Mentor Clinical Trials: Mentor Silicone Breast Implants

Core Gel Clinical Study: Mentor's Round Silicone Gel-Filled Breast Implants

Mentor is conducting a clinical study to evaluate the safety and effectiveness of our silicone gel-filled breast implants. In this nationwide study, 1,000 patients enrolled at up to 60 study sites have been implanted with Mentor silicone gel-filled breast implants and will be followed for 10 years.

The study follows 3 groups of patients: those seeking breast implants for general breast enlargement (breast augmentation); those who are undergoing breast reconstruction (mastopexy); and those patients who need a breast augmentation revision of a previous saline or silicone gel breast implant (breast implant revision).

Silicone gel breast implants have not been generally available since 1992, when the FDA required implant manufacturers to collect clinical trial data. This core study will provide the required information to the FDA. While all patients will be followed for 10 years, Mentor has submitted a Premarket Approval (PMA) application to the FDA, demonstrating the safety and effectiveness of our silicone gel breast implants.

Alternative products and surgical options to silicone gel-filled breast implants are limited. These options include saline-filled breast implants for breast augmentation and breast reconstruction procedures, as well as autologous tissue, which utilize the patient's own tissue during the breast reconstruction procedures.

Current Status: Patient enrollment for this study is complete. While the PMA has been submitted to the FDA, all patients are currently being seen for their required postoperative follow-up.

Contour Profile® Gel (CPG) Clinical Study

Mentor is conducting a clinical study to evaluate the safety and effectiveness of our contour profile (shaped) gel breast implants. In this nationwide study, 950 patients enrolled at up to 60 study sites will be implanted with Mentor silicone gel-filled breast implants and followed for 10 years.

The CPG study follows 3 groups of patients: those seeking breast implants for general breast enlargement (breast augmentation); those who are undergoing breast reconstruction (mastopexy); and those patients who need a breast implant revision of a previous saline or silicone gel breast implant (breast implant revision). Surgeons participating in the study as investigators will determine patient eligibility based on the specific criteria of the protocol and patient group.

Current Status: Patient enrollment for this study is complete, and patients are currently being seen for their required postoperative follow up.