Breast Implant Safety: an Overview of Current Regulations and Screening Guidelines

Abstract

Breast implant surgery for cosmetic or reconstructive purposes is becoming increasingly common. While the devices used are regulated and approved by the US Food and Drug Administration, all patients with breast implants require continued follow-up. Many patients will seek this care from their primary care providers, especially when follow-up with their plastic surgeon is difficult. It is vital that treating clinicians are knowledgeable about the history of breast implants, routine screening guidelines, and the recent breast implant "hot topics"-breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), connective tissue disease, and breast implant illness. This paper will provide the necessary information for primary care providers to appropriately counsel patients with breast implants to maintain not only their trust, but also their health. Abbreviations BIA-ALCLBreast implant-associated anaplastic large cell lymphoma FDA US Food and Drug Administration MRI Magnetic resonance imaging TNM Tumor, node, metastasis

Major Clinical Adverse Events of Breast Implant in the Manufacturer and User Facility Device Experience Database

“…17,18 At the same time, some experts believe that silicone breast implants are not associated with BII, because many reported symptoms may have other causes, such as genetic susceptibility and family history of the patient, and there is no appropriate control group. 19 Cohen Tervaert et al 17 confirmed that silicone breast implants may lead to autoimmune diseases in genetically In this study, we analyzed the adverse events of breast implants that were reported to the FDA's MAUDE database from July 2019 to June 2022. Furthermore, by analyzing the local complications and BII of breast implants, we hope to make women who want breast implants think more about whether it is worth it.…”

“…In addition, recent studies have found that silicone breast implants are associated with an increased risk of autoimmune diseases such as systemic sclerosis, Sjögren syndrome, and sarcoidosis 17,18 . At the same time, some experts believe that silicone breast implants are not associated with BII, because many reported symptoms may have other causes, such as genetic susceptibility and family history of the patient, and there is no appropriate control group 19 . Cohen Tervaert et al 17 confirmed that silicone breast implants may lead to autoimmune diseases in genetically susceptible individuals, but they also failed to fully consider and correct some confounding factors, such as changes in microbiome, the presence of other chemical factors, and patients’ diet, hormone levels, and psychological factors.…”

Perceptions and attitudes toward unusual complications following breast implant surgeries among Saudi female patients: How knowledgeable are our patients?

“…Moreover, primary care physicians should actively screen for breast implant-related pathology when patients present with nonspecific signs or symptoms suggesting these complications and refer them to a specialized clinic when needed, especially considering the fact that BIA-ALCL has a favorable prognosis when discovered early. [ 21 ]…”

Public Awareness of Breast Implant-associated Anaplastic Large Cell Lymphoma in Saudi Arabia

“…A notable contribution was the article by McKernan et al, which was directed at guiding internal medicine physicians to better understand and handle BIA-ALCL cases. 13 The role of The National Comprehensive Cancer Network guidelines on BIA-ALCL have been recognized by the US Food and Drug Administration and widely advocated by other national specialty societies. These guidelines have helped create a standardized treatment for BIA-ALCL at all stages of the disease.…”

“…A notable contribution was the article by McKernan et al, which was directed at guiding internal medicine physicians to better understand and handle BIA-ALCL cases. 13 The role of The National Comprehensive Cancer Network guidelines…”