Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00691327
First received: June 3, 2008
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.


Condition Intervention
Breast Reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Local Complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts


Secondary Outcome Measures:
  • Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied


Enrollment: 84329
Study Start Date: December 1997
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Primary reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
Experimental: 2
Revision-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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
  • Females seeking revision augmentation or revision reconstruction, where problems exist
  • Have any of the following conditions or situations present:
  • Post mastectomy surgical removal of the breast for cancer or other disease;
  • Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
  • Severe ptosis requiring reconstruction;
  • Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
  • Adequate tissue available to cover implants.
  • Saline-filled implants are not an appropriate choice.

Exclusion Criteria:

  • Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
  • Existing carcinoma of the breast, without mastectomy.
  • Abscess of infection in the body at the time of enrollment.
  • Pregnant or nursing.
  • Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
  • Show tissue characteristics which are clinically incompatible with mammaplasty.
  • Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
  • Are not willing to undergo further surgery for revision, if medically required.
  • Diagnosis of lupus or scleroderma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691327

Locations
United States, Indiana
Indianapolis, Indiana, United States
Sponsors and Collaborators
Allergan Medical
  More Information

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00691327     History of Changes
Other Study ID Numbers: 910044
Study First Received: June 3, 2008
Results First Received: December 30, 2013
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Allergan Medical:
Revision of augmentation or reconstruction

ClinicalTrials.gov processed this record on April 16, 2014