Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant (NCT00811525) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant
Started 2004-08
Plain-language summary
The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's Mammary Prostheses 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 help determine device safety.
With approval of MemoryShape™ Medium Height, Moderate Profile (CPG 321) Breast Implants on June 14, 2013, CPG CA Study subject enrollment has closed and the study has converted to a post approval study for this style.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is Genetic female and is at least 18 years old
* A candidate for:
* Primary breast augmentation (for general breast enlargement)
* Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity)
* Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
* Signs the Informed Consent
* Agrees to return device to Mentor if device is explanted
* 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
* Confirmed diagnosis of rheumatic disease
* 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, except 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 postoper…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.