Non-Breast Implantable Medical Devices and Associated Malignancies: A Systematic Review.

ABSTRACT

Innovation in healthcare has led to the development of numerous implantable medical devices (IMDs). However, advances in our knowledge of breast implant-associated malignancies have raised questions about the prevalence, etiology and management of malignancies associated with non-breast IMDs. The objective of this study was to examine the prevalence and characteristics of malignancies associated with non-breast IMDs. An expert medical librarian developed the search strategy for this review. Databases included MEDLINE (National Library of Medicine, Bethesda, MD; date range of search 1946 to June 21, 2023), EMBASE (Elsevier, Amsterdam, the Netherlands; date range of search 1946 to June 21, 2023), and Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane Library, Wiley, Hoboken, NJ; date range of search 1946 to June 21, 2023). In addition, grey literature sources were searched and relevant references from systematic reviews and meta-analyses were included. The PRISMA guideline was used to guide the review. Risk of bias was evaluated using the JBI Critical Appraisal tools. A total of 12,230 articles were reviewed with a total of 77 meeting inclusion criteria. Risk of bias was highest with case reports (moderate, average of 65.1% with range of 37.5 to 100%) and low for the remaining study types. In total, 616 cases of IMD-associated malignancies were identified. Malignancies associated with IMDs were reported in the head/neck (543, 88.1%), lower extremity (57, 9.6%), thorax (9, 1.4%), abdomen (3, 0.5%), and genitourinary system (2, 0.3%). The most common malignancy type in the lower extremity was sarcoma, in the head and neck was squamous cell carcinoma, and in the thorax was lymphoma. This study is the first comprehensive systematic review of its kind. Overall, the oncologic risk of IMDs is low. The discussion of malignancy is an important part to the overall consent process and malignancy should be considered with any new signs or symptoms in the anatomic area of an implant. More data is needed to better understand how primary malignancies occur around IMDs and how to reduce this risk.