Medical device vigilance case study : breast implants

Thumbnail Image
Μπαγουρδή, Κυριακή
Journal Title
Journal ISSN
Volume Title
Breast implants have been used for more than half a century and primarily in breast augmen-tation, one of the most popular procedures in the US. Breast implants as medical devices have, in some ways, contributed to the creation of the new medical device regulations, with stricter re-quirements in both the pre-approval and post-approval phases. This study includes bibliographic data obtained from databases such as Medline and EMBASE with the aim of providing an in-depth analysis of the evolution of breast implants as well as presenting the main adverse events that have been associated with them and have led to the updated European Medical Device Regulation of 2017. At first, specific characteristics of breast implants are presented, such as the filling material and the shell surface, their structure and shape, the place they are implanted as well as the manufacturing techniques depending on the desired texture of their surface. Moreover, a detailed history of the development and evolution of breast implants from their first market launch and their use for medical purposes, mainly for breast augmentation procedures, is presented. Adverse events observed in patients with breast implants are also reported in this chapter, and with start-ing point the PIP incident involving non-medical grade approved cases of silicone breast implants, their most important adverse events in patients worldwide are presented. Rupture and capsular contracture has been shown to be one of the most common adverse events caused by PIP breast implants. Through a more specific and thorough literature search, capsular contracture is investigated in relation to the surface topography of breast implants. The foreign body reaction of immune sys-tem, in an implantable implant, is proved to be one of the causes of capsular contracture and the role of biocompatibility appears crucial. The surface of textured implants is demonstrated to be associated with increased biocompatibility compared to implants that have a smooth surface, while the risk of capsular contracture is reduced in textured implants. However, the scientific community has been faced with a dilemma for the past decade or so. Anaplastic large cell lymphoma (ALCL) identified and recognized by health authorities in 2016 as a risk directly associated with textured breast implants has led to further studies of these types of implants. To this end, a thorough literature search was conducted along with data provided by the FDA safety database, MAUDE, with the aim of presenting the increasing incidence of ALCL associ-ated with textured breast implants. The statistics and studies presented confirm the dilemma that arises with the use of textured breast implants. Although they present a reduced risk of capsular contracture in the long term, the new risk of ALCL associated with them has led the scientific community as well as breast implant manufacturers to turn to other manufacturing techniques and innovations.
Vigilance, Breast implants, Adverse events, Capsular contracture, Breast augmentation, Literature review