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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00691327
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : February 12, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )

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

Condition or disease Intervention/treatment Phase
Breast Reconstruction Device: Natrelle(TM) Silicone-Filled Breast Implants Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84329 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Study Start Date : December 1997
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Local Complications [ Time Frame: 5 years ]
    By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts


Secondary Outcome Measures :
  1. Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale [ Time Frame: 5 years ]
    Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691327


Locations
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United States, Indiana
Indianapolis, Indiana, United States
Sponsors and Collaborators
Allergan Medical
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00691327    
Other Study ID Numbers: 910044
First Posted: June 5, 2008    Key Record Dates
Results First Posted: February 12, 2014
Last Update Posted: October 13, 2014
Last Verified: December 2013
Keywords provided by Allergan ( Allergan Medical ):
Revision of augmentation or reconstruction