Spectra Breast Implant Study

Withdrawn before enrolling · Phase 3

Conditions studied: Augmentation, Augmentation Revision, General Breast Enlargement, Post-lactational Involution, Asymmetry

In brief

The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation. Safety information on the rate of complications, such as infection, will be collected and used to help determine device safety. These implants are investigational devices. Approximately 450 patients at sites across the United States will be enrolled in this research study by up to 30 sites. These patients will be implanted with Spectra/Becker 80 implant and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.

Key facts

Study ID

NCT00981266

Run by

Mentor Worldwide, LLC

People needed

0

Starts

2013-06-01

Expected to finish

2026-10-01

Last updated by the study team

2013-03-01

Who can join

Age: 22 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mentor Worldwide LLC — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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