Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1788 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2018-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Breast Augmentation Breast Reconstruction Breast Revision

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

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Silimed Gel-Filled Mammary Implant

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No