Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

NCT00905645 | Completed Results

• 1 other identifier: G010193
• Study Type: interventional
• Target: 1,788
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Augmentation; Breast Reconstruction; Breast Revision

Keywords

Breast Augmentation; Breast Reconstruction; Breast Revision; Silicone breast implants

Outcome Measures

Primary Outcomes (1)

• Local Complications

  Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.

  10 Years

Secondary Outcomes (1)

• Satisfaction Determined by Patients

  10 Years

Study Arms (4)

Primary Augmentation

EXPERIMENTAL

Silimed Gel-Filled Mammary Implant

Device: Silimed Gel-Filled Mammary Implant

Revision-Augmentation

EXPERIMENTAL

Silimed Gel-Filled Mammary Implant

Device: Silimed Gel-Filled Mammary Implant

Primary Reconstruction

EXPERIMENTAL

Silimed Gel-Filled Mammary Implant

Device: Silimed Gel-Filled Mammary Implant

Revision-Reconstruction

EXPERIMENTAL

Silimed Gel-Filled Mammary Implant

Device: Silimed Gel-Filled Mammary Implant

Interventions

Silimed Gel-Filled Mammary Implant DEVICE

Primary Augmentation; Primary Reconstruction; Revision-Augmentation; Revision-Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead

Study Sites (1)

Sientra, Inc.

Santa Barbara, California, 93117, United States

Location

Related Publications (4)

• 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.

  PMID: 23096598 BACKGROUND

• 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.

  PMID: 25948657 BACKGROUND

• 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.

  PMID: 26961987 BACKGROUND

• 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.

  PMID: 29595714 BACKGROUND

Results Point of Contact

• Title: Chief Technology Officer
• Organization: Sientra

denise.dajles@sientra.com

(805) 562-3500

Study Officials

• Denise Dajles, PhD

  Tiger Biosciences, LLC.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: November 1, 2002
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)