary reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
Experimental: 3
Revision-augmentation
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
Experimental: 4
Revision-reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Complications
Time Frame: 10 years
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Time Frame: 10 years
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
10 years

Collaborators and Investigators

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

Sponsor

Allergan Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 1999

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 020056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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