Long-term safety and efficacy of breast biopsy markers in clinical practice

References

• Parker SH, Burbank F. A practical approach to minimally invasive breast biopsy. Radiology. 1996 July;200(1):11–20.
   PubMed Web of Science ®Google Scholar
• Burbank F, Forcier N. Tissue marking clip for stereotactic breast biopsy: initial placement accuracy, long-term stability, and usefulness as a guide for wire localization. Radiology. 1997 Nov;205(2):407–415.
   PubMed Web of Science ®Google Scholar
• Nurko J, Mancino AT, Whitacre E, et al. Surgical benefits conveyed by biopsy site marking system using ultrasound localization. Am J Surg. 2005 Oct;190(4):618–622.
   PubMed Web of Science ®Google Scholar
• Dash N, Chafin SH, Johnson RR, et al. Usefulness of tissue marker clips in patients undergoing neoadjuvant chemotherapy for breast cancer. AJR Am J Roentgenol. 1999 Oct;173(4):911–917.
   PubMed Web of Science ®Google Scholar
• Thomassin-Naggara I, Lalonde L, David J, et al. A plea for the biopsy marker: how, why and why not clipping after breast biopsy? Breast Cancer Res Treat. 2012 Apr;132(3):881–893.
   PubMed Web of Science ®Google Scholar
• Yen P, Dumas S, Albert A, et al. Post-vacuum-assisted stereotactic core biopsy clip displacement: a comparison between commercially available clips and surgical clip. Can Assoc Radiol J. 2018 Feb;69(1):10–15.
   PubMed Web of Science ®Google Scholar
• Esserman LE, Cura MA, DaCosta D. Recognizing pitfalls in early and late migration of clip markers after imaging-guided directional vacuum-assisted biopsy. Radiographics. 2004 Jan-Feb;24(1):147–156.
   PubMed Web of Science ®Google Scholar
• Bourke AG, Peter P, Jose CL. The disappearing clip: an unusual complication in MRI biopsy. BMJ Case Rep. 2014 Aug 19; 2014. DOI:10.1136/bcr-2014-204092
   Google Scholar
• DiPiro PJ. Disappearance of a localizing clip placed after stereotactic core biopsy of the breast. AJR Am J Roentgenol. 1999 Oct;173(4):1134.
   PubMed Web of Science ®Google Scholar
• Orel SG, Rosen M, Mies C, et al. MR imaging-guided 9-gauge vacuum-assisted core-needle breast biopsy: initial experience. Radiology. 2006 Jan;238(1):54–61.
   PubMed Web of Science ®Google Scholar
• Portnow LH, Thornton CM, Milch HS, et al. Biopsy marker standardization: what’s in a name? AJR Am J Roentgenol. 2019;11:1–6.
   Google Scholar
• Wegner U, Rainford S. Adverse reaction regarding titanium-based marker clip: case report of a potential complication. Int Med Case Rep J. 2019;12:291–295.
   PubMed Web of Science ®Google Scholar
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Available from: https://eur-lex.europa.eu/eli/reg/2017/745/oj
   Google Scholar
• Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013 Aug;128(9):944–953.
   PubMed Web of Science ®Google Scholar
• Scheffes IJ, Kroon AA, Schmidli J, et al. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010 Oct;56(15):1254–1258.
   PubMed Web of Science ®Google Scholar
• Sarr MG, Bilington CJ, Brancatisano R, et al. The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity. Obes Surg. 2012 Nov;22(11):1771–1782.
   PubMed Web of Science ®Google Scholar
• Sakamoto N, Fukuma E, Tsunoda Y, et al. Evaluation of the dislocation and long-term sonographic detectability of a hydrogel-based breast biopsy site marker. Breast Cancer. 2018 Sept;25(5):575–582.
   PubMed Web of Science ®Google Scholar
• Corsi F, Sorrentino L, Sartani A, et al. Localization of nonpalpable breast lesions with sonographically visible clip: optimizing tailored resection and clear margins. Am J Surg. 2015 June;209(6):950–958.
   PubMed Web of Science ®Google Scholar
• Meeting international standard for medical device reliability and risk management. Available from: https://3hti.com/wp-content/uploads/documents/Medical-Device-Reliability-White-Paper.pdf
   Google Scholar
• Medical Device Reporting (MDR): How to Report Medical Device Problems. [ cited 2020 June 20]. Available from: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
   Google Scholar
• European Commission Guidance Document-Guidance on Medical Device Vigilance System. [ cited 2020 June 20]. Available from: file:///C:/Users/shash/Downloads/2_%2012-1_rev8_en%20(1).pdf
   Google Scholar
• MAUDE - Manufacturer and User Facility Device Experience. [ cited 2020 June 20]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
   Google Scholar
• Rajan PV, Kramer DB, Kesselheim AS. Medical device postapproval safety monitoring: where does the United States stand? Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):124–131.
   PubMed Web of Science ®Google Scholar
• Shuren J, Califf RM. Need for a national evaluation system for health technology. JAMA. 2016 Sept 20;316(11):1153–1154.
   PubMed Web of Science ®Google Scholar
• Liberman L, Dershaw DD, Morris EA, et al. Clip placement after stereotactic vacuum-assisted breast biopsy. Radiology. 1997 Nov;205(2):417–422.
   PubMed Web of Science ®Google Scholar
• Pinkney DM, Mychajlowycz M, Shah BA. A prospective comparative study to evaluate the displacement of four commercially available breast biopsy markers. Br J Radiol. 2016 Sept;89(1065):20160149.
   PubMed Web of Science ®Google Scholar
• Rosen EL, Baker JA, Soo MS. Accuracy of a collagen-plug biopsy site marking device deployed after stereotactic core needle breast biopsy. AJR Am J Roentgenol. 2003 Nov;181(5):1295–1299.
   PubMed Web of Science ®Google Scholar
• Shah AD, Mehta AK, Talati N, et al. Breast tissue markers: why? What’s out there? How do I choose? Clin Imaging. 2018 Nov - Dec;52:123–136.
   PubMed Web of Science ®Google Scholar
• Klein RL, Mook JA, Euhus DM, et al. Evaluation of a hydrogel based breast biopsy marker (HydroMARK®) as an alternative to wire and radioactive seed localization for non-palpable breast lesions. J Surg Oncol. 2012 May;105(6):591–594.
   PubMed Web of Science ®Google Scholar
• Ko N, Mine A, Egusa H, et al. Allergic reaction to titanium-made fixed dental restorations: a clinical report. J Prosthodont. 2014 Aug;23(6):501–503.
   PubMedGoogle Scholar
• Lalor PA, Gray AB, Wright S, et al. Contact sensitivity to titanium in a hip prosthesis? Contact Dermatitis. 1990 Sept;23(3):193–194.
   PubMed Web of Science ®Google Scholar
• Motton S, Gardinal I, Soulé-Tholy M, et al. Hurt eczematiforme column (chronicle) of the breast after implementation of a surgical clip. J Gynecol Obstet Biol Reprod (Paris). 2011 Apr;40(2):174–177.
   PubMedGoogle Scholar
• Tamai K, Mitsumori M, Fujishiro S, et al. A case of allergic reaction to surgical metal clips inserted for postoperative boost irradiation in a patient undergoing breast-conserving therapy. Breast Cancer. 2001;8(1):90–92. .
   PubMedGoogle Scholar
• Yamauchi R, Morita A, Tsuji T. Pacemaker dermatitis from titanium. Contact Dermatitis. 2000 Jan;42(1):52–53.
   PubMed Web of Science ®Google Scholar
• Sicilia A, Cuesta S, Coma G, et al. Titanium allergy in dental implant patients: a clinical study on 1500 consecutive patients. Clin Oral Implants Res. 2008 Aug;19(8):823–835.
   PubMed Web of Science ®Google Scholar