Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

• Sponsor: Sientra, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00905645
• Collaborator: (none)
• Enrollment: 1,788
• Location: 1
• Arms: 3
• Duration (Months): 193
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation; Breast Reconstruction; Breast Revision	Device: Silimed Gel-Filled Mammary Implant	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1788 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
• Study Start Date: Nov 1, 2002
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

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: Revison Silimed Gel-Filled Mammary Implant	Device: Silimed Gel-Filled Mammary Implant

Outcome Measures

Primary Outcome Measures

1. Local complications [10 Years]

Secondary Outcome Measures

1. Satisfaction determined by patients [10 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sientra, Inc.	Santa Barbara	California	United States	93117

Sponsors and Collaborators

• Sientra, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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, 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® 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.

• Responsible Party: Sientra, Inc.
• ClinicalTrials.gov Identifier: NCT00905645
• Other Study ID Numbers: G010193
• First Posted: May 20, 2009
• Last Update Posted: May 6, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sientra, Inc.: Breast Augmentation; Breast Reconstruction; Breast Revision; Silicone breast implants

Study Results

No Results Posted as of May 6, 2019