Status:
APPROVED_FOR_MARKETING
Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant
Lead Sponsor:
Mentor Worldwide, LLC
Conditions:
Breast Augmentation
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Brief Summary
The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. S...
Detailed Description
Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1...
Eligibility Criteria
Inclusion
- Subject is Genetic female and is at least 18 years old
- A candidate for:
- Primary breast augmentation (for general breast enlargement)
- Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity)
- Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
- Signs the Informed Consent
- Agrees to return device to Mentor if device is explanted
- Agrees to comply with follow-up procedures, including returning for all follow-up visits
Exclusion
- Subject is pregnant
- Has nursed a child within three months of study enrollment
- Been implanted with any silicone implant other than breast implants
- Confirmed diagnosis of rheumatic disease
- Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
- Subject in Augmentation cohort and has diagnosis of active cancer of any type, except low-grade non-metastasizing skin cancer
- Infection or abscess anywhere in the body
- Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
- Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk.
- Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
- Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
- Premalignant breast disease without a subcutaneous mastectomy.
- Untreated or inappropriately treated breast malignancy, without mastectomy
- Are HIV positive
- Work for Mentor or the study doctor or are directly-related to anyone that works for Mentor or the study doctor
Key Trial Info
Start Date :
August 1 2004
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00811525
Start Date
August 1 2004
Last Update
December 2 2014
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