CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)

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 pre-market approval. In May 1990, the Food and Drug
Administration (FDA) published a proposed request (515(b)) for Pre-market 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 pre-market 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 subjects. Every subject implanted had to be part of an adjunct study, in addition
to being offered participation in a registry of gel-filled breast implant subjects. In
order to be implanted with gel-filled implants for augmentation, women had to be enrolled in
an IDE clinical trial.

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

The objective of the CPG Styles Study is to determine the safety of the different styles of
Mentor's Contour Profile Gel (CPG) breast implants in women undergoing breast augmentation,
reconstruction, or revision.

Throughout the duration of this study, patients are required to have follow-up visits at 10
weeks post-surgery and every year after surgery through the 10th year of study completion.

Total subject population: Up to 500 new subjects, plus up to 1500 subjects rolled over from
the CPG Continued Access Study will continue the 10-year follow-up under this protocol.

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), or 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, spondyarthropathies, 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