Adverse Events When Using Advanced Sealing Devices During Vaginal Hysterectomy: An Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database

Introduction

Hysterectomy is a common surgical procedure in the United States and can be accomplished via abdominal, vaginal, or laparoscopic approaches. ¹ Of these methods, vaginal hysterectomy is associated with shorter recovery times and hospital stays as well as decreased postoperative pain.^2–4 The AAGL (formerly the American Association of Gynecologic Laparoscopists) and the American College of Obstetricians and Gynecologists (ACOG) recommend minimally invasive approaches to hysterectomy, with the ACOG favoring vaginal approaches when possible.^3,5

During vaginal hysterectomy, conventional suturing can be challenging, given the limited access to vascular pedicles. ⁶ Utilization of energy-based bipolar sealing devices (EBVS) enables rapid vessel-sealing ⁷ that is considered safe and effective; and that reduces operative time, blood loss, and postoperative pain scores.^6,8–12 Two such instruments include the ENSEAL^® x1 Tissue Sealer™ (Ethicon Endo-Surgery, Cincinnati, OH) and the LigaSure Impact™ (Covidien, Medtronic, Minneapolis, MN), both advanced bipolar vessel sealers. ¹³

A potential risk of using vessel-sealing devices is thermal injury to adjacent structures. While these injuries are not common, ⁸ they can occur,^11,14 potentially resulting in visceral injuries.^15–17 Complication rates from use of EBVS range from 5.3% ⁸ to 10%. ¹⁷ A systematic review including several randomized controlled trials using EBVS found intraoperative complication rates as high as 8% and postoperative complication rates up to 12%. ¹⁸ Several studies have reported no complications caused by using EBVS during vaginal hysterectomy. ¹¹ The objective of this study was to investigate the prevalence of reported thermal injuries using the LigaSure and ENSEAL devices as reported to the U.S. Food and Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database.*

Materials and Methods

The MAUDE database is run by the FDA and contains reports of device malfunctions that caused serious injuries or fatalities. MAUDE is comprised of reports that are submitted by certain mandatory reporters—manufacturers, importers, and device-user facilities—as well as voluntary reports from patients, consumers, and health care workers. Voluntary reports have been compiled on the database from June 1993, user-facility reports from 1991, distributor reports from 1993, and manufacturer reports from August 1996. This study was exempt from institutional review board approval.

The MAUDE was queried from the dates November 1, 1990 to November 1, 2021 for Brand Names LigaSure Impact and ENSEAL x1 and for Event Type Injury. Two individuals independently reviewed these events and categorized these reports into “NON-HYST” for procedures not specifically identified as hysterectomies, “HYST—ABD” for abdominal hysterectomies, “HYST—LSC” for laparoscopic hysterectomies, “HYST—VAG” for vaginal and laparoscopic-assisted vaginal hysterectomies, and “HYST—UNK” for hysterectomies with unknown approaches. Duplicate entries were removed. These reviewers screened the reports for thermal bowel-injury events.

Results

From November 1, 1990, to November 1, 2021, the MAUDE database included 50 incident reports for LigaSure Impact and 42 reports for ENSEAL x1 (Table 1).

Of the 50 LigaSure Impact reports, 11 (22%) described injuries during hysterectomies—7 during abdominal approaches and 4 during vaginal approaches (Table 2). Device malfunction was the most-common report for vaginal hysterectomies, occurring in 3 reports. The other incident report noted a bladder injury identified postoperatively. Injury reports related to abdominal hysterectomies included ureteral injury, urinary leakage, improper locking of the device, and inadequate sealing. There were no thermal bowel injuries reported for the LigaSure Impact.

Eighteen reports described injuries during hysterectomies with ENSEAL x1—8 during abdominal approaches, 5 during vaginal approaches, 2 during laparoscopic approaches, and 3 via an unspecified approach (Table 2). Of the 5 injuries involving vaginal hysterectomy using ENSEAL x1, 2 were due to inadequate sealing of the device, 2 were associated with thermal injury to skin, and 1 resulted in ureteral injury. Reports related to other types of hysterectomy included thermal injury to skin, inadequate sealing, postoperative bleeding, and ureteral injury. There were no reports of thermal bowel injury involving the ENSEAL x1 device.

Other injuries that occurred during hysterectomy via any approach (Table 3) included thermal injury to skin (n = 3), urinary-tract injury (n = 4), and hematoma formation (n = 3). The ENSEAL x1 device had more (n = 12) non–thermal bowel-injury complications reported than the LigaSure Impact (n = 8). All of the non–thermal bowel-injury complications for LigaSure were reported during abdominal hysterectomies (n = 7), as well as most of those for ENSEAL x1 (8/12).

Discussion

Over the last decade, rates of total vaginal hysterectomy have decreased while total laparoscopic hysterectomy rates increased.^19–21 Differences in operative times likely have contributed to decisions to use the latter approach, as some studies have shown that operative time for vaginal hysterectomy has increased over time while those for laparoscopic hysterectomy have decreased, although vaginal hysterectomy has a shorter median operative time overall. ¹⁹ In a study of hysterectomies done at the Veterans Administration, both laparoscopic and vaginal hysterectomy rates increased, compared to abdominal hysterectomy rates, although a greater percentage of these hysterectomies were performed laparoscopically than vaginally. ²² This was reflected in the current study, as only 5% of reports for LigaSure and 12% of reports for ENSEAL x1 were vaginal hysterectomies, indicating, that despite its benefits, vaginal hysterectomy is a lesser-used surgical approach.

Another consideration for both approaches to hysterectomy and use of bipolar sealing devices is the prevalence of obesity, which can significantly impact surgical complexity and outcomes. Obesity has been increasing in prevalence in the United States, and estimates project that half of the U.S. population will be obese by 2030. ²³ Obesity has been correlated with increased rates of wound complications and infections ²⁴ as well as with postoperative complications and longer hospital stays. ²⁵ Abdominal hysterectomy has been shown to have higher complication rates for obese women, ²⁵ thus, minimally invasive techniques for these patients have come to be preferred. As discussed above, vaginal hysterectomy has been reported as having lower complication rates and shorter hospital stays,^2,4,6 and it is the recommended primary route for hysterectomy for obese women. ²⁶

A limitation of this current study was the small number of reports found for LigaSure and ENSEAL x1 in the MAUDE database. Given that the MAUDE utilizes voluntary reporting for its data collection, it may not represent fully all the instances of device malfunctions or thermal bowel injuries that occur. Adverse events when using any device can occur as a result of user error or device malfunction, and another limitation of the MAUDE database is that it only presents the latter, thus not capturing fully all the possible etiologies of device malfunction. Further research that utilizes clinical data obtained prospectively and including multiple centers could help reflect the complication rates more accurately that are the result of using bipolar surgical-sealing devices. In addition, given current trends that indicate rising rates of laparoscopic hysterectomy, future studies could investigate rates of thermal bowel injury during laparoscopic versus vaginal hysterectomy.

Conclusions

Based on the limited number of reports, using advanced bipolar sealing devices during vaginal hysterectomy is likely a safe option given the limited access to vascular pedicles. This may be particularly applicable in the presence of obesity and fibroids and given the high rates of cesarean delivery, ²⁷ which can potentially distort pelvic anatomy. ²⁸