title: Anchor placement and subsequent movement in a mesh kit with self-fixating tips: 6-month follow-up of a prospective cohort.
abstract: OBJECTIVE
  To describe the initial placement of Elevate single-incision mesh kit device tips relative to the sacrospinous ligament, and to measure tip movement over a 6-month period from initial placement.
  
  
  METHODS
  Prospective cohort.
  
  
  METHODS
  Tertiary care urogynaecology centre in Calgary, Canada.
  
  
  METHODS
  Women electing for surgical management of anterior vaginal wall prolapse.
  
  
  METHODS
  Ten women underwent anterior prolapse repair using the Elevate single-incision mesh kit with a metallic fiducial marker attached to the tips of the surgical device. Women were imaged by magnetic resonance imaging (MRI) within 48 hours of surgery, and again 6 months later to investigate the position of the device tips and change ≥4 mm over the 6-month postoperative period.
  
  
  METHODS
  Position of self-fixating tips within 48 hours of surgery, and at six months post-operative.
  
  
  RESULTS
  Anchor insertion was directly into the sacrospinous ligament in 10 of 20 insertion points (50%, 95% CI 27-73%). Movement was most often noted in the cranial-caudal direction: a change in location of ≥4 mm was observed for 8/20 anchors (40%, 95% CI 19-64%). Cranial-caudal movement was observed less frequently among sacrospinous anchors than among anchors inserted into other pelvic structures (1/10 versus 7/10, P = 0.020, difference in proportion -60%, 95% CI -94 to -26%). PFDI-20 scores improved statistically significantly by 6 months (P = 0.008, mean change -62.9%, 95% CI -105.1 to -20.7%), but PFIQ-7 scores did not change statistically significantly over the same time period (P = 0.523, mean change -12.4%, 95% CI -54.5 to 29.8%).
  
  
  CONCLUSIONS
  The novel self-fixating anchoring tips of this single-incision mesh kit do not reliably anchor into the sacrospinous ligament. The tips have been shown to move with time, although not all cases of anchor movement were associated with recurrent prolapse.
authors.affiliation: Department of Obstetrics & Gynecology, University of Calgary, Calgary, AB, Canada.
authors.forename: E A
authors.initials: EA
authors.lastname: Brennand
authors.forename: D
authors.initials: D
authors.lastname: Bhayana
authors.forename: S
authors.initials: S
authors.lastname: Tang
authors.forename: C
authors.initials: C
authors.lastname: Birch
authors.forename: M
authors.initials: M
authors.lastname: Murphy
authors.forename: D
authors.initials: D
authors.lastname: Cenaiko
authors.forename: S
authors.initials: S
authors.lastname: Ross
authors.forename: M
authors.initials: M
authors.lastname: Robert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D057918:Fiducial Markers; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000175:diagnosis*; D013509:Gynecologic Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008022:Ligaments / Q000601:surgery; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000601:surgery; D011446:Prospective Studies; D013526:Surgical Mesh; D014596:Uterine Prolapse / Q000601:surgery*
keywords: Cystocele; prolapse; vaginal mesh