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Invited Commentary
Public Health
September 20, 2021

Silicone Breast Implants and Disease—Many Questions Unanswered

Author Affiliations
  • 1Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
  • 2Department of Reconstructive Plastic Surgery, Karolinska University Hospital, Stockholm, Sweden
  • 3Department of Endocrine, Breast and Sarcoma Surgery, Karolinska University Hospital, Stockholm, Sweden
JAMA Netw Open. 2021;4(9):e2128947. doi:10.1001/jamanetworkopen.2021.28947

The study by Dijkman et al1 set out to investigate whether there were differences in silicone bleed and migration among cohesive and noncohesive silicone gel breast implants, and they found no significant differences. In the study by Dijkman et al,1 histological presence of silicone in tissues from women who had undergone removal or revision surgery for silicone breast implants between 1986 and 2020 at the Radboud University Medical Centre in the Netherlands was investigated. Specimens from capsules, surrounding tissues, and lymph nodes were included for 389 women. Of these women, 384 (98.7%) had silicones present in the samples. In 40 of 41 women (97.6%) for whom analysis of lymph nodes had been conducted, silicone was present.1

The indication for implant removal was not documented in the study by Dijkman et al1; therefore, it is not known which symptoms, if any, the women had experienced. It is unlikely that asymptomatic women represent a large proportion of the women who underwent removal or revision surgery in this public hospital setting. Therefore, the women in the study cannot be assumed to be representative of women with silicone breast implants in general. It is also not clear if the implants were ruptured or intact.

The clinical relevance of silicone deposition in the capsule, surrounding tissue, and lymph nodes remain to be investigated. In 360 women (92.5%), Dijkman et al1 detected evidence of histiocytic reaction and/or inflammatory response. This indicates that silicone may not be inert. Whether this inflammatory response can lead to or contribute to the development of disease remains to be investigated in well-designed, unbiased, prospective trials and cohort studies.

Women with silicone breast implants sometimes present with symptoms consistent with suspected implant rupture as well as adenopathy. In addition to histological analysis to investigate for silicone deposition, it is possible to perform radiological assessment. Magnetic resonance imaging (MRI) has been considered the criterion standard by the American College of Radiology for assessment of breast implants and silicone deposition in regional lymph nodes. However, new guidelines from the US Food and Drug Administration consider ultrasonographic examination as an equivalent modality.2

Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) has emerged as a rare but malignant complication of breast implants. Textured implants have been reported to have a risk of complication many times higher than that of smooth-surface implants, and therefore, certain implants have been retracted from the market.3 Incidence of BIA-ALCL and policy on the use of textured silicone breast implants vary greatly among European countries.4 This gives rise to many research questions relating to implant-related risk factors, as well as potential genetic predispositions in certain populations. Theories regarding how silicone and biofilm with resulting low-grade chronic infection may trigger inflammatory response that could lead to the development of BIA-ALCL exist. Well-designed prospective research has yet to verify or refute these theories.

Silicone breast implants were introduced in the 1960s, and their associations with connective tissue diseases have been proposed since then.5 Breast implant illness is the most current term for a potential association between silicone breast implants and a range of symptoms, including fatigue, hair loss, and chronic pain. The existence of this syndrome is debated. A 2021 literature review by Kaplan and Rohrich6 concluded there was no evidence to support the formation of such a syndrome. Nonetheless, many women with breast implants experience these sometimes debilitating symptoms, and the level of evidence to support the treatment of these women leaves room for improvement.5

Each year, millions of women receive silicone breast implants for reconstructive and aesthetic purposes. Therefore, whether the use of these implants is associated with or may even cause certain diseases and syndromes is of great public health interest. The potential pool of participants with breast implants for large trials and cohort studies definitely exists to investigate outcomes associated with or even caused by silicone bleed and migration, as well as other issues that may be related to silicone breast implants. One would expect that the funding for such studies could also be available, given the significant amounts of financial resources that are involved in the use of silicone breast implants.

As we wait for these studies to be carried out, there is probably room for more transparent information to women who are considering or already have breast implants.7 This transparency is vital to improve informed decision-making regarding the likelihood of silicone deposition in tissues adjacent to and distant from the implants.

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Article Information

Published: September 20, 2021. doi:10.1001/jamanetworkopen.2021.28947

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Löfgren J et al. JAMA Network Open.

Corresponding Author: Jenny Löfgren, MD, PhD, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Solna (L1:00), Stockholm, N/A 17177 Sweden (jenny.lofgren@ki.se).

Conflict of Interest Disclosures: None reported.

Dijkman  HBPM, Slaats  I, Bult  P.  Assessment of silicone particle migration among women undergoing removal or revision of silicone breast implants in the Netherlands.   JAMA Netw Open. 2021;4(9):e2125381. doi:10.1001/jamanetworkopen.2021.25381Google Scholar
Carr  LW, Roberts  J, Mericli  AF, Liu  J, Arribas  EM, Clemens  MW.  Breast implant imaging surveillance among U.S. plastic surgeons: U.S. Food and Drug Administration recommendations versus clinical reality.   Plast Reconstr Surg. 2020;145(6):1381-1387. doi:10.1097/PRS.0000000000006812 PubMedGoogle ScholarCrossref
Food and Drug Administration. Medical device reports of breast implant-associated anaplastic large cell lymphoma. Accessed August 20, 2021. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
Stark  B, Magnéli  M, van Heijningen  I,  et al.  Considerations on the demography of BIA-ALCL in European countries based on an E(A)SAPS survey.   Aesthetic Plast Surg. Published online July 20, 2021. doi:10.1007/s00266-021-02411-3 PubMedGoogle Scholar
Magnusson  MR, Cooter  RD, Rakhorst  H, McGuire  PA, Adams  WP  Jr, Deva  AK.  Breast Implant Illness: A Way Forward.   Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):74S-81S. doi:10.1097/PRS.0000000000005573PubMedGoogle Scholar
Kaplan  J, Rohrich  R.  Breast implant illness: a topic in review.   Gland Surg. 2021;10(1):430-443. doi:10.21037/gs-20-231 PubMedGoogle ScholarCrossref
Food and Drug Administration. Breast implants—certain labeling recommendations to improve patient communication. Accessed August 20, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication