McGhan Medical Silicone-Filled Breast Implant Adjunct Study
Breast Reconstruction With Silicone Implants
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||McGhan Medical Silicone-Filled Breast Implant Adjunct Study|
- Evidence of breast implant complications [ Time Frame: 10 years 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 1998|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|