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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014