Ten-year literature review of global endometrial ablation with the novasure® device

International Journal of Women's Health

Volumn 6, Issue 1, 2014, Pages 269-280

  Gimpelson, Richard J ^a  

^a Mercy Hospital St Louis   (United States)

Author keywords

Abnormal uterine bleeding; Endometrial ablation; Menorrhagia; Novasure

Indexed keywords

ANTICOAGULANT AGENT;

ABLATION DEVICE; AMENORRHEA; BLOOD CLOTTING DISORDER; CANCER RISK; CESAREAN SECTION; CLINICAL EFFECTIVENESS; CONTRACEPTION; DEVICE SAFETY; DYSMENORRHEA; ENDOMETRIUM ABLATION; GENERATOR; HUMAN; MENORRHAGIA; OUTCOME ASSESSMENT; PATIENT SATISFACTION; POSTOPERATIVE NAUSEA AND VOMITING; PREGNANCY; PREMENSTRUAL SYNDROME; RADIOFREQUENCY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; TREATMENT DURATION; UTERUS DISEASE;

EID: 84897876583     PISSN: None     EISSN: 11791411     Source Type: Journal    
DOI: 10.2147/IJWH.S56364     Document Type: Review

References (50)

1. Committee on Practice Bulletins Gynecology. Practice bulletin 128: diagnosis of abnormal uterine bleeding in reproductive-aged women. Obstet Gynecol. 2012;120(1):197-206.
2. Davies A, Hart R, Magos A, Hadad E, Morris R. Hysterectomy: surgical route and complications. Eur J Obstet Gynecol Reprod Biol. 2002;104(2):148-151.
3. Morgan H, Advincula AP. Global endometrial ablation: a modern day solution to an age-old problem. Int J Gynaecol Obstet. 2006;94(2): 156-166.
4. Committee on Practice Bulletins-Gynecology. Practice Bulletin 81. Endometrial ablation. Obstet Gynecol. 2007;109(5):1233-1248.
5. Kalkat RK, Cartmill RS. NovaSure endometrial ablation under local anaesthesia in an outpatient setting: an observational study. J Obstet Gynaecol. 2011;31(2):152-155.
6. Penninx JP, Mol BW, Bongers MY. Endometrial ablation with paracervical block. J Reprod Med. 2009;54(10):617-620.
7. US Food and Drug Administration, Center for Devices and Radiological Health. P970021 ThermaChoice® Uterine Balloon Therapy System Approval, December 12, 1997. Available from: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pma&id=1645. Accessed on January 6, 2014.
8. US Food and Drug Administration, Center for Devices and Radiological Health. P000032 Her Option™ Uterine Cryoblation Therapy™ System Approval Letter, April 20, 2001. Available from: http://www. accessdata.fda.gov/cdrh_docs/pdf/P000032A.pdf. Accessed on January 6, 2014.
9. US Food and Drug Administration, Center for Devices and Radiological Health. P000040 Hydro ThermAblator® Endometrial Ablation System Approval Letter, April 20, 2001. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000040a.pdf.Accessed on January 6, 2014.
10. US Food and Drug Administration, Center for Devices and Radiological Health. P010013 NovaSure™ Impedance Controlled Endometrial Ablation System Approval Letter, September 28, 2001. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010013a.pdf. Accessed on January 6, 2014.
11. US Food and Drug Administration, Center for Devices and Radiological Health. P020031 Microsulis Microwave Endometrial Ablation (MEA) System Approval Letter, September 23, 2003. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020031a.pdf. Accessed on January 6, 2014.
12. Cooper J, Gimpelson R, Laberge P, etal. A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4): 418-428.
13. Zarek S, Sharp HT. Global endometrial ablation devices. Clin Obstet Gynecol. 2008;51(1):167-175.
14. Asgari Z, Moini A, Samiee H, Tehranian A, Mozafar-Jalali S, Sabet S. Endometrial ablation with the NovaSure system in Iran. Int J Gynaecol Obstet. 2011;114(1):73-75.
15. Baskett TF, Clough H, Scott TA. NovaSure bipolar radiofrequency endometrial ablation: report of 200 cases. J Obstet Gynaecol Can. 2005;27(5):473-476.
16. Busund B, Erno LE, Grønmark A, Istre O. Endometrial ablation with NovaSure GEA, a pilot study. Acta Obstet Gynecol Scand. 2003;82(1): 65-68.
17. Fulop T, Rákóczi I, Barna I. NovaSure impedance-controlled endometrial ablation: long-term follow-up results. J Minim Invasive Gynecol. 2007;14(1):85-90.
18. Gallinat A. NovaSure impedance-controlled system for endometrial ablation: three-year follow-up on 107 patients. Am J Obstet ynecol. 2004;191(5):1585-1589.
19. Gallinat A. An impedance-controlled system for endometrial ablation: f ive-year follow-up of 107 patients. J Reprod Med. 2007;52(6): 467-472.
20. Gallinat A, Nugent W. NovaSure impedance-controlled system for endometrial ablation. J Am Assoc Gynecol Laparosc. 2002;9(3): 283-289.
21. Bongers MY, Bourdrez P, Mol BW, Heintz AP, Brölmann HA. Randomised controlled trial of bipolar radio-frequency endometrial ablation and balloon endometrial ablation. BJOG. 2004;111(10):1095-1102.
22. Kleijn JH, Engels R, Bourdrez P, Mol BW, Bongers MY. Five-year follow-up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation. BJOG. 2008;115(2):193-198.
23. Clark TJ, Samuels N, Malick S, Middleton L, Daniels J, Gupta J. Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial. Obstet Gynecol. 2011;117(5):1228.
24. Abbott J, Hawe J, Hunter D, Garry R. A double-blind randomized trial comparing the Cavaterm and the NovaSure endometrial ablation systems for the treatment of dysfunctional uterine bleeding. Fertil Steril. 2003;80(1):203-208.
25. Penninx JP, Mol BW, Engels R, et al. Bipolar radiofrequency endometrial ablation compared with hydrothermablation for dysfunctional uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2010;116(4):819-826.
26. Penninx JP, Herman MC, Mol BW, Bongers MY. Five-year follow-up after comparing bipolar endometrial ablation with hydrothermablation for menorrhagia. Obstet Gynecol. 2011;118(6):1287-1292.
27. Daniels JP, Middleton LJ, Champaneria R, et al; International Heavy Menstrual Bleeding IPD Meta-analysis Collaborative Group. Second generation endometrial ablation techniques for heavy menstrual bleeding: network meta-analysis. BMJ. 2012;344:e2564.
28. Laberge PY, Sabbah R, Fortin C, Gallinat A. Assessment and comparison of intraoperative and postoperative pain associated with NovaSure and ThermaChoice endometrial ablation systems. J Am Assoc Gynecol Laparosc. 2003;10(2):223-232.
29. Lukes AS, McBride RJ, Herring AH, Fried M, Sherwani A, Dell D. Improved premenstrual syndrome symptoms after NovaSure endometrial ablation. J Minim Invasive Gynecol. 2011;18(5):607-611.
30. Elmardi A, Furara S, Khan F, Hamza M. NovaSure impedance controlled system for endometrial ablation: the experience of the first UK reference centre. J Obstet Gynaecol. 2009;29(5):419-422.
31. Sabbah R, Desaulniers G. Use of the NovaSure Impedance-Controlled Endometrial Ablation System in patients with intracavitary disease: 12-month follow-up results of a prospective, single-arm clinical study. J Minim Invasive Gynecol. 2006;13(5):467-471.
32. Khan Z, El-Nashar SA, Hopkins MR, Famuyide AO. Efficacy and safety of global endometrial ablation after cesarean delivery: a cohort study. Am J Obstet Gynecol. 2011;205(5):450. e1-e4.
33. Rooney KE, Cholhan HJ. Vesico-uterine fistula after endometrial ablation in a woman with prior cesarean deliveries. Obstet Gynecol. 2010;115(2 Pt 2):450-451.
34. Evantash E. Vesico-uterine fistula after endometrial ablation in a woman with prior cesarean deliveries. Obstet Gynecol. 2010;115(4):869. Available from: http://journals.lww.com/greenjournal/Fulltext/2010/04000/ Corrections.38.aspx. Accessed January 17, 2014.
35. El-Nashar SA, Hopkins MR, Feitoza SS, et al. Global endometrial ablation for menorrhagia in women with bleeding disorders. Obstet Gynecol. 2007;109(6):1381-1387.
36. El-Nashar SA, Hopkins MR, Barnes SA, et al. Health-related quality of life and patient satisfaction after global endometrial ablation for menorrhagia in women with bleeding disorders: a follow-up survey and systematic review. Am J Obstet Gynecol. 2010;202(4):348. e1-e7.
37. Neuwirth RS, Loffer FD, Trenhaile T, Levin B. The incidence of endometrial cancer after endometrial ablation in a low-risk population. J Am Assoc Gynecol Laparosc. 2004;11(4):492-494.
38. Krogh RA, Lauszus FF, Guttorm E, Rasmussen K. Surgery and cancer after endometrial resection. Long-term follow-up on menstrual bleeding and hormone treatment by questionnaire and registry. Arch Gynecol Obstet. 2009;280(6):911-916.
39. Valle RF, Baggish MS. Endometrial carcinoma after endometrial ablation: high-risk factors predicting its occurrence. Am J Obstet Gynecol. 1998;179(3 Pt 1):569-572.
40. AlHilli MM, Hopkins MR, Famuyide AO. Endometrial cancer after endometrial ablation: systematic review of medical literature. J Minim Invasive Gynecol. 2011;18(3):393-400.
41. Lo JS, Pickersgill A. Pregnancy after endometrial ablation: English literature review and case report. J Minim Invasive Gynecol. 2006;13(2): 88-91.
42. Smith SE, Bacher-Lind L. Pregnancy outcomes following a NovaSure® endometrial ablation procedure. J Minim Invasive Gynecol. 2012;19(6):S21.
43. Gurtcheff SE, Sharp HT. Complications associated with global endometrial ablation: the utility of the MAUDE database. Obstet Gynecol. 2003;102(6):1278-1282.
44. Della Badia C, Nyirjesy P, Atogho A. Endometrial ablation devices: review of a manufacturer and user facility device experience database. J Minim Invasive Gynecol. 2007;14(4):436-441.
45. NovaSure Impedance-controlled Endometrial Ablation System: Instructions for Use and Controller's Manual. Marlborough, MA: Hologic, Inc; 2010.
46. Brown J, Blank K. Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions. Obstet Gynecol. 2012;120(4):865-870.
47. ACOG Committee on Practice Bulletins Gynecology. ACOG practice bulletin No 104: antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2009;113(5):1180-1189.
48. McCausland AM, McCausland VM. Long-term complications of endometrial ablation: cause, diagnosis, treatment and prevention. J Minim Invasive Gynecol. 2007;14(4):399-406.
49. [No authors listed]. A Scottish audit of hysteroscopic surgery for menorrhagia: complications and follow up. Scottish Hysteroscopy Audit Group. Br J Obstet Gynaecol. 1995;102(3):249-254.
50. Overton C, Hargreaves J, Maresh M. A national survey of the complications of endometrial destruction for menstrual disorders: the MISTLETOE study. Minimally Invasive Surgical Techniques Laser, EndoThermal or Endorescetion. Br J Obstet Gynaecol. 1997;104(12): 1351-1359.