Hello All,

An important new study:

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

In:  JAMA Network Open 2021;4(9):e2125381. doi:10.1001/jamanetworkopen.2021.25381

Authors:  Henry B. P. M. Dijkman PhD; Inca Slaats BSc; Peter Bult PhD MD.

Abstract:  "IMPORTANCE:  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.  OBJECTIVE:  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. DESIGN, SETTING, AND PARTICIPANTS:  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.  EXPOSURES: Silicone breast implants.  MAIN OUTCOMES AND MEASURES:  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.  RESULTS:  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 (silicon detected outside or inside capsule: 44 women [95.7%] vs 340 women [99.1%];P= .19). 
CONCLUSIONS AND RELEVANCE:  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."

From the full text:  "CONCLUSIONS: In this case series, we found that noncohesive as well as cohesive gel SBIs bleed silicones, resulting in migration of silicones beyond the capsule, which occurred in 86.6% of women investigated. As SBIs are associated with complications and even cancer, women should be well informed about the potential harms before these implants are placed into the body.

"As the safety of SBIs is questioned more and more, we propose some recommendations. First, future studies should focus more on a potential causative relationship between silicones and complications and malignant neoplasms (BIA-ALCL), including samples from healthy women without SBIs and women with implants with and without signs of toxic effects. Such analyses might include blood analysis with ciRNaseq technology for early stage detection of silicone toxic effects, other blood analyses (eg, antibodies against silicones, cytokine levels, number of different types of inflammatory cells), analyses of hairs of the crown to detect systemic spread of silicones (eg, platinum levels), tissue analyses (eg, amount of silicones, type and amount of inflammatory cells, cytokine levels), and analysis of potential (e.g., genetic) predisposition of women for developing silicone-related complications.

"Second, the use of silicone gel-filled implants should be stopped until their safety has been proven. For breast reconstruction, autologous reconstruction should be used as often as possible. If silicone shell breast implants are used (when other options are not possible), they should be filled with saline or other known nontoxic fluids. If patients experience complications from their SBIs, explantation (with complete excision of the capsule) should be offered. The costs of this procedure should be reimbursed by the health insurance companies."

Open access:  https://pubmed.ncbi.nlm.nih.gov/34542618/


With best regards,

Debbie

Debra Swank, RN BSN IBCLC
Program Director
More Than Reflexes Education
Elkins, West Virginia USA
http://www.MoreThanReflexes.org

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