Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction

Protocol: OSU-16100

Full Title

A Study of the Safety and Effectiveness of the Mentor® Smooth and Textured Larger Size MemoryGel® Ultra High Profile (UHP-L) Breast Implants in Subjects who are Undergoing Primary Breast Reconstruction or Revision Reconstruction ( Athena Study )

Purpose

The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size

Ultra High Profile (UHP-L) Breast Implants.

Study Objective

Subjects, whose body shape is suited to a larger size implant than are currently available,

will have their breasts reconstructed using the UHP-L Breast Implants either for the first

time after a full mastectomy or as a revision of a previous breast reconstruction.

Are you eligible?

Inclusion Criteria:

Subject is female and is at least 18 years old

A candidate for:

Primary breast reconstruction in women at least 18 years old with surgically absent

breast tissue (two-stage reconstruction [tissue expanders utilized with or without

the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD®

PLIABLE, utilized in a prior surgery to expand tissue for study device placement] to

replace breast tissue post-mastectomy)

Revision surgery in women at least 18 years old with surgically absent breast tissue

(previous reconstruction with silicone-filled or saline-filled implants or revision

reconstruction requiring expansion surgery prior to surgery for study device

implantation, with or without the use of human acellular dermal matrices (ADM),

limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand

tissue for study device placement)

Subject understands and signs the Informed Consent

Subject agrees to return device to Mentor if device is explanted

Subject agrees to comply with follow-up procedures, including returning for all

follow-up visits

Physician determines implant volume appropriate for the patient taking into account

the subject's BMI and chest width

Exclusion Criteria:

Subject is pregnant at time of enrollment

Subject is a current smoker, or has smoked within 3 months prior to enrollment, or

plans to resume smoking within 3 months post-enrollment

Currently has uncontrolled diabetes (at time of screening or enrollment)

Has nursed a child within 3 months of study enrollment

Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases

or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or

any connective tissue disorder, rheumatoid arthritis, crystalline arthritis,

infectious arthritis, spondyloarthropathies, any other inflammatory arthritis,

fibromyalgia, or chronic fatigue syndrome

Currently has a condition that could compromise or complicate wound healing. Note,

obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes,

smoking history, and prior radiation) should be considered in totality for proper

subject selection

Infection or abscess anywhere in the body

Demonstrates tissue characteristics that are clinically incompatible with successful

use of a breast implant (e.g. 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 that could lead to significant postoperative

adverse events

Demonstrates characteristics that are unrealistic/unreasonable with the risks

involved with the surgical procedure

Untreated active, or inappropriately/inadequately treated breast malignancy, without

surgical treatment

Anticipated need for use of ADM/mesh at the time of implant or implant exchange

Subject is HIV positive

Works for Mentor or the study doctor or is directly related to anyone who works for

Mentor or the study doctor

Implanted metal or metal devices that make a MRI scan prohibitive, history of

claustrophobia or other condition that would make a MRI scan prohibitive