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

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.