Microscopy analysis of breast implant rupture caused by surgical instrument damage.

BACKGROUND The mechanism of breast implant rupture has continued to be an important topic throughout the plastic surgery community and regulatory agencies, such as the US Food and Drug Administration. Retrieved ruptured implants returned to Allergan (Santa Barbara, CA; formerly Inamed Corporation) for analysis exhibit various modes of failure, which can include a small pinhole (approximately 1 to 2 mm in size) in the shell, a ruptured shell, or a severely fragmented shell. OBJECTIVE The failure mechanisms and associated morphologic features for the modes of implant failure can be quite different. The objective of this study is to analyze and describe the rupture characteristics of silicone gel-filled implants that failed because of surgical instrument damage. METHODS There are several types of diagnostic techniques available to analyze ruptured implants. Visual inspection, physical examination, and photographic analysis provided an overall description of the implant shape and gross features of the shell failure region. These techniques allowed categorization and documentation of the mode of failure and were quite useful as a supplemental tool in the diagnosis of implant failure mechanisms. Microscopy techniques provided details of the ruptured shell region and could be used to determine the cause of breast implant failure. This study involved the use of optical microscopy and scanning electron microscopy in the analysis of ruptured breast implants. RESULTS Details of the geometry of ruptured shell regions are described. Illustrations are also presented in which 35-mm photography is used to assist in substantiating the cause of failure. Many of the ruptured regions exhibit striations across the thickness of the shell. Micrographs are presented that clearly show that the striations are due to lines in the cutting surface of the surgical instrument that were formed during the manufacturing process. CONCLUSIONS This article demonstrates that, with the proper background and experience in analyzing ruptured breast implant shells, the features at the failure site can be correctly interpreted and the corresponding failure mechanisms can be diagnosed. Breast implants are subject to surgical instrument damage during implantation, and this damage can develop into a shell rupture, with the failure mode identifiable via microscopy analysis.