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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

ImplantE

 

 

 

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

Photos of the Mentor Contour Profile Cohesive Silicone Gel Breast Implant



Mentor's new Contour Profile Gel Breast Implant - (cohesive silicone gel)
 

Cohesive silicone gel breast implant has been cut into, and is being squeezed, to demonstrate that the silicone cannot leak

Vertical view of the Mentor Contour Profile (cohesive silicone) gel breast implant


Related Links:

History of Cohesive Silicone Gel Breast Implants
Advantages and Disadvantages of Cohesive Gels
Cohesive Gel Breast Implants - General Info
Cohesive Silicone Gel FAQ
McGhan Cohesil Study Information for Cohesive Silicone Gel Breast Implants

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