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Full analysis of Pilot Survey

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Full and Detailed Analysis of Surgical Mesh survey          (Pilot Study September 2016)
Sample size 60 of the 197 mesh injured New Zealanders on the Mesh Down Under website. Margin of error of up ±11% on responses (including the finite population correction), i.e., of the estimated rates of the population of 197 on the website.
The response rate is just over 30 percent.
Non-responses and N/A are not included in the percentages on individual tables.
Percentages may not sum exactly to 100% due to rounding.


Table B:                Age
Age group
Age at operation
Current age
30 - 39
6
3
40 - 49
30
11
50 - 59
16
25
60 - 69
8
19
70 +
0
2
TOTAL
60
60

Table :  Time (years) since operation
Time
Number of respondents
%
0 - 4
19
31.7
5 - 9
27
45.0
10 - 14
10
16.7
15 +
4
6.7
TOTAL
60
100.0

Table D:               Gender

Number of respondents
%
Female
56
93.3
Male
4
6.7
TOTAL
60
100.0

Table H:               Type of hospital
Type of hospital
Number of respondents
%
Private
32
53.3
Public
26
43.3
Both
2
3.3
TOTAL
60
100.0

Table I:                 Diagnosis
Operation/s performed
Number of responses
%
BL prolapse
22
36.7
BW prolapse
12
20.0
VG prolapse
5
8.3
UT prolapse
3
5.0
SUI
12
20.0
ING
9
15.0
INS
7
11.7
ABD
2
3.3
Breast reconstruction
1
1.7
Percentages do not sum to 100% as respondents may have multiple diagnoses.

Table L:                                Advised of potential risks associated with mesh use

Number of respondents
%
Yes
6
10.0
No
53
88.3
Don’t know
1
1.7
TOTAL
60
100.0

The large majority of respondents said that they were not advised of the risk of using mesh. Four of the six people who said that they were advised of the potential risk reported that they had been informed that the risks were very rare or that “the issues with mesh had been resolved”. The other two did not comment.
A few (seven) of those who said that they had not been informed made comments that suggested that perhaps some information had been given to them, but that the information was insufficient. One stated that they “weren’t told it was plastic. I am allergic to plastic”. While another referred just to the surgical risk.
Table N:                               Alternative offered

Number of respondents
%
Yes
5
8.3
No
55
91.7
TOTAL
60
100.0


Of the five who were offered alternatives, two mentioned strengthening exercises. Another said that their surgeon recommended it, but that ACC declined this option. One person who said that they had not been offered alternatives did mention native tissue repair, “but recurrence of symptoms was emphasised and he did not think this would be appropriate”.

Table P:                                Alternative encouraged

Number of respondents
%
Encouraged
2
3.3
Discouraged
4
6.7
Not discussed
54
90.0
TOTAL
60
100.0


Post operative symptoms/complications

Table R:                                Pain

Number of respondents
%
Yes
56
93.3
No
4
6.7
No response
-
-
TOTAL
60
100.0

Table S:                                Erosion

Number of respondents
%
Yes
27
45.8
No
32
54.2
No response
1
-
TOTAL
60
100.0

Table T:                                Hematoma

Number of respondents
%
Yes
11
18.6
No
48
81.4
No response
1
-
TOTAL
60
100.0

Table V:               Infection

Number of respondents
%
Yes
30
50.8
No
29
49.2
No response
1
-
TOTAL
60
100.0



Table W:              Urinary Tract Infection UTI

Number of respondents
%
Yes
24
40.7
No
35
59.3
No response
1
-
TOTAL
60
100.0

Table X:                Voiding dysfunction

Number of respondents
%
Yes
28
47.5
No
31
52.5
No response
1
-
TOTAL
60
100.0

Table Y:      Painful Intercourse/Intercourse impossible

Number of respondents
%
Yes
39
66.1
No
20
33.9
No response
1
-
TOTAL
60
100.0

Table Z:                         Unexpected bleeding

Number of respondents
%
Yes
15
25.4
No
44
74.6
No response
1
-
TOTAL
60
100.0

Table G10:          Incontinence (Urinary & Faecal)

Number of respondents
%
Yes
26
44.1
No
33
55.9
No response
1
-
TOTAL
60
100.0

The most commonly mentioned issue was with pain, with almost all respondents mentioning this. This included numbers of comments about ongoing, chronic pain. Comments also indicated that there were various seats of the pain (groin, thigh, leg, foot, abdomen, back, genitals). About two-thirds explicitly mentioned painful intercourse or that intercourse was impossible. Hematoma and unexpected bleeding were the least commonly reported post-operative issues, with about a fifth to a quarter of respondents reporting these. The others were reported by close to half of the respondents.
Patients typically experienced a number of different post-operative symptoms or complications (see Table G11), with an average of over 4 issues per patient.
Four of the respondents mention mental health issues including depression, anxiety and fear, plus suicidal thoughts.

Table   G11:        Number of the nine post operative symptoms/complications
Number of outcomes
Number of respondents
%
0
0
0.0
1
4
6.7
2
12
20.0
3
10
16.7
4
10
16.7
5
7
11.7
6
5
8.3
7
6
10.0
8
4
6.7
9
2
3.3
TOTAL
60
100.0

Table U:               Recurrence of Symptoms

Number of respondents
%
Yes
25
42.4
No
34
57.6
No response
1
-
TOTAL
60
100.0

Nearly half of the patients reported a recurrence of the symptoms they were experiencing pre-operatively. Recurrence was not included in the post-operative outcomes as it covers a range of possible symptoms, and is more a measure of the long-term efficacy of the operation.

Notification of  issues

Table AD:                            Told GP

Number of respondents
%
Yes
46
78.0
No
13
22.0
No response
1
-
TOTAL
60
100.0

Table AF:                             Told Implant Surgeon

Number of respondents
%
Yes
59
98.3
No
1
1.7
No response
0
-
TOTAL
60
100.0


Table AG:                            Told different surgeon

Number of respondents
%
Yes
21
35.6
No
38
64.4
No response
1
-
TOTAL
60
100.0

Table AH:                            Told other Health Practitioner

Number of respondents
%
Yes
13
21.7
No
47
78.3
TOTAL
60
100.0

All but one respondent told their implant surgeon about their post operative symptoms, and over three-quarters mentioned these to their GP. Approximately half of the respondents told other surgeons or other health professionals. Of those who told other health professionals, three mentioned the emergency department of a hospital and one mentioned a psychologist. One mentioned seeing a locum as well as seeing a GP.
Table AJ:      GP aware of surgical Mesh complications & symptoms

Number of respondents
%
Yes
7
14.9
No
36
76.6
Don’t know
4
8.5
N/A
12
-
No response
1
-
TOTAL
60
100.0

Table AL:             Went to another (Health Practitioner) 

Number of respondents
%
Yes
43
71.7
No
17
28.3
TOTAL
60
100.0

Table AN:            Symptoms taken seriously by Implant Surgeon

Number of respondents
%
Yes
13
22.0
No
43
72.9
Don’t know
3
5.1
N/A
1
-
TOTAL
60
100.0

The perception of respondents was that their symptoms were generally not taken seriously. Their comments suggest that there is a divergence of opinion on the effects of mesh within both the GPs and the surgeons. Several respondents reported that their GP and their surgeons had differing opinions on the mesh. This suggests a need for further research and for a wider dissemination of this and current research on the pros and cons of using the mesh.
Several noted that the GPs “had little or no knowledge of mesh injury or problems”. Others noted that the GP had to do research to find out about the potential effects of mesh surgery, and that this had been initiated on several occasions by the patient them self. Several GPs were reported as having prior knowledge of the effects of the mesh, or were willing to accept that the symptoms their patients had were as a result of the mesh.
Respondents reported how numbers of both GPs and surgeons had discounted that their concerns were the result of the mesh implant. One respondent reported “[The] implant surgeon said it was placed properly so pain was nothing to do with it”. One surgeon reportedly commented that “Surgeons haven't seen this reaction in the 12 yrs they have operated”.
 Other GPs and surgeons ascribed the symptoms to a variety of other causes such as neuropathic pain, a lack of oestrogen after breast cancer or a hysterectomy, spinal causes, a hernia, of a psychosomatic nature “it’s all in your mind”, or to a superbug. These were often put down to the operation itself rather than to issues with the mesh. For example, one respondent stated that “They suggested that the problems would diminish over time”, while others stated “[The] implant surgeon didn't believe there was a problem. [They] seemed dismissive & defensive [and] said it was post-surgery pain or neuropathic pain” while another reported “[The] implant surgeon blamed issue on Mirena perforation of uterus, even though palpating of mesh caused extreme pain”.
Some reported responses that seemed inappropriate to them, such as “The surgeon who recognised the first mesh was in the wrong position was angry with me mentioning it could be a problem. He yelled at me”; “Got patted on the head and sent home from hospital although crying in pain”; or “Buy a vibrator, have some fun and stretch yourself”.
On the other hand, numbers of surgeons and GPs acknowledged that there were issues with the mesh. One surgeon went so far as to state to the respondent that they would never use the mesh again.  Another surgeon “saw and felt the mesh coming through the vaginal wall. ‘This definitely is not where it should be - you will need to have further surgery’”. Yet another responded reported that the “Implant surgeon admitted putting it in the wrong place as well as being an inferior product”.
Table AP:             Identification time of surgical mesh complications

Number of respondents
%
Immediate
11
18.6
Up to 3 mths
6
10.2
3 – 12 mths
11
18.6
Over 12 mths
30
50.8
Don’t know
1
1.7
N/A
1
-
TOTAL
60
100.0


Initial Treatments offered (for mesh erosion)
Treatment offered
Number of respondents*
Explant surgery
20
Partial explant
7
Trim/cut mesh
10
Insert other mesh1
6
Drainage of infection
4
Other surgery2
7
Pain medications
8
Antidepressant3
4
Ovestin or eostrogen cream
3
Antibiotics
4
Physiotherapy
2
Psychotherapy
2
Nursing
2
*Sums to more than 60 as some received various options, often over a period of time.
1 Including Alloderm
2 Including three examinations, and three repairing hysterectomy, breast etc.
3 Including Nortriptyline

Table AS:             Surgical diagnosis for post-op symptoms            

Number of respondents
%
Yes
29
48.3
No
31
51.7
TOTAL
60
100.0

Table AT:             Non-surgical diagnosis for post-op symptoms  

Number of respondents
%
Yes
47
78.3
No
13
21.7
TOTAL
60
100.0

Table AV:            Excision of mesh suggested

Number of respondents
%
Yes
43
74.1
No
14
24.1
Y / N
1
1.7
N/A
2
-
TOTAL
60
100.0

Table AW:           Proceeded with excision of mesh

Number of respondents
%
Yes
35
81.4
No
8
18.6
No response
1
-
N/A
16
-
TOTAL
60
100.0

Table AX:                             Excision – Partial or complete

Number of respondents
%
Partial
22
62.9
Complete
7
20.0
Both
3
8.6
Neither
1
2.9
Don’t know
2
5.7
N/A
25
-
TOTAL
60
100.0
Percentages out of the 35 who proceeded with the operation.
A total of 35 of the 43 people (81 percent) who responded that they had excision of the mesh suggested to them, said that they had proceeded with it. (see Table AW). Of these, 22 reported that the removal was partial, and just 7 said that it was complete. The 3 who responded “Both” had multiple surgical interventions.
Table BB: More surgical intervention required following initial excision surgery (including other possible additional complications e.g. seroma)        
Number of additional surgeries
Number of respondents
%
1
20
40.8
2
8
16.3
3
8
16.3
4
3
6.1
5
3
6.1
6
2
4.1
7
2
4.1
10 or more
3
6.1
N/A
11
-
TOTAL
60
100.0
Percentages out of 49

Table BC:             Improvement in symptoms

Number of respondents
%
Yes
22
47.8
No
19
41.3
Y & N
5
10.9
N/A
14
-
TOTAL
60
100.0

While this table implies that about half of the respondents had experienced improvement, most of those who answered “Yes” qualified their response. Just three of these gave fully positive comments, such as “Good resolution of pain” or “Leg pain improved greatly after removal of IVS”.
Others who replied “Yes” were more equivocal, with comments such as “1st surgery bladder improved. 2nd surgery decreased pain in perineum, vagina and right leg. Felt less toxic”, “Lower back pain reduced”, “Incontinence improved; tightness & feeling of cutting in vagina stopped” or “Still in constant pain, however pain levels less than that previously”.
Still others who replied in the affirmative noted ongoing problems or experienced new issues. Examples of these were: “Pain on right improved. Burning in the vagina the same. Lump at top of vagina gone. Pain on left and at incision the same”; “Instant relief after removal of mesh. However, pain came back and is now bad”; or “2nd surgeon did not address primary issues but removed abdominal fascia tissue to relieve ache in testicle”.
Of the 19 who gave a negative response, seven noted ongoing problems that had not been resolved. Comments such as “Did have more comfort further down track sexually, apart from erosion & sharp jabbing which has got worse”; “Abdominal pain & infection cleared. Still get pain in lower back, intercourse painful & on meds for anxiety”; or “Symptoms remained same from when mesh implanted & now suffer marked nerve damage due to 2nd surgery” were typical. At least one response implied incorrect initial application of the mesh. They commented “Told too much scar tissue and too much damage had been done. He saw the mesh shrink back on the table and said mesh was too tight”.
Table BE:             Told total mesh excision achieved

Number of respondents
%
Yes
15
42.9
No
16
45.7
Y & N
1
2.9
Don’t know
3
8.6
No response
1
-
N/A
24
-
TOTAL
60
100.0

Three respondents reported a difference in opinion between medical people as to whether all the mesh had been removed. Their comments were: “XXX notes said complete but they hadn't taken out the obturator nerve mesh. YYYY surgeon said not certain all was out.”; “Told full explant of both meshes by XXXX (2014) but 2nd trans labial (2016) found 2nd TVT mesh fully in place”; or “YYYY said total explant. XXXX said there was still mesh after her explant surgery”.

Table BG:            Removal of sutures, arms, staples etc.

Number of respondents
%
Yes
5
13.9
No
20
55.6
Y & N
1
2.8
Don’t know
10
27.8
No response
1
-
N/A
23
-
TOTAL
60
100.0


Table BH:            Further mesh found after told complete excision achieved

Number of respondents
%
Yes
7
36.8
No
5
26.3
Don’t know
7
36.8
No response
2
-
N/A
39
-
TOTAL
60
100.0

Table BI:                              New auto immune diagnosis

Number of respondents
%
Yes
10
16.9
No
15
25.4
Don’t know
34
57.6
N/A
1
-
TOTAL
60