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Publication - Publication

Transvaginal mesh implants independent review: final report

Published: 27 Mar 2017
Part of:
Health and social care
ISBN:
9781786528711

Final report on the use, safety and efficacy of implants in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

114 page PDF

1.5MB

114 page PDF

1.5MB

Contents
Transvaginal mesh implants independent review: final report
Appendix D - Interim Report Chapter 6 table

114 page PDF

1.5MB

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



65.1%



83%

RR 0.95, 95% CI
0.80 to 1.12.

4 trials, 714 women.

RR 0.97, 95%
CI 0.90 to 1.06;
3 trials, 400 women

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