Spectra Breast Implant 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 premarket 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. The
Adjunct Study devices included the round MemoryGel, Becker Expander/Prosthesis and the
Lumera implants. In order to be implanted with gel-filled implants for augmentation, women
had to be enrolled in an Investigational Device Exemption (IDE) clinical trial.

A PMA for Mentor's MemoryGel™ Silicone Gel-Filled breast implants (which did not include the
Becker Expander/Breast Implants) was subsequently filed with FDA in December 2003, and
approved in November 2006 (P030053). As a condition of approval of P030053, new enrollment
in Mentor's Adjunct Study has ceased, and women no longer have access to the Becker
Expander/Breast Implants or any Adjustable Gel-Filled implants. The Spectra/Becker 80
Adjustable Breast Implants were not included in the Adjunct Study.

This study is designed to study the safety and effectiveness of Mentor's Spectra/Becker 80
Adjustable Breast Implants for primary breast augmentation or augmentation revision.

Inclusion Criteria:

- Subject is genetic female and is at least 22-years-old

- A candidate for primary breast augmentation (general breast enlargement,
post-lactational involution, asymmetry) or augmentation revision (previous
augmentation 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

- Patient is a US citizen with a Social Security Number

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

- Has diagnosis of active cancer of any type

- Infection or abscess anywhere in the body

- Demonstrates tissue characteristics which are clinically incompatible with implant
placement (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 physician(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