A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

Study Objective: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women.

Design: Multicenter, randomized, controlled, international study (Canadian Task Force classification I).

Setting: Thirteen academic and private medical centers.

Direct injection of vasopressin during hysteroscopic myomectomy: a case report.

Background: Hysteroscopic myomectomy is the ideal procedure for symptomatic women with submucosalfibroids who desire to preserve their fertility. Vascular myomas can limit visualization when a mechanical morcellator is used. Injection of a dilute vasopressin solution has been shown to decrease blood loss during laparoscopic myomectomy.

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

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.

Postmenopausal bleeding due to a Cu-7 intrauterine device retained for thirty years.

Background: A retained intrauterine device is a rare, but easily correctable, cause of postmenopausal bleeding (PMB).

Case: A 64-year-old woman presented to her gynecologist with PMB. Sonographic evaluation of the endometrium revealed the presence of a Cu-7 IUD retained for at least 30 years.

Unilateral placement of the Adiana device after failed bilateral placement of the Essure device for hysteroscopic sterilization.

This case report outlines the successful completion of hysteroscopic sterilization using the Adiana Permanent Contraception device (Hologic, Inc., Bedford, MA) after failure of multiple attempts to bilaterally place the Essure Permanent Birth Control system (Conceptus Inc., Mountain View, CA).

Summary of safety and effectiveness data from FDA: a valuable source of information on the performance of global endometrial ablation devices.

Objective: To provide an overview of the approved second-generation endometrial ablation technologies.

Study Design: Data from the FDA Summary of Safety and Effectiveness Data were compared for Thermachoice, HydroThermablator, Her Option and Novasure devices.

Results: At 12 months' follow-up, Novasure and HydroThermablator had the highest amenorrhea rates.

A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia.

Study Objective: To compare the safety and effectiveness of the NovaSure impedance-controlled endometrial ablation system with hysteroscopic wire loop resection plus rollerball ablation for treatment of excessive uterine bleeding in premenopausal women.

Design: Randomized, multicenter, double-arm study (Canadian Task Force classification I).

Setting: Nine academic medical centers and private offices.

Hysteroscopic treatment of the patient with intracavitary pathology (myomectomy/polypectomy).

Hysteroscopy is a simple and effective method for treating intrauterine leiomyomas and polyps. These lesions often cause abnormal uterine bleeding and infertility. Using the techniques in this article, most lesions can be removed in an office or outpatient setting.

Using amino-cerv after cervical LEEP.

Objective: To evaluate the ability of Amino-Cerv to promote healing of the cervix following loop electrical excision procedure (LEEP) of the cervix for cervical intraepithelial neoplasia.

Study Design: A randomized study was conducted on 48 women in a private office setting. Patients were divided into two groups, to use or not use Amino-Cerv intravaginally for two weeks after the procedure.

Treatment of acardiac twinning.

Background: The twin reversed-arterial-perfusion sequence is a complication of monochorionic twin pregnancies characterized by the hemodynamic dependence of a "recipient" twin from a "pump" twin. The recipient twin exhibits lethal abnormalities including acardia and acephaly. The pump twin has a mortality rate of 50% as a result of high-output heart failure.

Not so benign endometrial hyperplasia: endometrial cancer after endometrial ablation.

The masking or development of endometrial cancer after endometrial ablation is a concern often alluded to in discussions of complications of endometrial ablation. It is necessary to look for a common factor when this complication occurs. Six cases published in peer-reviewed literature were collected to establish a link between the development of endometrial cancer and endometrial ablation.

Pressure and Flow Characteristics of Various Resectoscopes.

We evaluated the pressure and flow characteristics of four hysteroscopic resectoscopes using both gravity and suction. Each hysteroscope was introduced through a port into a sealed chamber of 150 ml volume. A pressure reading was made from the chamber and flow was measured.

Photodynamic therapy of rat endometrium sensitized with tin ethyl etiopurpurin.

Study Objective: To evaluate endometrial ablation in the rat using photodynamic therapy and the photosensitizer tin ethyl etiopurpurin (SnET2).

Design: Laboratory research.

Setting: A pharmaceutical and device manufacturing company.

Control of intrauterine fluid pressure during operative hysteroscopy.

Study Objective: To evaluate the safety of a commonly used piston pump that controls the infusion pressure of low-viscosity fluids in a continuous-flow hysteroscopic system during operative hysteroscopy.

Design: Consecutive patients requiring operative hysteroscopy.

Setting: Three hospital facilities in the Midwest.

Endometrial ablation. A report of four cases.

Three women had evidence of atypical endometrial hyperplasia at the time of endometrial ablation, discovered because they had mechanical preparation of the endometrium rather than medical preparation. In one of these patients, a frozen section revealed atypical endometrial hyperplasia, and the ablation was cancelled. A fourth woman had an unsuccessful endometrial ablation; repeat ablation was followed by nine months of amenorrhea, at which time she began spotting and requested a hysterectomy.

Incisional hernias after major laparoscopic gynecologic procedures.

Objective: Our purpose was to determine the incidence of incisional hernias after operative laparoscopy.

Study Design: A retrospective case review was performed.

Results: The frequency of incisional hernias at extraumbilical 10 and 12 mm trocar insertion sites was one in 429 (0.

Mechanical preparation of the endometrium prior to endometrial ablation.

Of 143 women who underwent endometrial ablation between May 1986 and August 1991, 16 also had repeat procedures. Medical preparation of the endometrial lining (danazol, leuprolide acetate, or nafarelin acetate) was used in 109 patients; mechanical preparation in the form of suction curettage, in 28 patients; and no preparation, in 6 postmenopausal patients. Evaluation of the results following endometrial ablation showed that the results in mechanically prepared patients were comparable to those in patients receiving traditional medical preparation; thus mechanical preparation can make the procedure simpler, enhance patient compliance, and reduce side effects considerably.

Endometrial ablation repeat procedures. Case studies.

Of 143 women who underwent endometrial ablation from May 1986 through August 1991, 16 requested repeat endometrial ablation and 7 underwent hysterectomy. Only two of the hysterectomies were performed for bleeding, and no hysterectomy was needed for any woman who had a repeat endometrial ablation. For patients undergoing one ablation, the results were amenorrhea in 55 women (38%), staining in 32 (22%), light flow in 33 (23%), 7 hysterectomies (5%) and 16 patients requesting repeat endometrial ablation (11%).