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Safety and Effectiveness 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:
NCT00689871
First received: June 2, 2008
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Breast Augmentation
Breast Reconstruction
Revision of Augmentation or 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Local Complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    By patient risk of complications occuring 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: 10 years ] [ Designated as safety issue: No ]
    Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied


Enrollment: 715
Study Start Date: January 1999
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689871

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

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00689871     History of Changes
Other Study ID Numbers: 020056
Study First Received: June 2, 2008
Results First Received: December 19, 2011
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013