Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant
Launched by MENTOR WORLDWIDE, LLC · Dec 17, 2008
Trial Information
Current as of April 25, 2025
Approved for marketing
Keywords
ClinConnect Summary
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 Premarket 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 ...
Gender
FEMALE
Eligibility criteria
- 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 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
Trial Officials
William Adams, M.D.
Principal Investigator
Dallas, TX
Frank Barone, M.D.
Principal Investigator
Toledo, OH
Joseph Bauer, M.D.
Principal Investigator
Alpharetta, GA
Michael Bentley, M.D.
Principal Investigator
Montgomery, AL
John Bishop, M.D.
Principal Investigator
Greenville, SC
David Caplin, M.D.
Principal Investigator
St. Louis, MO
E. Dale Collins Vidal, M.D.
Principal Investigator
Lebanon, NH (Dartmouth-Hitchcock)
Craig Colville, M.D.
Principal Investigator
Toledo, OH
Gloria Duda, M.D.
Principal Investigator
McLean, VA (D.C. Metro area)
Barry Fernando, M.D.
Principal Investigator
Phoenix, AZ
William Gorman, M.D.
Principal Investigator
Austin, TX
Scot Glasberg, M.D.
Principal Investigator
New York, NY
Strawford Dees, M.D.
Principal Investigator
Biloxi, MS
Dennis Hammond, M.D.
Principal Investigator
Grand Rapids, MI
Mark Jewell, M.D.
Principal Investigator
Eugene, OR
Robert Kevitch, M.D.
Principal Investigator
Allentown, PA
Shujaat Khan, M.D.
Principal Investigator
Fort Worth, TX
Philip Kierney, M.D.
Principal Investigator
Puyallup, WA
John Lettieri, M.D.
Principal Investigator
Spartanburg, SC
Tim Love, M.D.
Principal Investigator
Oklahoma City, OK
Mark Migliori, M.D.
Principal Investigator
Edina, MN
Bradley Remington, M.D.
Principal Investigator
Kirkland, WA
John Smoot, M.D.
Principal Investigator
La Jolla, CA
Grant Stevens, M.D.
Principal Investigator
Marina Del Rey, CA
Steven Teitelbaum, M.D.
Principal Investigator
Santa Monica, CA
Lewis Berger, M.D.
Principal Investigator
Tampa, FL
Patrick Maxwell, M.D.
Principal Investigator
Nashville, TN
Jack Fisher, M.D.
Principal Investigator
Nashville, TN
David A. Stoker, M.D.
Principal Investigator
Marina Del Rey, CA
About Mentor Worldwide, Llc
Mentor Worldwide LLC is a leading global medical device company specializing in innovative aesthetic and reconstructive solutions. A subsidiary of Johnson & Johnson, Mentor is dedicated to advancing patient care through the development of high-quality breast implants and other surgical products. With a strong commitment to clinical research and compliance with regulatory standards, Mentor Worldwide actively sponsors clinical trials aimed at enhancing the safety and efficacy of its offerings, thereby fostering ongoing improvements in patient outcomes and satisfaction in the fields of plastic and reconstructive surgery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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