Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 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 of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.

A premarket 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 patients. Every patient implanted had to be part of an adjunct study, and had to be offered participation in a registry of gel-filled breast implant patients. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in a core clinical study.

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

The objective of the Contour Profile Gel Continued Access is to determine the safety of the Silicone Contour Profile Gel Mammary Prostheses in women who are undergoing primary breast augmentation, primary breast reconstruction, or revision. While Core CPG patient follow-up is being completed, this Continued Access Study was designed to enroll patients at a limited rate per month to allow for continued physician experience with the device and to collect additional safety data to support a future PMA. Safety data will be collected and submitted as supplemental data. The CPG-CA study includes the same original investigators and surgical sites in the Core CPG study. However, not all of the original Core CPG investigators are in the CPG-CA study.

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 completion as in the Core CPG study. (This follow-up requirement changed from 10 years to 5 years upon device approval). Unlike the Core CPG study, the CPG-CA study does not have a randomized selection of MRI patients as a required component of the study.

On June 14, 2013, the FDA approved Mentor® MemoryShape™ Breast Implants (CPG Style 321 Medium Height, Moderate Profile) for the following indications:

- Breast Augmentation for women at least 22 years old.

- Breast Reconstruction. ;


Study Design

N/A


Related Conditions & MeSH terms


NCT number NCT00811525
Study type Expanded Access
Source Mentor Worldwide, LLC
Contact
Status Approved for marketing
Phase N/A
Start date August 2004

See also
  Status Clinical Trial Phase
Recruiting NCT03757793 - Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
Completed NCT05491473 - Negative Pressure in PAP Donor Sites
Not yet recruiting NCT06013514 - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Completed NCT02169011 - Secondary Breast Reconstruction With a Flap of Skin From the Back N/A
Completed NCT01216319 - Evaluation of the Cook Biodesign Plastic Surgery Matrix N/A
Not yet recruiting NCT00973544 - Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis? N/A
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Active, not recruiting NCT00748722 - Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography N/A
Completed NCT00753922 - Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses Phase 3
Completed NCT05897463 - Nipple Neurotization
Recruiting NCT05377723 - Abdominal Scar Improvement in Microsurgical Breast Reconstruction N/A
Completed NCT04350411 - Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction N/A
Completed NCT06321549 - New Era of DIEP With Minimally Invasive Mastectomy
Withdrawn NCT03135392 - Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer N/A
Completed NCT01256502 - The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery N/A
Active, not recruiting NCT04715802 - Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Active, not recruiting NCT04491591 - Implementing BREASTChoice Into Practice N/A
Recruiting NCT04661501 - BREAST ADM Trial for Alloplastic Breast Reconstruction N/A
Suspended NCT03625765 - Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye N/A
Withdrawn NCT00778947 - Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction N/A