Mentor MemoryShape Breast Implant Study

Objective:

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.

Design:

• Multicenter
• 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:
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

• 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

Summary

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.

Safety Endpoint:

Incidence, severity, method of resolution, and duration for all adverse events on a per implant and per subject basis


Effectiveness Endpoints:

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