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

Sponsored by Mentor Worldwide, LLC

About this trial

Last updated 9 years ago

Study ID

110390SS-0313-2

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Trial Timing

Ended 10 years ago

What is this trial about?

The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture and infection will be collected and used to determine device safety.

What are the participation requirements?

Yes

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

No

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, spondylarthropathies, 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

Locations

Location

Status