Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions

Obstetrics and Gynecology

Volumn 120, Issue 4, 2012, Pages 865-870

  Brown, Jill ^b   Blank, Ken ^a  

^a GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

^b NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABDOMINAL ABSCESS; ABDOMINAL PAIN; BURN; COLON INJURY; CRYOABLATION; DEATH; ENDOMETRITIS; ENDOMETRIUM ABLATION; ENDOMETRIUM ABLATION DEVICE; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; HYSTERECTOMY; INTESTINE RESECTION; MAJOR CLINICAL STUDY; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RADIOFREQUENCY ABLATION; REVIEW; SEPSIS; SURGICAL EQUIPMENT; URINARY TRACT DISEASE; UTERUS ISCHEMIA; UTERUS RUPTURE;

ABDOMINAL ABSCESS; BURNS; ENDOMETRIAL ABLATION TECHNIQUES; EQUIPMENT FAILURE; FEMALE; HUMANS; HYSTEROSCOPY; INTESTINES; PRODUCT LABELING; PRODUCT SURVEILLANCE, POSTMARKETING; SEPSIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UTERINE RUPTURE;

EID: 84866939413     PISSN: 00297844     EISSN: None     Source Type: Journal    
DOI: 10.1097/AOG.0b013e31826af4fe     Document Type: Review

References (12)

1. Zarek S, Sharp HT. Global endometrial ablation devices. Clin Obstet Gynecol 2008;51:167-75.
2. Gurtcheff SE, Sharp HT. Complications associated with global endometrial ablation: the utility of the MAUDE database. Obstet Gynecol 2003;102:1278-82.
3. Baggish MS, Savells ST. Complications associated with minimally invasive, nonhysteroscopic endometrial ablation techniques. J oGynecol Surg 2007;23:7-12.
4. Della Badia C, Nyirjesy P, Atogho A. Endometrial ablation devices: review of a manufacturer and user facility device experience database. J Min Invas Gynecol 2007;14:436-41.
5. Baggish MS, Bhati A. Intestinal injuries associated with the Novasure bipolar device. J of Gynecol Surg 2009;25:73-8.
6. Food and Drug Administration. Medical and radiation emitting device recalls. Available at: http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfRES/ res.cfm?id-83991. Retrieved February 1, 2012.
7. Cooper J, Gimpelson RJ. Summary of safety and effectiveness data from FDA: A valuable source of information of the performance of global endometrial ablation devices. J Reprod Med 2004;4:267-73.
8. Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermal balloon and rollerball ablation to treat menorrhagia: A multicenter comparison. Obstet Gynecol 1998; 92:98-103.
9. Corson SL. A multicenter evaluation of endometrial ablation by Hydro ThermAblator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc, 2001;8:359-67.
10. Cooper J, Gimpelson R, Laberge P, Galen D, Garza-Leal JG, Scott J, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc 2002;9:418-28.
11. Duleba AJ, Heppard MC, Soderstrom RM, Townsend DE. A randomized study comparing endometrial cryoablation and rollerball electroablation for treatment of dysfunctional uterine bleeding. J Am Assoc Gynecol Laparosc 2003;10: 17-26.
12. Cooper JM, Anderson TL, Fortin CA, Jack SA, Plentl MB. Microwave endometrial ablation vs. rollerball electroablation for menorrhagia: A multicenter randomized trial. J Am Assoc Gynecol Laparosc 2004;11:394-403.