Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant

NCT00811525 | Unknown

• 1 other identifier: 110390CA-0912-2
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Augmentation; Breast Reconstruction; Breast Revision

Keywords

Breast Augmentation; Breast Reconstruction; Breast Revision; Silicone gel; Contour Profile Gel; Siltex

Interventions

Mentor Siltex® Contour Profile Gel Mammary Prosthesis DEVICE

The CPG mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. The Siltex® shell is textured to provide a disruptive surface for collagen interface. The CPG implant contains a gel that is a more cohesive silicone gel than that used in other Mentor gel implants. The gel is made from the same materials as Mentor's standard gel. The contour shape of the CPG is designed to provide inferior projection with reduced superior fullness. The CPG mammary prosthesis contains raised orientation marks on the anterior and posterior of the implant which may help the physician ensure proper placement. CPG was available in sizes 120 cc-775 cc and 5 styles with various projection and height options. With approval of MemoryShape™ (CPG 321) Breast Implants, the study converted to a post approval study for this style.

Also known as: MemoryShape™ Breast Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

Related Links

• Related Info

Study Officials

• William Adams, M.D.

  Dallas, TX

  PRINCIPAL INVESTIGATOR

• Frank Barone, M.D.

  Toledo, OH

  PRINCIPAL INVESTIGATOR

• Joseph Bauer, M.D.

  Alpharetta, GA

  PRINCIPAL INVESTIGATOR

• Michael Bentley, M.D.

  Montgomery, AL

  PRINCIPAL INVESTIGATOR

• John Bishop, M.D.

  Greenville, SC

  PRINCIPAL INVESTIGATOR

• David Caplin, M.D.

  St. Louis, MO

  PRINCIPAL INVESTIGATOR

• E. Dale Collins Vidal, M.D.

  Lebanon, NH (Dartmouth-Hitchcock)

  PRINCIPAL INVESTIGATOR

• Craig Colville, M.D.

  Toledo, OH

  PRINCIPAL INVESTIGATOR

• Gloria Duda, M.D.

  McLean, VA (D.C. Metro area)

  PRINCIPAL INVESTIGATOR

• Barry Fernando, M.D.

  Phoenix, AZ

  PRINCIPAL INVESTIGATOR

• William Gorman, M.D.

  Austin, TX

  PRINCIPAL INVESTIGATOR

• Scot Glasberg, M.D.

  New York, NY

  PRINCIPAL INVESTIGATOR

• Strawford Dees, M.D.

  Biloxi, MS

  PRINCIPAL INVESTIGATOR

• Dennis Hammond, M.D.

  Grand Rapids, MI

  PRINCIPAL INVESTIGATOR

• Mark Jewell, M.D.

  Eugene, OR

  PRINCIPAL INVESTIGATOR

• Robert Kevitch, M.D.

  Allentown, PA

  PRINCIPAL INVESTIGATOR

• Shujaat Khan, M.D.

  Fort Worth, TX

  PRINCIPAL INVESTIGATOR

• Philip Kierney, M.D.

  Puyallup, WA

  PRINCIPAL INVESTIGATOR

• John Lettieri, M.D.

  Spartanburg, SC

  PRINCIPAL INVESTIGATOR

• Tim Love, M.D.

  Oklahoma City, OK

  PRINCIPAL INVESTIGATOR

• Mark Migliori, M.D.

  Edina, MN

  PRINCIPAL INVESTIGATOR

• Bradley Remington, M.D.

  Kirkland, WA

  PRINCIPAL INVESTIGATOR

• John Smoot, M.D.

  La Jolla, CA

  PRINCIPAL INVESTIGATOR

• Grant Stevens, M.D.

  Marina Del Rey, CA

  PRINCIPAL INVESTIGATOR

• Steven Teitelbaum, M.D.

  Santa Monica, CA

  PRINCIPAL INVESTIGATOR

• Lewis Berger, M.D.

  Tampa, FL

  PRINCIPAL INVESTIGATOR

• Patrick Maxwell, M.D.

  Nashville, TN

  PRINCIPAL INVESTIGATOR

• Jack Fisher, M.D.

  Nashville, TN

  PRINCIPAL INVESTIGATOR

• David A. Stoker, M.D.

  Marina Del Rey, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 19, 2008
• Study Start: August 1, 2004
• Last Updated: December 2, 2014

Record last verified: 2014-11