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

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

Interventions

DEVICE

Mentor Siltex® Contour Profile Gel Mammary Prosthesis

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.

Sponsors & Collaborators

• Mentor Worldwide, LLC

  lead INDUSTRY

Principal Investigators

• William Adams, M.D. · Dallas, TX

• Frank Barone, M.D. · Toledo, OH

• Joseph Bauer, M.D. · Alpharetta, GA

• Michael Bentley, M.D. · Montgomery, AL

• John Bishop, M.D. · Greenville, SC

• David Caplin, M.D. · St. Louis, MO

• E. Dale Collins Vidal, M.D. · Lebanon, NH (Dartmouth-Hitchcock)

• Craig Colville, M.D. · Toledo, OH

• Gloria Duda, M.D. · McLean, VA (D.C. Metro area)

• Barry Fernando, M.D. · Phoenix, AZ

• William Gorman, M.D. · Austin, TX

• Scot Glasberg, M.D. · New York, NY

• Strawford Dees, M.D. · Biloxi, MS

• Dennis Hammond, M.D. · Grand Rapids, MI

• Mark Jewell, M.D. · Eugene, OR

• Robert Kevitch, M.D. · Allentown, PA

• Shujaat Khan, M.D. · Fort Worth, TX

• Philip Kierney, M.D. · Puyallup, WA

• John Lettieri, M.D. · Spartanburg, SC

• Tim Love, M.D. · Oklahoma City, OK

• Mark Migliori, M.D. · Edina, MN

• Bradley Remington, M.D. · Kirkland, WA

• John Smoot, M.D. · La Jolla, CA

• Grant Stevens, M.D. · Marina Del Rey, CA

• Steven Teitelbaum, M.D. · Santa Monica, CA

• Lewis Berger, M.D. · Tampa, FL

• Patrick Maxwell, M.D. · Nashville, TN

• Jack Fisher, M.D. · Nashville, TN

• David A. Stoker, M.D. · Marina Del Rey, CA

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-08-31