Transvaginal mesh implants independent review: final report
Final report on the use, safety and efficacy of implants in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Appendix D - Interim Report Chapter 6 table
Table 6.1
| Outcomes from the recent systematic review from the Cochrane Collaboration (Ford et al) |
Retropubic mesh tape device |
Transobturator mesh tape device |
RR, 95% CI,number of studies and participants |
Favours... |
Notes on research evidence from the Cochrane Collaboration |
|---|---|---|---|---|---|
| Short term efficacy |
Similar Subjective: 84.4% Objective: 87.2% |
Similar 82.3% 85.7% |
RR 0.98, 95% CI 0.96 to 1.00 36 trials, 5514 women. RR 0.98, 95% CI 0.96 to 1.00 40 trials, 6145 women |
None |
Research evidence favouring retropubic approach for both patient- reported and clinician-reported outcomes did not reach statistical significance. |
| Long term efficacy |
Similar Subjective: 70.7% Objective: 85.5% |
Similar |
RR 0.95, 95% CI 4 trials, 714 women. RR 0.97, 95% |
None |
Research evidence favouring retropubic approach for both patient- reported and clinician-reported outcomes did not reach statistical significance. |
| Need for repeat continence surgery after 1 year |
Lower 1.1% |
Higher 11.3% |
RR 8.79, 95% CI 3.36 to 23.00; 4 trials, 695 women |
Retropubic |
Research evidence favours retropubic approach. Despite reaching statistical significance, the number of studies and participants are relatively smaller than those contributing to short-term efficacy. |
| Bladder injury |
higher risk 4.5% |
lower risk 0.6% |
RR 0.13, 95% CI 0.08 to 0.20; 40 trials, 6372 women |
Obturator |
While risk of bladder injury is higher with retropubic approach, it is diagnosed intra-operatively in almost all cases, as cystoscopy is routinely employed. The tape is replaced in the correct position and no long-term problems are expected. |
| Voiding problems |
higher risk 7.2% |
lower risk 3.8% |
RR 0.53, 95% CI 0.43 to 0.65; 37 trials, 6200 women |
Obturator |
Retropubic tapes appear to be more 'obstructive'. Patients at increased risk of voiding dysfunction following surgery (using an obturator or retropubic approach) may need to learn self- catheterisation beforehand. |
| groin, pelvic and thigh pain |
lower risk 1.3%; |
higher risk 6.4% v |
RR 4.12, 95% CI 2.71 to 6.27; 18 trials, 3221 women |
Retropubic |
Chronic pain and dyspareunia appear to be the most common symptoms reported by mesh-injured women. |
| mesh exposure |
Similar risk 2.1% |
Similar risk 2.4% |
RR 1.13, 95% CI 0.78 to 1.65; 31 trials, 4743 women |
None |
None |
| mesh erosion into bladder or urethra |
Similar risk |
Similar risk |
None |
None |
|
| Operative blood loss |
Higher |
Lower |
MD 6.49 95% CI 12.33 to 0.65 |
Obturator |
The 6.5-ml statistically-significant difference in favour of the obturator approach is clinically-insignificant. |
| Operation time |
Longer |
Shorter |
MD 7.54 95% CI 9.31 to 5.77 |
Obturator |
The 7.5-minute statistically significant difference in favour of the obturator approach is thought to be due to usage of cystoscopy to rule out bladder injury during the retropubic approach. The time is thought to be well-invested. |
| Feasibility and characteristics of complete surgical removal |
Possible, regardless of duration of implantation. Removal usually requires an abdomino- perineal approach. The surgical technique and anatomy of the retropubic space are well understood by most surgeons. Removal is usually complete. |
Possible, only during the first few weeks of implantation. Removal is difficult afterwards. Removal usually requires only a perineal approach. The surgical technique and anatomy of the upper thigh are poorly understood. Removal is usually incomplete. |
Clinical Opinion (Level III) |
Retropubic |
In either condition, complete removal of the mesh device does not guarantee cure from pain. |
Contact
Email: David Bishop
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