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Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study

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ClinicalTrials.gov Identifier: NCT00690339
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : February 4, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )

Brief Summary:
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.

Condition or disease Intervention/treatment Phase
Breast Augmentation Breast Reconstruction Revision of Augmentation or Reconstruction Device: Style 410 Silicone-Filled Breast Implants Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 941 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : February 2001
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Augmentation
Device: Style 410 Silicone-Filled Breast Implants
Breast Implant Surgery
Experimental: 2
Reconstruction
Device: Style 410 Silicone-Filled Breast Implants
Breast Implant Surgery
Experimental: 3
Revision-augmentation
Device: Style 410 Silicone-Filled Breast Implants
Breast Implant Surgery
Experimental: 4
Revision-reconstruction
Device: Style 410 Silicone-Filled Breast Implants
Breast Implant Surgery



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



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
  • Patients 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, aplasia
  • Patients seeking breast reconstruction
  • Patients seeking breast revision-augmentation
  • Patients seeking breast revision-reconstruction
  • Adequate tissue available to cover implants
  • Patients must be willing to undergo MRI at their 1, 3, 5, 7, and 10-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., Hb AIc > 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

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): NCT00690339


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

Publications of Results:
Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00690339     History of Changes
Obsolete Identifiers: NCT00557674
Other Study ID Numbers: 00201
First Posted: June 4, 2008    Key Record Dates
Results First Posted: February 4, 2014
Last Update Posted: October 13, 2014
Last Verified: December 2013