Michael P. Diamond

Adverse obstetric outcomes associated with sonographically identified large uterine fibroids.

STUDY OBJECTIVEnTo determine the impact of sonographically identified large uterine fibroids (>5 cm in diameter) on obstetric outcomes.nnnDESIGNnRetrospective cohort study.nnnSETTINGnUniversity teaching hospital.nnnPATIENT(S)nWomen with singleton gestations (n = 95) noted to have uterine fibroids on obstetric ultrasonography from September 2009 through April 2010 and age-matched controls (n = 95).nnnINTERVENTION(S)nNone.nnnMAIN OUTCOME MEASURE(S)nObstetric outcomes including short cervix, preterm premature rupture of membranes, and preterm delivery.nnnRESULT(S)nCompared to women with no fibroids or small fibroids (≤5 cm), women with large fibroids (>5 cm) delivered at a significantly earlier gestational age (38.6 vs. 38.4 vs. 36.5 weeks). Short cervix, preterm premature rupture of membranes, and preterm delivery were also significantly more frequent in the large fibroid group, and were associated with number of fibroids >5 cm in diameter. Blood loss at delivery was significantly higher in the large fibroid group (486.8 vs. 535.6 vs. 645.1 mL), as was need for postpartum blood transfusion (1.1 vs. 0.0 vs. 12.2%).nnnCONCLUSION(S)nWomen with large uterine fibroids in pregnancy are at significantly increased risk for delivery at an earlier gestational age compared to women with small or no fibroids, as well as obstetric complications including excess blood loss and increased frequency of postpartum blood transfusion.

Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.

STUDY OBJECTIVEnThe Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database.nnnDESIGNnRetrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III).nnnSETTINGnOnline retrospective review.nnnPATIENTSnOnline reports of patients who underwent Essure tubal sterilization.nnnINTERVENTIONnEssure tubal sterilization.nnnMEASUREMENTS AND MAIN RESULTSnFour hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies.nnnCONCLUSIONnSixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.