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

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

Study Overview

• Status: Completed
• Conditions: Breast Augmentation; Breast Reconstruction; Revision of Augmentation or Reconstruction
• Intervention / Treatment: Device: Style 410 Silicone-Filled Breast Implants

• Study Type: Interventional
• Enrollment (Actual): 941
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Complications	By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Allergan Medical

Publications and helpful links

General Publications

• Gladfelter J, Murphy D. Breast augmentation motivations and satisfaction: a prospective study of more than 3,000 silicone implantations. Plast Surg Nurs. 2008 Oct-Dec;28(4):170-4; quiz 175-6. doi: 10.1097/PSN.0b013e31818ea7e0.
• Largent JA, Reisman NR, Kaplan HM, Oefelein MG, Jewell ML. Clinical trial outcomes of high- and extra high-profile breast implants. Aesthet Surg J. 2013 May;33(4):529-39. doi: 10.1177/1090820X13484035. Epub 2013 Apr 4.
• Namnoum JD, Largent J, Kaplan HM, Oefelein MG, Brown MH. Primary breast augmentation clinical trial outcomes stratified by surgical incision, anatomical placement and implant device type. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1165-72. doi: 10.1016/j.bjps.2013.04.046. Epub 2013 May 9.
• Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP; Style 410 U.S. Core Clinical Study Group. Style 410 highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):40S-48S. doi: 10.1097/01.prs.0000286666.29101.11.
• Maxwell GP, Van Natta BW, Murphy DK, Slicton A, Bengtson BP. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J. 2012 Aug;32(6):709-17. doi: 10.1177/1090820X12452423. Epub 2012 Jun 29.

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 2, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (Estimate): June 4, 2008

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 00201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No