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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT00690339
First received: June 2, 2008
Last updated: October 6, 2014
Last verified: December 2013

June 2, 2008
October 6, 2014
February 2001
December 2012   (final data collection date for primary outcome measure)
Local Complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Local complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00690339 on ClinicalTrials.gov Archive Site
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
Satisfaction determined by patients and physicians. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Breast Augmentation
  • Breast Reconstruction
  • Revision of Augmentation or Reconstruction
Device: Style 410 Silicone-Filled Breast Implants
Breast Implant Surgery
  • Experimental: 1
    Augmentation
    Intervention: Device: Style 410 Silicone-Filled Breast Implants
  • Experimental: 2
    Reconstruction
    Intervention: Device: Style 410 Silicone-Filled Breast Implants
  • Experimental: 3
    Revision-augmentation
    Intervention: Device: Style 410 Silicone-Filled Breast Implants
  • Experimental: 4
    Revision-reconstruction
    Intervention: Device: Style 410 Silicone-Filled Breast Implants

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
941
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690339
00201
Not Provided
Allergan ( Allergan Medical )
Allergan Medical
Not Provided
Not Provided
Allergan
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP