Electromechanical Morcellators in Minimally Invasive Gynecologic Surgery: An Update

Study ObjectiveTo assess all electromechanical morcellators used in gynecology to achieve an objective comparison between them and to make suggestions for improvements in future developments.DesignLiterature review.InterventionThe PubMed, Web of Science, EMBASE, and MAUDE databases were systematically searched for all available literature using the terms “morcellator,” “morcellators,” “morcellate,” “morcellation,” and “morcellated.” All articles with information on morcellation time and morcellated tissue mass or the calculated morcellation rate of electromechanical morcellators used for gynecologic laparoscopic surgery were included. For general data of an existing morcellator, the manufacturer was contacted and Google was searched. Data for morcellation rate, type of procedure, and general characteristics were compared.Measurements and Main ResultsSeven articles were suitable for analysis, and 11 different morcellators were found. In the past decades the morcellation rate has increased. The described morcellation rate ranged from 6.2 to 40.4 g/min. Motor peeling is currently the fastest working principle. Comparing hysterectomy and myomectomy per device, the Morcellex and Rotocut morcellators demonstrated a higher morcellation rate for myomectomy, 25.9 vs 30 g/min and 28.4 vs 33.1 g/min, respectively, although the X-Tract morcellator showed a higher rate for hysterectomy, 14.2 vs 11.7 g/min.ConclusionOver the years, the morcellator has improved with respect to the morcellation rate. However, the morcellation process still has limitations, including tissue scattering, morcellator-related injuries, and the inevitable small blade diameter, which all come at the expense of the morcellation rate and time. Therefore, development of improved morcellators is required, with consideration of the observed limitations.     

Robotic-Assisted Laparoscopic Myomectomy versus Traditional Laparoscopic Myomectomy: Are They the Same?

The relative pros and cons of robotic-assisted laparoscopic myomectomy (RALM) and laparoscopic myomectomy (LM) are still debated. The short-term surgical outcomes such as estimated blood loss, need for blood transfusion, intra-operative complications, and conversion to laparotomy are similar for RALM and LM. Although RALM was previously thought to require longer operative time when compared to LM, recent studies show comparative surgical duration. On longer follow-up, high pregnancy rates and low pregnancy morbidity have been reported for both surgical approaches. The increased cost of RALM when compared to LM may be amortized in high-volume surgical centers. Specimen removal via power morcellation is limited by the FDA safety communication, but strategies for “contained” power and cold-knife morcellation may prevent unintentional fibroid spread. To conclude, RALM and LM are both safe minimally invasive alternatives to open abdominal myomectomy. Future technical developments may allow for the widespread implementation of single-site RALM and LM.     

ESGE survey on tissue power morcellation complications other than leiomyosarcoma

The exact incidence of power morcellation complications (PMC) is unknown and probably underestimated. Medical literature mainly describes case reports and the vast majority of complications after tissue power morcellation are not reported. ESGE has run a survey among its members about complications emerging after laparoscopic electromechanical morcellation including the risk of leiomyosarcoma (LMS). The reported risk of a sarcoma after myoma or uterus morcellation is low and presented in a separate article. The Central office using the ESGE server and website, activating the ‘Survey Monkey’ programme, sent a request to 3422 ESGE members to answer, anonymously, a structured electronic questionnaire with multiple structured answer options, within 3 months. The doctors responding to the call were automatically given a serial number in an EXCEL spreadsheet, enabling statistical analysis using the SPSS v.18. The probabilities were calculated by using the raw data as reported to each individual question, dividing the number of incidence with surgeon’s lifetime experience in laparoscopic surgery. The electronic questionnaire was answered by 216 (6 %) surgeons. The majority of the respondents used the morcellator for 10 years. The overall probability of direct power morcellator injuries to internal organs is more frequent (0.12 %) than that of morcellator injuries to the abdominal and pelvic wall (0.06 %). The risk of parasitic myoma is estimated 0.08 and 0.16 % for the de novo endometriosis after myoma and adenomyoma morcellation. Furthermore, the vast majority of surgeons have never experienced bladder or ureter, aorta and vessel injuries by using the morcellator, proven by the standard deviation being close to zero. Three surgeons with morcellator experience between 1 and 5 years were involved in an injury that caused permanent damage, 1 nerve, 2 bowel and 1 port-site hernia injury due to the morcellator. According to surgeons’ answers, death has never occurred after power morcellation. Morcellator technical problems found also to be of low probability between 0.12 and 0.3 % as estimated for all endoscopic surgeries in lifetime of 188 surgeons. The average number of times per doctor where the morcellator stacked and stopped working is 2.17 with standard deviation equal to 4.4 and sum of incidents equal to 426 times for all 196 doctors. The most frequent technical problem was morcellator transient stacking and the least frequent was the morcellator stopped working and colpotomy needed to evacuate the tissue out of the abdominal cavity 0.12 % operations. The majority of surgeons 136/188 (72 %) are using reusable morcellator devices and 51 (27 %) are using disposable devices. Moreover, 97/188 (51.6 %) of surgeons are using exclusively, only reusable morcellators; 56/188 (29.8 %) are using both disposable and reusable types of morcellators. The incidence of power morcellation complications is very low reputedly. The ESGE board advises that endoscopic operations must be performed only by doctors who have had an adequate training and knowledge. It is compulsory to know the publications about dangers, contraindications and complications before performing these operations. A complete knowledge of techniques and principles of endoscopic surgery is needed to avoid and minimize complications. A training session prior to morcellator first use might decrease further PMC.     

Laparoscopic morcellator-related injuries

STUDY OBJECTIVE: To identify and summarize all electric morcellator-related injuries published in the medical literature. DESIGN: Systematic review (Canadian Task Force classification II-2). SETTING: Databases. SUBJECTS: Articles on morcellator-related injuries published from 1992 through February 2002, plus additional sources of information. INTERVENTION: Search of MEDLINE and referencing of the FDA device report database. Measurements and Main Results: We were unable to locate any references to morcellator-related visceral injuries in the medical literature. Of 17 cases identified from the FDA database, 3 were excluded based on the trivial nature of the event (e.g., instrument did not function). The remaining 14 visceral injuries were to small and large bowel (11), kidney (2), pancreas (1), and major vascular structures (3). Identification of the complication was immediate in 10 patients, but was not until 4 days postoperatively in 1 woman. Three patients died. No device manufacturer or surgical specialty was responsible for a preponderance of the injuries. CONCLUSION: These potentially fatal complications are unreported in the medical literature.     

Role and Risks of Morcellation Associated with Laparoscopic Management of Myomas

Since its introduction, morcellation has paved the way for laparoscopic management of myomas. In the hands of an experienced surgeon, it has enabled even bulky tumours to be removed using a minimally invasive approach, affording patients the advantages of laparoscopic surgery. Initial reports on intraoperative safety of morcellation appeared promising and its introduction subsequently gained momentum. Despite two decades passing since the initial introduction of mechanical morcellation, there are still significant gaps in our knowledge of the longer term outcomes and complications. Recently, the technique has come under scrutiny as cases of iatrogenic spread of uterine tissue secondary to morcellation have been reported. Even more concerning is the inadvertent spread of unsuspected malignancy, which led the FDA to articulate a safety communication and discourage the use of uterine morcellation. This article aims to summarise current evidence for the roles and risks of morcellation in the laparoscopic management of myomas.     

Sydney Contained in Bag Morcellation for Laparoscopic Myomectomy

Study ObjectiveTo demonstrate a new technique of contained in bag morcellation of a myoma after laparoscopic myomectomy.DesignStep-by-step explanation of the technique in a narrated video.InterventionContained In Bag Morcellation of myoma after laparoscopic myomectomy.Measurements and Main ResultsRecent controversy regarding the risk of disseminating occult leiomyosarcomatous tissue during morcellation means we need to revise our current approach to tissue extraction at laparoscopic myomectomy and morcellation in general. Herein we present a novel technique, conceived by Dr. Danny Chou, called the Sydney Contained In Bag Morcellation technique for laparoscopic myomectomy. In this technique an EndoCatch bag (EndoCatch II Auto Suture Specimen Retrieval Pouch; Covidien, Mansfield, MA) is introduced in the typical fashion, the myoma is retrieved, and the mouth of the bag is exteriorized onto the abdominal wall. A 12-mm trocar is then introduced within the bag, and pneumoperitoneum is created before introducing an optical balloon tip port (KII Balloon Blunt Tip System; Applied Medical, Rancho Santa Margarita, CA) and the power morcellator device. Morcellation is then performed within the bag, under direct vision.This technique may offer a safer approach to morcellation because the bowel is not within the morcellation field and there is lower risk of disseminating occult leiomyosarcomatous tissue during morcellation. Subsequent to the morcellation process, suctioning of the bag removes any aerosolized particles of myoma, further minimizing the risk of possible dissemination.ConclusionThis technique may enable a minimally invasive approach to myomectomy to continue as a viable option in the era since the warning by the US Food and Drug Administration.     

Safety of Minimally Invasive Tissue Extraction in Myoma Management: A Systematic Review

ObjectiveThis review seeks to establish the incidence of adverse outcomes associated with minimally invasive tissue extraction at the time of surgical procedures for myomas.Data SourcesArticles published in the following databases without date restrictions: PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews and Trials. Search was conducted on March 25, 2020.Methods of Study SelectionIncluded studies evaluated minimally invasive surgical procedures for uterine myomas involving morcellation. This review did not consider studies of nonuterine tissue morcellation, studies involving uterine procedures other than hysterectomy or myomectomy, studies involving morcellation of known malignancies, nor studies concerning hysteroscopic myomectomy. A total of 695 studies were reviewed, with 185 studies included for analysis.Tabulation, Integration, and ResultsThe following variables were extracted: patient demographics, study type, morcellation technique, and adverse outcome category. Adverse outcomes included prolonged operative time, morcellation time, blood loss, direct injury from a morcellator, dissemination of tissue (benign or malignant), and disruption of the pathologic specimen.ConclusionComplications related to morcellation are rare; however, there is a great need for higher quality studies to evaluate associated adverse outcomes.     

Iatrogenic parasitic myoma: A case report and review of the literature

ObjectiveTo investigate the possible causes of iatrogenic parasitic myoma and methods to prevent its occurrence.Case reportA 27-year-old nulliparous unmarried patient underwent laparoscopic myomectomy with morcellation for a submucosal myoma at the National Taiwan University Hospital (Taipei, Taiwan). Seven years later, an asymptomatic pelvic tumor was noted during a regular annual follow up. Two pelvic tumors were detected and excised by laparoscopic surgery. The masses were confirmed by histopathology to be cellular leiomyomas.ConclusionIn the past 7 years, the incidence of iatrogenic parasitic myomas has increased because of the increased use of minimally invasive surgery using a morcellator. Forty-one cases of iatrogenic parasitic myoma were reviewed from 23 published studies. Parasitic myoma frequently occurs in the dependent part of the abdominal cavity, which suggests seeding of myometrial tissues during morcellation. In situ morcellation and vigorous irrigation with concomitant changes in position may decrease the incidence of retained myoma tissue in the abdomen during surgery.     

A newly developed morcellator creates a new dimension in minimally invasive surgery

We compared the efficiency and safety of a newly developed morcellator with a conventional device for minimally invasive supracervical hysterectomy. The prospective, randomized parallel-group study was set in a department of obstetrics and gynecology within an Academic Teaching Hospital. Patients included 48 women; 20 treated with an existing laparoscopic morcellator (Group 1); 28 treated with newly developed laparoscopic morcellator (Group 2). The weight-adjusted dissection time was reduced significantly by more than half with the new morcellator (p <.01). Significantly fewer (p <.05) and longer pieces of tissue were removed with the new morcellator. The median weight of morcellated tissue in Group 1 was 120 g (range 35-450 g), and the median operating time to remove the morcellated tissue was 10 minutes (range 2-45 minutes). The corresponding figures in Group 2 were 110 g (range 50-320 g) and 4 minutes (range 0.5-12 minutes). No bladder or intestinal lesions or other iatrogenic organ damage was seen with either morcellator. None of the patients in either group had postoperative complications. All interventions were completed as planned in both groups, and none of the procedures had to be converted to an open operation. Adequate tissue for histologic analysis was obtained from all patients. We concluded that the newly developed morcellator is a safe and effective instrument for laparoscopic supracervical hysterectomy, offering a much shorter operation time for the removal of morcellated tissue than a conventional device and a low risk of injury to surrounding organs and tissue.     

Urinary Tract Injuries in Laparoscopic Hysterectomy: A Systematic Review

The aim of this review was to estimate the incidence of urinary tract injuries associated with laparoscopic hysterectomy and describe the long-term sequelae of these injuries and the impact of early recognition. Studies were identified by searching the PubMed database, spanning the last 10 years. The key words “ureter” or “ureteral” or “urethra” or “urethral” or “bladder” or “urinary tract” and “injury” and “laparoscopy” or “robotic” and “gynecology” were used. Additionally, a separate search was done for “routine cystoscopy” and “gynecology.” The inclusion criteria were published articles of original research referring to urologic injuries occurring during either laparoscopic or robotic surgery for gynecologic indications. Only English language articles from the past 10 years were included. Studies with less than 100 patients and no injuries reported were excluded. No robotic series met these criteria. A primary search of the database yielded 104 articles, and secondary cross-reference yielded 6 articles. After reviewing the abstracts, 40 articles met inclusion criteria and were reviewed in their entirety. Of those 40 articles, 3 were excluded because of an inability to extract urinary tract injuries from total injuries. Statistical analysis was performed using a generalized linear mixed effects model. The overall urinary tract injury rate for laparoscopic hysterectomy was 0.73%. The bladder injury rate ranged from 0.05% to 0.66% across procedure types, and the ureteral injury rate ranged from 0.02% to 0.4% across procedure type. In contrast to earlier publications, which cited unacceptably high urinary tract injury rates, laparoscopic hysterectomy appears to be safe regarding the bladder and ureter.     

Comparison of a New Reusable Gynecologic Laparoscopic Electric Morcellator with a Disposable Morcellator: a Preliminary Trial

We compared the efficiency and safety of a newly developed reusable morcellator (Olympus VarioCarve) with that of a disposable morcellator (GyneCare Morcellex) for gynecologic laparoscopic surgery. In group 1 (n = 15 patients; 11 myomectomies and 4 supracervical hysterectomies), the laparoscopic disposable morcellator was used, and in group 2 (n = 14; 11 myomectomies and 3 supracervical hysterectomies), the reusable morcellator was used. There were no statistical differences in total tissue weight. Morcellating time was significantly shorter in group 2, and the rate of morcellation was significantly greater in group 2. Significantly fewer and longer pieces of tissue were removed with the reusable morcellator. No iatrogenic organ damage was observed.     

Same-Day Discharge in Minimally Invasive Surgery Performed by Gynecologic Oncologists: A Review of Patient Selection

ObjectiveTo review the literature about same-day discharge (SDD) in minimally invasive surgery performed by gynecologic oncologists and identify factors associated with SDD and admission to provide selection criteria.Data SourcesSystematic review of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and SCOPUS between May 2007 and May 2019. The search included the following medical subject heading terms and keywords: “same day discharge,” “patient discharge,” “minimally invasive surgical procedures,” “hysterectomy,” “gynecologic malignancy,” “gynecologic neoplasm,” “cervical cancer,” “ovarian cancer,” and “endometrial cancer.”Methods of Study SelectionArticles published in English about women who underwent minimally invasive procedures for benign and malignant conditions of the reproductive tract performed by gynecologic oncologists (robotic or laparoscopic) and who received SDD or admission were included. The following were described: SDD and admission rate, readmission or unscheduled evaluation rates within 30 days after surgery, and associated factors for each one.Tabulation, Integration, and ResultsNine studies with a total of 16 423 patients were included. The complication rates in the studies were variable, with only 2 studies showing advantages in the SDD group with respect to intraoperative complications and wound complications. There were no statistically significant differences in postoperative complications in the first 30 days after the adoption of SDD. There were no higher readmission rates within the first 30 days in the group of patients who were discharged on the same day vs those admitted. The common factors associated with admission were as follows: age <70 years, surgery after 1 PM, duration of surgery more than 2 hours, and intraoperative complications. Other factors to consider were the presence of comorbidities that require follow-up within the hospital after surgery, adequate postoperative evaluation, and the patient accepting SDD.ConclusionSDD seems to be safe and feasible in minimally invasive surgery performed by gynecologic oncologists. The proposed selection criteria includes the following: younger than 70 years, surgery before 1 PM, procedure less than 2 hours, and no intraoperative complications.     

Laparoscopic Supracervical Hysterectomy with Transcervical Morcellation: Initial Experience

Study ObjectiveTo describe a novel method for morcellation at laparoscopic supracervical hysterectomy and to define its potential benefits.DesignRetrospective observational study (Canadian Task Force classification III).SettingHospital-based urogynecology and general gynecology practice and a single community teaching hospital of a university medical school.PatientsThe first 51 women to undergo laparoscopic supracervical hysterectomy with transcervical morcellation at a single institution.InterventionA novel surgical technique that uses a transcervical approach for morcellation of the uterine fundus after amputation from, and coring of, the cervix.Measurements and Main ResultsLaparoscopic supracervical hysterectomy with transcervical morcellation was completed successfully in all 51 patients. Mean (SD) operating time for laparoscopic supracervical hysterectomy with transcervical morcellation alone was 64.3 (28.4) minutes, and median hospital stay was 1 day. There were no intraoperative or postoperative complications related to transcervical morcellation at a median (range) follow-up of 4.4 (1.6–11.7) months.ConclusionLaparoscopic supracervical hysterectomy with transcervical morcellation is a feasible procedure that removes the cervical core and does not require enlarging an abdominal port site for introduction of the uterine morcellator.     

Promises and Pitfalls of the AAGL LISTSERV: A Descriptive Analysis

The objectives of this retrospective database review were to describe and quantify the information contained in the Issues in Endoscopy LISTSERV database and to determine the sensitivity and specificity of the LISTSERV search engine for common topics in minimally invasive gynecology. All LISTSERV entries from January 1 to December 31, 2008, were reviewed for 30 commonly discussed minimally invasive gynecology topics. Each entry was categorized by primary topic(s), and the database was used to search for terms related to total laparoscopic hysterectomy and endometrial ablation. The search engine sensitivity and specificity were calculated for both topics. In 2008, 812 entries were recorded from at least 27 countries. The most frequently discussed topics were hysterectomy and endometrial ablation. Approximately 10% of posts cited literature. The term “TLH” had 69.2% sensitivity and 97.2% specificity for identifying posts in which the subject was total laparoscopic hysterectomy. The addition of the term “total lap hysterectomy” increased the sensitivity to 90.4%. Additional terms led to minimal improvements in sensitivity. A second search using the term “endometrial ablation” yielded sensitivity and specificity of 68.1% and 96.7%, respectively. The addition of the search terms “NovaSure” and “ThermaChoice” changed the sensitivity to 90.4%, and specificity to 95.7%. Although the sensitivity and specificity of the search engine is reasonable for commonly used terms, the use of nontraditional medical terms and abbreviations limits the utility of the LISTSERV database for research. The presence of more than 800 posts in 2008 suggests that surgeons worldwide frequent the forum to discuss various topics. However, minor changes such as the addition of a topic selection menu for entry submission may improve the accuracy of the database search engine. Standardized post hoc filtering of the database at regular intervals may be preferable to substantially altering the current user-friendly entry format.     

Laparoscopic Power Morcellation: Techniques to Avoid Tumoral Spread

Study ObjectiveTo show 3 different techniques for achieving an endobag morcellation without adding extra time and cost to the surgery.DesignStepwise demonstration of the 3 techniques with narrated video footage.SettingMorcellation is a useful procedure for fragmenting and extracting specimens during laparoscopic surgery without the need to perform a laparotomy. Patients who otherwise would not be eligible for minimally invasive surgery (i.e., those with a large uterus or myomas) could benefit from laparoscopic advantages. However, morcellation has a major limitation: the risk of dissemination of unsuspected malignancies. In 2017, the Food and Drug Administration released an updated assessment of the use of laparoscopic power morcellators for treatment of leiomyomas. A total of 23 studies were included in the analysis, and 20 studies (90 910 women) contributed to the estimated prevalence of leiomyosarcoma at the time of surgery for presumed leiomyomas. Depending on the modeling methodology used, the estimated prevalence of uterine sarcoma was 1 in 305 to 1 in 360 women, and for leiomyosarcoma, the estimated prevalence was 1 in 570 to 1 in 750 women [1].Currently available evidence has suggested that if an undiagnosed uterine malignancy is intra-abdominally morcellated, there is a risk of intraperitoneal dissemination of the disease [2]. Therefore, the European Society of Gynecological Oncology emitted a statement in 2016 recommending avoiding morcellation if there is any suspicion of sarcoma and using endobag containers for morcellation of the surgically removed uterine myomas [3]. In addition, in the United States, the Food and Drug Administration recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the United States [4].InterventionsThere are several techniques described in the literature for contained uterine myomas morcellation [5]. In this video, we present 3 of them:First, an indirect-view morcellation is described. In this technique, we placed the myoma in the bag and exteriorize it through one of the trocars. Once outside the abdomen, we placed the morcellator through the bag opening and did the morcellation inside the bag while checking through the umbilicus camera. Special attention must be paid to avoid any damage to the bag because the visualization is limited in this technique.Second, a direct-view technique is described, in which we exteriorized the opening of a 15-mm bag through the suprapubic trocar and a closed end of the bag through the umbilicus. We made a hole in the umbilicus end of the bag and introduced the camera trocar through it. Once done, we introduced the morcellator through the opening and the camera in the umbilicus port.Third, a single-port–contained morcellation is explained. The bag was exteriorized through the umbilicus, and a skin retractor was placed. A glove was placed outside the retractor to isolate the bag. Once placed, 2 of the fingers were opened and used as trocars (one for the morcellator and the other for a 30° camera). After using this technique, the scope should be replaced to minimize the risk of contamination.The following are possible limitations of each technique: in the indirect-view technique, owing to the limited visualization, the surgeon must pay special attention to avoid tearing the bag while morcellating the specimen. In the direct-view technique method, the surgeon needs to ensure the proper closure of the bag before removing it from the abdomen to avoid possible dissemination risk. Finally, in the single-port technique, the surgeon must have previous experience in this type of approach, minimizing the risk of contamination by changing the scope after the morcellation process.ConclusionLaparoscopic power morcellation may provide several benefits for our patients, when performing a hysterectomy or a multiple myomectomy. We presented 3 different and feasible techniques for laparoscopic power morcellation using an endobag container.     

Outcomes of Minimally Invasive Management of Tubo-ovarian Abscess: A Systematic Review

ObjectiveTo compare the success rate, complications, and hospital length-of-stay of 3 modalities of minimally invasive management of tubo-ovarian abscesses (TOAs): laparoscopy, ultrasound-guided drainage, and computed tomography–guided drainage.Data SourcesElectronic-based search in PubMed, EMBASE, Ovid MEDLINE, Google Scholar, and Cochrane Central Register of Controlled Trials, using the following Medical Subject Heading terms: “minimally invasive surgical procedures,” “drainage,” “abscess,” “tubo-ovarian,” “ovarian diseases,” and “fallopian tube diseases.”Methods of Study SelectionOf the 831 articles in the initial results, 10 studies were eligible for inclusion in our systematic review.Tabulation, Integration, and ResultsA total of 975 patients were included in our study; 107 (11%) had laparoscopic drainage procedures, and 406 (42%) had image-guided (ultrasound or computed tomography) drainage of TOAs. Image-guided TOA drainage had higher success rates (90%–100%) than laparoscopic drainage (89%–96%) and the use of antibiotic treatment alone (65%–83%). Patients treated with image-guided drainage had no complications (for up to 6 months of follow-up) and shorter lengths of hospital stay (0–3 days on average) compared with laparoscopic drainage (5–12 days) or conservative management with antibiotics alone (7–9 days).ConclusionAlthough conservative management of TOAs with antibiotics alone remains first-line, our review indicates that better outcomes in the management of TOA were achieved by minimally invasive approach compared with conservative treatment with antibiotics only. Of the minimally invasive techniques, image-guided drainage of TOAs provided the highest success rates, the fewest complications, and the shortest hospital stays compared with laparoscopy. The low magnitude of evidence in the included studies calls for further randomized trials. This systematic review was registered in the International Prospective Register of Systematic Review (register, http://www.crd.york.ac.uk/PROSPERO;CRD 42020170345).     

Trocar-associated injuries and fatalities: an analysis of 1399 reports to the FDA

Laparoscopic trocars, medical devices used to gain access into the abdominal cavity, are the most common device named in malpractice injury claims associated with laparoscopic procedures. As part of its ongoing adverse event reporting program, the U.S. Food and Drug Administration (FDA) requires manufacturers and user facilities to file a report whenever a device was or may have been a factor in a death or serious injury. The FDA collects data from these reports in its Manufacturer and User Facility Device Experience (MAUDE) database. This study presents an analysis of fatality and injury data on laparoscopic trocars found in MAUDE reports received from January 1, 1997, through June 30, 2002, including 31 fatal injury cases and 1353 reports on nonfatal injuries. Cholecystectomy was the procedure most frequently associated with both fatal and nonfatal trocar injuries. Most fatalities involved vascular injuries. All fatality reports that identified the trocar design involved either a shielded trocar (which has a retractable shield that covers the trocar blade before and after insertion to help protect abdominal and pelvic organs from inadvertent puncture) or an optical trocar (which allows laparoscopists to view the cutting tip as it penetrates the tissues). Narrative comments cited surgical technique, device problems, and patient characteristics as contributing factors. Among nonfatal injuries, a change in surgical management such as additional surgical procedure--primarily laparotomy--prolonged surgery, or aborted surgery was reported most frequently for vascular and hollow viscus injuries. Many reports did not identify the device model, surgical procedure, or event timing, limiting Food and Drug Administration (FDA) and manufacturer investigations into whether the device contributed to the event. The most common manufacturer conclusions indicated the trocar was not returned, and no conclusions could be drawn about the trocar's contribution to the event. Fatalities occur with procedures in which shielded trocars and optical trocars are used. Further study is needed to evaluate the high proportion of reports associated with laparoscopic cholecystectomy. Laparoscopists should retain for evaluation any devices implicated in patient injuries and should ensure that detailed information on adverse events is provided in adverse event reports to the FDA. The FDA's Manufacturer and User Facility Device Experience (MAUDE) database can be a valuable source for information on adverse outcomes associated with medical devices and, given an understanding of its limitation, provides researchers with a viable adjunct to published literature and litigation surveys for obtaining this information.     

Laparoscopy in the Morbidly Obese: Physiologic Considerations and Surgical Techniques to Optimize Success

The objectives of this review were to analyze the literature describing the benefits of minimally invasive gynecologic surgery in obese women, to examine the physiologic considerations associated with obesity, and to describe surgical techniques that will enable surgeons to perform laparoscopy and robotic surgery successfully in obese patients. The Medline database was reviewed for all articles published in the English language between 1993 and 2013 containing the search terms “gynecologic laparoscopy” “laparoscopy,” “minimally invasive surgery and obesity,” “obesity,” and “robotic surgery.” The incidence of obesity is increasing in the United States, and in particular morbid obesity in women. Obesity is associated with a wide range of comorbid conditions that may affect perioperative outcomes including hypertension, atherosclerosis, angina, obstructive sleep apnea, and diabetes mellitus. In obese patients, laparoscopy or robotic surgery, compared with laparotomy, is associated with a shorter hospital stay, less postoperative pain, and fewer wound complications. Specific intra-abdominal access and trocar positioning techniques, as well as anesthetic maneuvers, improve the likelihood of success of laparoscopy in women with central adiposity. Performing gynecologic laparoscopy in the morbidly obese is no longer rare. Increases in the heaviest weight categories involve changes in clinical practice patterns. With comprehensive and thoughtful preoperative and surgical planning, minimally invasive gynecologic surgery may be performed safely and is of particular benefit in obese patients.     

Current state of uterine artery embolization for treating symptomatic leiomyomas of the uterus

A number of new approaches in treating symptomatic leiomyomas of the Uterus have been introduced in recent years. Only little scientific data is available an percutaneous or laparoscopic myolysis using focussed ultrasound, laser, or coagulation guided by magnetic resonance imaging or an laparoscopic ligation of the uterine vessels by means of bipolar coagulation or clipping. Established therapeutic options are limited by a number of disadvantages, except for total laparoscopic hysterectomy with morcellation. The latter is a minimally invasive procedure that spares important pelvic structures and thereby reduces the risk of prolapse and is associated with rapid recovery of the patients. Another minimally invasive therapeutic approach with preservation of the uterus is transarterial catheter embolization of uterine leiomyomas in which the vessels supplying the leiomyomas, in particular the branches of the uterine artery, are partly occluded by injection of synthetic (polyvinyl) beads. Uterine artery embolization has since developed into a good alternative to other therapeutic options. Studies report cure rates ranging from 77-93 %.     

Biopsy of Uterine Leiomyomata and Frozen Sections Before Laparoscopic Morcellation

Uterine sarcoma is rare. However, its morcellation can be associated with spread of disease. The definitive diagnosis of uterine sarcomas is made via histology. To date, the only reliable preoperative test for determination of the types of myometrial tumors is analysis of either frozen sections or permanent formalin-fixed tissue sections of surgical specimens. We report 2 cases in which the feasibility of obtaining multiple biopsy specimens of uterine leiomyomas and frozen sections before laparoscopic morcellation is demonstrated. This procedure might reduce the risk of laparoscopic morcellation of unsuspected leiomyosarcomas while still offering the advantages of a minimally invasive technique.