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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mentor Worldwide, LLC
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT01959880
First received: September 25, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants 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 determine device safety.


Condition Intervention Phase
Breast Augmentation
Breast Reconstruction
Breast Revision
Device: The Contour Profile Gel (CPG) breast implants
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision

Resource links provided by NLM:


Further study details as provided by Mentor Worldwide, LLC:

Primary Outcome Measures:
  • Safety will be determined by the incidence, severity, and method of resolution for all adverse events on a per implant and per subject basis [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety will be determined by time to occurrence of all compliations. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: August 2013
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Primary Augmentation
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
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.

Primary Reconstruction

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

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.

Revison Augmentation
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
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.

Revision Reconstruction
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
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.


Detailed Description:

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 pre-market approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Pre-market 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 of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.

A pre-market approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants.

In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision subjects. Every subject implanted had to be part of an adjunct study, in addition to being offered participation in a registry of gel-filled breast implant subjects. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an IDE clinical trial.

In September of 2000 the Core Gel study began, leading the way to the November 2006 FDA approval of MemoryGel breast implant.

The objective of the CPG Styles Study is to determine the safety of the different styles of Mentor's Contour Profile Gel (CPG) breast implants in women undergoing breast augmentation, reconstruction, or revision.

Throughout the duration of this study, patients are required to have follow-up visits at 10 weeks post-surgery and every year after surgery through the 10th year of study completion.

Total subject population: Up to 500 new subjects, plus up to 1500 subjects rolled over from the CPG Continued Access Study will continue the 10-year follow-up under this protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is genetic female, 18 years of age or older
  • A candidate for: Primary breast augmentation (general breast enlargement), Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry), or Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
  • Signs the Informed Consent
  • Agrees to return device to Mentor if explant necessary
  • 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 (e.g. silicone artificial joints or facial implants)
  • Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
  • 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. (Exception is 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959880

Contacts
Contact: Gregory Golden 800-525-0245 ext 6459 GGolden1@its.jnj.com

Locations
United States, California
Mentor Worldwide LLC Recruiting
Santa Barbara, California, United States, 93111
Contact: Gregory Golden    800-525-0245 ext 6459      
Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Principal Investigator: Michael P. Bentley, M.D. Montgomery, AL
Principal Investigator: David A. Caplin, M.D. Saint Louis, MO
Principal Investigator: Craig W. Colville, M.D. Toledo, OH
Principal Investigator: Strawford H. Dees III, M.D. Biloxi, MS
Principal Investigator: William H. Gorman, M.D. Austin, TX
Principal Investigator: Dennis Hammond, M.D. Grand Rapids, MI
Principal Investigator: Mark L. Jewell, M.D. Eugene, OR
Principal Investigator: Robert B. Kevitch, M.D. Allentown, PA
Principal Investigator: Philip C. Kierney, M.D. Puyallup, WA
Principal Investigator: Tim R. Love, M.D. Oklahoma City, OK
Principal Investigator: G. Patrick Maxwell, M.D. Nashville, TN
Principal Investigator: Bradley L. Remington, M.D. Kirkland, WA
Principal Investigator: W. Grant Stevens, M.D. Marina Del Rey, CA
Principal Investigator: Steven Teitelbaum, M.D. Santa Monica, CA
Principal Investigator: Jon Trevisani, M.D. Maitland, FL
Principal Investigator: Joseph Bauer, M.D. Alpharetta, GA
Principal Investigator: William P. Adams Jr., M.D. Dallas, TX
Principal Investigator: Peter Geldner, M.D. Chicago, IL
Principal Investigator: Rhett High, M.D Raleigh, NC
Principal Investigator: Tim R Love, M.D. Oklahoma, OK
Principal Investigator: Gregory Liebscher, M.D. Colorado Springs, CO
Principal Investigator: Thomas D McKim, M.D. Boise, ID
Principal Investigator: Renato V. O'Campo, M.D. Boca Raton, FL
Principal Investigator: Robert D. Peterson, M.D. Houston, TX
Principal Investigator: Eugene E Sloan, M.D. Little Rock, AR
Principal Investigator: David A. Stoker, M.D. Marina Del Ray, CA
Principal Investigator: Louis L Strock, M.D. Fort Worth, TX
Principal Investigator: Frederick E Thompson, M.D. Liberty, OH
Principal Investigator: Dale C. Vidal, M.D. Lebanon, NH
Principal Investigator: Lewis Berger, M.D. Tampa, FL
Principal Investigator: John B. Bishop, M.D. Greenville, SC
  More Information

Additional Information:
No publications provided

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT01959880     History of Changes
Other Study ID Numbers: 110390SS-0313-2
Study First Received: September 25, 2013
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mentor Worldwide, LLC:
Breast Augmentation
Breast Reconstruction
Breast Revision
Silicone Gel
Contour Profile Gel
Siltex
CPG Styles

ClinicalTrials.gov processed this record on August 01, 2014