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Safety and Effectiveness 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: NCT00689871
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : January 23, 2012
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Breast Augmentation Breast Reconstruction Revision of Augmentation or Reconstruction Device: Natrelle(TM) Silicone-Filled Breast Implants

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 715 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : January 1999
Primary Completion Date : December 2010
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Local Complications [ Time Frame: 10 years ]
    By patient risk of complications occuring 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: 10 years ]
    Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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): NCT00689871


Locations
United States, District of Columbia
Washington, District of Columbia, United States
Sponsors and Collaborators
Allergan Medical
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00689871     History of Changes
Other Study ID Numbers: 020056
First Posted: June 4, 2008    Key Record Dates
Results First Posted: January 23, 2012
Last Update Posted: October 13, 2014
Last Verified: January 2014