McGhan Medical Silicone-Filled Breast Implant Adjunct Study
This study will collect 5 year data about any possible health problems associated with breast implants. This data will be used to help see if the implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If they are not proven safe and effective to the satisfaction of the FDA, they may not be available in the future.
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|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 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.
|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|