There are several new devices designed to perform global endometrial ablation without the use of an operative hysteroscope. These devices have been developed to reduce operative time, decrease risk of fluid overload syndrome, and provide a means of performing endometrial ablation without the technical skill required for the use of a resectoscope. Of these devices, four are commercially available in the United States: Her Option (formerly First Option, CryoGen, San Diego, CA), a cryoablation device; the Hydro ThermAblator (Microvasive Urology, a division of Boston Scientific, Natick, MA) hysteroscopic system of circulating intrauterine heated normal saline; NovaSure (Novacept, Palo Alto, CA), which uses radiofrequency electrosurgical energy; and ThermaChoice (Gynecare, Menlo Park, CA), which uses a heated intrauterine balloon.
To date, few and mostly minor complications have been reported in connection with these methods in the medical literature. These include hemorrhage, pelvic inflammatory disease, endometritis, first-degree skin burns, hematometra, vaginitis, and cystitis.1–7 However, we are aware of serious complications associated with these devices which are not reported in the medical literature. To explore the number of such complications, the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database was searched for additional reported adverse events. The MAUDE database represents reports of adverse events involving medical devices. The data consist of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The database is maintained by a division of the US Food and Drug Administration and available for public use under the Freedom of Information Act.
MATERIALS AND METHODS
As part of our initial “traditional” review of the medical literature published before and after US Food and Drug Administration approval of these devices, we searched MEDLINE for the period from 1990 to May 2003, using PubMed (http://www.nlm.nih.gov). The following key words and subject terms were searched: “endometrial” and “ablation,” “endometrium” and “cryoablation,” “thermal balloon ablation,” “hydrothermal ablation,” “Her Option,” “First Option,” “ThermaChoice,” “NovaSure,” “Hydro ThermAblator,” and “HTA.” All publication types in the English language were included. Bibliographies of pertinent articles and reviews were searched for additional references. Relevant textbooks were also reviewed. In addition, the Cochrane database was searched.
The MAUDE database was accessed through the US Food and Drug Administration web site (http://www.fda.gov/cdrh/maude.html). An online search was then performed to obtain information by using the search words used in our traditional MEDLINE search. These were further delineated into four categories of event type: device malfunction, injury, death, and other. Each company was then contacted to provide an estimate of the number of procedures performed to date in the United States. This allowed the calculation of approximate complication rates.
The traditional MEDLINE search revealed 27 studies published in the medical literature regarding these devices: three using First Option/Her Option (203 patients),8–10 five using the Hydro ThermAblator (265 patients),1,11–14 three using NovaSure (328 patients),2,15,16 and 16 using ThermaChoice or ThermaChoice II (1170 patients).3–7,17–27 Eighteen of the 27 studies reported no complications. Of the nine studies reporting complications, there were two cases of hemorrhage,2,9 one case of pelvic inflammatory disease,2 20 cases of endometritis,1–4,6,7,15,26 two cases of first-degree skin burns,1 nine cases of hematometra,1,2,5,7,26 and 16 cases of vaginitis and/or cystitis.1–3,6 Specifically, no cases of uterine perforation or thermal bowel injury were reported in the medical literature. All cases of infection were treated postoperatively in the outpatient setting. All cases of hematometra were treated successfully with outpatient cervical dilation. A search of the Cochrane database revealed no additional cases.
The MAUDE database search revealed a total of 206 reports. Of the 206 reports, 120 were related to device malfunctions. The remaining 86 reports noted 85 complications in 62 patients, including many major complications: 30 cases of uterine perforation, eight cases of thermal bowel injury, and one case of necrotizing fasciitis. Twelve patients required emergent laparotomy. Three patients were admitted to the intensive care unit. The patient who developed necrotizing fasciitis eventually underwent vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee amputations. One patient with a thermal bowel injury eventually died. A breakdown of each device and the number and type of associated complications found are listed in Table 1. Estimated complication rates are presented in Table 2.
The patient death occurred 4 weeks after use of the ThermaChoice balloon, complicated by a perforation and thermal bowel injury requiring laparotomy and bowel resection in an obese woman who had previously undergone cesarean delivery. Based on the limited data available in the report, the death was thought to have resulted from a wound infection and hepatorenal syndrome. One of the five bowel injuries with ThermaChoice occurred in a patient with a uterus that sounded to 11 cm (the device has not been fully evaluated in women with large uterine cavity, greater than 10 cm, as stated in the device labeling). The case of uterine necrosis, endometritis, and sepsis requiring laparotomy after use of ThermaChoice was found to be caused by group A streptococcal necrotizing fasciitis, a rare complication that can occur after a number of gynecologic procedures.28
The causes of laparotomy included eight thermal bowel injuries, one necrotizing fasciitis and necrosis, one endometritis complicated by sepsis, and two uterine perforations (one broad ligament hematoma and one requiring emergent hysterectomy).
The results of this study indicate that the use of global endometrial ablation devices can be associated with significant complications, despite the paucity of reports of such adverse events in the medical literature. The MAUDE database was searched, because it is maintained by the US Food and Drug Administration for the listing of adverse events associated with medical devices. Based on these data, at least eight thermal bowel injuries and nine cases of thermal injury to the lower genital tract have occurred. One of each of these complications is noted from a European report. Significant infections have also been reported, leading to laparotomy, hysterectomy, intensive care unit admission, bilateral below-the-knee amputation (one case), and death (one case).
It should be acknowledged that several of the adverse event reports with ThermaChoice (one bowel perforation, two hemorrhages, ten uterine perforations) were reported in MAUDE after being solicited as an anonymous postal survey of European physicians entitled “European Survey of Uterine Thermal Balloon Ablation System in 5800 Women.” These reports were anonymous, and thus no further information is available regarding the circumstances.
There are several potential reasons for the discrepancy between what is published in the medical literature and what is available in the MAUDE database. First, most clinical trials are performed by experts and conform to rigorously defined protocols that might not translate into what can be expected in widespread use. Second, physicians might be reluctant to publish their own complications because of medicolegal and time constraints. Last, there is often a significant time lag in event occurrence and subsequent peer review publication.
Unfortunately, reports from these databases lack sufficient details to clearly establish a causal relationship between complications and use of these devices. In addition, the relative or absolute degree of risk with these devices is difficult to determine for two reasons. First, the relative or absolute degree of risk is not known because there is no way to determine whether the complications have been underreported. Second, the number of cases performed with these techniques during this period could only be estimated based on manufacturer data. Therefore, our complication rate estimates are subject to both numerator and denominator limitations.
Based on the acknowledged limited information from the MAUDE database, there appear to be issues associated with these complications. First, in the cases involving thermal bowel injuries with the NovaSure device, both occurred after the operator manually overrode the inherent safety mechanism of the instrument that is specifically designed to prevent this type of complication. The new NovaSure devices no longer have an override option. Second, the case of thermal bowel injury with the Hydro ThermAblator occurred after use of the device after a known uterine perforation. This is contraindicated. Third, lower genital tract thermal injury might be avoided by ensuring a tight seal, so that fluid does not egress from the cervix while using the Hydro ThermAblator. Fourth, one of the thermal injuries resulting from use of the Hydro ThermAblator was caused by tubing containing heated fluid coming into contact with the patient's skin. This tubing has been redesigned with insulation to avoid accidental contact with the patient. Fifth, several uterine perforations with the ThermaChoice occurred while being used in women with large or small uteri (out of indicated size range of the device). Last, although there are a greater number of reported adverse events associated with the ThermaChoice balloon, it should be noted there have been significantly more ThermaChoice procedures performed in the United States, because it was introduced to the market 4 years before any other device.
We recommend additional study of two issues. First, previous cesarean delivery: One serious complication occurred in a patient with a prior cesarean delivery. Because the hysterotomy repair site is thin in some cases, patients with a prior history of cesarean delivery might not be appropriate for these devices. Second, prophylactic antibiotics: Due to the infections reported and the significant subsequent morbidity, prophylactic antibiotics might be useful when these techniques are used.
We encourage physicians to review the MAUDE database when considering the use of a new medical device, to research the possibility of complications not yet reported in the published medical literature. Likewise, we recommend that physicians report complications associated with medical devices through the US Food and Drug Administration MedWatch adverse event reporting program. This outreach reporting system can be accessed through the Internet at http://www.fda.gov/medwatch.
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© 2003 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
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