View clinical trials related to Breast Revision.
Filter by:Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants. This study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant. The two main complications of breast implants are capsular contracture and rupture; these complications can take years to develop. The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years. Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3, 5, 8 and 10 years thereafter. The study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture and infection will be collected and used to determine device safety.
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. With approval of MemoryShape™ Medium Height, Moderate Profile (CPG 321) Breast Implants on June 14, 2013, CPG CA Study subject enrollment has closed and the study has converted to a post approval study for this style.
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at centers across the United States will be enrolled in this research study. These patients will be implanted with silicone breast prostheses and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.