Adjunct Study for Mentor H/S Gel-filled Mammary Prosthesis
To gather safety data regarding short term, post-implant events and complications needed to support Premarket Approval (PMA) submissions for Mentor H/S Silicone Gel-Filled Mammary Prostheses and to maintain a comprehensive record of the patient's outgoing medical history.
McGhan Medical Corporation Silicone-Filled Breast Implant Adjunct Clinical Study
This study is designed to collect 5 year data about possible health problems associated with breast implants. These data will be used to help determine if these implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If the data from the studies does not show that they are safe and effective to the satisfaction of the FDA, they may not be available in the future.
