Minimally Invasive Endometrial Ablation Device Complications and Use Outside of the Manufacturersʼ Instructions

Brown, Jill; Blank, Ken

doi:10.1097/aog.0b013e31826af4fe

Cited by 15 publications

(15 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…More serious complications may include bowel injury, cardiac arrest, urinary tract injury, carbon dioxide embolus, sepsis, and death 45. It is recognized that inappropriate use and physician error are contributors to device-related complications 44,46. In the most recent review of the Manufacturer and User Facility Device Experience (MAUDE) database, Brown and Blank noted the possibility of false tracking with the NovaSure device leading to transmural thermal injury, thus highlighting the importance of on-label use of the device and proper technique in deployment and seating procedure 46…”

Section: Safety Of Novasure Endometrial Ablationmentioning

confidence: 99%

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

Gimpelson¹

2014

IJWH

View full text Add to dashboard Cite

This review examines the peer-reviewed literature describing prospective studies that report amenorrhea rates, patient satisfaction, and surgical reintervention rates following the NovaSure® endometrial ablation procedure. A search of the English-language literature published from 2000 to 2011 was conducted using PubMed. Ten prospective studies, six single-arm NovaSure trials, and four randomized controlled trials comparing the NovaSure procedure with other global endometrial ablation modalities met the inclusion criteria and were reviewed. The follow-up periods ranged from 6 to 60 months. Amenorrhea rates for the NovaSure procedure ranged from 30.0% to 75.0%. Patients who reported being satisfied with the NovaSure procedure ranged from 85.0% to 94.0%. In randomized controlled trials with other global endometrial ablation modalities, amenorrhea rates at 12 months with the NovaSure procedure ranged from 43.0% to 56.0%, while other modalities ranged from 8% to 24%. In addition, this manuscript reviews the following: the NovaSure technology; use of the NovaSure procedure in the office setting; intraoperative and postoperative pain; effects on premenstrual syndrome (PMS); dysmenorrhea; special circumstances, including presence of uterine disease, history of cesarean delivery, coagulopathy, or use of anticoagulant medication; post-procedure uterine cavity assessment and cancer risk; contraception and pregnancy; and safety.

show abstract

Section: Safety Of Novasure Endometrial Ablationmentioning

confidence: 99%

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

Gimpelson¹

2014

IJWH

View full text Add to dashboard Cite

show abstract

“… 4 Both of the endometrial ablation systems used in the current study provide the level of safety expected of modern endometrial ablative procedures, although the NovaSure system has a much longer record of post-market safety surveillance. 17 , 33 The number of AEs in the current study was low and did not significantly differ between treatments. Two serious AEs occurred in the NovaSure group (vaginal bleeding and fever with pain), and one occurred in the Minerva arm (renal failure secondary to dehydration).…”

Section: Discussionmentioning

confidence: 52%

Efficacy and patient satisfaction after NovaSure and Minerva endometrial ablation for treating abnormal uterine bleeding: a retrospective comparative study

Scordalakes

delRosario²,

Shimer

et al. 2018

IJWH

View full text Add to dashboard Cite

ObjectiveCompare amenorrhea rate, menstrual symptoms, patient satisfaction, and adverse events in women who underwent endometrial ablation with the NovaSure versus the Minerva radiofrequency ablation systems.MethodsWe surveyed 189 premenopausal women (mean 40.8±6.2 years old) who underwent endometrial ablation for abnormal uterine bleeding using the NovaSure (n=97) or Minerva (n=92) systems, at four private US gynecology clinics, and whose procedure date was after July 2015 with follow-up ≥3 months. Women were surveyed an average of 11.3±3.9 months (range 137–532 days) after ablation.ResultsThe subject-reported amenorrhea rate was 52% higher in NovaSure subjects than Minerva subjects (64% and 42%, respectively; p=0.004). Age and bleeding cyclicity did not affect amenorrhea rate in either group. Normal-to-no bleeding was reported by >90% of subjects after either treatment. NovaSure was significantly more effective than Minerva at reducing pad/tampon use in women with any residual bleeding (2.4±5.2 items/day versus 4.7±5.5 items/day, p=0.049). NovaSure was significantly more effective than Minerva at reducing premenstrual syndrome (PMS) symptoms (p=0.019) and menstrual pain (p=0.003), and more NovaSure subjects (94%) than Minerva subjects (78%) were satisfied with clinical outcomes (p=0.003). Adverse events did not differ by treatment; three women in each group progressed to hysterectomy.ConclusionWhile overall bleeding reduction in premenopausal women with abnormal uterine bleeding was excellent with either endometrial ablation system, NovaSure treatment resulted in a higher patient-reported 1-year amenorrhea rate, and women with residual bleeding used fewer pads and tampons than Minerva-treated women. Additionally, NovaSure subjects reported better menstrual-related life quality and PMS symptom alleviation, and greater satisfaction with outcomes than Minerva-treated women.

show abstract

“…Based on the available information, 66 of the 829 adverse events (8%) occurred when the endometrial ablation was performed outside of the labeled instructions for use of the procedure. The total number of endometrial ablations performed during this time period was not reported by the authors; therefore, the proportion of procedures with adverse events could not be determined from these data [39].…”

Section: Hysteroscopic Devicesmentioning

confidence: 92%

“…In 2012, Brown and Blank analyzed adverse events associated with endometrial ablation procedures that were reported in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database [39]. A total of 829 adverse events were reported between 2005 and 2011.…”

Section: Hysteroscopic Devicesmentioning

confidence: 99%

Complications of hysteroscopy and how to avoid them

McGurgan

McIlwaine

2015

Best Practice & Research Clinical Obstetrics & Gynaecol

View full text Add to dashboard Cite

Minimally Invasive Endometrial Ablation Device Complications and Use Outside of the Manufacturersʼ Instructions

Abstract: III.

Cited by 15 publications

References 9 publications

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

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

Efficacy and patient satisfaction after NovaSure and Minerva endometrial ablation for treating abnormal uterine bleeding: a retrospective comparative study

Complications of hysteroscopy and how to avoid them

Contact Info

Product

Resources

About

Minimally Invasive Endometrial Ablation Device Complications and Use Outside of the Manufacturersʼ Instructions

Abstract: III.

Cited by 15 publications

References 9 publications

Ten-year literature review of global endometrial ablation with the NovaSure&reg; device

Ten-year literature review of global endometrial ablation with the NovaSure&reg; device

Efficacy and patient satisfaction after NovaSure and Minerva endometrial ablation for treating abnormal uterine bleeding: a retrospective comparative study

Complications of hysteroscopy and how to avoid them

Contact Info

Product

Resources

About

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

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