MENTOR CPG CLINICAL STUDY PROTOCOL

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 that need a revision of a previous saline or silicone gel breast implant (Revision).

Current Status

Surgeons participating in the study as investigators will determine patient eligibility based on the specific criteria of the protocol and patient group.

At the present time, patient enrollment for this study is continuing. Women desiring general breast enlargement may be enrolled into the Augmentation group. Patients may be included in the Reconstruction group if they have a breast defect, breast trauma, or surgical loss of breast tissue (such as lumpectomy), or are undergoing tissue expansion requiring a permanent breast implant. If a patient needs her previous saline or silicone gel breast implants replaced, she may be included in the Revision group.

While patients or their insurance will have to pay for the surgery, there is monetary compensation for participating in the study.