Demonstrate safety and effectiveness of Mentor's MemoryShape® Breast Implants (known as Contour Profile Gel Mammary Prosthesis internationally) in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Non-masked, open label
- Two year data submitted to FDA as part of the Premarket Application
- Follwing FDA approval, follow up data collected: Rheumatic Disease Diagnosis, QoLs, silent rupture with MRI, and Adverse Events up to 10 years annually
- Total subject population - 95
- Population reflective of the target subject population with respect to indication
Enrollment numbers by indication:
Total number of Investigators: up to 60
Total number of surgical sites: up to 100
Study Device: Mentor Siltex Contour Profile Gel Mammary Prosthesis
- 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
- 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 vascularit)
- Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physician(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 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 claustrophobia or other condition that would make a MRI scan prohibitive.
Study Evaluation Schedule
1 - 10 Years
|Subject informed consent||X|
|Mammography (if performed)||X||X||X|
|Quality of LifeA,B||X||X|
|Nipple/Breast Sensitivity Assessment||X||X||X|
|Investigator satisfaction with implantE||X|
A At 1, 2, 4, 6, 8, and 10 years.
B Rosenberg Self Esteem Scale, SF-36, Body Esteem Scale, Breast Evaluation Questionnaire
C Required for randomly selected 400 of subjects
D Including secondary procedures and reimplantations upon occurrence, whether noted at a schedule or interim visit.
E At 1, 2, and 3 years.
Incidence, severity, method of resolution, and duration for all adverse events on a per implant and per subject basis
Primary - Changes in chest circumference and bra and cup size (may not be applicable to reconstruction subjects)
Secondary - Changes in Quality of Life results
Photos of the Mentor's MemoryShape® Breast Implant