Known simply as the CPG, Mentor’s cohesive gel filled implant is becoming increasingly popular. Recognizing the increasing popularity of the MM version of the 410, Mentor initially made a single size of the CPG, which was similar to the MM. They also believed that some surgeons considered the 410 to be too firm, so they formulated their gel to be a little softer than the 410.
Subsequently, the CPG line has been expanded to include 4 different shapes of implants in Europe. However, only the original reduced height version has been available.
Objective:
Demonstrate safety and effectiveness of Mentor’s Contour Profile Gel (CPG) Mammary Prosthesis in women who are undergoing primary augmentation, primary reconstruction, or revision.
Design:
- Multicenter
- Non-masked, open label
- Two year data submitted to FDA as part of Pre-Market Application
- Follwing FDA approval, follow up data collected: Rheumatic Disease Diagnosis, QoLs, silent rupture with MRI, and Adverse Events up to 10 years annually
Population:
- Total subject population 950
- Population reflective of the target subject population with respect to indication
Enrollment numbers by indication:
Augmentation: 570
Reconstruction: 190
Total number of Investigators: up to 60
Total number of surgical sites: up to 100
Study Device: Mentor Siltex ® Contour Profile Gel Mammary Prosthesis
Inclusion Criteria:
- 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 explant necessary
- Agrees to comply with follow-up procedures, including returning for all follow-up visits
Exclusion Criteria:
- 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
- Implanted metal or metal devices, history of cla