Seven-Year Outcomes After Hysteroscopic and Laparoscopic Sterilizations

Journal Obstetrics & Gynecology
Authors MaoJialin; Guiahi, Maryam; Chudnoff, Scott; Schlegel, Peter; Pfeifer, Samantha; Sedrakyan, Art
Year Published 2019
Link to publication

Abstract

OBJECTIVE: 

To evaluate 7-year outcomes after hysteroscopic and laparoscopic sterilizations, including subsequent tubal interventions and hysterectomies.

METHODS: 

This observational cohort study included women undergoing hysteroscopic and laparoscopic sterilizations in outpatient and ambulatory surgical settings in New York State during 2005–2016. We examined subsequent procedures (tubal ligation or resection, and hysterectomy not related to uterine leiomyomas or gynecologic tumors) after the index procedures. After propensity score matching, we used Kaplan-Meier analysis to obtain estimated risks of subsequent procedures within 7 years of index sterilization procedures, and Cox proportional hazard models to compare the differences between groups.

RESULTS: 

We identified 10,143 and 53,206 women who underwent interval hysteroscopic and laparoscopic sterilizations, respectively, in New York State during 2005–2016. The mean age of the cohort was 34.2 years (range 18–80). The propensity score–matched cohort consisted of 10,109 pairs of women. The estimated risk of undergoing an additional tubal ligation or resection within 7 years was higher after hysteroscopic sterilization than it was after laparoscopic sterilization (3.9% vs 1.6%, HR 2.89, 95% CI 2.33–3.57). The difference was most pronounced within the initial year after attempted sterilization (1.5% vs 0.2%; HR 6.39, 95% CI 4.16–9.80). There was no significant difference in the risk of receiving a hysterectomy (0.9% vs 1.2%; HR 0.73, 95% CI 0.53–1.00) between women who underwent hysteroscopic and laparoscopic sterilizations.

CONCLUSION: 

Patients undergoing hysteroscopic sterilization have a higher risk of receiving an additional tubal resection or ligation than those undergoing laparoscopic sterilization, particularly within the first year of the index procedure. There is no difference in undergoing a subsequent hysterectomy between the two groups. With limited evidence of outcomes after hysteroscopic sterilization beyond 7 years and existing reports of removals years after initial implantations, continuous monitoring of long-term outcomes for women who received the device is warranted.

Regulatory warnings and use of surgical mesh in pelvic organ prolapse

Journal JAMA Internal Medicine
Authors Sedrakyan A, Chughtai B, & Mao J.
Year Published 2015
Link to article

In 2008, the FDA released a warning about the use of transvaginal mesh in pelvic organ prolapse repair procedures, advising all surgeons to seek special training in mesh implantation before using it in their own practice. A second warning was released in 2011 describing complications following mesh implantation as “not rare” and suggesting non-mesh pelvic organ prolapse repairs. This study used the New York State SPARCS database to look at trends in transvaginal mesh use since the second FDA warning in 2011. Use of mesh in pelvic organ prolapse repair decreased from a 30% rate of use in 2011 to a 23% rate of use in 2013, reflecting a change in practice in response to the second FDA warning, and a total of 22 physicians ceased mesh use altogether.

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

Journal BMJ
Authors Mao J, Pfeifer S, Schlegel P, & Sedrakyan A.
Year Published 2015
Link to publication

Abstract

Female sterilization is one of the most commonly used methods of contraception, and is traditionally performed via laparoscopy to ligate fallopian tubes of both sides. Since the introduction of the Essure device 12 years ago, interval sterilization can be also performed by inserting the device with hysteroscopy. With the increasing use of Essure, there have been reports to the FDA of adverse events, and the efficacy has also been questioned. The present study compared the safety and efficacy of Essure-based hysteroscopic sterilization to the traditional laparoscopic procedure. Short-term adverse events following both procedures were rare. Hysteroscopic and laparoscopic sterilization also had similar risks of unintended pregnancy following surgery. However, the Essure procedure was associated with a 10 times higher risk of reoperation within the first year following surgery.

 

Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study

Journal BMJ
Authors Chughtai, Bilal; Mao, Jialin; Buck, Jessica; Kaplan, Steven; Sedrakyan, Art
Year Published 2015
Link to article

Abstract

OBJECTIVE: To assess the use of mesh in pelvic organ prolapse surgery, and compare short term outcomes between procedures using and not using mesh.

DESIGN: All inclusive, population based cohort study.

SETTING: Statewide surgical care captured in the New York Statewide Planning and Research Cooperative System.

PARTICIPANTS: Women who underwent prolapse repair procedures in New York state from 2008 to 2011.

MAIN OUTCOMES MEASURES: 90 day safety events and reinterventions within one year, after propensity score matching. Categorical, time to event, and subgroup analyses (<65 and ≥65 year age groups) were conducted.

RESULTS: Of 27 991 patients in total, 7338 and 20 653 underwent prolapse repair procedures with and without mesh, respectively. Mesh use increased by 44.7%, from 1461 procedures in 2008 to 2114 procedures in 2011. Most patients in the cohort were younger than 65 years (62.3% (n=17 424/27 991)). However, more patients were aged 65 years and older in the mesh group than in the non-mesh group (44.3% (n=3249) v 35.4% (n=7318)). Complications after surgery were not common, irrespective of the use or non-use of mesh. After propensity score matching, patients who received the surgery with mesh had a higher chance of having a reintervention within one year (mesh 3.3% v no mesh 2.2%, hazard ratio 1.47 (95% confidence interval 1.21 to 1.79)) and were more likely to have urinary retention within 90 days (mesh 7.5% v no mesh 5.6%, risk ratio 1.33 (95% confidence interval 1.18 to 1.51)), compared with those who received surgery without mesh. In subgroup analyses based on age, mesh use was associated with an increased risk of reintervention within one year in patients under age 65 years, and increased risk of urinary retention in patients aged 65 years and over.

CONCLUSIONS: Despite multiple warnings released by the US Food and Drug Administration since 2008, use of mesh in pelvic organ prolapse surgery continues to grow. In this statewide comprehensive study, mesh procedures were associated with an increased risk of reinterventions within one year and urinary retention after surgery.

Population-Based Estimates of the Prevalence of Uterine Sarcoma Among Patients With Leiomyomata Undergoing Surgical Treatment

Journal JAMA Surgery
Authors Mao, Jialin ; Pfeifer,Samantha; Zheng, Xi Emily; Schlegel, Peter; Sedrakyan, Art
Year Published 2015
Link to publication

Abstract

Uterine leiomyomata are one of the most common gynecologic problems among women in the United States, with an annual diagnosis range from 2.0 to 12.8 per 1000 reproductive-age women.1 Intervention is a standard management for symptomatic patients, and various procedures include open and laparoscopic hysterectomy, myolysis, uterine artery embolization, and magnetic resonance–guided focused ultrasonographic surgery.

The practice of electric morcellation has been used by gynecologic surgeons during laparoscopic and robotic-assisted hysterectomies and myomectomies as a less invasive alternative to open surgery. In April 2014, the US Food and Drug Administration (FDA) stated that they discouraged the use of this technique over concern that morcellation may spread unsuspected sarcoma tissue. Based on the literature, the FDA reported that 1 in 352 women have unsuspected uterine sarcoma while undergoing surgery for presumed benign leiomyoma. A recent study using an all-payer database found that 1 in 368 women who underwent morcellation had uterine cancer. However, the estimates in this study were limited by the selective participation of hospitals and by the lack of pathologic confirmation. The literature estimates used by the FDA are prone to referral and reporting bias. We sought to determine the population-based estimates of the prevalence of uterine sarcoma, as well as the risks of major complications following open surgery.