Search

Objectives: Our primary objective was to assess patient awareness by observing Google Trends comparing search terms used in relation to morcellation rather than morcellation alone. Our secondary objective was to review trends and locations of publications on leiomyosarcoma and morcellation following the US Food and Drug Administration (FDA) position statement.Study Design: To assess Internet trends, we obtained the relative search volume (RSV) for each month from 1 January 2004 to 1 March 2019 from Google Trends using the terms 'fibroid', 'morcellation', and 'fibroid cancer'. RSV ranges from 0 to 100 with 100 being peak popularity for the term, and all other monthly search activity relative to the peak. To assess academic trends, we performed a systematic review of published literature discussing fibroid morcellation within the same time period. We used a two-way independent t-test to compare median RSV, and chi-squared test to compare academic output. P < 0.05 was considered statistically significant.Results: Search volume for 'morcellation' peaked during the FDA statement (RSV 0.5 to 2.9, t = 17.5, p < 0.05) but was not sustained. There is an increase in 'fibroid' activity post-FDA statement (RSV 68.8 to 76.3, t = 3.9, p < 0.05). 'Fibroid cancer' remained static throughout (t = 1.5, p = 0.1 and t=-0.5, p = 0.6). Afro-Caribbean countries had the highest RSV for 'fibroid', whereas 'morcellation' RSV was highest in predominantly Western countries. There was a significant increase in the rate of papers published on the subject following the FDA statement (6.8 vs 55.6 papers per year, 95% CI -53.96 to -43.64, p < 0.0001). No academic papers on morcellation were published from countries with the highest RSV for 'fibroid'.Conclusion: Our study suggests that interest in uterine fibroids has increased since the FDA statement, but the public are perhaps unaware or not concerned of the consequent potential risk of leiomyosarcoma following morcellation. Countries where fibroid interest is highest are not necessarily those that can offer power morcellation. Further studies are required to address how the Internet influences patient choice and informed consent, and how medical professionals can use it to further educate patients on the risks and benefits of laparoscopic myomectomy and power morcellation. [ABSTRACT FROM AUTHOR]

Objective: To analyze utilization of, and payments for, pelvic organ prolapse procedures after the 2011 U.S. Food and Drug Administration (FDA) communication regarding transvaginal mesh.Methods: This is a retrospective cohort study examining private claims from three insurance providers for inpatient and outpatient prolapse procedures from 2010 to 2013 in the Health Care Cost Institute. Primary outcomes were the change in utilization of prolapse procedures, with and without mesh, before and after the July 2011 FDA communication. Secondary outcomes were the changes in payments and reimbursements for these procedures. Utilization rates and payments were compared using generalized linear models and interrupted time-series analysis.Results: Utilization of prolapse procedures decreased from 12.3 to 9.7 per 10,000 woman-years (P=.027) with a decrease of 30.7% (3.9 in 2010 to 2.7 in 2013, P=.05) in number of mesh procedures and 16.6% (8.4 in 2010 to 7.0 in 2013, P=.011) for nonmesh procedures. Quarterly utilization of mesh procedures was increasing before the FDA communication and then significantly declined after its release (slope=0.024 vs -0.025, P=.002). Nonmesh procedures, however, were already slightly decreasing before July 2011 and continued to decline at a more rapid pace after that time, although not significantly (slope=-0.004 vs -0.022, P=.47). Inpatient utilization decreased 52.2% (P=.002), whereas outpatient utilization increased 18.5% (P=.132). Payments for individual inpatient procedures, with and without mesh, increased by 12.0% ($8,315 in 2010 to $9,315 in 2013, P=.001) and 15.6% ($7,826 in 2010 to $9,048 in 2013, P=.005), respectively, whereas those for outpatient procedures increased by 41% ($4,961 in 2010 to $6,981 in 2013, P=.006) and 30% ($3,955 in 2010 to $5,149 in 2013, P=.004), respectively.Conclusion: Use of prolapse surgery declined during the study period. After the 2011 FDA communication regarding transvaginal mesh, there was a significant decrease in the utilization of procedures with mesh but not for those without mesh. A shift toward outpatient surgeries was observed, and payments for both individual inpatient and outpatient cases increased. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas.Methods: This is a cross-sectional study using data from 2013 to 2014 in the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgical Databases from Arizona, Florida, Kentucky, and New Jersey. Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis. Multivariable models were used to assess changes in the proportion of hysterectomies performed laparoscopically, vaginally, or by laparotomy in the 15 months before the FDA safety communication in April 2013 (January 2013 to March 2014) to the 9 months after the FDA communication (April to December 2014). Changes in the proportion of women who underwent myomectomy compared with hysterectomy were also evaluated during this time period.Results: There were 77,637 hysterectomy and myomectomy cases analyzed from states with both inpatient and ambulatory surgery data; 59% of patients were outpatients. Overall, there was a 4% (95% CI 3.2-4.8%) decrease in the use of laparoscopic hysterectomy for treatment of uterine leiomyomas from 62% of all hysterectomies before the FDA communication on morcellation to 58% afterward. Changes in surgical practice were more pronounced in the inpatient compared with outpatient setting; inpatient laparoscopic hysterectomy decreased by 7% (95% CI 6.1-7.9%) from 24% to 17% of all hysterectomies with an accompanying increase in abdominal hysterectomy of 8% (95% CI 6.7-8.6%) from 71% to 79%. There were no significant changes in the proportion of women with leiomyomas who underwent myomectomy compared with hysterectomy.Conclusion: The FDA communication discouraging the use of power morcellators was associated with a decline in laparoscopy to perform hysterectomy, particularly in the inpatient setting. There was no change in the selection of myomectomy compared with hysterectomy for leiomyoma treatment after the FDA communication. [ABSTRACT FROM AUTHOR]

Objective: To investigate the temporal trends in minimally invasive myomectomy at one reproductive medicine center before and after the US Food and Drug Administration (FDA) recommendation against electric morcellation.Methods: A retrospective chart review was undertaken of patients undergoing minimally invasive myomectomy between April 1, 2012, and April 30, 2016, at a center in New York. Temporal trends in laparoscopic myomectomy (LM), robot-assisted laparoscopic myomectomy (RAM), and laparoscopically assisted myomectomy (LAM), and intraoperative and postoperative outcomes before and after the April 2014 recommendation were compared.Results: Minimally invasive myomectomy was performed in 73 patients. No difference was noted in the rates of minimally invasive myomectomy 2 years before (35/74 [47.3%]) and after (38/79 [48.1%]) the FDA's recommendation. The ratio of abdominal to minimally invasive myomectomy remained relatively constant before (68/59=1.15) and during the study period (80/73=1.10). There was a significant decrease in LM and RAM and a corresponding rise in LAM immediately after the recommendation (P<0.001).Conclusion: The rates of minimally invasive myomectomy before and after the FDA's recommendation did not differ, indicating that technical modifications to laparoscopic technique can allow surgeons to offer minimally invasive myomectomy to patients with symptomatic leiomyomas. [ABSTRACT FROM AUTHOR]

Objective: To examine the association between the 2014 U.S. Food and Drug Administration (FDA) safety communication on power morcellation and surgical approach and morbidity after myomectomy.Methods: In this retrospective cohort study, data were abstracted from the American College of Surgeons National Surgical Quality Improvement Program database on 3,160 myomectomies between April 2012 and December 2013 (pre-FDA) and 4,378 between April 2014 and December 2015 (post-FDA). Aims were to 1) compare rates of abdominal and laparoscopic myomectomy pre-FDA and post-FDA (primary outcome), 2) directly compare the morbidity of abdominal and laparoscopic myomectomy during each time period (secondary outcome 1), and 3) compare the morbidity after all myomectomies performed pre-FDA and post-FDA (secondary outcome 2). Adjusted means, odds ratios, and rate ratios with 95% confidence intervals were calculated using linear, logistic, and Poisson regression, respectively, adjusting for age, race, ethnicity, body mass index, and myoma burden.Results: Myomectomies performed post-FDA were more likely to be abdominal (60.0%, 95% confidence interval [CI] 58.6-61.5%) than laparoscopic (40.0%, 95% CI 38.5-41.4%) as compared with myomectomies pre-FDA, which were equally divided between surgical approaches (49.1% abdominal, 95% CI 47.4-50.9% compared with 50.9% laparoscopic, 95% CI 49.1-52.6%; P<.001). When directly compared with laparoscopic myomectomy, abdominal myomectomy was associated with longer hospitalizations, higher readmission rates, and greater morbidity both pre-FDA and post-FDA (P<.05, all comparisons). Adjusted models demonstrated shorter operative times post-FDA for all myomectomies (P<.001), although composite morbidity was similar between myomectomies performed pre-FDA and post-FDA (P=.809).Conclusions: The FDA safety communication on power morcellation was associated with an 11% absolute increase in the use of abdominal myomectomy. Although morbidity is consistently higher after abdominal as compared with laparoscopic myomectomy, the increased reliance on abdominal myomectomy post-FDA did not result in clinically significant changes in morbidity in this cohort. [ABSTRACT FROM AUTHOR]

Objective: The objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).Study Design: US health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.Results: Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.Conclusion: Events related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.Implications: This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide. [ABSTRACT FROM AUTHOR]

Objective: To understand the effect of the Food and Drug Administration (FDA) public health notifications regarding transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) on surgeon practice patterns in tertiary care academic medical centers.Materials and Methods: Surgical volume for procedures performed primarily by fellowship trained Female Pelvic Medicine and Reconstructive Surgery at a sampling of 8 academic institutions across the US were collected using current procedural technology codes for POP repair and revision surgeries from 2007 to 2013. SAS statistical software was used to analyze data for trends and to assess differences in number of procedures across years by performing Spearman correlation analysis and Pearson's chi-squared test. Significance of trend was defined as P <.05 for both analysis methods.Results: There has been a substantial reduction in transvaginal mesh-augmented repair of POP since the FDA warning statements of 2008 and 2011. Mesh revision surgery has increased over this same period. However, the total number of interventions for POP has remained stable over the study period. Abdominal sacrocolpopexy has increased as a whole but represents only a small percentage of total cases.Conclusion: Surgical correction of POP comprises a large portion of Female Pelvic Medicine and Reconstructive Surgery practice that continues to evolve in the aftermath of the FDA public health notifications. The utilization of transvaginal placement of surgical mesh augmented POP repair has decreased among practicing urologists at a sampling of academic institutions across the United States. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study; however, such data may provide alternative insights into the reasons for the observed trends. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether there was a change in surgical practice immediately after the U.S. Food and Drug Administration (FDA) warning statement discouraging the use of power morcellation in the surgical treatment of uterine leiomyomas.Methods: We performed a time-series analysis. Surgical case logs from the Florida Hospital operating room documentation system were used to retrospectively identify patients who underwent a hysterectomy or myomectomy between August 1, 2013, and December 31, 2014. Cases performed during the 8 months before the FDA announcement on April 17, 2014, were compared with cases performed during the 8 months after the FDA announcement. Six hospitals and 98 surgeons were included. We compared the proportion of minimally invasive surgery cases (vaginal, laparoscopic, or robotic-assisted) for each study period.Results: There was a 5.8% decrease in minimally invasive hysterectomies after the FDA warning statement (85.7% [1,451/1,694] compared with 79.9% [1,350/1,690]; P<.001) and an 8.7% decrease when oncologist cases were excluded (90.2% [985/1,092] compared with 81.5% [834/1,023]; P<.001). There was a 19% decrease in minimally invasive myomectomies (62.7% [64/102] compared with 43.7% [38/87]; P=.009). Analysis by subspecialty showed a significant decrease in minimally invasive hysterectomies by obstetrician-gynecologists (ob-gyns) and minimally invasive gynecologic specialists but not urogynecologists or oncologists and a significant decrease in minimally invasive myomectomies by reproductive endocrinologists and minimally invasive gynecologic specialists but not ob-gyns.Conclusion: There was a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Objective: The United States Food and Drug Administration (FDA) Manufacture and User Device Experience (MAUDE) Database houses reports of deaths, injuries, and malfunctions related to FDA-approved devices. This article evaluates the 10-year statistics from MAUDE related to robotic gynecologic surgery. Materials and Methods: This study is a database analysis. The MAUDE database was queried for events occurring between 2003 and 2012. The following information was abstracted: date of surgery; report date; type of surgery; indication; injury sustained; interventions required; device malfunction; and involvement in legal proceedings. Results: During the 10 years studied, 455 injuries and 177 malfunctions were reported. Reporting increased over time. Gynecologic cases represented 61% of all reported robotic injuries; 81% of these led to legal proceedings. The most common gynecologic procedure resulting in injury was hysterectomy ( n=399, 87%). Common complications included ureteral injuries (19%), infections (18%), and small-bowel injuries (16%). This resulted in 435 interventions, most commonly ureteral reimplantation (14%), bowel resection or repair (10%), and vaginal cuff closure (13%). Ninety-three device-related deaths were reported; 30 were associated with gynecologic surgeries. The most common cause of gynecologic procedure-related death was sepsis with or without bowel injury (28%) followed by hemorrhage (18%). Fifty adverse events resulted from 177 robot malfunctions. Conclusions: Reporting of robotic injuries, deaths, and malfunctions to the FDA is steadily increasing; however, as reporting in the MAUDE system is voluntary, the true incidence is unknown. Compulsory reporting would allow identification of absolute risks associated with robotic surgery and lead to improved root-cause analyses. (J GYNECOL SURG 31:331) [ABSTRACT FROM AUTHOR]

Intensive media and policy attention has been focused on the ongoing controversy surrounding uterine morcellation in gynecologic surgery. What has been missing from this impassioned discourse is an objective analysis of the ethical implications of uterine power morcellation in gynecologic surgery. This article discusses competing ethical duties of physicians, industry, the U.S. Food and Drug Administration, and the media to develop a more robust and nuanced understanding of informed consent for the use of morcellation in benign gynecologic surgery. Ultimately, as physicians, we must remain steadfast in our dedication to the use of evolving technologies to better patient health in a safe and ethical manner that is well-studied, informed, and implemented with appropriate training and precautions. [ABSTRACT FROM AUTHOR]

The reprocessing and reuse of single-use instruments has become increasingly common. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is the operating surgeon's ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices. Obstetrician-gynecologists are encouraged to report adverse events and outcomes associated with medical devices to the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. [ABSTRACT FROM AUTHOR]

The author reflects on the use of mesh grafts for the adjunctive therapy of pelvic organ prolapse and stress incontinence. He argues on changing native tissue for prolapse repair to the use of mesh in many surgeries even with prolapse not to the hymenal ring. An overview of the reasons why mesh grafts must not be used is offered. The author notes that the U.S. Food and Drug Administration (FDA) allows the devices to be used in order to accomplish the surgery which includes trocars and mesh.

Reports that the U.S. Food and Drug Administration has received notification of a voluntary withdrawal of Gynecare Intergel Adhesion Prevention Solution from the market. Call by the manufacturer for customers to immediately stop using this device; Use of the product in open, conservative gynecological surgery as an adjunct to good surgical technique to reduce post-surgical adhesions; Reports of adverse events associated with the off-label use in laparoscopy and non-conservative surgical procedures such as hysterectomy.