Assessment of Silicone Particle Migration Among Women Undergoing Removal or Revision of Silicone Breast Implants in the Netherlands

Henry B P M Dijkman,Inca Slaats,Peter Bult

doi:10.1001/jamanetworkopen.2021.25381

Abstract

Silicone breast implants have been on the market for breast augmentation or breast reconstruction for approximately 60 years but may lead to medical complications, also called breast implant illness. To evaluate the existence of silicone gel bleed and migration over a long time period, including the period in which the newer cohesive silicone gel breast implants were used. In this single-center case series, capsule tissue and lymph node samples were collected from women who underwent removal or revision of silicone breast implants from January 1, 1986, to August 18, 2020, and data were extracted from the pathological reports and revision of the histology if data were missing. All tissues were examined using standard light microscopy, some extended with modified oil red O staining and energy-dispersive radiographic spectroscopy. A total of 365 women had capsular tissue removed, including 15 patients who also had lymph nodes removed, and 24 women had only lymph nodes removed. Data were analyzed from January to May 2021. Silicone breast implants. The main outcome was presence or absence of silicones inside or outside the capsule. One-way analysis of variance was used to determine significance between groups. Among a total of 389 women with silicone breast implants (mean [SD] age, 50.5 [11.2] years), 384 women (98.8%) had silicone particles present in the tissues, indicating silicone gel bleed. In 337 women (86.6%), silicone particles were observed outside the capsule (ie, in tissues surrounding the capsule and/or lymph nodes), indicating silicone migration. In 47 women (12.1%), silicone particles were only present within the capsule. In 5 women (1.2%), no silicone particles were detected in the tissues. Patients were divided into 2 groups, with 46 women who received cohesive silicone gel breast implants and 343 women who received either an older or a newer type of breast implant. There were no differences in silicone gel bleed or migration between groups (silicone detected outside or inside capsule: 44 women [95.7%] vs 340 women [99.1%]; P = .19). In this case series including women with noncohesive or cohesive silicone gel breast implants, silicone leakage occurred in 98.8% of women, indicating silicone gel bleed, and in 86.6% of women, migration of silicone particles outside the capsule was detected.

Highlights

Silicone breast implants (SBIs), first marketed in 1962, are used worldwide for reconstructive and cosmetic purposes
In 337 women (86.6%), silicone particles were observed outside the capsule, indicating silicone migration
In this case series including women with noncohesive or cohesive silicone gel breast implants, silicone leakage occurred in 98.8% of women, indicating silicone gel bleed, and in 86.6% of women, migration of silicone particles outside the capsule was detected

Summary

Introduction

Silicone breast implants (SBIs), first marketed in 1962, are used worldwide for reconstructive and cosmetic purposes. 25 000 people receive SBIs in the Netherlands annually, compared with approximately 400 000 people in the United States, and millions of people around the world. There has been an ongoing discussion about the toxicity of SBIs, and an association with diseases and complications has been suggested.[1,2]. Attention has refocused on SBI-associated anaplastic large cell lymphoma (BIA-ALCL).[3,4] The major 2019 recall of specific SBIs owing to associations with BIA-ALCL, of which incidence is rising, has highlighted safety concerns with cosmetic SBIs and the increasing number of patients with breast implant illness.[5,6,7,8,9] Breast implant illness is used to describe various complications associated with SBIs, ranging from brain fog, hair loss, fatigue, chest pain, sleep disturbances, irritable bowel syndrome, headaches, chronic pain all over the body, and autoimmune diseases, such as lupus and fibromyalgia.[8]

Methods

Results

Discussion

Conclusion