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

Not Applicable

Completed

• Conditions: Breast Augmentation; Revision of Augmentation or Reconstruction; Breast Reconstruction
• Interventions: Device: Style 410 Silicone-Filled Breast Implants

• Registration Number: NCT00690339
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-17
• Results First Submitted QC: 2013-12-18
• Results First Posted: 2014-02-04
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 941

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4	Style 410 Silicone-Filled Breast Implants	Revision-reconstruction
2	Style 410 Silicone-Filled Breast Implants	Reconstruction
3	Style 410 Silicone-Filled Breast Implants	Revision-augmentation
1	Style 410 Silicone-Filled Breast Implants	Augmentation

Primary Outcome Measures

Name	Time	Method
Local Complications	10 years	By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.	10 years	Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied