Symptom Improvement After Explantation With No Capsulectomy for Systemic Symptoms Associated With Breast Implants.

BACKGROUND: Systemic symptoms associated with breast implants (SSBI) is a term used to describe a group of patients who attribute a variety of symptoms to their implants. Previous studies have shown symptom improvement after implant removal in these patients irrespective of whether part or all the implant capsule has been removed. OBJECTIVES: The aim of this study was to evaluate implant removal with no capsule removed in symptomatic and control subjects. METHODS: Eligible study subjects were sequentially enrolled at 5 investigator sites. The SSBI Cohort included patients with systemic symptoms they attributed to their implants who requested explantation. The Non-SSBI Cohort included subjects without systemic symptoms attributed to their implants who requested explantation with or without replacement. All subjects agreed to undergo explantation without removal of any capsule. RESULTS: Systemic symptom improvement was noted in SSBI subjects without removal of the implant capsule, comparable to the results of our previously published study. SSBI patients showed a 74% reduction in self-reported symptoms at 6 months with no capsulectomy which was not statistically different from partial or total capsulectomies (P = .23). CONCLUSIONS: Explantation with or without capsulectomy provides symptom improvement in patients with systemic symptoms they associate with their implants.

IL-9 is a Biomarker of BIA-ALCL Detected Rapidly By Lateral Flow Assay.

BACKGROUND: A delayed seroma around breast implants is the most common clinical presentation of BIA-ALCL. However, most seromas are due to benign causes. Therefore, it is essential to distinguish benign seromas from seromas due to BIA-ALCL. In a prior study mean concentrations of IL-9, IL-10 and IL-13 were found to be significantly higher in BIA-ALCL than in benign seromas. OBJECTIVES: The aim of this research was to test the ability to detect high concentrations of IL-9 rapidly with a lateral flow assay (LFA). Because we previously reported that a LFA for CD30 detected BIA-ALCL in seromas we compared CD30 and IL-9 LFAs in distinguishing BIA-ALCL from benign seromas. METHODS: Thirty microliter samples of 26 seromas (15 benign, 11 malignant) were tested on in-house prepared strips for IL-9 and CD30. Nanoparticle-conjugated antibodies specific to IL-9 and CD30 were used for detection. IL-9 was analyzed in undiluted samples and CD30 samples were optimized at 1:3 dilution. The dynamic range of detection was determined by spiking recombinant IL-9 into a benign seroma. Image analysis measured intensity of both test line (TL) and control line (CL) and a TL/CL ratio was calculated. IL-9 protein and IL-9 transcription factor PU.1 were stained in BIA-ALCL lines and clinical samples. RESULTS: The IL-9 LFA was reliable in distinguishing BIA-ALCL from benign seromas when the concentration of IL-9 was greater than 10 ng/ml. The CD30 LFA was positive in all 11 malignant cases. In one case with only faint CD30 and IL-10 test lines, the IL-9 LFA was clearly positive. Immunohistochemistry showed IL-9 and its essential transcription factor PU.1 were present in tumor cells in BIA-ALCL lines and clinical samples. CONCLUSIONS: IL-9 is a tumor cell biomarker of BIA-ALCL that can be detected by lateral flow assay and immunohistochemistry. Concentrations of IL-9 greater than 10 ng/ml reliably distinguished BIA-ALCL from benign seromas. Moreover, IL-9 LFA could detect BIA-ALCL when CD30 LFA was not definitive and IL-10 was of low concentration with a faint IL-10 TL, suggesting a multiplex LFA including IL-9, CD30 and IL-10 might be more effective in detecting BIA-ALCL in selected cases.

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

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.

Is capsulectomy necessary for symptom improvement in patients undergoing implant removal for systemic symptoms?

A case of symptom improvement after implant removal without capsulectomy is presented with a review of the literature.