Mentor Cohesive Gel Breast Implants

This just in . .. Mentor has officially begun a clinical trial on their new Contour Profile Gel implant.

This product is a cohesive silicone gel with an anatomical shape. Any patients interested can direct their calls to Diane Hart at Mentor (1-800-MENTOR-8). Below are all the details on the clinical study, but basically it is a first come first serve basis.

Synopsis: Mentor Clinical Study of the Contour Profile Gel Mammary Prosthesis

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.

Study Device: Mentor Siltex® Contour Profile Gel Mammary Prosthesis (click image to enlarge)

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.

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