McGhan Medical Silicone-Filled Breast Implant Adjunct Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00581984|
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : October 16, 2013
|Condition or disease|
|Breast Reconstruction With Silicone Implants|
This prospective clinical study is being undertaken to document the safety of McGhan Medical Silicone-Filled Breast Implants. Patients will be evaluated pre-operatively, intraoperatively, and at one, three and five years following implant surgery. Safety of McGhan Medical Silicone-Filled Breast Implants will be assessed based on the incidence of medical complications, implant failure and serious adverse effects.
This prospective clinical study of McGhan Medical Silicone-Filled Breast Implants is part of an ongoing research effort to document the safety and effectiveness of silicone-filled breast implants.
|Study Type :||Observational|
|Actual Enrollment :||1016 participants|
|Official Title:||McGhan Medical Silicone-Filled Breast Implant Adjunct Study|
|Study Start Date :||September 1998|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
- Evidence of breast implant complications [ Time Frame: 10 years 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581984
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Peter Cordeiro, MD||Memorial Sloan Kettering Cancer Center|