Supplementary appendix · Q08 (paired with ICD10 diagnostic code N81) Vaginal hysterectomy for prolapse Note that P22.8 and P23.8 codes have been excluded when paired with codes Y03

Supplementary appendixThis appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors.

Supplement to: Morling JR, McAllister DA, Agur W, et al. Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997–2016: a population-based cohort study. Lancet 2016; published online Dec 20. http://dx.doi.org/10.1016/S0140-6736(16)32572-7.

ESM 1 Index procedure coding Index incontinence procedures: defined as the following OPCS-4 codes:

Open colposuspension (non mesh) M52.3 (not with Y50.8 to 31.3.06 or Y75 from 1.4.06)

Urethral injection therapy (non mesh) M56.3

Suprapubic sling (non mesh) M52.1

Unspecified mesh M53.8 to 31.3.06

Retropubic mesh M53.3 from 1.4.06

Transobturator mesh M53.6 from 1.4.06

Index prolapse procedures: defined as the following OPCS-4 codes:

Anterior colporrhaphy (non mesh) P23.2 or P23.5 (not with Y02, Y36 or Y37) (not with Q01 or Q08), (P23.5 from 1.4.06)

Anterior colporrhaphy with mesh P23.6 from 1.4.07 (Not with Q01 or Q08)

Posterior colporrhaphy (non mesh) P23.3 or P23.4 (Not with Y02, Y36 or Y37) (Not with Q01 or Q08)

Posterior colporrhaphy with mesh P23.7 from 1.4.07 (Not with Q01 or Q08)

Sacrospinous fixation of vagina (non mesh)

P24.4 to 31.3.06 or P24.7 from 1.4.06

Vaginal mesh vault repair (mesh) P24.6 from 1.4.06

Open sacrocolpopexy (abdominal mesh)

P24.2 or P24.5 (P24.5 from 1.4.06) (Not with Y50.8 to 31.3.06 or Y75 from1.4.06)

Vaginal hysterectomy for prolapse (non mesh)

Q08 (Paired with ICD10 diagnostic code N81)

Restricting to single procedures Women undergoing concurrent additional procedures for incontinence or prolapse were excluded. Concurrent/combination procedures were defined as any of the following OPCS4 codes (in addition to the specific index procedure codes listed above) occurring on the index procedure discharge record. For all procedures except sacrospinous fixation of vagina; open sacrocolpopexy; and vaginal mesh vault repair: M51-M58; P18: P22-P24: P26; Q54; Q07-Q08 For sacrospinous fixation of vagina; open sacrocolpopexy; and vaginal mesh vault repair: As above apart from the following concurrent codes (denoting anterior and/or posterior non mesh colporrhaphy without cervical amputation or vaginal hysterectomy) were specifically allowed as vault repair procedures were very rarely done without a concurrent procedure: P23.1-P23.5 (Not with Y02; Y36; Y37; Q01; Q08) Restricting to first procedures Women who had undergone a previous procedure for incontinence or prolapse were excluded. Prior procedures were defined as any of the following OPCS4 codes occurring on a previous hospital discharge record up to 5 years before index procedure. For all procedures except sacrospinous fixation of vagina; open sacrocolpopexy; and vaginal mesh vault repair:

M51-M58; P18: P22-P24: P26; Q54; Q07-Q08 paired with ICD10 diagnostic code N81 For sacrospinous fixation of vagina; open sacrocolpopexy; and vaginal mesh vault repair: As above apart from the following previous codes (denoting hysterectomy) were specifically allowed as vault repair procedures inevitably follow a prior hysterectomy: Q07-Q08

ESM 2 Outcome coding

Immediate procedural complication

Identification of complications likely to be related to the index event, for example urinary tract infection,

pain, sepsis.

‘Immediate procedural complication’ was defined as a qualifying ICD-10 code occurring during the index

procedure hospital stay where the patient was discharged within 90 days of their operation. Patients were

categorised as either having a complication during their initial hospital stay (regardless of how many

separate complication codes were recorded) or not.

Admission with a late procedural complication (within 5 years)

Identification of complications likely to be related to the index event but occurring after the index

admission.

‘Late procedural complication’ was defined as a qualifying ICD-10 or OPCS-4 code occurring during a

hospital stay subsequent to, and with a discharge date within 5 years of, the index procedure date. Each of

a patient’s subsequent admissions was categorised as indicating a complication or not (regardless of how

many separate complication codes were recorded) and counted separately.

Admission for further incontinence surgery (within 5 years)

Identification of hospital admissions for further incontinence surgery.

‘Readmission for further incontinence surgery’ was defined as a qualifying OPCS-4 code occurring during

a hospital stay subsequent to, and with a discharge date within 5 years of, the index procedure date. Each

of a patient’s subsequent admissions was categorised as indicating a further surgery event or not

(regardless of how many separate procedure codes were recorded) and counted separately.

Admission for further prolapse surgery (within 5 years)

Identification of hospital admissions for further prolapse surgery.

‘Readmission for further of prolapse surgery’ was defined as a qualifying OPCS-4 code occurring during a

hospital stay subsequent to, and with a discharge date within 5 years of, the index procedure date. Each of

a patient’s subsequent admissions was categorised as indicating a further surgery event or not (regardless

of how many separate procedure codes were recorded) and counted separately.

Adverse event outcome coding

Data

source Timing Codes

1. Immediate procedural complication

SMR01 During the index admission

and where the patient was

discharged within 90 days of

their operation

ICD10 diagnostic codes:

Haemorrhage related:

T81.0 Haemorrhage and haematoma complicating a procedure, NEC

T81.1 Shock during or resulting from a procedure, NEC

R58 Haemorrhage, NEC

Infection related:

T81.4 Infection following procedure, NEC

T83.5 Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system

T83.6 Infection and inflammatory reaction due to prosthetic device, implant and graft in genital tract

N30 Cystitis

N39.0 Urinary tract infection, site not specified

R30 Pain associated with micturition

R57.2 Septic shock

R65 Systemic inflammatory response syndrome

A40 Streptococcal sepsis

A41 Other sepsis

Pain related:

N94.1 Dyspareunia

R10.2 Pelvic and perineal pain

R52.1 Chronic intractable pain

R52.2 Other chronic pain

Procedure related:

T81.2 Accidental puncture and laceration during a procedure, not elsewhere classified

T81.3 Disruption of operation wound, NEC

T81.5 Foreign body accidentally left in body cavity or operation wound following a procedure

T81.6 Acute reaction to foreign substance accidentally left during a procedure

T81.7 Vascular complications following a procedure, NEC

T81.8 Other complications of procedures, NEC

T81.9 Unspecified complication of procedure

T83.0 Mechanical complication of urinary (indwelling) catheter

T83.1 Mechanical complication of other urinary devices and implants

T83.2 Mechanical complication of graft of urinary system

T83.3 Mechanical complication of intrauterine contraceptive device

T83.4 Mechanical complication of other prosthetic devices, implants and grafts in genital tract

T83.8 Other complications of genitourinary prosthetic devices, implants and grafts

T83.9 Unspecified complication of genitourinary prosthetic device, implant and graft

T88.8 Other specified complications of surgical and medical care, NEC

T88.9 Complication of surgical and medical care, unspecified

T98.3 Sequelae of complications of surgical and medical care, not elsewhere classified

Y60 Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care

Y73 Gastroenterology and urology devices associated with adverse incidents

Y76 Obstetric and gynaecological devices associated with adverse incidents

Y83 Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of

later complication, without mention of misadventure at the time of the procedure

Y88 Sequelae with surgical and medical care as external cause

R33 Retention of urine

R39.1 Other difficulties with micturition

2. Late procedural complication

SMR01 During a subsequent

admission with discharge date

within 5 years of the date of

index procedure

ICD10 diagnostic codes:

Haemorrhage related:

T81.0* Haemorrhage and haematoma complicating a procedure, NEC

T81.1* Shock during or resulting from a procedure, NEC

R58* Haemorrhage, NEC

Infection related:

T81.4 Infection following procedure, NEC

T83.5 Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system

T83.6 Infection and inflammatory reaction due to prosthetic device, implant and graft in genital tract

N30* Cystitis

N39.0* Urinary tract infection, site not specified

R30* Pain associated with micturition

R57.2* Septic shock

R65* Systemic inflammatory response syndrome

A40* Streptococcal sepsis

A41* Other sepsis

Pain related:

N94.1 Dyspareunia

R10.2 Pelvic and perineal pain

R52.1 Chronic intractable pain

R52.2 Other chronic pain

Procedure related:

T81.2 Accidental puncture and laceration during a procedure, not elsewhere classified

T81.3 Disruption of operation wound, NEC

T81.5 Foreign body accidentally left in body cavity or operation wound following a procedure

T81.6 Acute reaction to foreign substance accidentally left during a procedure

T81.7 Vascular complications following a procedure, NEC

T81.8 Other complications of procedures, NEC

T81.9 Unspecified complication of procedure

T83.0 Mechanical complication of urinary (indwelling) catheter

T83.1 Mechanical complication of other urinary devices and implants

T83.2 Mechanical complication of graft of urinary system

T83.3 Mechanical complication of intrauterine contraceptive device

T83.4 Mechanical complication of other prosthetic devices, implants and grafts in genital tract

T83.8 Other complications of genitourinary prosthetic devices, implants and grafts

T83.9 Unspecified complication of genitourinary prosthetic device, implant and graft

T88.8 Other specified complications of surgical and medical care, NEC

T88.9 Complication of surgical and medical care, unspecified

T98.3 Sequelae of complications of surgical and medical care, not elsewhere classified

Y60* Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care

Y73* Gastroenterology and urology devices associated with adverse incidents

Y76* Obstetric and gynaecological devices associated with adverse incidents

Y83 Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of

later complication, without mention of misadventure at the time of the procedure

Y88 Sequelae with surgical and medical care as external cause

R33* Retention of urine

R39.1* Other difficulties with micturition

OPCS4 procedure codes:

Mesh removal:

M53.4 Total removal of tension-free vaginal tape

M53.5 Partial removal of tension-free vaginal tape

M53.7 Removal of transobturator tape

P05, P20, P22.8, P23.8, or P29 paired with Y03 or Y26 Non specific vaginal prolapse repair or other procedure on

lower genital tract paired with supplementary code indicating 'attention to prosthesis' or 'other repair of organ' to

denote removal of prolapse mesh

*code only applicable if admission date within 90 days of the index procedure date

3. Further incontinence surgery




index procedure

OPSC4 procedural codes:

M51-M58 (excl. episodes with only code M53.4, M53.5 or M53.7) Any operation on outlet of female bladder

Note that M53,4, M53.5, and M53.7 have been excluded as these codes indicate removal of previously inserted

mesh tapes hence they indicate a complication rather than simply repeat continence surgery

4. Further prolapse surgery




index procedure

OPSC4 procedural codes:

P18, P22 (except P22.8 when paired with Y03 or Y26), P23 (except P23.8 when paired with Y03 or Y26), P24, P26,

Q54 Any procedure for pelvic organ prolapse

Q08 (paired with ICD10 diagnostic code N81 ) Vaginal hysterectomy for prolapse

Note that P22.8 and P23.8 codes have been excluded when paired with codes Y03 or Y26 as examination of the

PROSPECT validation data suggested these codes are used to code prolapse mesh removal rather than (or possibly

as well as) repeat colporrhaphy hence they are likely to indicate a complication rather than simply repeat prolapse

surgery. As such these codes are included in the list for late procedural complications

Further prolapse surgery codes classified by compartment operated on

Anterior

P22.1

P22.2

P23.1

P23.2

P23.5

P23.6

Posterior

P22.1

P22.3

P23.1

P23.3

P23.4

P23.7

Vault

P24

Other (includes uterine prolapse repair and unspecified procedures)

P18

P22.8 not paired with Y03 or Y26

P22.9

P23.8 not paired with Y03 or Y26

P23.9

P26

Q54

Q08 paired with ICD10 code N81

SMR Scottish Morbidity Record

ESM 3 Directed acyclic graph

Causal relationship underpinning analysis

ESM 4 Characteristics of patients undergoing first combined incontinence and prolapse procedures in Scotland, 1997/98-2015/16

i.e. the specified included procedure done at the same time as another incontinence or prolapse procedure (see ESM1 for codes used)

Incontinence surgery

Open colposuspension

(non mesh)

Urethral injection therapy

(non mesh)

Suprapubic sling

(non mesh) Unspecified mesh Retropubic mesh

Transobturator mesh

Number of patients 454 6 84 743 1094 966

Years 1997/98-2015/16 1997/98-2015/16 1997/98-2015/16 1997/98-2005/06 2006/07-2015/16 2006/07-2015/16

Age, years, mean (SD) 49.8 (10.2) 59.5 (15.7) 54.9 (10.9) 56.9 (12.0) 56.3 (12.4) 54.4 (11.9)

Most deprived quintile, % (number) 20.3 (92) 16.7 (1) 34.5 (29) 12.3 (91) 17.5 (191) 17.0 (162)

Co-morbidity, % (number) 3.7 (17) 16.7 (1) 14.3 (12) 8.5 (63) 7.2 (79) 8.9 (86)

Teaching hospital, % (number) 38.3 (174) 16.7 (1) 78.6 (66) 51.4 (382) 43.2 (473) 23.7 (229)

Low volume consultant, % (number) 74.7 (339) 50.0 (3) 42.9 (36) 41.6 (309) 40.0 (438) 39.0 (377)

Prolapse surgery

Anterior colporrhaphy

(non mesh)

Anterior colporrhaphy with mesh

Posterior colporrhaphy

(non mesh)

Posterior colporrhaphy with mesh

Sacrospinous fixation of vagina

(non mesh)

Vaginal mesh vault repair

(mesh)

Open sacrocolpopexy

(abdominal mesh)

Vaginal hysterectomy

(non mesh)

Number of patients 9656 379 3108 429 1231 289 461 12496

Years 1997/98-2015/16

2007/08-2015/16 1997/98-2015/16

2007/08-2015/16 1997/98-2015/16 2006/07-2015/16

1997/98-2015/16 1997/98-2015/16

Age, years, mean (SD)

62.5 (11.1) 61.7 (10.9) 59.8 (12.1) 59.7 (11.9) 62.3 (11.7) 59.6 (12.0) 60.3 (13.0) 62.7 (11.1)

Most deprived quintile, % (number)

14.7 (1409) 22.4 (85) 16.2 (501) 21.2 (91) 18.6 (228) 25.0 (72) 14.3 (66) 14.6 (1814)

Co-morbidity, % (number)

7.4 (712) 7.1 (27) 9.2 (287) 11.9 (51) 8.4 (104) 14.2 (41) 7.8 (36) 6.9 (860)

Teaching hospital, % (number)

29.3 (2834) 75.2 (285) 33.9 (1054) 49.7 (213) 49.2 (606) 5.9 (17) 47.7 (220) 30.1 (3763)

Low volume consultant, % (number)

75.2 (7265) 67.8 (257) 68.5 (2128) 53.4 (229) 66.5 (819) 12.5 (36) 73.8 (340) 80.3 (10032)

This table is directly comparable to Table 1 in the main paper showing characteristics of patients undergoing first single procedures.

Specifically, the percentage of operations performed by a low volume consultant has been derived in the same way for both tables: consultants performing an incontinence or

prolapse procedure are considered ‘low volume’ if they performed fewer than 20 included first single incontinence or prolapse procedures respectively in that year.

ESM 5 Index procedure frequency


First single incontinence procedures in Scotland, 1997/98-2015/16

1997/

98 1998/

99 1999/

00 2000/

01 2001/

02 2002/

03 2003/

04 2004/

05 2005/

06 2006/

07 2007/

08 2008/

09 2009/

10 2010/

11 2011/

12 2012/

13 2013/

14 2014/

15 2015/

16 Total


(non mesh)

554 622 447 285 139 89 54 22 15 32 17 9 11 4 1 2 8 31 25 2367


(non mesh)

42 57 69 38 16 25 19 17 21 17 28 37 44 42 61 53 27 34 38 685

Suprapubic sling

(non mesh)

23 41 50 34 45 25 29 47 22 34 9 18 14 6 8 8 12 19 31 475

Unspecified mesh

5 3 21 234 511 585 733 726 837 - - - - - - - - - - 3655

Retropubic mesh

- - - - - - - - - 451 593 666 629 478 478 562 465 188 118 4628

Transobturator mesh

- - - - - - - - - 370 597 710 735 679 606 608 389 129 27 4850

Total 624 723 587 591 711 724 835 812 895 904 1244 1440 1433 1209 1154 1233 901 401 239 16660

Prolapse surgery

First single prolapse procedures in Scotland, 1997/98-2015/16

1997/

98 1998/

99 1999/

00 2000/

01 2001/

02 2002/

03 2003/

04 2004/

05 2005/

06 2006/

07 2007/

08 2008/

09 2009/

10 2010/

11 2011/

12 2012/

13 2013/

14 2014/

15 2015/

16 Total


(non mesh)

363 396 317 346 298 367 409 408 432 412 404 506 513 411 515 449 455 381 261 7643


with mesh - - - - - - - - - - 23 38 44 49 60 44 18 1 1 278


(non mesh)

302 270 296 274 250 312 321 305 312 301 283 397 408 348 346 424 352 335 225 6061


with mesh - - - - - - - - - - 22 18 23 37 66 34 5 4 0 209

Sacrospinous fixation of

vagina

(non mesh)

5 4 3 6 6 7 21 38 33 61 103 137 163 137 154 247 376 300 257 2058


(mesh)

- - - - - - - - - 18 25 15 24 14 5 4 4 1 2 112

Open sacrocolpope

xy

(abdominal mesh)

40 78 50 81 71 47 42 40 79 22 16 16 10 9 17 32 8 12 10 680


(non mesh)

111 123 118 110 87 89 100 96 98 135 114 113 112 135 120 84 70 72 58 1945

Total 821 871 784 817 712 822 893 887 954 949 990 1240 1297 1140 1283 1318 1288 1106 814 1898

6

ESM 6 Index procedure length of inpatient stay

Length of stay in days for complete index procedure inpatient admission including any transfers between units

Length of stay in days, median (interquartile range)


Open colposuspension (non mesh) 6 (5-8)

Urethral injection therapy (non mesh) 1 (0-2)

Suprapubic sling (non mesh) 3 (2-5)

Unspecified mesh 2 (1-2)

Retropubic mesh 1 (0-1)

Transobturator mesh 1 (0-2)

Prolapse surgery

Anterior colporrhaphy (non mesh) 3 (2-5)

Anterior colporrhaphy with mesh 4 (3-4)

Posterior colporrhaphy (non mesh) 3 (2-4)

Posterior colporrhaphy with mesh 3 (3-4)

Sacrospinous fixation of vagina (non mesh) 3 (2-4)

Vaginal mesh vault repair (mesh) 4 (3-5)

Open sacrocolpopexy (abdominal mesh) 5 (4-6)

Vaginal hysterectomy (non mesh) 4 (3-5)

ESM 7 Immediate and late complications by complication subgroups



(non mesh)


(non mesh)

Suprapubic sling

(non mesh)

Unspecified mesh

Retropubic mesh Transobturator

mesh

Number of patients 2367 685 475 3655 4628 4850

Years 1997/98-2015/16

1997/98-2015/16

1997/98-2015/16

1997/98-2005/06

2006/07-2015/16

2006/07-2015/16

[A] Immediate postoperative complications

Patients with a haemorrhage related immediate complication, % (n) 0·8 (18) 0·0 (0) 0·4 (2) 0·7 (25) 0·3 (15) 0·2 (11)

Patients with an infection related immediate complication, % (n) 4·9 (117) 5·4 (37) 2·1 (10) 2·2 (80) 0·9 (42) 0·7 (35)

Patients with a pain related immediate complication, % (n) 0·2 (4) 0·1 (1) 0·2 (1) 0·3 (11) 0·2 (8) 0·3 (13)

Patients with a procedure related immediate complication, % (n) 5·2 (124) 2·8 (19) 4·2 (20) 4·8 (175) 2·6 (122) 1·6 (77)

Patients with any immediate complication, % (n) 7·8 (185) 8·2 (56) 5·7 (27) 7·1 (258) 3·7 (169) 2·5 (120)

[B] Late postoperative complication admissions

Total person-years of follow-up 11454 2832 2090 18074 19608 21378

Haemorrhage related late complication admissions, CIR (n) 2·1 (24) 0·0 (0) 1·9 (4) 0·7 (13) 0·5 (10) 0·3 (7)

Infection related late complication admissions, CIR (n) 12·0 (137) 54·0 (153) 23·0 (48) 12·7 (230) 14·1 (277) 14·2 (304)

Pain related late complication admissions, CIR (n) 0·4 (5) 0·4 (1) 0·5 (1) 0·3 (5) 0·3 (6) 0·1 (2)

Procedure related late complication admissions, CIR (n) 29·2 (335) 54·0 (153) 44·0 (92) 28·1 (508) 29·3 (574) 26·6 (569)

Mesh removal related late complication admissions, CIR (n) 2·0 (23) 2·1 (6) 10·0 (21) 4·6 (84) 10·9 (214) 8·3 (178)

Any late complication admission, CIR (n) 34·1 (391) 88·6 (251) 54·1 (113) 33·9 (612) 35·6 (698) 33·0 (706)

Prolapse surgery


(non mesh)



(non mesh)



(non mesh)


(mesh)

Open sacrocolpopexy

(abdominal mesh)


(non mesh)


Years 1997/98-2015/16

2007/08-2015/16

1997/98-2015/16

2007/08-2015/16

1997/98-2015/16

2006/07-2015/16

1997/98-2015/16

1997/98-2015/16


Patients with a haemorrhage related immediate complication, % (n) 0·3 (22) 0·4 (1) 0·6 (37) 0·0 (0) 0·6 (13) 0·0 (0) 1·2 (8) 1·8 (35)

Patients with an infection related immediate complication, % (n) 2·4 (186) 1·4 (4) 1·5 (90) 0·5 (1) 1·7 (36) 0·9 (1) 3·8 (26) 1·5 (29)

Patients with a pain related immediate complication, % (n) 0·1 (5) 0·0 (0) 0·3 (16) 0·5 (1) 0·0 (1) 0·0 (0) 0·3 (2) 0·5 (10)

Patients with a procedure related immediate complication, % (n) 2·4 (187) 2·5 (7) 1·8 (109) 1·0 (2) 3·0 (61) 3·6 (4) 3·5 (24) 3·8 (73)

Patients with any immediate complication, % (n) 4·5 (343) 3·6 (10) 3·3 (199) 1·4 (3) 4·4 (91) 4·5 (5) 6·3 (43) 5·4 (105)


Total person-years of follow-up 33205 1236 26000 934 6562 518 3127 8726

Haemorrhage related late complication admissions, CIR (n) 1·9 (62) 1·6 (2) 3·3 (85) 2·1 (2) 3·4 (22) 9·7 (5) 1·9 (6) 4·8 (42)

Infection related late complication admissions, CIR (n) 5·1 (170) 35·6 (44) 6·7 (175) 32·1 (30) 9·6 (63) 29·0 (15) 15·4 (48) 6·3 (55)

Pain related late complication admissions, CIR (n) 0·2 (7) 0·0 (0) 0·4 (11) 0·0 (0) 0·3 (2) 0·0 (0) 0·0 (0) 0·7 (6)

Procedure related late complication admissions, CIR (n) 17·5 (582) 58·3 (72) 20·6 (536) 64·2 (60) 30·2 (198) 44·4 (23) 30·7 (96) 18·5 (161)

Mesh removal related late complication admissions, CIR (n) 3·6 (120) 29·1 (36) 5·0 (130) 31·0 (29) 10·4 (68) 29·0 (15) 9·3 (29) 5·0 (44)

Any late complication admission, CIR (n) 22·0 (730) 70·4 (87) 25·9 (673) 77·1 (72) 39·5 (259) 52·1 (27) 38·7 (121) 24·9 (217)

CIR is crude incidence rate per 1000 person-years calculated as [number of late complication admissions/total person-years of follow-up]*1000

The number of patients with immediate complications in each subgroup can sum to greater than the total number of patients with any immediate complication as more than one complication type may be recorded on an index procedure

record.

Similarly, the number of late complication admissions in each subgroup can sum to greater than the total number of late complication admissions as more than one complication type may be recorded on a readmission record.

Patients with non-mesh index procedures may have subsequent mesh removal related late complication admissions if they had a mesh procedure after their index procedure.

ESM 8 Deviance and residual degrees of freedom for all Poisson regression models

Main/subgroup Outcome modelled Covariates Residual deviance

Residual degrees of freedom

Ratio of residual deviance to degrees of freedom

Full model, incontinence Patients with a complication, % (n) Unadjusted 4739·43 16580 0·29

Full model, incontinence Any late complication admission, CIR (n) Unadjusted 13946·62 16580 0·84

Full model, incontinence Further incontience surgery Unadjusted 6721·30 16580 0·41

Full model, incontinence Further prolapse surgery Unadjusted 3809·47 16580 0·23

Full model, incontinence Patients with a complication, % (n) Adjusted 4685·85 16570 0·28

Full model, incontinence Any late complication admission, CIR (n) Adjusted 13784·86 16570 0·83

Full model, incontinence Further incontience surgery Adjusted 6695·65 16570 0·40

Full model, incontinence Further prolapse surgery Adjusted 3793·22 16570 0·23

Full model, prolapse Patients with a complication, % (n) Unadjusted 5022·05 18877 0·27

Full model, prolapse Any late complication admission, CIR (n) Unadjusted 11842·83 18877 0·63

Full model, prolapse Further incontience surgery Unadjusted 3894·22 18877 0·21

Full model, prolapse Further prolapse surgery Unadjusted 10388·08 18877 0·55

Full model, prolapse Patients with a complication, % (n) Adjusted 4994·56 18867 0·26

Full model, prolapse Any late complication admission, CIR (n) Adjusted 11735·10 18867 0·62

Full model, prolapse Further incontience surgery Adjusted 3811·14 18867 0·20

Full model, prolapse Further prolapse surgery Adjusted 10302·29 18867 0·55

Retropubic vs transobturator model Patients with a complication, % (n) Unadjusted 1999·17 9422 0·21

Retropubic vs transobturator model Any late complication admission, CIR (n) Unadjusted 7471·27 9422 0·79

Retropubic vs transobturator model Further incontience surgery Unadjusted 3214·60 9422 0·34

Retropubic vs transobturator model Further prolapse surgery Unadjusted 1636·00 9422 0·17

Retropubic vs transobturator model Patients with a complication, % (n) Adjusted 1969·88 9412 0·21

Retropubic vs transobturator model Any late complication admission, CIR (n) Adjusted 7298·22 9412 0·78

Retropubic vs transobturator model Further incontience surgery Adjusted 3196·05 9412 0·34

Retropubic vs transobturator model Further prolapse surgery Adjusted 1612·90 9412 0·17

Anterior compartment prolapse model Patients with a complication, % (n) Unadjusted 1032·28 4142 0·25

Anterior compartment prolapse model Any late complication admission, CIR (n) Unadjusted 2360·54 4142 0·57

Anterior compartment prolapse model Further incontience surgery Unadjusted 833·20 4142 0·20

Anterior compartment prolapse model Further prolapse surgery Unadjusted 2201·06 4142 0·53

Anterior compartment prolapse model Patients with a complication, % (n) Adjusted 1006·36 4132 0·24

Anterior compartment prolapse model Any late complication admission, CIR (n) Adjusted 2328·16 4132 0·56

Anterior compartment prolapse model Further incontience surgery Adjusted 809·12 4132 0·20

Anterior compartment prolapse model Further prolapse surgery Adjusted 2157·57 4132 0·52

Posterior compartment prolapse model Patients with a complication, % (n) Unadjusted 656·65 3293 0·20

Posterior compartment prolapse model Any late complication admission, CIR (n) Unadjusted 1996·63 3293 0·61

Posterior compartment prolapse model Further incontience surgery Unadjusted 601·56 3293 0·18

Posterior compartment prolapse model Further prolapse surgery Unadjusted 1483·01 3293 0·45

Posterior compartment prolapse model Patients with a complication, % (n) Adjusted 639·59 3283 0·19

Posterior compartment prolapse model Any late complication admission, CIR (n) Adjusted 1963·46 3283 0·60

Posterior compartment prolapse model Further incontience surgery Adjusted 577·56 3283 0·18

Posterior compartment prolapse model Further prolapse surgery Adjusted 1470·36 3283 0·45

Vaginal vault prolapse model Patients with a complication, % (n) Unadjusted 615·63 2193 0·28

Vaginal vault prolapse model Any late complication admission, CIR (n) Unadjusted 1493·63 2193 0·68

Vaginal vault prolapse model Further incontience surgery Unadjusted 331·96 2193 0·15

Vaginal vault prolapse model Further prolapse surgery Unadjusted 1269·95 2193 0·58

Vaginal vault prolapse model Patients with a complication, % (n) Adjusted 609·33 2183 0·28

Vaginal vault prolapse model Any late complication admission, CIR (n) Adjusted 1453·91 2183 0·67

Vaginal vault prolapse model Further incontience surgery Adjusted 315·53 2183 0·14

Vaginal vault prolapse model Further prolapse surgery Adjusted 1248·63 2183 0·57

Further prolapse , by compartment model Further prolapse surgery, same compartment Unadjusted 4360·19 16938 0·26

Further prolapse , by compartment model Further prolapse surgery, different compartment Unadjusted 7938·80 16938 0·47

Further prolapse , by compartment model Further prolapse surgery, same compartment Adjusted 4287·97 16928 0·25

Further prolapse , by compartment model Further prolapse surgery, different compartment Adjusted 7894·18 16928 0·47

Anterior compartment prolapse model Further prolapse surgery, same compartment Unadjusted 1243·20 4142 0·30

Anterior compartment prolapse model Further prolapse surgery, different compartment Unadjusted 1801·86 4142 0·44

Anterior compartment prolapse model Further prolapse surgery, same compartment Adjusted 1231·70 4132 0·30

Anterior compartment prolapse model Further prolapse surgery, different compartment Adjusted 1769·53 4132 0·43

Posterior compartment prolapse model Further prolapse surgery, same compartment Unadjusted 445·18 3293 0·14

Posterior compartment prolapse model Further prolapse surgery, different compartment Unadjusted 1399·26 3293 0·42

Posterior compartment prolapse model Further prolapse surgery, same compartment Adjusted 437·62 3283 0·13

Posterior compartment prolapse model Further prolapse surgery, different compartment Adjusted 1378·92 3283 0·42

Vaginal vault prolapse model Further prolapse surgery, same compartment Unadjusted 633·39 2193 0·29

Vaginal vault prolapse model Further prolapse surgery, different compartment Unadjusted 1155·21 2193 0·53

Vaginal vault prolapse model Further prolapse surgery, same compartment Adjusted 613·95 2183 0·28

Vaginal vault prolapse model Further prolapse surgery, different compartment Adjusted 1130·67 2183 0·52

Jo

Text Box

PAGE INTENTIONALLY BLANK

●

●

●

●

●

0.03 0.04 0.05 0.06 0.07 0.08

0.03

0.05

0.07

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Full model, incontinence Immediate complications

Unadjusted

●

●

●

●

●

●

0.1 0.2 0.3 0.4

0.15

0.25

0.35

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, incontinence Later complication

Unadjusted

●●

●●

●

●

0.1 0.2 0.3 0.4

0.1

0.2

0.3

0.4

0.5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, incontinence Further incontience surgery

Unadjusted

●

●

●

●

●

●

0.02 0.04 0.06 0.08

0.02

0.04

0.06

0.08

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Full model, incontinence Further prolapse surgery

Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15

0.00

0.05

0.10

0.15

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Full model, incontinence Immediate complications

Adjusted

●●

●

●

●

●

0.2 0.4 0.6 0.8

0.5

1.0

1.5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, incontinence Later complication

Adjusted

●

●

●

●●

●

0.1 0.2 0.3 0.4 0.5 0.6

0.2

0.4

0.6

0.8

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, incontinence Further incontience surgery

Adjusted

●

●

●

●

●

●

0.02 0.06 0.10 0.14

0.05

0.10

0.15

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Full model, incontinence Further prolapse surgery

Adjusted

●

●

●

●

●

0.02 0.03 0.04 0.05 0.06

0.02

0.04

0.06

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Full model, prolapse

Immediate complications Unadjusted

●

●

●

●

●

●

0.05 0.15 0.25 0.35

0.10

0.20

0.30

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, prolapse Later complication

Unadjusted

●

●

●

●

●

●

0.02 0.04 0.06 0.08 0.10

0.02

0.06

0.10

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, prolapse Further incontience surgery

Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15 0.20 0.25

0.05

0.10

0.15

0.20

0.25

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin


Further prolapse surgery Unadjusted

●

●

● ●

●

●

0.04 0.06 0.08 0.10 0.12

0.03

0.05

0.07

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin


Immediate complications Adjusted

●●

●

● ●

●

0.1 0.2 0.3 0.4 0.5 0.6 0.7

0.2

0.4

0.6

0.8

1.0

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, prolapse Later complication

Adjusted

●

●●

●

●

●

0.05 0.15 0.25

0.0

0.2

0.4

0.6

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Full model, prolapse Further incontience surgery

Adjusted

●

●

●

●

●

●

0.1 0.2 0.3 0.4

0.10

0.20

0.30

0.40

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin


Further prolapse surgery Adjusted

●

●

0.026 0.030 0.034

0.02

60.

030

0.03

4

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Retropubic vs transobturator model


●

●

●

●

●

●

0.05 0.10 0.15

0.06

0.10

0.14

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Retropubic vs transobturator model Later complication

Unadjusted

●

●

●

●

●

●

0.01 0.02 0.03 0.04 0.05 0.06

0.01

0.03

0.05

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Retropubic vs transobturator model Further incontience surgery

Unadjusted

●

●

●

●●

●

0.005 0.010 0.015 0.020 0.025

0.00

00.

010

0.02

0

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●●

●

●

●

●

0.02 0.04 0.06 0.08

0.02

0.06

0.10

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

●

●

●●

0.1 0.2 0.3 0.4 0.5 0.6

0.10

0.20

0.30

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Retropubic vs transobturator model Later complication

Adjusted

●

●

●

●●

●

0.02 0.04 0.06 0.08 0.10 0.12

0.05

0.10

0.15

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Retropubic vs transobturator model Further incontience surgery

Adjusted

●

●

●●

●

●

0.01 0.02 0.03 0.04 0.05

0.00

0.02

0.04

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

0.0360 0.0370 0.0380

0.03

600.

0370

0.03

80

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Anterior compartment prolapse model


●

●● ●

●

●

0.05 0.15 0.25 0.35

0.05

0.15

0.25

0.35

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Anterior compartment prolapse model Later complication

Unadjusted

●

●

●

●

●

●

0.02 0.04 0.06 0.08 0.10

0.02

0.06

0.10

0.14

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Anterior compartment prolapse model Further incontience surgery

Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15 0.20 0.25

0.05

0.15

0.25

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●●

●

●

●

●

0.05 0.10 0.15

0.1

0.2

0.3

0.4

0.5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



● ●● ●

●

●

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8

0.0

1.0

2.0

3.0

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Anterior compartment prolapse model Later complication

Adjusted

●

●

●

●

●

●

0.05 0.15 0.25 0.35

0.05

0.10

0.15

0.20

0.25

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Anterior compartment prolapse model Further incontience surgery

Adjusted

●

●

●

●

●

●

0.1 0.2 0.3 0.4 0.5 0.6

0.2

0.4

0.6

0.8

1.0

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

0.015 0.020 0.025

0.01

50.

020

0.02

5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Posterior compartment prolapse model


●

●

●

●

●

●

0.05 0.15 0.25 0.35

0.10

0.20

0.30

0.40

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Posterior compartment prolapse model Later complication

Unadjusted

●

●

●

●

●

●

0.01 0.02 0.03 0.04

0.00

0.02

0.04

0.06

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Posterior compartment prolapse model Further incontience surgery

Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15 0.20

0.05

0.10

0.15

0.20

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

●

●

●

●

0.02 0.04 0.06 0.08 0.10 0.12

0.00

0.04

0.08

0.12

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

●

●

●

●

0.1 0.2 0.3 0.4 0.5 0.6 0.7

0.1

0.2

0.3

0.4

0.5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Posterior compartment prolapse model Later complication

Adjusted

●

●

●

●

●

●

0.05 0.10 0.15

0.00

0.05

0.10

0.15

0.20

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Posterior compartment prolapse model Further incontience surgery

Adjusted

●

●

● ●

●

●

0.05 0.10 0.15 0.20 0.25

0.05

0.15

0.25

0.35

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

0.045 0.055 0.065

0.04

50.

055

0.06

5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Vaginal vault prolapse model


●

●

●

●

●

●

0.05 0.10 0.15 0.20 0.25

0.10

0.14

0.18

0.22

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Vaginal vault prolapse model Later complication

Unadjusted

●

●

●

●

●

●

0.01 0.02 0.03 0.04

0.00

0.01

0.02

0.03

0.04

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Vaginal vault prolapse model Further incontience surgery

Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15 0.20

0.00

0.05

0.10

0.15

0.20

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



● ●

●

●

●

●

0.04 0.06 0.08 0.10 0.12

0.00

0.10

0.20

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



● ●●

●

●

●

0.1 0.2 0.3 0.4

0.2

0.4

0.6

0.8

1.0

1.2

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Vaginal vault prolapse model Later complication

Adjusted

●

●

● ●

● ●

0.02 0.06 0.10 0.14

0.00

0.02

0.04

0.06

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Vaginal vault prolapse model Further incontience surgery

Adjusted

●

●

●

●

●

●

0.1 0.2 0.3 0.4 0.5 0.6

0.0

0.1

0.2

0.3

0.4

0.5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

● ●

●

●

0.02 0.04 0.06 0.08

0.01

0.03

0.05

0.07

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Further prolapse , by compartment model

Further prolapse surgery, same compartment Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15 0.20

0.05

0.10

0.15

0.20

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Further prolapse , by compartment model Further prolapse surgery, different compartment

Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15 0.20

0.00

0.10

0.20

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Further prolapse , by compartment model Further prolapse surgery, same compartment

Adjusted

●

●

●

●

●

●

0.05 0.10 0.15 0.20 0.25 0.30

0.05

0.15

0.25

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)Further prolapse , by compartment model

Further prolapse surgery, different compartment Adjusted

●

●

●●

●

●

0.02 0.04 0.06 0.08

0.00

0.04

0.08

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

●

●

●

●

0.05 0.10 0.15 0.20

0.05

0.10

0.15

0.20

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Anterior compartment prolapse model Further prolapse surgery, different compartment

Unadjusted

●●

●

●

●

●

0.02 0.06 0.10 0.14

0.05

0.15

0.25

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Anterior compartment prolapse model Further prolapse surgery, same compartment

Adjusted

●

●

●

● ●

●

0.1 0.2 0.3 0.4

0.05

0.15

0.25

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



● ●

●

●

●

●

0.01 0.02 0.03 0.04

0.00

0.02

0.04

0.06

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

●

●

●

●

0.05 0.10 0.15 0.20

0.05

0.15

0.25

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Posterior compartment prolapse model Further prolapse surgery, different compartment

Unadjusted

●

●

●

● ● ●

0.02 0.06 0.10 0.14

0.00

0.04

0.08

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Posterior compartment prolapse model Further prolapse surgery, same compartment

Adjusted

●

●●

●

●

●

0.05 0.15 0.25 0.35

0.1

0.2

0.3

0.4

0.5

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

●

●

●

●

0.01 0.03 0.05 0.07

0.00

0.02

0.04

0.06

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



●

●

●

●

●

●

0.05 0.10 0.15

0.00

0.05

0.10

0.15

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Vaginal vault prolapse model Further prolapse surgery, different compartment

Unadjusted

●

●

●

●

●

●

0.05 0.10 0.15

0.04

0.08

0.12

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin

e)

Vaginal vault prolapse model Further prolapse surgery, same compartment

Adjusted

● ●

●

●

●

●

0.1 0.2 0.3 0.4 0.5

0.0

0.2

0.4

0.6

Predicted

Obs

erve

d (p

oint

s) a

nd p

redi

cted

(lin



ESM 10 Further prolapse surgery on same and different anatomical compartment following first single prolapse procedures


(non mesh)



(non mesh)



(non mesh)


(mesh)

Open sacrocolpopexy

(abdominal mesh)

Number of patients 7643 278 6061 209 2058 112 680

Years 1997/98-2015/16 2007/08-2015/16 1997/98-2015/16 2007/08-2015/16 1997/98-2015/16 2006/07-2015/16

1997/98-2015/16

Total person-years of follow-up

33205 1236 26000 934 6562 518 3127

All further prolapse surgery

Total number of admissions within 5 years

990 66 584 38 313 21 170

Crude incidence rate per 1,000 person-years

29·8 53·4 22·5 40·7 47·7 40·5 54·4

Further prolapse surgery, same compartment


384 21 127 9 100 8 54


11·6 17·0 4·9 9·6 15·2 15·4 17·3

Unadjusted IRR (95% CI) 1 (ref)

1·47 (0·94-2·27) 0·42 (0·35-0·52) 0·83 (0·43-1·61) 1·32 (1·06-1·64) 1·33 (0·66-2·68) 1·49 (1·12-1·98)

Adjusted IRR (95% CI) 1·23 (0·79-1·92) 0·40 (0·32-0·49) 0·68 (0·35-1·32) 1·26 (1·01-1·58) 1·23 (0·61-2·50) 1·57 (1·18-2·10)

Further prolapse surgery, different or unspecified compartment


631 52 475 38 254 15 131


19·0 42·1 18·3 40·7 38·7 29·0 41·9


2·21 (1·67-2·94) 0·97 (0·86-1·09) 2·14 (1·54-2·97) 2·04 (1·76-2·36) 1·52 (0·91-2·54) 2·20 (1·83-2·66)

Adjusted IRR (95% CI) 2·11 (1·58-2·81) 0·94 (0·83-1·06) 1·94 (1·39-2·70) 2·01 (1·73-2·33) 1·41 (0·84-2·36) 2·35 (1·94-2·85)

IRR incidence rate ratio

ESM 11 Direct comparison of further prolapse surgery on same and different anatomical compartment following specific mesh and non mesh first single procedures for prolapse, by anatomical compartment of index procedure

Anterior compartment prolapse Posterior compartment prolapse Vaginal vault prolapse


(non mesh)



(non mesh)



(non mesh)


(mesh)

Open sacrocolpopexy

(abdominal mesh)


Years 2007/08-2015/16 2007/08- 2015/16 2007/08-2015/16 2007/08-2015/16 2006/07-2015/16 2006/07-2015/16 2006/07-2015/16

Further prolapse surgery, same compartment


1·31 (0·83-2·05) 1 (ref)

2·35 (1·15-4·79) 1 (ref)

0·99 (0·48-2·03) 0·65 (0·28-1·48)

Adjusted IRR (95% CI) 1·22 (0·77-1·93) 2·26 (1·07-4·74) 0·95 (0·45-1·99) 0·68 (0·30-1·58)

Further prolapse surgery, different or unspecified compartment


2·15 (1·60-2·88) 1 (ref)

2·07 (1·47-2·92) 1 (ref)

0·73 (0·43-1·23) 0·85 (0·54-1·35)

Adjusted IRR (95% CI) 2·02 (1·49-2·74) 1·99 (1·39-2·85) 0·72 (0·43-1·23) 0·80 (0·50-1·27)

IRR incidence rate ratio

ESM 12 Comparison of estimates from Poisson models and from generalized estimating equation models to accommodate clustering by consultant

Outcome modelled Main/subgroup Covariates Procedure Poisson regression Generalized estimating equation model

Immediate complications Full model, prolapse Adjusted Anterior colporrhaphy with mesh 0·78 (0·41-1·46) 0·78 (0·42-1·45)

Immediate complications Full model, prolapse Adjusted Vaginal mesh vault repair (mesh) 0·95 (0·39-2·31) 0·95 (0·40-2·28)

Immediate complications Full model, prolapse Adjusted Posterior colporrhaphy (non mesh) 0·74 (0·62-0·89) 0·74 (0·63-0·88)

Immediate complications Full model, prolapse Adjusted Posterior colporrhaphy with mesh 0·31 (0·10-0·98) 0·31 (0·10-0·97)

Immediate complications Full model, prolapse Adjusted Open sacrocolpopexy (abdominal mesh) 1·32 (0·96-1·82) 1·32 (0·97-1·81)

Immediate complications Full model, prolapse Adjusted Sacrospinous fixation of vagina (non mesh) 0·94 (0·74-1·19) 0·94 (0·75-1·18)

Immediate complications Full model, prolapse Adjusted Vaginal hysterectomy (non mesh) 1·24 (0·99-1·54) 1·24 (1·00-1·53)

Immediate complications Full model, incontinence Adjusted Suprapubic sling (non mesh) 0·75 ( 0·50- 1·13) 0·75 ( 0·50- 1·12)

Immediate complications Full model, incontinence Adjusted Retropubic mesh 0·44 ( 0·36- 0·55) 0·44 ( 0·36- 0·55)

Immediate complications Full model, incontinence Adjusted Transobturator mesh 0·31 ( 0·24- 0·40) 0·31 ( 0·25- 0·39)

Immediate complications Full model, incontinence Adjusted Unspecified mesh 0·84 ( 0·68- 1·02) 0·84 ( 0·69- 1·00)

Immediate complications Full model, incontinence Adjusted Urethral injection therapy (non mesh) 1·01 ( 0·74- 1·37) 1·01 ( 0·75- 1·36)

Immediate complications Anterior compartment prolapse model Adjusted Anterior colporrhaphy with mesh 0·93 ( 0·49- 1·79) 0·93 ( 0·49- 1·77)

Immediate complications Posterior compartment prolapse model Adjusted Posterior colporrhaphy with mesh 0·49 (0·15-1·58) 0·49 (0·15-1·59)

Immediate complications Retropubic vs transobturator model Adjusted Transobturator mesh 0·71 (0·56-0·90) 0·71 (0·56-0·90)

Immediate complications Vaginal vault prolapse model Adjusted Vaginal mesh vault repair (mesh) 1·14 ( 0·46- 2·84) 1·10 ( 0·42- 2·87)

Immediate complications Vaginal vault prolapse model Adjusted Open sacrocolpopexy (abdominal mesh) 1·70 ( 0·89- 3·27) 1·72 ( 0·95- 3·13)

Later complication Full model, prolapse Adjusted Anterior colporrhaphy with mesh 3·18 (2·54-3·99) 3·18 (2·28-4·44)

Later complication Full model, prolapse Adjusted Vaginal mesh vault repair (mesh) 2·22 (1·51-3·27) 2·22 (1·27-3·89)

Later complication Full model, prolapse Adjusted Posterior colporrhaphy (non mesh) 1·15 (1·03-1·27) 1·15 (0·98-1·34)

Later complication Full model, prolapse Adjusted Posterior colporrhaphy with mesh 3·23 (2·52-4·13) 3·23 (2·25-4·63)

Later complication Full model, prolapse Adjusted Open sacrocolpopexy (abdominal mesh) 1·86 (1·53-2·26) 1·86 (1·39-2·49)

Later complication Full model, prolapse Adjusted Sacrospinous fixation of vagina (non mesh) 1·79 (1·55-2·07) 1·79 (1·46-2·20)

Later complication Full model, prolapse Adjusted Vaginal hysterectomy (non mesh) 1·09 (0·93-1·27) 1·09 (0·87-1·36)

Later complication Full model, incontinence Adjusted Suprapubic sling (non mesh) 1·54 (1·25-1·91) 1·54 (1·15-2·07)

Later complication Full model, incontinence Adjusted Retropubic mesh 1·12 (0·98-1·27) 1·12 (0·93-1·35)

Later complication Full model, incontinence Adjusted Transobturator mesh 1·02 (0·89-1·16) 1·02 (0·81-1·28)

Later complication Full model, incontinence Adjusted Unspecified mesh 1·03 (0·91-1·18) 1·03 (0·85-1·26)

Later complication Full model, incontinence Adjusted Urethral injection therapy (non mesh) 2·43 (2·07-2·86) 2·43 (1·77-3·33)

Later complication Anterior compartment prolapse model Adjusted Anterior colporrhaphy with mesh 3·15 (2·46-4·04) 3·05 (1·93-4·83)

Later complication Posterior compartment prolapse model Adjusted Posterior colporrhaphy with mesh 2·76 (2·11-3·61) 2·76 (1·85-4·12)

Later complication Retropubic vs transobturator model Adjusted Transobturator mesh 0·90 (0·81-1·01) 0·90 (0·75-1·09)

Later complication Vaginal vault prolapse model Adjusted Vaginal mesh vault repair (mesh) 1·23 (0·82-1·86) 1·24 (0·68-2·26)

Later complication Vaginal vault prolapse model Adjusted Open sacrocolpopexy (abdominal mesh) 0·88 (0·54-1·44) 0·88 (0·50-1·54)

Further prolapse surgery Full model, prolapse Adjusted Anterior colporrhaphy with mesh 1·62 (1·26-2·09) 1·63 (1·23-2·14)

Further prolapse surgery Full model, prolapse Adjusted Vaginal mesh vault repair (mesh) 1·24 (0·80-1·91) 1·24 (0·79-1·96)

Further prolapse surgery Full model, prolapse Adjusted Posterior colporrhaphy (non mesh) 0·73 (0·66-0·81) 0·73 (0·65-0·82)

Further prolapse surgery Full model, prolapse Adjusted Posterior colporrhaphy with mesh 1·19 (0·86-1·65) 1·19 (0·78-1·82)

Further prolapse surgery Full model, prolapse Adjusted Open sacrocolpopexy (abdominal mesh) 1·93 (1·64-2·28) 1·93 (1·61-2·32)

Further prolapse surgery Full model, prolapse Adjusted Sacrospinous fixation of vagina (non mesh) 1·55 (1·36-1·76) 1·55 (1·35-1·77)

Further prolapse surgery Full model, prolapse Adjusted Vaginal hysterectomy (non mesh) 0·90 (0·78-1·03) 0·89 (0·77-1·04)

Further prolapse surgery Full model, incontinence Adjusted Suprapubic sling (non mesh) 0·68 (0·44-1·04) 0·68 (0·41-1·12)

Further prolapse surgery Full model, incontinence Adjusted Retropubic mesh 0·30 (0·24-0·39) 0·30 (0·23-0·40)

Further prolapse surgery Full model, incontinence Adjusted Transobturator mesh 0·26 (0·20-0·34) 0·26 (0·20-0·35)

Further prolapse surgery Full model, incontinence Adjusted Unspecified mesh 0·37 (0·29-0·48) 0·37 (0·28-0·49)

Further prolapse surgery Full model, incontinence Adjusted Urethral injection therapy (non mesh) 0·20 (0·11-0·38) 0·20 (0·10-0·40)

Further prolapse surgery Anterior compartment prolapse model Adjusted Anterior colporrhaphy with mesh 1·69 (1·29-2·20) 1·69 (1·27-2·26)

Further prolapse surgery Posterior compartment prolapse model Adjusted Posterior colporrhaphy with mesh 1·70 (1·20-2·42) 1·70 (1·07-2·69)

Further prolapse surgery Retropubic vs transobturator model Adjusted Transobturator mesh 0·86 (0·66-1·14) 0·87 (0·64-1·16)

Further prolapse surgery Vaginal vault prolapse model Adjusted Vaginal mesh vault repair (mesh) 0·83 (0·53-1·31) 0·83 (0·53-1·33)

Further prolapse surgery Vaginal vault prolapse model Adjusted Open sacrocolpopexy (abdominal mesh) 0·77 (0·50-1·18) 0·77 (0·48-1·23)

Further incontience surgery Full model, prolapse Adjusted Anterior colporrhaphy with mesh 2·91 (1·95-4·34) 2·91 (1·92-4·40)

Further incontience surgery Full model, prolapse Adjusted Vaginal mesh vault repair (mesh) 1·30 (0·53-3·18) 1·30 (0·54-3·14)

Further incontience surgery Full model, prolapse Adjusted Posterior colporrhaphy (non mesh) 0·85 (0·69-1·04) 0·85 (0·68-1·06)

Further incontience surgery Full model, prolapse Adjusted Posterior colporrhaphy with mesh 1·21 (0·62-2·36) 1·20 (0·58-2·52)

Further incontience surgery Full model, prolapse Adjusted Open sacrocolpopexy (abdominal mesh) 1·70 (1·18-2·47) 1·70 (1·15-2·52)

Further incontience surgery Full model, prolapse Adjusted Sacrospinous fixation of vagina (non mesh) 0·87 (0·62-1·23) 0·87 (0·60-1·27)

Further incontience surgery Full model, prolapse Adjusted Vaginal hysterectomy (non mesh) 0·77 (0·56-1·05) 0·77 (0·55-1·07)

Further incontience surgery Full model, incontinence Adjusted Suprapubic sling (non mesh) 2·39 (1·79-3·20) 2·39 (1·70-3·37)

Further incontience surgery Full model, incontinence Adjusted Retropubic mesh 0·90 (0·73-1·11) 0·90 (0·71-1·15)

Further incontience surgery Full model, incontinence Adjusted Transobturator mesh 1·06 (0·86-1·30) 1·06 (0·83-1·34)

Further incontience surgery Full model, incontinence Adjusted Unspecified mesh 1·26 (1·03-1·54) 1·26 (0·99-1·59)

Further incontience surgery Full model, incontinence Adjusted Urethral injection therapy (non mesh) 7·15 (5·83-8·76) 7·15 (5·64-9·06)

Further incontience surgery Anterior compartment prolapse model Adjusted Anterior colporrhaphy with mesh 3·20 (2·06-4·96) 3·19 (1·98-5·13)

Further incontience surgery Posterior compartment prolapse model Adjusted Posterior colporrhaphy with mesh 1·40 (0·68-2·86) 1·40 (0·64-3·07)

Further incontience surgery Retropubic vs transobturator model Adjusted Transobturator mesh 1·16 (0·97-1·38) 1·16 (0·95-1·42)

Further incontience surgery Vaginal vault prolapse model Adjusted Vaginal mesh vault repair (mesh) 1·46 (0·55-3·85) 1·46 (0·57-3·74)

Further incontience surgery Vaginal vault prolapse model Adjusted Open sacrocolpopexy (abdominal mesh) 0·86 (0·26-2·84) 0·85 (0·17-4·33)

ESM 13 Adverse events following first single incontinence procedures in Scotland, 2006/07-2015/16 with 15 year look back to define first procedures


(non mesh)


(non mesh)

Suprapubic sling

(non mesh) Retropubic mesh Transobturator mesh

Number of patients 134 365 151 4528 4747

Years 2006/07-2015/16 2006/07-2015/16 2006/07-2015/16 2006/07-2015/16 2006/07-2015/16

Follow-up in months, median (interquartile range) 40·4 (15·2-60·9) 52·6 (28·5-60·9) 60·9 (14·5-60·9) 60·9 (43·6-60·9) 60·9 (48·5-60·9)


Patients with a complication, % (n) 6·7 (9) 7·1 (26) 5·3 (8) 3·7 (166) 2·5 (118)

Unadjusted RR (95% CI) 1 (ref)

1·06 ( 0·50- 2·26) 0·79 ( 0·30- 2·04) 0·54 ( 0·28- 1·06) 0·37 ( 0·19- 0·74)

Adjusted RR (95% CI) 1·01 (0·47-2·16) 0·77 (0·30-2·00) 0·58 (0·29-1·15) 0·41 (0·21-0·83)


Patients with 1 or more admission 16 46 28 441 403

Total number of admissions within 5 years 33 107 44 669 683

Total person-years of follow-up 415 1314 512 19163 20887

Crude incidence rate per 1,000 person-years 79·5 81·5 85·9 34·9 32·7


1·03 (0·69-1·51) 1·08 (0·69-1·70) 0·44 (0·31-0·62) 0·41 (0·29-0·59)

Adjusted IRR (95% CI) 0·97 (0·66-1·44) 1·02 (0·65-1·60) 0·50 (0·35-0·72) 0·46 (0·33-0·66)

[C] Further incontinence surgery admissions






3·82 (2·07-7·07) 1·18 (0·55-2·54) 0·43 (0·24-0·80) 0·52 (0·29-0·95)

Adjusted IRR (95% CI) 3·96 (2·14-7·35) 1·12 (0·52-2·42) 0·47 (0·26-0·87) 0·56 (0·31-1·04)

[D] Further prolapse surgery admissions






0·27 (0·09-0·81) - 0·32 (0·15-0·69) 0·28 (0·13-0·59)

Adjusted IRR (95% CI) 0·26 (0·09-0·77) - 0·23 (0·10-0·50) 0·19 (0·09-0·43)

Crude incidence rate per 1000 person-years = [total number of admissions within 5 years/total person-years of follow-up]*1000 RR relative risk; IRR incidence rate ratio

ESM 14 Direct comparison of adverse events following specific mesh first single incontinence procedures, Scotland 2006/07-2015/16 with 15 year look back to define first procedures

Retropubic mesh Transobturator mesh

Number of patients 4523 4698

Years 2006/07-2015/16 2006/07-2015/16


Unadjusted RR (95% CI) 1 (ref)

0·69 (0·54-0·87)

Adjusted RR (95% CI) 0·72 (0·56-0·91)



0·94 (0·84-1·05)

Adjusted IRR (95% CI) 0·91 (0·82-1·02)



1·20 (1·01-1·43)

Adjusted IRR (95% CI) 1·18 (0·99-1·41)



0·85 (0·65-1·13)

Adjusted IRR (95% CI) 0·84 (0·64-1·12)

RR rate ratio; IRR incidence rate ratio· Number of patients undergoing each procedure may be lower than that seen in ESM 12 as patients with missing data were excluded from the regression models.

ESM 15 Adverse events following first single prolapse procedures in Scotland, 2006/07-2015/16 with 15 year look back to define first procedures


(non mesh)



(non mesh)



(non mesh)


(mesh)

Open sacrocolpopexy

(abdominal mesh)


(non mesh)


Years 2006/07-2015/16

2007/08-2015/16

2006/07-2015/16

2007/08-2015/16

2006/07-2015/16

2006/07-2015/16

2006/07-2015/16

2006/07-2015/16

Follow-up in months, median (interquartile range) 60·9

(35-60·9)

60·9

(50·5-60·9)

58·3

(33·1-60·9)

59

(50·5-60·9)

36

(20·3-60·9)

60·9

(60·9-60·9)

59·2

(40·1-60·9)

60·9

(42·5-60·9)


Patients with a complication, % (n) 3·7 (153) 2·9 (7) 3·0 (94) 0·6 (1) 4·4 (75) 3·1 (3) 8·6 (11) 5·5 (54)

Unadjusted RR (95% CI) 1 (Ref)

0·79 (0·37-1·68)

0·81 (0·63-1·05)

0·15 (0·02-1·07)

1·18 (0·89-1·55)

0·82 (0·26-2·57)

2·30 (1·25-4·24)

1·47 (1·08-2·01)

Adjusted RR (95% CI) 1 (Ref)

0·78 (0·36-1·66)

0·84 (0·65-1·09)

0·15 (0·02-1·08)

1·13 (0·85-1·49)

0·77 (0·24-2·43)

2·19 (1·18-4·06)

1·55 (1·13-2·12)


Patients with 1 or more admission 258 44 234 33 153 15 12 82

Total number of admissions within 5 years 368 74 319 58 203 23 15 125


Crude incidence rate per 1,000 person-years 23·0 69·0 26·8 73·0 39·2 50·3 29·7 31·1

Unadjusted IRR (95% CI) 1 (Ref)

2·99 (2·33-3·83)

1·17 (1·00-1·36)

3·16 (2·39-4·17)

1·69 (1·42-2·01)

2·18 (1·43-3·32)

1·28 (0·77-2·15)

1·35 (1·10-1·65)

Adjusted IRR (95% CI) 1 (Ref)

3·19 (2·47-4·11)

1·11 (0·95-1·29)

2·94 (2·22-3·90)

1·75 (1·48-2·09)

2·02 (1·32-3·09)

1·44 (0·85-2·41)

1·32 (1·08-1·63)







3·46 (2·22-5·39)

1·00 (0·74-1·34)

1·36 (0·63-2·93)

0·90 (0·60-1·35)

1·69 (0·69-4·15)

0·31 (0·04-2·18)

0·73 (0·45-1·19)


3·15 (2·00-4·94)

0·93 (0·69-1·26)

1·22 (0·56-2·63)

0·95 (0·63-1·43)

1·55 (0·62-3·84)

0·35 (0·05-2·48)

0·71 (0·44-1·17)







1·65 (1·24-2·20)

0·73 (0·63-0·85)

1·18 (0·81-1·73)

1·68 (1·44-1·95)

1·17 (0·71-1·93)

1·32 (0·85-2·07)

1·10 (0·91-1·34)


1·61 (1·21-2·14)

0·69 (0·59-0·80)

1·10 (0·75-1·62)

1·73 (1·48-2·02)

1·13 (0·68-1·87)

1·39 (0·89-2·18)

1·05 (0·87-1·28)

Crude incidence rate per 1000 person-years = [total number of admissions within 5 years/total person-years of follow-up]*1000 RR relative risk; IRR incidence rate ratio

ESM 16 Direct comparison of adverse events following specific mesh and non mesh first single procedures for prolapse, by anatomical compartment, Scotland 2006/07-2015/16 with 15 year look back to define first procedures

Anterior compartment prolapse Posterior compartment prolapse Vaginal vault prolapse


(non mesh)



(non mesh)



(non mesh)


(mesh)

Open sacrocolpopexy

(abdominal mesh)


Years 2007/08-2015/16 2007/08-2015/16 2007/08-2015/16 2007/08-2015/16 2006/07-2015/16 2006/07-2015/16 2006/07-2015/16



0·78 (0·36-1·66) 1 (ref)

0·19 (0·03-1·39) 1 (ref)

0·69 ( 0·22- 2·20) 1·95 ( 1·03- 3·67)

Adjusted IRR (95% CI) 0·76 ( 0·35- 1·64) 0·20 (0·03-1·43) 0·70 ( 0·22- 2·26) 1·99 ( 1·02- 3·87)

B] Late postoperative complication admissions


2·95 (2·29-3·79) 1 (ref)

2·73 (2·06-3·63) 1 (ref)

1·29 (0·84-1·98) 0·76 (0·45-1·28)

Adjusted IRR (95% CI) 3·32 (2·54-4·33) 2·75 (2·05-3·69) 1·06 (0·68-1·66) 0·87 (0·51-1·49)



3·45 (2·20-5·42) 1 (ref)

1·43 (0·66-3·12) 1 (ref)

1·89 (0·73-4·86) 0·34 (0·05-2·50)

Adjusted IRR (95% CI) 3·20 (2·01-5·12) 1·35 (0·61-3·01) 1·58 (0·58-4·27) 0·37 (0·05-2·77)



1·69 (1·27-2·25) 1 (ref)

1·61 (1·09-2·39) 1 (ref)

0·70 (0·42-1·16) 0·79 (0·50-1·24)

Adjusted IRR (95% CI) 1·60 (1·19-2·14) 1·64 (1·10-2·46) 0·65 (0·39-1·09) 0·74 (0·46-1·18)

RR relative risk; IRR incidence rate ratio. Number of patients undergoing each procedure may be lower than that seen in ESM 14 as patients with missing data were excluded from the regression models.

Documents

Supplementary appendix · Q08 (paired with ICD10 diagnostic code N81) Vaginal hysterectomy for prolapse Note that P22.8 and P23.8 codes have been excluded when paired with codes Y03