Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905645
• Other study ID #: G010193
• Status: Completed
• Phase: N/A
• Start date: November 2002
• Est. completion date: December 2018

Study information

• Verified date: September 2023
• Source: Sientra, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1788
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Reconstruction
• Breast Revision

Intervention

Device:
• Silimed Gel-Filled Mammary Implant

Locations

Country	Name	City	State
United States	Sientra, Inc.	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Sientra, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Complications	Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.	10 Years
Secondary	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