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

Breast Reconstruction Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

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 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.

On September 10th, 2014, Mentor received FDA approval for the CPG Styles 312, 322, 323, and 332. The study is now closed to new subject enrollment. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Reconstruction
• Breast Revision

• NCT number: NCT01959880
• Study type: Interventional
• Source: Mentor Worldwide, LLC
• Status: Completed
• Phase: Phase 3
• Start date: August 2013
• Completion date: December 2014