Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial

Trial Information

Study of the Safety and Effectiveness of Mentor Siltex® Contour Profile Gel Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation,Primary Breast Reconstruction or Revision

Silicone gel-filled breast implants were introduced in the early sixties and were in
wide-scale distribution by the time the Medical Device Amendments to the Food Drug and
Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as
Class III devices requiring premarket approval. In May 1990, the Food and Drug
Administration (FDA) published a proposed request (515(b)) for Premarket Approval
Applications (PMA) and in April 1991 published the final request. This final publication put
manufacturers of gel-filled breast implants on notice that for continued marketing of
gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.

A premarket approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA
in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November
1991, the committee recommended the submission of additional information to establish the
safety and effectiveness of gel-filled breast implants.

In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of
gel-filled breast implants to allow the advisory panel time to assess additional
information. In April 1992, the moratorium was lifted but only for reconstruction and
revision patients. Every patient implanted had to be part of an adjunct study, and had to be
offered participation in a registry of gel-filled breast implant patients. In order to be
implanted with gel-filled implants for augmentation, women had to be enrolled in a core
clinical study.

In September of 2000 the Core Gel study began, leading the way to the November 2006 FDA
approval of the Core Gel implant or Memory Gel breast implant.

The objective of the Contour Profile Gel Study, which started in 2002 is to determine the
safety and effectiveness of the Silicone Contour Profile Gel Mammary Prostheses in women who
are undergoing primary breast augmentation, primary breast reconstruction, or revision. In
the duration of this study patients are required to have follow-up visits 10 weeks
post-surgery and every year after surgery through the 10th year of completion. Additionally,
out of the approximately 1000 patients enrolled in the CPG study, 400 have been randomly
selected to have MRI scans at their 1,2,4,6,8,and 10 year post-surgery visits. Protocol
changes now require all patients in this study to have MRI scans at years 6, 8, and 10.

Inclusion Criteria:

- Subject is genetic female, 18 years of age or older

- A candidate for:

- Primary breast augmentation (general breast enlargement)

- Primary breast reconstruction (for trauma, loss of breast tissue due to
mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital
deformity, including asymmetry)

- 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 (e.g. silicone
artificial joints or facial implants)

- Confirmed diagnosis of the following rheumatic diseases or syndromes: 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 (except
reconstruction subjects)

- Subject in Augmentation cohort and has diagnosis of active cancer of any type.
(Exception is 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and a per patient basis.

Outcome Time Frame:

10 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

A105-0601-4

NCT ID:

NCT00812097

Start Date:

February 2002

Completion Date:

July 2014

Related Keywords:

Breast Augmentation
Breast Reconstruction
Breast Revision
Breast Augmentation
Breast Reconstruction
Breast Revision
Silicone gel
Contour Profile Gel
Siltex®

Name	Location
Mentor Worldwide, LLC	Santa Barbara, California 93111

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