A Clinical Study of McGhan Corporation-Style 410 Silicone-Filled Breast Implants

The McGhan Style 410 Silicone-Filled Breast Implant is an investigational device. The purpose of this study is to evaluate the long-term appearance and quality of life of women who receive this implant. The principal feature that distinguishes this style from other silicone-filled breast implants is that the implant contains a cohesive “silicone fill.” The device also has a broader range of shapes and sizes.

Women who participate in this study will complete quality of life and activity/lifestyle questionnaires before receiving the implant, and periodically throughout the following 10 years. A year after surgery, photographs will be taken of the breast/chest area by each woman’s surgeon or his/her staff. All photographs and questionnaire responses will be kept confidential.