- Email: [email protected]
Polyacrylamide gel breast augmentation: report of two cases and review of the literature
Clinical Imaging xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Clinical Imaging journal homepage: http://www.clinicalimaging.org
Polyacrylamide gel breast augmentation: report of two cases and review of the literature Nathaniel E. Margolis a,⁎, Brian Bassiri-Tehrani b, Chloe Chhor a, Cory Singer a, Osvaldo Hernandez c, Linda Moy a a b c
Department of Radiology, New York University Langone Medical Center, New York, NY USA Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA USA Department of Pathology, New York University Langone Medical Center, New York, NY USA
a r t i c l e
i n f o
Article history: Received 23 May 2014 Received in revised form 25 November 2014 Accepted 12 December 2014 Available online xxxx Keywords: Polyacrylamide gel Breast augmentation Foreign body reaction Breast injection Mammography
a b s t r a c t Polyacrylamide gel (PAAG) injection remains an uncommon method of breast augmentation. Providers must recognize the clinical and radiological manifestations to optimize management. The clinical and radiological findings of PAAG injection may mimic malignancy and silicone breast augmentation. We described two patients with prior PAAG breast augmentation with physical exam and imaging findings concerning for malignancy. We reviewed the literature on PAAG breast augmentation and compare PAAG to silicone breast augmentation. The management of such patients is discussed. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Polyacrylamide gel (PAAG) is a stable, nontoxic highly hydrophilic substance with 2.5% cross-linked polyacrylamide and 97.5% water [1]. Its high water content allows PAAG to be readily integrated within surrounding connective tissue and fat. When hydrated, PAAG forms a gel, which is commonly exploited in everyday items such as contact lenses, food packaging, and water purification [2]. Though PAAG was first introduced in the 1970s, it was not popularized for breast augmentation until 1997 by China and the Soviet Union [2]. Soon after, the Russian ministry prohibited PAAG injection for fear that it may lead to glandular atrophy [3]. The Chinese State Food and Drug Administration followed suit in 2006 and also banned PAAG sale, production, and use. There are still countries, such as Iran, that have yet to prohibit PAAG use. Thousands of women in foreign countries to date have used PAAG injection for breast augmentation, though exact numbers are not published [4]. Although PAAG is banned in most countries, patients may present with symptoms related to PAAG augmentation, which may mimic malignancy clinically and radiographically [2]. Because of this, it is essential
⁎ Corresponding author. Department of Radiology, New York University Langone Medical Center, New York, NY, USA. Tel.: +1 914 844 8634; fax: +1 212 731 5556. E-mail addresses: [email protected] (N.E. Margolis), [email protected] (B. Bassiri-Tehrani), [email protected] (C. Chhor), [email protected] (C. Singer), [email protected] (O. Hernandez), [email protected] (L. Moy).
for health care providers to be cognizant of the signs and symptoms PAAG breast augmentation. Radiologists in particular should be aware of the imaging findings of PAAG in order to correctly diagnose patients who present for workup of palpable abnormalities or for cancer screening. In the absence of an accurate surgical history, the clinical and radiological features of PAAG augmentation may overlap with silicone breast augmentation. However, the pathologic features and management techniques of PAAG augmentation differ from those of silicone augmentation. If removal of PAAG is desired, several management strategies are available: watchful waiting, aspiration, and surgical removal. In this article, we report two cases of PAAG breast augmentation and present an associated review of the literature. 2. Case #1 A 42-year-old Chinese female with history of breast augmentation with injection of PAAG in China 4 years prior (in 2008) presented with a palpable lump in the left breast. A well-circumscribed mass was seen in the upper outer left breast on mammogram and ultrasound (Figs. 1 and 2), which was biopsy proven to be foreign body reaction (Fig. 3). A right mammogram performed as part of the workup showed pleomorphic microcalcifications in the upper outer quadrant of the right breast middle to posterior depth (Fig. 4). Patient underwent stereotactic core biopsy of the microcalcifications. The samples obtained consisted of thick gelatinous material that extruded from the biopsy site. A clip was inserted into the biopsy cavity but was displaced out of the
http://dx.doi.org/10.1016/j.clinimag.2014.12.008 0899-7071/© 2015 Elsevier Inc. All rights reserved.
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
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Fig. 1. Case #1: Left breast mammograms. (A) Left mediolateral oblique (MLO) mammogram demonstrating a mass in left upper outer breast corresponding with the patient’s palpable abnormality (arrow). The breast parenchyma appears extremely dense, which may be related to the injected PAAG. (B) Left MLO spot magnification view of the palpable mass demonstrating indistinct margins and associated pleomorphic microcalcifications (arrow).
breast by the extruding gel like material. Once the needle was removed, no additional gel-material extruded from the access site. The right breast biopsy yielded foreign body reaction (Fig. 5). 3. Case #2 A 29-year-old Chinese female with a history of breast augmentation with injection of PAAG in China 8 years prior (in 2003) presented with a palpable left breast mass. Ultrasound of the palpable abnormality in the left breast at the 5:00 axis, 2 cm from the nipple revealed a small hypoechoic mass outside the injected PAAG material (Fig. 6). Ultrasound-guided fine needle aspiration yielded benign ductal proliferation with hyperplastic/papillary features. Subsequently, the patient underwent needle localization (Fig. 7) and excision, with final surgical pathology consistent with sclerosing intraductal papilloma. As this was a high-risk lesion, the patient also underwent follow-up magnetic resonance imaging (MRI), which demonstrated extensive PAAG injection within the retroglandular tissues and pectoralis muscle (Fig. 8). There was extension of the PAAG into the extrapleural space. 4. Discussion The purpose of our manuscript is to report two cases of women who have undergone breast augmentation with PAAG injections and to perform an associated review of the literature in this section. Marketed as a “minimally invasive” procedure, patients became enthralled with PAAG as a quick, nonsurgical, and seemingly safe way to undergo breast
A
augmentation. While PAAG was once believed to be safe for injection for breast augmentation, recent literature exhibits a constellation of complications associated with its use. We have reported two cases of patients presenting with palpable breast masses and suspicious imaging findings following PAAG breast augmentation. Since PAAG is injected blindly, the outcome is often unpredictable. Though typically retroglandular, an intraglandular approach has been seen, producing multiple PAAG masses in the breast. Inadvertently, the gel can be injected into the pectoralis muscle. The gel can then extravasate into the extrapleural space, as seen in case #2 [6]. PAAG can spread via direct extension to create subcutaneous nodules in the inframammary fold, axilla, sternum, and infraclavicular region if the gel is injected in the subcutaneous plane [7]. Gel migration is more likely to occur if the fibrous capsule surrounding the gel is thin. Certain factors like gravity or constant pectoralis major muscle contraction can accelerate gel migration by disrupting the fibrous capsule. In contrast, the fibrous capsule surrounding ruptured silicone breast implants is generally thicker than those after PAAG injection, thereby making silicone gel migration relatively less common [1]. Signs and symptoms of PAAG breast augmentation include breast lumps, contour abnormalities, abnormal skin sensation, mastalgia, mastodynia, infection, induration, and inflammation [8]. The most common sign or symptom of PAAG injection is the development of breast lumps, which are concerning to the patient and provider as they may simulate malignancy [9]. There is a tendency for PAAG to form globules, which may present as a palpable mass on physical examination and be
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Fig. 2. Case #1: Left breast ultrasound images. (A) Left breast sagittal grayscale ultrasound demonstrating a complex cystic mass measuring 2.1×1.5×2.0 cm. (B) Left breast sagittal color Doppler ultrasound shows that the mass is avascular. (c) Left breast transverse gray-scale ultrasound during fine needle aspiration.
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
N.E. Margolis et al. / Clinical Imaging xxx (2015) xxx–xxx
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Fig. 3. Case #1: Left breast FNA pathology. Histologic specimen from left breast fine needle aspiration with Diff-Quik (rapid and Papinicolaou) stain demonstrating (A) acellular material containing crystals (arrow). The crystals show birefringence under polarized light (B) and may represent calcium oxalate, which correlates with the microcalcifications on imaging. (C) Multinucleate giant cell containing foreign acellular material within the cytoplasm, as well as numerous neutrophils, representing a foreign body reaction with acute inflammation (arrow).
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Fig. 4. Case #1: Right breast mammograms. Right breast mediolateral oblique (A) and mediolateral spot magnification (B) mammograms demonstrating cluster of pleomorphic microcalcifications within the upper outer breast, posterior depth (circle). Larger dystrophic calcifications are seen inferiorly in the upper outer breast middle depth (arrow). The breast parenchyma is extremely dense.
seen on imaging as a discrete mass [10]. In a study of patients undergoing surgery following PAAG augmentation, breast pain was the most common indication for surgery, followed by breast hardening and breast deformity [2]. Rarely, late complications such as hematomas, seromas, and galactoceles can result from PAAG breast augmentation
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[11]. Similar to PAAG, silicone granulomas may present as masses in breast tissue following extracapsular implant rupture or direct injection [12]. The silicone is known to migrate to axillary lymph nodes, skin, pectoral muscle, and even the lungs, spreading via hematogenous or lymphatic systems [13–15].
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Fig. 5. Case #1: Right breast stereotactic biopsy histologic specimen with hematoxylin eosin stain demonstrating (A) acellular material with granular calcifications (arrow), (B) granular calcifications (arrow) surrounded by acellular material and blood, and (C) foreign body giant cell with acellular material within the cytoplasm (arrows).
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
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B Fig. 6. Case #2: Left breast ultrasound. (A) Longitudinal grayscale sonogram demonstrating a 4×4-mm irregular hypoechoic mass (arrow). (B) Longitudinal grayscale sonogram closer to the nipple, showing the injected PAAG, which appears predominantly anechoic with internal debris (arrowheads on both images).
In the workup of palpable abnormalities in these patients, mammography and ultrasound are often performed first [2]. On mammography, the density of PAAG is similar to that of breast parenchyma and may be difficult to distinguish. In comparison, silicone gel is focally dense compared to breast parenchyma. Moreover, silicone gel can cause calcifications in the breast, not seen or described in the literature related to PAAG breast augmentation. The breast parenchyma may have amorphous overall increased density due to PAAG, limiting the sensitivity for detection of malignancy. Typically, the gel is confined to the retroglandular space as a large globule; however, at times smaller globules of PAAG may be found distributed through the breast on ultrasound [16]. In addition, the appearance of the PAAG may not be classic for a foreign body and may be suspicious. This dilemma may prompt an imaging guided biopsy and/or close clinical follow-up. Given the limitations of mammography and ultrasound, PAAG is best evaluated by MRI, which clearly depicts the volume and distribution of PAAG [5]. Since PAAG consists of almost exclusively of water, T2-weighted sequences are the best to use to detect its extent [7]. In patients with a questionable history of PAAG breast augmentation, a silicone implant MRI protocol with silicone and water suppressed short tau inversion recovery sequences may be warranted to differentiate silicone from PAAG. The PAAG globule may simulate a saline or silicone implant on MRI, yet it will be less defined due to the lack of a shell. Since PAAG is a foreign body, a fibrous capsule may form over time, as is seen in case #2 [9]. This fibrous capsule may simulate a silicone implant shell on imaging studies, forming a so-called pseudocapsule. While calcification of the capsule surrounding silicone breast implants is a universal phenomenon 10 years after implantation, calcifications in the breast surrounding injected PAAG have not been described in the literature. The calcification in the silicone implant capsule is in the form of hydroxyapatite related to necrosis in the setting of foreign body reaction [17]. In case #1, the calcifications seen on high power microscopy consisted of positively birefringent crystals and morphological characteristics suggesting that they comprised calcium oxalate.
Fig. 7. Case #2: Left breast mammogram with needle localization. Left mediolateral mammogram demonstrates a wire localization of the 4mm mass. A metallic clip indicating the location of the mass that was localized is adjacent to the hook portion of the wire (arrow). Note the extremely dense breast parenchyma, which may reflect injected PAAG.
To our knowledge, this is the first case of microcalcification on mammography in a patient with a history of PAAG breast augmentation. Microcalcifications are a suspicious finding on mammography, with a positive predictive value for malignancy of 28.8% [18]. In contradistinction, larger calcifications, generally described as coarse or dystrophic, correspond with a benign etiology, that is, fat necrosis or postsurgical changes. While imaging surveillance of silicone breast implants for silent rupture has been recommended by the Food and Drug Administration, no guidelines are available for monitoring patients with PAAG breast augmentation [19]. As of 2013, The American College of Radiology recommends breast MRI for cancer screening in patients with a history of breast augmentation, including silicone and PAAG augmentation, in which mammography is difficult [20]. Although familiarity with the physical examination and imaging findings of PAAG injections can help reassure patients presenting with palpable abnormalities, occasionally pathologic sampling is required to differentiate benign changes from malignancy. Under the microscope, inflammatory foreign body reactions to the injected material can be appreciated. Inflammatory reaction features infiltration by lymphocytes and plasma cells, histiocytic cells, and foreign body-type multinucleated giant cells walling off PAAG [6,8]. Christensen et al. [21] described histological findings of the breast tissue bordering the gel showed three different patterns: large collections of gel gave rise to a thick, soft-looking cellular membrane of macrophages and foreignbody giant cells; medium-size deposits were surrounded by just a thin layer of macrophages; and small deposits were not associated with any reaction in the surrounding tissue. Palpable abnormalities related to PAAG breast augmentation may prompt the patient to request surgical removal. However, it is prudent to confirm that the symptoms are in fact related to PAAG with imaging and histological sampling. If biopsies are negative, it is feasible for the patient to forgo surgery and to be routinely followed. Despite this, however, most patients who do present to their providers complain of breast pain and breast deformities and chose to alleviate their pain and remove lumps or indurations [1]. Depending on how much gel was injected and
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
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Fig. 8. Case #2: Bilateral breast MRI. (A) On axial T2-weighted MRI, injected PAAG appears bright in the retroglandular space, as well as within the right pectoralis muscle and extrapleural space (arrow). (B) More inferiorly, fibrous capsules are seen bilaterally within the injected material (arrows); these may simulate silicone implant shells. The gel is in close proximity to the skin at the lateral aspects of both breasts. (C) Right breast sagittal T2-weighted MRI depicts the retroglandular (arrow) and intramuscular (arrowhead) extent of the injected gel.
to what extent the PAAG has migrated, different surgical options are available. Nodules presenting in the sternal region were the most common reason for removal of migrated PAAG in one study [7]. Atraumatic aspiration of PAAG is accomplished by a blunt tip cannula that has an orifice on a taper [3,4]. Saline irrigation and breast massage can facilitate the removal of all PAAG. In complicated cases where PAAG is too difficult to remove, local anesthesia can be used with ultrasound to better visualize PAAG distribution, especially in the posterior mammary space [11].
5. Conclusion PAAG breast augmentation is a procedure performed outside the United States with a constellation of complications. In addition to concerns with blind injections into the breast causing suspicious palpable masses and cosmetic deformity, this technique can confound radiological examinations as its imaging appearance may mimic silicone breast augmentation and malignancy. Although palpable masses in these patients tend to reflect foreign body reactions to globules of PAAG, a thorough workup, including imaging and pathologic evaluation, is often necessary to exclude malignancy and high-risk lesions. To our knowledge, this is the first reported case of PAAG injections mimicking the microcalcifications typically seen in cancerous lesions on mammography. This becomes an important consideration when counseling patients with a history of this procedure, as PAAG may mimic malignancy clinically and radiographically. PAAG breast augmentation continues to be performed in countries outside the United States. Health care providers therefore should be familiar with the imaging and pathological appearance of PAAG breast augmentation.
References [1] Cheng NX, Wang YL, Wang JH, Zhang XM, Zhong H. Complications of breast augmentation with injected hydrophilic polyacrylamide gel. Aesthetic Plast Surg 2002;26(5):375–82. [2] Unukovych D, Khrapach V, Wickman M, Liljegren A, Mishalov V, Patlazhan G, Sandelin K. Polyacrylamide gel injections for breast augmentation: management of complications in 106 patients, a multicenter study. World J Surg 2012;36(4): 695–701. [3] Wang Z, Li S, Wang L, Zhang S, Jiang Y, Chen J, Luo D. Polyacrylamide hydrogel injection for breast augmentation: another injectable failure. Med Sci Monit 2012;18(6): CR399–408.
[4] Christensen L, Breiting V. Management of postoperative complications of breast augmentation by injected polyacrylamide hydrogel. Aesthetic Plast Surg 2006;30(1): 132. [5] Khedher NB, David J, Trop I, Drouin S, Peloquin L, Lalonde L. Imaging findings of breast augmentation with injected hydrophilic polyacrylamide gel: patient reports and literature review. Eur J Radiol 2011;78(1):104–11. [6] Manafi A, Emami AH, Pooli AH, Habibi M, Saidian L. Unacceptable results with an accepted soft tissue filler: polyacrylamide hydrogel. Aesthetic Plast Surg 2010;34(4):413–22. [7] Lui CY, Ho CM, Iu PP, Cheung WY, Lam HS, Cheng MS, Liu HL. Evaluation of MRI findings after polyacrylamide gel injection for breast augmentation. AJR Am J Roentgenol 2008;191(3):677–88. [8] Leung KM, Yeoh GP, Chan KW. Breast pathology in complications associated with polyacrylamide hydrogel (PAAG) mammoplasty. Hong Kong Med J 2007;13(2): 137–40. [9] Qiao Q, Wang X, Sun J, Zhao R, Liu Z, Wang Y, Sun B, Yan Y, Qi K. Management for postoperative complications of breast augmentation by injected polyacrylamide hydrogel. Aesthetic Plast Surg 2005;29(3):156–61 [discussion 162]. [10] Legrand AP, Marinov G, Pavlov S, Guidoin MF, Famery R, Bresson B, Zhang Z, Guidoin R. Degenerative mineralization in the fibrous capsule of silicone breast implants. J Mater Sci Mater Med 2005;16(5):477–85. [11] Cheng NX, Zhang YL, Luo SK, Zhang XM, Hui L, Chen YL, Sheng SY, Wu DH, Wang HB, Li P. Late hematoma, seroma, and galactocele in breasts injected with polyacrylamide gel. Aesthetic Plast Surg 2011;35(3):365–72. http://dx.doi.org/10.1007/ s00266-010-9617-4. [12] Caskey CI, Berg WA, Hamper UM, Sheth S, Chang BW, Anderson ND. Imaging spectrum of extracapsular silicone: correlation of US, MR imaging, mammographic, and histopathologic findings. Radiographics 1999;19:S39–51 [quiz S261-2]. [13] Dragu A, Theegarten D, Bach AD, Polykandriotis E, Arkudas A, Kneser U, Horch RE, Ingianni G. Intrapulmonary and cutaneous siliconomas after silent silicone breast implant failure. Breast J 2009;15(5):496–9. [14] Ali L, Mcgivern D, Teoh R. Silicon granuloma mimicking lung cancer. BMJ Case Rep 2012;19:2012. http://dx.doi.org/10.1136/bcr-2012-006351 [pii: bcr2012006351]. [15] Nicolet G, Rouleau C, Flandrin A, Giacalone PL. Siliconoma mimicking pectoral tumor: about one case report. Ann Chir Plast Esthet 2010;55(3):249–51. [16] Teo SY, Wang SC. Radiologic features of polyacrylamide gel mammoplasty. AJR Am J Roentgenol 2008;191(3):W89–95. [17] Miglioretti DL, Rutter CM, Geller BM, Cutter G, Barlow WE, Rosenberg R, Weaver DL, Taplin SH, Ballard-Barbash R, Carney PA, Yankaskas BC, Kerlikowske K. Effect of breast augmentation on the accuracy of mammography and cancer characteristics. JAMA 2004;291(4):442–50. [18] Bent CK, Bassett LW, D'Orsi CJ, Sayre JW. The positive predictive value of BI-RADS microcalcification descriptors and final assessment categories. AJR Am J Roentgenol 2010;194(5):1378–83. [19] Center for Devices and Radiological Health U.S. Food and Drug Administration. FDA update on the safety of silicone gel-filled breast implants. http://www.fda.gov/ downloads/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/BreastImplants/UCM260090.pdf; 2011. [Last accessed April 23, 2014]. [20] ACR Committee on Breast Imaging for Appropriateness Criteria and Practice Guidelines. http://www.acr.org/~/media/2a0eb28eb59041e2825179afb72ef624. pdf. [Revised 2013 (Resolution 12). Last accessed April 23, 2014]. [21] Christensen LH, Breiting VB, Aasted A, Jorgensen A, Kebuladze I. Long-term effects of polyacrylamide hydrogel on human breast tissue. Plast Reconstr Surg 2003;111(6): 1883–90.
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
Contents lists available at ScienceDirect
Clinical Imaging journal homepage: http://www.clinicalimaging.org
Polyacrylamide gel breast augmentation: report of two cases and review of the literature Nathaniel E. Margolis a,⁎, Brian Bassiri-Tehrani b, Chloe Chhor a, Cory Singer a, Osvaldo Hernandez c, Linda Moy a a b c
Department of Radiology, New York University Langone Medical Center, New York, NY USA Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA USA Department of Pathology, New York University Langone Medical Center, New York, NY USA
a r t i c l e
i n f o
Article history: Received 23 May 2014 Received in revised form 25 November 2014 Accepted 12 December 2014 Available online xxxx Keywords: Polyacrylamide gel Breast augmentation Foreign body reaction Breast injection Mammography
a b s t r a c t Polyacrylamide gel (PAAG) injection remains an uncommon method of breast augmentation. Providers must recognize the clinical and radiological manifestations to optimize management. The clinical and radiological findings of PAAG injection may mimic malignancy and silicone breast augmentation. We described two patients with prior PAAG breast augmentation with physical exam and imaging findings concerning for malignancy. We reviewed the literature on PAAG breast augmentation and compare PAAG to silicone breast augmentation. The management of such patients is discussed. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Polyacrylamide gel (PAAG) is a stable, nontoxic highly hydrophilic substance with 2.5% cross-linked polyacrylamide and 97.5% water [1]. Its high water content allows PAAG to be readily integrated within surrounding connective tissue and fat. When hydrated, PAAG forms a gel, which is commonly exploited in everyday items such as contact lenses, food packaging, and water purification [2]. Though PAAG was first introduced in the 1970s, it was not popularized for breast augmentation until 1997 by China and the Soviet Union [2]. Soon after, the Russian ministry prohibited PAAG injection for fear that it may lead to glandular atrophy [3]. The Chinese State Food and Drug Administration followed suit in 2006 and also banned PAAG sale, production, and use. There are still countries, such as Iran, that have yet to prohibit PAAG use. Thousands of women in foreign countries to date have used PAAG injection for breast augmentation, though exact numbers are not published [4]. Although PAAG is banned in most countries, patients may present with symptoms related to PAAG augmentation, which may mimic malignancy clinically and radiographically [2]. Because of this, it is essential
⁎ Corresponding author. Department of Radiology, New York University Langone Medical Center, New York, NY, USA. Tel.: +1 914 844 8634; fax: +1 212 731 5556. E-mail addresses: [email protected] (N.E. Margolis), [email protected] (B. Bassiri-Tehrani), [email protected] (C. Chhor), [email protected] (C. Singer), [email protected] (O. Hernandez), [email protected] (L. Moy).
for health care providers to be cognizant of the signs and symptoms PAAG breast augmentation. Radiologists in particular should be aware of the imaging findings of PAAG in order to correctly diagnose patients who present for workup of palpable abnormalities or for cancer screening. In the absence of an accurate surgical history, the clinical and radiological features of PAAG augmentation may overlap with silicone breast augmentation. However, the pathologic features and management techniques of PAAG augmentation differ from those of silicone augmentation. If removal of PAAG is desired, several management strategies are available: watchful waiting, aspiration, and surgical removal. In this article, we report two cases of PAAG breast augmentation and present an associated review of the literature. 2. Case #1 A 42-year-old Chinese female with history of breast augmentation with injection of PAAG in China 4 years prior (in 2008) presented with a palpable lump in the left breast. A well-circumscribed mass was seen in the upper outer left breast on mammogram and ultrasound (Figs. 1 and 2), which was biopsy proven to be foreign body reaction (Fig. 3). A right mammogram performed as part of the workup showed pleomorphic microcalcifications in the upper outer quadrant of the right breast middle to posterior depth (Fig. 4). Patient underwent stereotactic core biopsy of the microcalcifications. The samples obtained consisted of thick gelatinous material that extruded from the biopsy site. A clip was inserted into the biopsy cavity but was displaced out of the
http://dx.doi.org/10.1016/j.clinimag.2014.12.008 0899-7071/© 2015 Elsevier Inc. All rights reserved.
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
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Fig. 1. Case #1: Left breast mammograms. (A) Left mediolateral oblique (MLO) mammogram demonstrating a mass in left upper outer breast corresponding with the patient’s palpable abnormality (arrow). The breast parenchyma appears extremely dense, which may be related to the injected PAAG. (B) Left MLO spot magnification view of the palpable mass demonstrating indistinct margins and associated pleomorphic microcalcifications (arrow).
breast by the extruding gel like material. Once the needle was removed, no additional gel-material extruded from the access site. The right breast biopsy yielded foreign body reaction (Fig. 5). 3. Case #2 A 29-year-old Chinese female with a history of breast augmentation with injection of PAAG in China 8 years prior (in 2003) presented with a palpable left breast mass. Ultrasound of the palpable abnormality in the left breast at the 5:00 axis, 2 cm from the nipple revealed a small hypoechoic mass outside the injected PAAG material (Fig. 6). Ultrasound-guided fine needle aspiration yielded benign ductal proliferation with hyperplastic/papillary features. Subsequently, the patient underwent needle localization (Fig. 7) and excision, with final surgical pathology consistent with sclerosing intraductal papilloma. As this was a high-risk lesion, the patient also underwent follow-up magnetic resonance imaging (MRI), which demonstrated extensive PAAG injection within the retroglandular tissues and pectoralis muscle (Fig. 8). There was extension of the PAAG into the extrapleural space. 4. Discussion The purpose of our manuscript is to report two cases of women who have undergone breast augmentation with PAAG injections and to perform an associated review of the literature in this section. Marketed as a “minimally invasive” procedure, patients became enthralled with PAAG as a quick, nonsurgical, and seemingly safe way to undergo breast
A
augmentation. While PAAG was once believed to be safe for injection for breast augmentation, recent literature exhibits a constellation of complications associated with its use. We have reported two cases of patients presenting with palpable breast masses and suspicious imaging findings following PAAG breast augmentation. Since PAAG is injected blindly, the outcome is often unpredictable. Though typically retroglandular, an intraglandular approach has been seen, producing multiple PAAG masses in the breast. Inadvertently, the gel can be injected into the pectoralis muscle. The gel can then extravasate into the extrapleural space, as seen in case #2 [6]. PAAG can spread via direct extension to create subcutaneous nodules in the inframammary fold, axilla, sternum, and infraclavicular region if the gel is injected in the subcutaneous plane [7]. Gel migration is more likely to occur if the fibrous capsule surrounding the gel is thin. Certain factors like gravity or constant pectoralis major muscle contraction can accelerate gel migration by disrupting the fibrous capsule. In contrast, the fibrous capsule surrounding ruptured silicone breast implants is generally thicker than those after PAAG injection, thereby making silicone gel migration relatively less common [1]. Signs and symptoms of PAAG breast augmentation include breast lumps, contour abnormalities, abnormal skin sensation, mastalgia, mastodynia, infection, induration, and inflammation [8]. The most common sign or symptom of PAAG injection is the development of breast lumps, which are concerning to the patient and provider as they may simulate malignancy [9]. There is a tendency for PAAG to form globules, which may present as a palpable mass on physical examination and be
B
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Fig. 2. Case #1: Left breast ultrasound images. (A) Left breast sagittal grayscale ultrasound demonstrating a complex cystic mass measuring 2.1×1.5×2.0 cm. (B) Left breast sagittal color Doppler ultrasound shows that the mass is avascular. (c) Left breast transverse gray-scale ultrasound during fine needle aspiration.
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
N.E. Margolis et al. / Clinical Imaging xxx (2015) xxx–xxx
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Fig. 3. Case #1: Left breast FNA pathology. Histologic specimen from left breast fine needle aspiration with Diff-Quik (rapid and Papinicolaou) stain demonstrating (A) acellular material containing crystals (arrow). The crystals show birefringence under polarized light (B) and may represent calcium oxalate, which correlates with the microcalcifications on imaging. (C) Multinucleate giant cell containing foreign acellular material within the cytoplasm, as well as numerous neutrophils, representing a foreign body reaction with acute inflammation (arrow).
A
B
Fig. 4. Case #1: Right breast mammograms. Right breast mediolateral oblique (A) and mediolateral spot magnification (B) mammograms demonstrating cluster of pleomorphic microcalcifications within the upper outer breast, posterior depth (circle). Larger dystrophic calcifications are seen inferiorly in the upper outer breast middle depth (arrow). The breast parenchyma is extremely dense.
seen on imaging as a discrete mass [10]. In a study of patients undergoing surgery following PAAG augmentation, breast pain was the most common indication for surgery, followed by breast hardening and breast deformity [2]. Rarely, late complications such as hematomas, seromas, and galactoceles can result from PAAG breast augmentation
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[11]. Similar to PAAG, silicone granulomas may present as masses in breast tissue following extracapsular implant rupture or direct injection [12]. The silicone is known to migrate to axillary lymph nodes, skin, pectoral muscle, and even the lungs, spreading via hematogenous or lymphatic systems [13–15].
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Fig. 5. Case #1: Right breast stereotactic biopsy histologic specimen with hematoxylin eosin stain demonstrating (A) acellular material with granular calcifications (arrow), (B) granular calcifications (arrow) surrounded by acellular material and blood, and (C) foreign body giant cell with acellular material within the cytoplasm (arrows).
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
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B Fig. 6. Case #2: Left breast ultrasound. (A) Longitudinal grayscale sonogram demonstrating a 4×4-mm irregular hypoechoic mass (arrow). (B) Longitudinal grayscale sonogram closer to the nipple, showing the injected PAAG, which appears predominantly anechoic with internal debris (arrowheads on both images).
In the workup of palpable abnormalities in these patients, mammography and ultrasound are often performed first [2]. On mammography, the density of PAAG is similar to that of breast parenchyma and may be difficult to distinguish. In comparison, silicone gel is focally dense compared to breast parenchyma. Moreover, silicone gel can cause calcifications in the breast, not seen or described in the literature related to PAAG breast augmentation. The breast parenchyma may have amorphous overall increased density due to PAAG, limiting the sensitivity for detection of malignancy. Typically, the gel is confined to the retroglandular space as a large globule; however, at times smaller globules of PAAG may be found distributed through the breast on ultrasound [16]. In addition, the appearance of the PAAG may not be classic for a foreign body and may be suspicious. This dilemma may prompt an imaging guided biopsy and/or close clinical follow-up. Given the limitations of mammography and ultrasound, PAAG is best evaluated by MRI, which clearly depicts the volume and distribution of PAAG [5]. Since PAAG consists of almost exclusively of water, T2-weighted sequences are the best to use to detect its extent [7]. In patients with a questionable history of PAAG breast augmentation, a silicone implant MRI protocol with silicone and water suppressed short tau inversion recovery sequences may be warranted to differentiate silicone from PAAG. The PAAG globule may simulate a saline or silicone implant on MRI, yet it will be less defined due to the lack of a shell. Since PAAG is a foreign body, a fibrous capsule may form over time, as is seen in case #2 [9]. This fibrous capsule may simulate a silicone implant shell on imaging studies, forming a so-called pseudocapsule. While calcification of the capsule surrounding silicone breast implants is a universal phenomenon 10 years after implantation, calcifications in the breast surrounding injected PAAG have not been described in the literature. The calcification in the silicone implant capsule is in the form of hydroxyapatite related to necrosis in the setting of foreign body reaction [17]. In case #1, the calcifications seen on high power microscopy consisted of positively birefringent crystals and morphological characteristics suggesting that they comprised calcium oxalate.
Fig. 7. Case #2: Left breast mammogram with needle localization. Left mediolateral mammogram demonstrates a wire localization of the 4mm mass. A metallic clip indicating the location of the mass that was localized is adjacent to the hook portion of the wire (arrow). Note the extremely dense breast parenchyma, which may reflect injected PAAG.
To our knowledge, this is the first case of microcalcification on mammography in a patient with a history of PAAG breast augmentation. Microcalcifications are a suspicious finding on mammography, with a positive predictive value for malignancy of 28.8% [18]. In contradistinction, larger calcifications, generally described as coarse or dystrophic, correspond with a benign etiology, that is, fat necrosis or postsurgical changes. While imaging surveillance of silicone breast implants for silent rupture has been recommended by the Food and Drug Administration, no guidelines are available for monitoring patients with PAAG breast augmentation [19]. As of 2013, The American College of Radiology recommends breast MRI for cancer screening in patients with a history of breast augmentation, including silicone and PAAG augmentation, in which mammography is difficult [20]. Although familiarity with the physical examination and imaging findings of PAAG injections can help reassure patients presenting with palpable abnormalities, occasionally pathologic sampling is required to differentiate benign changes from malignancy. Under the microscope, inflammatory foreign body reactions to the injected material can be appreciated. Inflammatory reaction features infiltration by lymphocytes and plasma cells, histiocytic cells, and foreign body-type multinucleated giant cells walling off PAAG [6,8]. Christensen et al. [21] described histological findings of the breast tissue bordering the gel showed three different patterns: large collections of gel gave rise to a thick, soft-looking cellular membrane of macrophages and foreignbody giant cells; medium-size deposits were surrounded by just a thin layer of macrophages; and small deposits were not associated with any reaction in the surrounding tissue. Palpable abnormalities related to PAAG breast augmentation may prompt the patient to request surgical removal. However, it is prudent to confirm that the symptoms are in fact related to PAAG with imaging and histological sampling. If biopsies are negative, it is feasible for the patient to forgo surgery and to be routinely followed. Despite this, however, most patients who do present to their providers complain of breast pain and breast deformities and chose to alleviate their pain and remove lumps or indurations [1]. Depending on how much gel was injected and
Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008
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Fig. 8. Case #2: Bilateral breast MRI. (A) On axial T2-weighted MRI, injected PAAG appears bright in the retroglandular space, as well as within the right pectoralis muscle and extrapleural space (arrow). (B) More inferiorly, fibrous capsules are seen bilaterally within the injected material (arrows); these may simulate silicone implant shells. The gel is in close proximity to the skin at the lateral aspects of both breasts. (C) Right breast sagittal T2-weighted MRI depicts the retroglandular (arrow) and intramuscular (arrowhead) extent of the injected gel.
to what extent the PAAG has migrated, different surgical options are available. Nodules presenting in the sternal region were the most common reason for removal of migrated PAAG in one study [7]. Atraumatic aspiration of PAAG is accomplished by a blunt tip cannula that has an orifice on a taper [3,4]. Saline irrigation and breast massage can facilitate the removal of all PAAG. In complicated cases where PAAG is too difficult to remove, local anesthesia can be used with ultrasound to better visualize PAAG distribution, especially in the posterior mammary space [11].
5. Conclusion PAAG breast augmentation is a procedure performed outside the United States with a constellation of complications. In addition to concerns with blind injections into the breast causing suspicious palpable masses and cosmetic deformity, this technique can confound radiological examinations as its imaging appearance may mimic silicone breast augmentation and malignancy. Although palpable masses in these patients tend to reflect foreign body reactions to globules of PAAG, a thorough workup, including imaging and pathologic evaluation, is often necessary to exclude malignancy and high-risk lesions. To our knowledge, this is the first reported case of PAAG injections mimicking the microcalcifications typically seen in cancerous lesions on mammography. This becomes an important consideration when counseling patients with a history of this procedure, as PAAG may mimic malignancy clinically and radiographically. PAAG breast augmentation continues to be performed in countries outside the United States. Health care providers therefore should be familiar with the imaging and pathological appearance of PAAG breast augmentation.
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Please cite this article as: Margolis NE, et al, Polyacrylamide gel breast augmentation: report of two cases and review of the literature, Clin Imaging (2015), http://dx.doi.org/10.1016/j.clinimag.2014.12.008