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Mentor CPG Coehsive SIlicone Gel Breast Implant Study

 

Mentor CPG Breast Implant Study

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 the 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 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
 

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 LifeA,B X     X
Nipple/Breast Sensitivity Assessment X   X X
Rheumatic ExamA X     X
Capsular Contracture     X X
Investigator satisfaction with implantE       X
Surgical Information   X    
MRI ScanA,C       X
Adverse EventsA,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

 

Photos of the Mentor CPG (Cohesive Profile Gel) Breast Implant

 

 


 

 

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