Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation

Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.

Study Overview

• Status: Completed
• Conditions: Breast Augmentation; Breast Reconstruction; Breast Revision
• Intervention / Treatment: Device: Silimed Gel-Filled Mammary Implant

• Study Type: Interventional
• Enrollment (Actual): 1788
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93117
      • Sientra, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Subjects are admitted into the study only if all of the following eligibility is true:

• Female

• Age limitation specific to the indication:

  • Primary Augmentation: Must be 18 years or older
  • Primary Reconstruction: No age limit
  • Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older.
• Adequate tissue available to cover implant(s)
• Willingness to follow study requirements (informed consent form, follow-up visits)
• Candidate for primary augmentation, primary reconstruction, or revision

Exclusion Criteria

Subjects are not eligible if any of the following criteria exist:

• Advanced fibrocystic disease, considered to be pre-malignant without mastectomy
• Inadequate or unsuitable tissue
• Active infection in the body at the time of surgery
• Pregnant or lactating
• Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator
• Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications
• Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
• Determination by physical examination that the subject does have any connective tissue/autoimmune disorder
• Existing carcinoma of the breast without accompanying mastectomy
• MRI scan is prohibited because of implanted metal device, claustrophobia, or other condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Augmentation; Silimed Gel-Filled Mammary Implant	Device: Silimed Gel-Filled Mammary Implant
Experimental: Primary Reconstruction; Silimed Gel-Filled Mammary Implant	Device: Silimed Gel-Filled Mammary Implant
Experimental: Revision-Augmentation; Silimed Gel-Filled Mammary Implant	Device: Silimed Gel-Filled Mammary Implant
Experimental: Revision-Reconstruction; Silimed Gel-Filled Mammary Implant	Device: Silimed Gel-Filled Mammary Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Complications	Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.	10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Determined by Patients	Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of "Strongly Agree" and "Agree."	10 Years

Collaborators and Investigators

• Sponsor: Sientra, Inc.
• Investigators: Study Director: Denise Dajles, PhD, Sientra, Inc.

Publications and helpful links

General Publications

• Stevens WG, Harrington J, Alizadeh K, Berger L, Broadway D, Hester TR, Kress D, d'Incelli R, Kuhne J, Beckstrand M. Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed(R) brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012 Nov;130(5):973-981. doi: 10.1097/PRS.0b013e31826b7d2f.
• Stevens WG, Harrington J, Alizadeh K, Broadway D, Zeidler K, Godinez TB. Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel. Aesthet Surg J. 2015 May;35 Suppl 1:S3-10. doi: 10.1093/asj/sjv020.
• Stevens WG, Calobrace MB, Harrington J, Alizadeh K, Zeidler KR, d'Incelli RC. Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel. Aesthet Surg J. 2016 Apr;36(4):404-16. doi: 10.1093/asj/sjw015.
• Stevens WG, Calobrace MB, Alizadeh K, Zeidler KR, Harrington JL, d'Incelli RC. Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):7S-19S. doi: 10.1097/PRS.0000000000004350.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 18, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimated): May 20, 2009

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Breast Reconstruction; Breast Augmentation; Breast Revision; Silicone breast implants
• Other Study ID Numbers: G010193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO