Mentor Clinical Study of the Contour Profile Gel Mammary Prosthesis Cohesive Silicone Gel Breast Implants

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 claustrophobia or other condition that would make a MRI scan prohibitive

Study Evaluation Schedule

Summary:

Data Collected	Timeframe
	Baseline	Operative	10 weeks	Annual 1 - 10 Years
Subject Informed Consent	X
Inclusion/Exclusion Criteria	X
Demo/History/Indication	X
Chest Measurements	X		X	X
Mammography (if performed)	X		X	X
Quality of Life A, B	X			X
Nipple/Breast Sensitivity Assessment	X		X	X
Rheumatic Exam A	X			X
Capsular Contracture			X	X
Investigator Satisfaction with Implant E				X
Surgical Information		X
MRI Scan A,C				X
Adverse Events D		X	X	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.

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