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DOI:10.2214/AJR.08.1041
AJR 2008; 191:1371-1373
© American Roentgen Ray Society


Clinical Observations

Malignant-Appearing Microcalcifications at the Lumpectomy Site with the Use of FloSeal Hemostatic Sealant

Amy Henkel1, Richard A. Cooper1, Kathleen A. Ward1, Davide Bova1 and Katharine Yao2

1 Department of Radiology, Loyola University, 2160 S First Ave., Maywood, IL 60153.
2 Department of Surgery, Loyola University, Maywood, IL.

Received April 9, 2008; accepted after revision May 23, 2008.

 
Address correspondence to A. Henkel (aehenkel{at}lumc.edu).


Abstract
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
 
OBJECTIVE. The aim of this article is to describe the benign mammographic calcifications that occur at the lumpectomy site after the use of a topical hemostatic sealant (FloSeal Matrix Hemostatic Sealant). These calcifications can have an appearance similar to that of recurrent carcinoma.

CONCLUSION. Application of FloSeal hemostatic sealant in the lumpectomy cavity results in benign mammographic microcalcifications that could be misinterpreted as malignant.

Keywords: breast cancer • breast imaging • hemostatic sealant • mammography • microcalcifications


Introduction
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Abstract
Introduction
Materials and Methods
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Mammographic surveillance after breast-conserving surgery is performed to detect local recurrence, residual disease in the setting of positive pathologic margins, and second primary breast cancers. In its current guidelines, the American Society of Clinical Oncology [1] recommends annual mammography but no earlier than 6 months after definitive surgery and radiation therapy. Microcalcifications in the lumpectomy site on a postoperative mammogram can indicate residual or recurrent cancer. Here, we present seven cases from our institution in which a topical hemostatic agent (FloSeal Matrix Hemostatic Sealant, Baxter International) used during lumpectomy mimicked the appearance of malignant microcalcifications on mammography.

Achieving hemostasis is a concern of all surgeons, particularly in breast-conserving surgery or lumpectomy in which a large hematoma can distort the appearance of the breast and make follow-up more difficult. FloSeal is one of a variety of topical hemostatic agents used as a surgical adjunct to conventional methods of achieving hemostasis. It falls under a subcategory of hemostatic agents that use a collagen-based matrix [2]. FloSeal consists of two products—a proprietary gelatin matrix and a dehydrated topical thrombin—that are combined immediately before use. The collagen expands to conform to irregular surgical cavities and the thrombin and gelatin granules promote clot formation. The U.S. Food and Drug Administration has approved FloSeal for achieving hemostasis in a variety of surgical settings. Myriad uses and potential uses for FloSeal have been described, including in the fields of urology, for nephrectomy and partial nephrectomy, and in cardiovascular and peripheral vascular surgery [26].


Materials and Methods
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
 
Recently at our institution, FloSeal was used for hemostasis during seven lumpectomies performed for treatment of breast cancer. These cases are not the first reported use of a hemostatic agent in breast surgery; a meta-analysis investigating the use of fibrin sealants to prevent seroma after lumpectomy was reported in 2006 [7]. The products used in those studies [7] differ from FloSeal in that they are fibrin based instead of thrombin based and do not contain a gelatin matrix. There was no mention of mammographic abnormalities after the use of those fibrin agents.


Results
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Abstract
Introduction
Materials and Methods
Results
Discussion
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In our experience, follow-up mammograms for all seven patients in whom FloSeal was used showed innumerable punctuate radiopaque densities throughout the lumpectomy site that mimicked the appearance of malignant microcalcifications. These microcalcifications were observed on the 6-month follow-up mammogram in six patients. In the seventh patient, the microcalcifications were observed on a mammogram obtained 1 month after lumpectomy before radiation therapy to evaluate for residual malignant calcifications (Figs. 1A, 1B and 2A, 2B). This finding contributed to the decision to perform reexcision lumpectomy in this seventh patient, and pathology results revealed numerous benign microcalcifications. In another case, the calcifications were slightly fewer in number on the mammogram 1 year after lumpectomy than on the initial 6-month postoperative study, suggesting that they may eventually be reabsorbed. However, the risk for recurrent disease after treatment of breast cancer is highest in the first 5 years after surgery [8].


Figure 1
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Fig. 1A 56-year-old woman 1 month after lumpectomy and application of FloSeal Matrix Hemostatic Sealant (Baxter International). Magnification craniocaudal (A) and mediolateral (B) views of lumpectomy site show pseudomalignant calcifications at lumpectomy site.

 

Figure 2
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Fig. 1B 56-year-old woman 1 month after lumpectomy and application of FloSeal Matrix Hemostatic Sealant (Baxter International). Magnification craniocaudal (A) and mediolateral (B) views of lumpectomy site show pseudomalignant calcifications at lumpectomy site.

 

Figure 3
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Fig. 2A 61-year-old woman 5 months after lumpectomy and application of FloSeal Matrix Hemostatic Sealant (Baxter International). Magnification craniocaudal (A) and mediolateral (B) views show pseudomalignant calcifications at lumpectomy site.

 

Figure 4
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Fig. 2B 61-year-old woman 5 months after lumpectomy and application of FloSeal Matrix Hemostatic Sealant (Baxter International). Magnification craniocaudal (A) and mediolateral (B) views show pseudomalignant calcifications at lumpectomy site.

 


Discussion
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
 
We applied FloSeal to an excised breast specimen but saw no microcalcific densities when the specimen underwent both analog and digital examination. Therefore, we conclude that the development of calcifications is a response to FloSeal that requires a living host.

In conclusion, the gelatin matrix and thrombin-based hemostatic agent FloSeal applied at a lumpectomy site mimics the appearance of malignant microcalcifications on mammography, thus limiting evaluation for residual or recurrent disease and is not recommended for use on breast tissue.


References
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
 

  1. Khatcheressian JL, Wolff AC, Smith TJ, et al.; American Society of Clinical Oncology. American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting. J Clin Oncol 2006;24 :5091 –5097[Abstract/Free Full Text]
  2. Oz MC, Rondinone JF, Shargill NS. FloSeal Matrix: new generation topical hemostatic sealant. J Card Surg2003; 18:486 –493[CrossRef][Medline]
  3. Richter F, Schnorr D, Deger S, et al. Improvement of hemostasis in open and laparoscopically performed partial nephrectomy using a gelatin matrix–thrombin tissue sealant (FloSeal). Urology 2003; 61:73 –77[CrossRef][Medline]
  4. Oz MC, Cosgrove DM, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg 2000; 69:1376 –1382[Abstract/Free Full Text]
  5. Reuthebuch O, Lachat ML, Vogt P, Schurr U, Turina M. FloSeal: a new hemostatic agent in peripheral vascular surgery. Vasa2000; 29:204 –206[CrossRef][Medline]
  6. Ellegala DB, Maartens NF, Laws ER Jr. Use of FloSeal hemostatic sealant in transsphenoidal pituitary surgery: technical note. Neurosurgery 2002;51 : 513–515; discussion 515–516[CrossRef][Medline]
  7. Carless PA, Henry DA. Systematic review and meta-analysis of the use of fibrin sealant to prevent seroma formation after breast cancer surgery. Br J Surg 2006;93 : 810–819[CrossRef][Medline]
  8. Jatoi I, Tsimelzon A, Weiss H, Clark GM, Hilsenbeck SG. Hazard rates of recurrence following diagnosis of primary breast cancer. Breast Cancer Res Treat 2005;89 : 173–178[CrossRef][Medline]

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This Article
Right arrow Abstract Freely available
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