Hepatobiliary complications from ruptured silicone breast implants

000292 10.3205/000292 urn:nbn:de:0183-0002923 Review Article Hepatobiliary complications from ruptured silicone breast implants – a comprehensive literature review Hepatobiliäre Komplikationen nach Ruptur von Brustimplantaten auf Silikonbasis – eine Übersicht der publizierten Literatur Agilinko Agilinko Joshua J

Department of General Surgery, North Middlesex University Hospital, Sterling Way, London N18 1QX, United Kingdom, Phone: +44 7759843220Department of General Surgery, North Middlesex University Hospital, London, United KingdomDepartment of General Surgery, Aberdeen Royal Infirmary, Aberdeen, United Kingdom

j.agilinko@doctors.org.uk author Raj Raj Dharshanan D

Department of General Surgery, Aberdeen Royal Infirmary, Aberdeen, United Kingdom

author Wong Wong Ken Vin KV

Department of General Surgery, Aberdeen Royal Infirmary, Aberdeen, United Kingdom

author Fanelli Fanelli Daniele D

Department of General Surgery, Aberdeen Royal Infirmary, Aberdeen, United Kingdom

author Ng Ng Nicklaus N

University of Aberdeen School of Medicine and Dentistry, Aberdeen, United Kingdom

author Agilinko Agilinko Bertrand B

Sandema District Hospital, Sandema, Ghana

author Hasan Hasan Mohammad M

Department of General Surgery, Aberdeen Royal Infirmary, Aberdeen, United Kingdom

author German Medical Science GMS Publishing House

Düsseldorf

610 literature review silicone implants hepatobiliary complications Surgery 20200801 20200918 20210525 engl This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). 1612-3174 19 GMS German Medical Science GMS Ger Med Sci 05 Cronin and Gerow first introduced silicone breast implants in 1962; they now serve as first-line for breast augmentation. Breast augmentation is effective in restoring both physical and psychological well-being in women post-mastectomy.Many studies in the literature on complications of silicone breast implant rupture focus on lymphomas and capsular contractures. Only a few studies discuss the hepatobiliary complications.By reviewing the literature over the past 30 years, the authors aim to analyse the clinical presentation, diagnostic findings, as well as management outcomes amongst women with ruptured silicone implant-relate</PlainText></TextGroup>d hepatobiliary complications. To the best of our knowledge, this is the first comprehensive review on this topic.</Pgraph></Abstract> <TextBlock linked="yes" name="Introduction"> <MainHeadline>Introduction</MainHeadline><Pgraph>Societal expectations and evolving importance of the ideal female body has led to a rise in the practice of breast augmentation surgeries.</Pgraph><Pgraph>In 1895, Vincenz Czerny was the first surgeon to attempt breast augmentation surgery by transferring lumbar lipoma to the breast tissue <TextLink reference="1"></TextLink>.</Pgraph><Pgraph>Concerns over first-generational breast implants like polytetrafluoroethylene stemmed from their thick shells, leading to higher rates of capsular contractures and subsequent rupture and leakage of implant material <TextLink reference="2"></TextLink>.</Pgraph><Pgraph>Cronin and Gerow introduced silicone breast implants in 1962; they are now the first line devices in breast augmentation. Their smooth-textured shells offer a stable spatial filling post-mastectomy <TextLink reference="3"></TextLink>.</Pgraph><Pgraph>Since then, silicone implants have undergone several modifications to reduce the risk of leak, which causes local and systemic post-surgical/procedure complications.</Pgraph><Pgraph>Proposed mechanisms for silicone implant rupture include trauma to implant and shell swelling; the latter a phenomenon explaining a decrease in shell strength due to migration of silicone fluid from the gel <TextLink reference="4"></TextLink>.</Pgraph><Pgraph>The focus of many studies on complications of silicone breast implant rupture centre on lymphoma and capsular contracture <TextLink reference="5"></TextLink>, <TextLink reference="6"></TextLink>. Only few studies discuss the hepatobiliary complications <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>, <TextLink reference="9"></TextLink>.</Pgraph><Pgraph>By reviewing the literature over the past 30 years, the aim of this review is to analyse the clinical presentation, diagnostic findings, as well as management and treatment outcomes amongst adults with ruptured silicone implant-related hepatobiliary complications.</Pgraph></TextBlock> <TextBlock linked="yes" name="Methods and materials"> <MainHeadline>Methods and materials</MainHeadline><SubHeadline>Search strategy</SubHeadline><Pgraph>This literature review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines <TextLink reference="10"></TextLink> (Figure 1 <ImgLink imgNo="1" imgType="figure"/>).</Pgraph><Pgraph>The literature search was performed using Pubmed, Medline and Embase in July 2020. The search terms included: (“silicone” AND “breast”) AND (“hepatobiliary” OR “liver” OR “hepatic”). The titles and abstracts were screened by DR and KW while NG independently verified inclusion of the articles. Any discrepancies were resolved by consulting the lead author (JA). Inclusion criteria included:</Pgraph><Pgraph><UnorderedList><ListItem level="1">silicone implants,</ListItem><ListItem level="1">hepatobiliary complications,</ListItem><ListItem level="1">English language.</ListItem></UnorderedList></Pgraph><Pgraph>Exclusion criteria were:</Pgraph><Pgraph><UnorderedList><ListItem level="1">saline or other implant type,</ListItem><ListItem level="1">non-hepatobiliary complications (local or systemic).</ListItem></UnorderedList></Pgraph><Pgraph>These criteria were applied throughout the titles and abstract screening stage and the full-text articles reviewing process.</Pgraph><SubHeadline>Data extraction and quality assessment</SubHeadline><Pgraph>Quantitative aspects were represented by demographics, type and severity of hepatobiliary complications.</Pgraph><Pgraph>Each study was assigned a level of evidence according to the Oxford (UK) CEBM Levels of Evidence. Quality assessment was conducted with the JBI critical appraisal checklist for case reports <TextLink reference="11"></TextLink>. This tool considers the quality of description of demographic characteristics, patients’ history, clinical course and investigations. Only case reports achieving a minimum score of 5 out of 8 were included.</Pgraph><Pgraph>We could not perform a formal meta-analysis considering the absence of randomized controlled trials and cohort studies. Instead, we conducted a critical appraisal of the available literature, describing patients’ characteristics, clinical course, investigations and treatment.</Pgraph><SubHeadline>Statistical analysis</SubHeadline><Pgraph>Descriptive statistics were performed with the numbers available. Weighted means and standard deviations (SD) were calculated for data regarding demographics and complications severity categories.</Pgraph><Pgraph>When SD were not directly provided, these were calculated with the equation [max range–min range/4].</Pgraph></TextBlock> <TextBlock linked="yes" name="Results"> <MainHeadline>Results</MainHeadline><Pgraph>The search strategy revealed paucity of literature in the research topic, with 3 papers (4 case reports) describing hepatobiliary complications after ruptured silicone breast implants <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>, <TextLink reference="9"></TextLink>. A paper by Tan et al. (titled: hepatobiliary complications following breast implants: a case report and literature review) was excluded, as the paper has since been retracted from literature by the time the authors of this paper finished writing.</Pgraph><Pgraph>The 3 studies (4 case reports) included in our final review are summarised in the Case summary and Table 1 <ImgLink imgNo="1" imgType="table"/>.</Pgraph></TextBlock> <TextBlock linked="yes" name="Case summary"> <MainHeadline>Case summary</MainHeadline><SubHeadline>Age and ethnicity</SubHeadline><Pgraph>The mean age in years at the time of presentation was 50 (range:38–58). Information about ethnicity was available in all the papers: 3 Caucasians <TextLink reference="8"></TextLink>, <TextLink reference="9"></TextLink>; and <TextGroup><PlainText>1 H</PlainText></TextGroup>ispanic <TextLink reference="7"></TextLink>.</Pgraph><SubHeadline>Type of implant and laterality</SubHeadline><Pgraph>A polyurethane cover, filled with synthetic thermostable rubber of low molecular structure was used in 1 patient <TextLink reference="9"></TextLink>. The type of implant material was not reported in the other studies. In the 3 cases (2 studies) reporting on laterality, the implants were inserted bilaterally <TextLink reference="7"></TextLink>, <TextLink reference="9"></TextLink> and unilaterally (left breast) in 1 case <TextLink reference="7"></TextLink>.</Pgraph><SubHeadline>Duration and presenting complaint</SubHeadline><Pgraph>The mean interval between implant insertion and onse<TextGroup><PlainText>t o</PlainText></TextGroup>f symptomatology was 18.2 years (range 10–30; S<TextGroup><PlainText>D 8</PlainText></TextGroup>.05).</Pgraph><Pgraph>Abdominal pain (right upper quadrant and epigastric pain) was the most common presenting complaint <TextLink reference="7"></TextLink>, <TextLink reference="9"></TextLink>. <TextGroup><PlainText>1 p</PlainText></TextGroup>atient presented with symptoms of chronic liver disease; pruritis and lethargy <TextLink reference="7"></TextLink> and weight loss <TextLink reference="8"></TextLink>.</Pgraph><SubHeadline>Medical history</SubHeadline><Pgraph>1 patient had Sjogren’s disease with positive anti-Ro a<TextGroup><PlainText>ntibod</PlainText></TextGroup>ies <TextLink reference="7"></TextLink>. Another patient had a history of iron-deficiency anaemia secondary to menorrhagia requiring regular iron supplements <TextLink reference="8"></TextLink>. Quicke’s oedema was reported in a patient with recurrent episodes of facial swelling <TextLink reference="9"></TextLink>.</Pgraph><SubHeadline>Biochemistry and haematology</SubHeadline><Pgraph>All the patients had deranged LFTs on admission. Alanine transaminase (ALT) and aspartate aminotransferase (AST) were commonly raised <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>. Patients presenting much later after implants were inserted presented with greater LFTs derangement. In 2 patients, mild anaemia was demonstrated on haematology findings <TextLink reference="7"></TextLink>, <TextLink reference="9"></TextLink>. In 1 patient, inflammatory markers such as C-reactive protein and erythrocyte sedimentation rate were raised <TextLink reference="8"></TextLink>.</Pgraph><SubHeadline>Virology and serology</SubHeadline><Pgraph>A test for viral hepatitis was normal in 3 patients <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>. In the same patients, antinuclear (ANCA) and antimitochondrial (AMA) antibodies were normal.</Pgraph><SubHeadline>Histology and immunohistochemistry</SubHeadline><Pgraph>Histology and immunohistochemistry findings were diagnostic for silica-induced hepatobiliary pathology in all the studies. The most common liver biopsy finding was granulomatous material within the liver parenchyma; <TextGroup><PlainText>1 p</PlainText></TextGroup>atient had necrotic material <TextLink reference="7"></TextLink> and 2 were non-necrotic <TextLink reference="8"></TextLink>. The foamy, multi-vacuolated granulomatous material compatible with silicone was reported in the former patient <TextLink reference="7"></TextLink>. In 2 cases, trichrome stain and energy dispe<TextGroup><PlainText>rsibl</PlainText></TextGroup>e spectroscopy (EDS) were used <TextLink reference="8"></TextLink>; with the former reporting a “swiss cheese-like” pattern, consistent with the appearance of a silicone granuloma.</Pgraph><SubHeadline>Imaging</SubHeadline><Pgraph>In the patient who underwent liver ultrasound, there was intra-hepatic biliary dilatation and a hypoechogenic focus within the right liver lobe, most likely a silicone deposit <TextLink reference="9"></TextLink>. In the patients who had CT scan performed (n=2), a small hepatic cyst <TextLink reference="8"></TextLink> and gastrosplenic varices <TextLink reference="8"></TextLink> were reported.</Pgraph><Pgraph>The most common MRI finding was cholecystitis. MRI of the breast in 1 patient was diagnostic of ruptured breast implant, as an aetiology of their symptoms <TextLink reference="8"></TextLink>.</Pgraph><SubHeadline>Treatment and outcome</SubHeadline><Pgraph>Treatment and outcomes were only reported in 3 patients <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>. 1 patient underwent cholecystectomy for chronic cholecystitis <TextLink reference="7"></TextLink>, 1 patient was lost to follow-up <TextLink reference="8"></TextLink>, and no further management was initiated in 1 patient <TextLink reference="8"></TextLink>.</Pgraph></TextBlock> <TextBlock linked="yes" name="Discussion"> <MainHeadline>Discussion</MainHeadline><Pgraph>Augmentation mammoplasty is among the most frequently performed operations in United Kingdom. The goal is to improve patients’ quality of life based on physical appearance and self-esteem. Satisfaction rates of up to 95% have been reported in studies reviewing quality of marital life following breast augmentation surgeries <TextLink reference="12"></TextLink>.</Pgraph><Pgraph>Cronin and Gerow first introduced silicone implants in 1962 <TextLink reference="3"></TextLink>. Since then, they are first line in breast augmentation surgeries. Their thin shells and inert nature allows them to function as spatial fillers as well as having a low risk of local and systemic reactions. Despite this, concerns over their use, including risk of lymphoma and capsular contractures have been well documented in literature <TextLink reference="5"></TextLink>, <TextLink reference="6"></TextLink>. As our review shows, only few studies discuss the hepatobiliary complications associated with their rupture <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>, <TextLink reference="9"></TextLink>.</Pgraph><Pgraph>Breast implant rupture and leakage can potentially cause foreign body granulomatous reactions and deposition of silica particles in the liver parenchyma <TextLink reference="13"></TextLink>.</Pgraph><Pgraph>In a study of 149 patients, Collis and Sharpe concluded that implant rupture begins at around 6 years and by 1<TextGroup><PlainText>3 y</PlainText></TextGroup>ears, 11.8% of implants have ruptured. The median life expectancy of silicone implants is reported to be approximately 10–16 years <TextLink reference="14"></TextLink>. In our review, the median age from time of insertion of implants to abdominal symptomatology was 18.2 years.</Pgraph><Pgraph>The link between silicone implants rupture and hepatobiliary disease is not well understood. Like other inflammatory and connective tissue diseases, silicone breast implants may act as a foreign body and elicit autoantibody production in the liver parenchyma after leakage. The term “autoimmune syndrome in adjuvants”(ASIA) was coined by the immunologist Shoenfield et al. to suggest such a probable link <TextLink reference="15"></TextLink>. A case of sarcoidosis in a patient with silicone breast implant rupture has also been reported in the literature <TextLink reference="16"></TextLink>. One patient in our review had Sjögren’s syndrome with positive serum anti-Ro antib<TextGroup><PlainText>odie</PlainText></TextGroup>s.</Pgraph><Pgraph>Further to the above, current research suggests that the liver is a common site for silicone particles deposition <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>. They tend to deposit within portal tract cells activating macrophages and Kupffer cells, resulting in chronic hepatitis. Symptomatology of acute on-chronic liver disease, chronically elevated liver enzymes are hallmarks of hepatobiliary complications of ruptured silicone implants. Histopathological evidence of granulomas and silica particles on electron microscopy and energy dispersive spectroscopy has also been reported in previous studies <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>, <TextLink reference="9"></TextLink>.</Pgraph><Pgraph>The activation of macrophages explains the findings of granulomas (epithelioid/activated macrophages). The necrotic nature of some of these granulomas is greater as more Kupffer cells are produced and function to cause further breakdown of cells within the liver parenchyma.</Pgraph><Pgraph>Mechanisms for the actual rupture of breast implants have been extensively studied.</Pgraph><Pgraph>Silicone implant rupture and subsequent leakage is likely a multi-factorial process. Various mechanisms which have been proposed include trauma to the implant and the so-called ‘shell swelling’ phenomenon <TextLink reference="4"></TextLink>. Shell swelling occurs after placement of implants, and it is described as a decrease in shell strength due to migration of silicone fluid from the gel into the shell. Brandon et al. postulated that failure at the site of implants fold, as an aetiology of implant rupture <TextLink reference="17"></TextLink>. As such, implant folding is more common in the presence of capsular contracture of prolonged duration.</Pgraph><Pgraph>Concerns over first-generational breast implants like polytetrafluoroethylene stemmed from their thick shells, leading to higher rates of capsular contractures and breast distortion <TextLink reference="2"></TextLink>. It is likely that the lower contracture rates associated with the thin-shelled silicone implants reduces the rate of leakage. Spear and Murphy reported an overall rupture rate of 13% in fourth generation silicone implants <TextLink reference="18"></TextLink>.</Pgraph><Pgraph>Intracapsular silicone implant leak is relatively easier to diagnose. Changes in breast shape and size, palpable lumps and pain often give initial diagnostic clues <TextLink reference="19"></TextLink>. Contrarily, extracellular implants leak (which often leads to systemic complications) do not manifest so clearly, with clinically significant signs or reported symptoms, often classified as ‘silent’ <TextLink reference="20"></TextLink>. This makes diagnosis and subsequent management challenging. It is unsurprising, therefore, that only 50% of the patients in our review presented with abdominal pain, and relying on this to diagnose a hepatobiliary complication of implant rupture is not clinically sufficient. It is perhaps more helpful to consider abdominal pain in the context of symptomatology of chronic liver disease. Symptoms and signs of chronic liver disease including pruritus, weight loss and lethargy were seen in the patients in our review. Additionally, physical examination is an important step in the evaluation of patient symptomatology. However, the aforementioned study conducted by Hölmich and colleagues, reviewing the role of physical examination implant rupture diagnosis, reported a modest sensitivity and specificity of 30% and 88% respectively <TextLink reference="20"></TextLink>.</Pgraph><Pgraph>MRI is widely regarded as the first-line imaging modality in diagnosing intracapsular implant rupture, with a specificity of more than 90% in evaluating rupture. Classic findings include the linguini and tear drop signs <TextLink reference="21"></TextLink>. Such findings were noted in one patient in our review with ruptured left breast implant 10 years after insertion. This has led to The Food and Drug Agency in the US recommending MRI screening of female patients with silicone implants every 2–3 years <TextLink reference="22"></TextLink>; this could be adopted globally as a follow-up and prognostic investigative tool. Ultrasound can also be utilised in detecting implant ruptures. One patient in our review showed signs of a hypoechogenic focus within the right liver lobe, suggestive of silica deposit. However, ultrasound has a lower sensitivity and negative predictive value in extracapsular rupture detection <TextLink reference="23"></TextLink>.</Pgraph><Pgraph>Based on previous studies on liver fibrosis and granulomatous diseases, liver biopsy is the gold standard for diagnosis of liver diseases <TextLink reference="24"></TextLink>. Histology and immunohistochemistry of sampled liver cells was diagnostic in all 4 patients included in our review. Granulomas, both necrotic and non-necrotic, were common findings, with the former highlighting the destructive nature of silica particles deposition in the liver parenchyma.</Pgraph><Pgraph>Further to this, the Masson trichrome stain is widely used in liver studies to distinguish collagenous tissue from muscle cells <TextLink reference="25"></TextLink>. This was important in the diagnostic work-up in the patients in our review, contributing to the diagnosis of silica particles in 2 of the studies.</Pgraph><Pgraph>Definitive treatment of silicone implant rupture requires removal of implant. Remission of sarcoidosis has been reported in a patient following removal of the silicone gel <TextLink reference="16"></TextLink>.</Pgraph><Pgraph>Additional treatment involve targeted treatment; such as cholecystectomy, which one patient underwent in our study.</Pgraph></TextBlock> <TextBlock linked="yes" name="Notes"> <MainHeadline>Notes</MainHeadline><SubHeadline>Competing interests</SubHeadline><Pgraph>The authors declare that they have no competing interests.</Pgraph></TextBlock> <References linked="yes"> <Reference refNo="1"> <RefAuthor>Czerny V</RefAuthor> <RefTitle>Plastic replacement of the breast with a lipoma</RefTitle> <RefYear>1895</RefYear> <RefJournal>Chir Kong Verhandl</RefJournal> <RefPage>216</RefPage> <RefTotal>Czerny V. Plastic replacement of the breast with a lipoma. 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DOI: 10.3350/cmh.2017.0078</RefTotal> <RefLink>https://doi.org/10.3350/cmh.2017.0078</RefLink> </Reference> </References> <Media> <Tables> <Table format="png"> <MediaNo>1</MediaNo> <MediaID>1</MediaID> <Caption><Pgraph><Mark1>Table 1: Summary of papers included in final review</Mark1></Pgraph></Caption> </Table> <NoOfTables>1</NoOfTables> </Tables> <Figures> <Figure format="png" height="680" width="545"> <MediaNo>1</MediaNo> <MediaID>1</MediaID> <Caption><Pgraph><Mark1>Figure 1: PRISMA flow diagram</Mark1></Pgraph></Caption> </Figure> <NoOfPictures>1</NoOfPictures> </Figures> <InlineFigures> <NoOfPictures>0</NoOfPictures> </InlineFigures> <Attachments> <NoOfAttachments>0</NoOfAttachments> </Attachments> </Media> </OrigData> </GmsArticle>