Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI‐MESH registry

Fritel, Xavier; Tayrac, Renaud de; Keizer, Joe de; Campagne-Loiseau, S.; Cosson, Michel; Ferry, P.; Deffieux, X.; Lucot, J P; Wagner, L.; Debodinance, P.; Saussine, C.; Pizzoferrato, Anne Cécile; Carlier-Guérin, Caroline; Thubert, Thibault; Panel, Laure; Bosset, P-O.; Nkounkou, E.; Ramanah, R.; Boisramé, Thomas; Charles, T.; Raiffort, C.; Charvériat, Anne; Ragot, Stéphanie

doi:10.1111/1471-0528.16892

Cited by 11 publications

(13 citation statements)

References 26 publications

(58 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…All these complications occurred in the postoperative period and none were reported to have occurred intraoperatively. These results concur with those reported in previous studies that used the VIGI-MESH database [ 11 ]. There were a total of six vaginal mesh exposures reported in relation to both anterior and posterior SSLF.…”

Section: Discussionsupporting

confidence: 93%

“…The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. This registry started in 2017 following its approval by the Comité de Protection des Personnes Ouest III (Institutional Review Board) (IDRBC 2017-A000308-45) and was registered on ClinicalTrials.gov (NCT03052985) in February 2017 [ 7 , 11 ]. Twenty-four French Health Centers participated in this registry.…”

Section: Methodsmentioning

confidence: 99%

“…The interventions of interest were any of the four different SSLF modifications performed between May 2017 and September 2021, irrespective of the instrument used for suspension (needle holder, Capio ® or Capio Slim ® (Boston Scientific), i-Stitch ® (A.M.I) or Digitex ® (Coloplast)). For each of the subjects included in this analysis, the authors verified that the procedure performed was an SSLF performed for an apical POP repair using the specific case report forms [ 11 ]. Patients who had a repair that involved combined approaches (anterior and posterior SSLF) and those who had an SSLF in association with another procedure for POP repair, were excluded from this analysis.…”

Section: Methodsmentioning

confidence: 99%

“…VIGI-MESH is a national registry for the prospective collection of POP surgical treatment outcomes in France, focusing on serious complications and POP recurrence [ 7 , 11 ]. We hypothesized that, compared with the native tissue, the use of mesh in SSLF would be associated with more complications and that anterior SSLF results in less prolapse recurrence compared with the posterior approach.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse

Gracia

Fatton

Cosson

et al. 2023

JCM

Self Cite

View full text Add to dashboard Cite

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan–Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien–Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.

show abstract

Section: Discussionsupporting

confidence: 93%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse

Gracia

Fatton

Cosson

et al. 2023

JCM

Self Cite

View full text Add to dashboard Cite

show abstract

“…Furthermore, the pathophysiology of mesh-related complications and recurrent prolapse are unclear. Based on the existing literature, it is difficult to ascertain whether adverse outcomes following minimally invasive SCP is related to modifiable factors, such as surgical technique, or related to patient factors, such as connective tissue integrity [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Long-Term Mesh Exposure 5 Years Following Minimally Invasive Total Hysterectomy and Sacrocolpopexy

Bretschneider,

Myers,

Geller

et al. 2024

Int Urogynecol J

View full text Add to dashboard Cite

Introduction and Hypothesis The objective was to assess long-term mesh complications following total hysterectomy and sacrocolpopexy. Methods In this second extension study, women from a multicenter randomized trial were followed for more than 36 months after surgery. Owing to COVID-19, participants were assessed through either in-person visits or telephone questionnaires. The primary outcome was the incidence of permanent suture or mesh exposure. Secondary outcomes included surgical success and late adverse outcomes. Results Out of the 200 initially enrolled participants, 82 women took part in this second extension study. Among them, 46 were in the permanent suture group, and 36 in the delayed absorbable group. The mean follow-up duration was 5.3 years, with the cumulative mesh or suture exposure of 9.9%, involving 18 cases, of which 4 were incident cases. Surgical success after more than 5 years stood at 95%, with few experiencing bothersome bulge symptoms or requiring retreatment. No serious adverse events occurred, including mesh erosion into the bladder or bowel. The most common adverse events were vaginal pain, bleeding, dyspareunia, and stress urinary incontinence, with no significant differences between suture types. Conclusion The study found that mesh exposure risk gradually increased over time, reaching nearly 10% after more than 5 years post-surgery, regardless of suture type. However, surgical success remained high, and no delayed serious adverse events were reported.

show abstract

Transvaginal mesh implant for pelvic organ prolapse: Huaxi protocol

Zhang,

Luo,

Shen

2024

UroPrecision

View full text Add to dashboard Cite

With increasing age, pelvic organ prolapse (POP), due to its high incidence, has become a common disease that seriously affects patients’ quality of life and places a heavy economic burden on families and society. Transvaginal mesh (TVM) is a minimally invasive and effective treatment for POP, although its use remains controversial due to the potential risk of mesh‐related complications. The US Foods and Drugs Administration, along with authorities in England, Australia, New Zealand, and other countries, have banned the sale and distribution of commercial TVM kits designed for POP. The TVM procedure remains an option for POP treatment and still appeals to many surgeons and patients today in Asia and most European countries, which suggests that a considerable number of POP patients can benefit from its continued refinement. Here we introduce the Huaxi protocol of the TVM plant for the treatment of POP.

show abstract

Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI‐MESH registry

Cited by 11 publications

References 26 publications

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse

Long-Term Mesh Exposure 5 Years Following Minimally Invasive Total Hysterectomy and Sacrocolpopexy

Transvaginal mesh implant for pelvic organ prolapse: Huaxi protocol

Contact Info

Product

Resources

About