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.
For more information, contact Diane Hart at Mentor
by calling 1-800-MENTOR-8 or visit Mentor's
website.
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