Clinical trial NCT00905645: Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Official title: Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Breast Reconstruction
Breast Revision
Keywords: Breast Augmentation
Breast Reconstruction
Breast Revision
Silicone breast implants
Lead sponsor: Tiger Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 1788
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Local Complications
timeFrame: 10 Years
Secondary outcomes:
measure: Satisfaction Determined by Patients
timeFrame: 10 Years
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sientra, Inc.
state: California
Study officials:
affiliation: Tiger Biosciences, LLC.
name: Denise Dajles, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.