Breast Implant Clinical Studies

Core Gel Study | Contour Profile^® Gel (CPG) Study

Clinical Studies

Over the years, Mentor has done a very thorough safety evaluation of both saline-filled breast implants and gel-filled breast implants. In addition to our own testing, Mentor has sponsored other state-of-the-art tests performed at leading academic institutions. The largest of these studies is a clinical study of more than 70,000 women with silicone gel-filled breast implants. This study was established by Mentor in 1992 in cooperation with the U.S. Food and Drug Administration (FDA).

Mentor also has conducted extensive investigations of saline-filled breast implants involving nearly 5,000 patients. The general objective of these studies was to gather information about the safety and effectiveness of breast implants. Mentor saline breast implants have received PMA (premarket application) approval from the FDA.

As we have for many years, Mentor will remain committed to providing the public with objective information about breast implant safety.

Core Gel Clinical Study of Mentor's Round Silicone Gel-Filled Mammary Implants

Mentor is conducting a clinical study to evaluate the safety and effectiveness of our silicone gel-filled mammary 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 three groups of patients: those seeking implants for general breast enlargement (Augmentation); those who are undergoing breast reconstruction (Reconstruction); and those patients who need a revision of a previous saline or silicone gel breast implant (Revision).

Silicone gel breast implants have not been generally available since 1992, when the Food and Drug Administration (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 augmentation and reconstruction procedures, as well as autologous tissue, which utilize the patient's own tissue during 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 mammary 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 three groups of patients: those seeking implants for general breast enlargement (Augmentation); those who are undergoing breast reconstruction (Reconstruction); and those patients who need a revision of a previous saline or silicone gel 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.