Protocol for retrieval and analysis of breast implants.
The Center for Implant Retrieval and Analysis has been established at Washington University's Division of Plastic and Reconstructive Surgery for the purpose of studying implantable devices retrieved after surgery or autopsy and assessing their condition after implantation. Since the early 1990s, significant experience has been gained in testing and analyzing silicone gel breast implants and, to a lesser extent, saline-filled devices. However, there has been no systematic method reported for collecting and evaluating these implants in a way that would permit different laboratories to compare their data. This article offers the plastic and reconstructive surgery community a standardized protocol for analyzing explanted silicone gel and saline-filled breast implants. The protocol gives surgeons a clearly defined approach for removing, handling, documenting, and shipping explanted breast implants. At the same time, biomaterials researchers can use the protocol to acquire implant data with reliable and reproducible methods. Because the study of saline implants has lagged behind the study of silicone gel implants, the article concludes with a demonstration of how this protocol can be applied to obtain mechanical properties data and use scanning electron microscopy to illuminate failure mechanisms of saline devices, including three explants removed after 20+ years in vivo.
Brandon
Harold J
HJ
Center for Implant Retrieval and Analysis, Washington University, St. Louis, Missouri 63130, USA. hjb@mecf.wustl.edu
Young
V Leroy
VL
Watson
Marla E
ME
Wolf
Clarence J
CJ
Jerina
Kenneth L
KL
D018427:Breast Implants / Q000009:adverse effects*; D002985:Clinical Protocols; D020878:Device Removal / Q000379:methods*; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods*; D005260:Female; D006801:Humans; D020034:Silicone Gels / Q000627:therapeutic use; D012965:Sodium Chloride / Q000627:therapeutic use
D020034:Silicone Gels; D012965:Sodium Chloride