CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,891

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Breast AugmentationBreast ReconstructionBreast Revision
Interventions
DEVICE

The Contour Profile Gel (CPG) breast implants

"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.~The Contour Profile Gel is available in sizes 125cc - 690cc and 4 styles with various projection and height options in this study."

Trial Locations (1)

93111

Mentor Worldwide LLC, Santa Barbara

All Listed Sponsors
lead

Mentor Worldwide, LLC

INDUSTRY

NCT01959880 - CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study) | Biotech Hunter | Biotech Hunter