FEMALE UROLOGY
Postoperative Outcomes Following Tension-Free Vaginal Mesh Surgery for Pelvic Organ Prolapse:
A Retrospective Study
Aki Oride*, Haruhiko Kanasaki, Tomomi Hara, Satoru Kyo
Purpose: We retrospectively reviewed the postoperative outcomes of patients who underwent tension-free vaginal
mesh (TVM) surgery in our institution.
Methods: In total, 195 TVM surgeries were performed at the Shimane University School of Medicine from Janu-
ary 2010 to May 2016 in patients with Pelvic Organ Prolapse–Quantification (POP-Q) stage II or higher. Perioper-
ative complications and problems arising following surgery were assessed from medical charts.
Results: Among the 195 patients, only 1 patient required blood transfusion due to massive intraoperative blood
loss. None of the patients experienced intraoperative complications, such as injury to the bladder or rectum during
surgery. Mesh exposure was observed in 10 patients (5.1%). Overall, 6 of these 10 patients were asymptomatic,
and surgical treatment was required in only 1 patient. Mesh exposure occurred at significantly higher frequencies
in patients aged less than 60 years. Postoperative recurrence of POP, which was defined as recurrence over POP-Q
stage 2, was noted in 13 of the 195 patients (6.6%). Re-operation was performed in 1 patient in whom recurrence
was observed within 3 months postoperatively. Recurrence of POP was likely to occur in patients with higher
POP-Q stages. Overall, 31 of the 195 patients (15.9%) required medication for postoperative stress urinary incon-
tinence (SUI) after surgery. Among these, 2 patients underwent surgical treatment for SUI.
Conclusion: Outcomes following the TVM procedure were satisfactory. However, caution should be exercised
against mesh exposure in younger patients and recurrence of POP in patients with advanced POP-Q stage.
Keywords: TVM; mesh surgery; pelvic organ prolapse; mesh exposure; stress urinary incontinence
INTRODUCTION
In the super-aging society of Japan, pelvic organ pro-
lapse (POP) is a major healthcare problem, and the
number of patients with this disorder has increased in
recent years. Although Japanese gynecologists have
traditionally performed vaginal hysterectomy (VH),
anterior and posterior colpoplasty, and circumferential
suturing of the levator ani muscles as curative surgery
for POP, a gold standard operation for POP is yet be
established worldwide. Thus, the surgical treatment of
POP continues to be a clinical challenge for gynecol-
ogists. After the development of tension-free vaginal
mesh (TVM) surgery for the repair of POP in France,
this new transvaginal technique has been adopted in
many countries(1). TVM surgery, which does not re-
quire hysterectomy, is associated with favorable cure
rates and a low frequency of complications(1), and many
gynecologists in Japan have now switched to using this
new technique as the first-line surgical option for POP.
The procedure of TVM surgery is simple and easy to
learn. However, there exist certain TVM surgery-spe-
cific peri- and postoperative complications, such as
mesh exposure, wound granulation, infection, dyspare-
unia, and stress urinary incontinence (SUI)(2,3). For ex-
ample, in a recent review, the overall mesh exposure
rate has been reported to be 10.3% (2), and the recurrence
Department of Obstetrics and Gynecology, Shimane University School of Medicine, Izumo, Japan.
*Correspondence: Department of Obstetrics and Gynecology, Shimane University School of Medicine89-1 Enya
Cho, Izumo City, Shimane 693-8501, Japan.
Tel.: +81-853-20-2268; Fax: +81-853-20-2264. Email: oride@med.shimane-u.ac.jp.
Received June 2018 & Accepted August 2019
rate following TVM operation has been reported to be
low but significant at 7.0% (1). Indeed, the US Food and
Drug Administration (FDA) expressed concerns about
the safety and effectiveness of TVM surgery in 2008
and 2011(4).
We have employed TVM surgery as the first-line sur-
gical treatment for POP in our institution since 2010.
To evaluate the postoperative outcomes and complica-
tions of this transvaginal surgery, we retrospectively
reviewed cases of POP treated with TVM surgery in
our institution.
MATERIALS AND METHODS
Between January 2010 and March 2016, 195 women
with POP underwent TVM surgery in Shimane Uni-
versity Hospital. Women with asymptomatic prolapse
designated Pelvic Organ Prolapse Quantification Sys-
tem (POP-Q) stage II (leading edge of the prolapse >
-1 cm) or higher were candidates for TVM surgery. Ex-
clusion criteria were premenopausal women, diabetes
mellitus, and very low activities of daily living. Patients
were provided preoperative counseling regarding uter-
ine preservation procedures, safety, efficacy, and poten-
tial complications. Moreover, we also provided expla-
nations about alternative measures such as the use of
pessary ring, native tissue repair, and sacrocolpopexy.
Urology Journal/Vol 16 No. 6/ November-December2019/ pp. 581-585. [DOI: 10.22037/uj.v0i0.4631]
Patients who had provided written informed consent
were scheduled for TVM surgery. Data were collected
retrospectively from the patients’ medical records, and
ethical approval for this study was obtained from the
Ethical Committee of Shimane University Hospital.
All procedures were performed by two experienced gy-
necologists in our hospital. The surgery was performed
under general or lumbar spinal anesthesia in the litho-
tomy position. The conventional TVM technique has
been described previously(5). We used monofilament
polypropylene mesh (Polyform™; Boston Scientific,
Natick, MA) cut into a shape similar to that used with
the Prolift system (Ethicon, Somerville, NJ) before each
operation, because mesh kits for TVM surgery are not
available in Japan. The anterior TVM (A-TVM) pro-
cedure starts with anterior colpotomy after local in-
filtration. Repair of a cystocele requires two arms of
transobturator mesh to be passed on both sides in order
to suspend the cystocele. On either side, both arms of
the mesh are passed into the paravesical region using a
modified Emmet needle. The anterior subvesical strap
is inserted into the tendinous arch of the pelvic fascia.
The posterior subvesical strap is inserted in the tendi-
nous arch 1 cm from the ischial spine using a gently
curved needle. In the posterior TVM (P-TVM) proce-
dure, posterior colpotomy is performed longitudinally
and the mesh is placed under the vaginal wall. On each
side, one strap of the mesh is passed into the pararectal
space through the sacrospinous ligament and exterior-
ized via incisions located outside and below the anus.
After cystoscopy and digital examination of the rectum,
the colpotomy is closed with a 2-0 PDS running suture
without additional colpectomy.
In our institution, patients with anterior vaginal wall
prolapse underwent A-TVM, patients with both ante-
rior and posterior vaginal wall prolapse underwent a
combined A-TVM and P-TVM (AP-TVM) procedure,
and patients without a uterus underwent total TVM
(T-TVM). For T‐TVM, we connected the A-TVM mesh
and P-TVM mesh, and created a one-piece mesh with
six arms. We then created a tunnel under the mucous
membranes of the vaginal stump through which the
mesh was passed and inserted in the anterior and pos-
terior walls.
Perioperative and postoperative complications, includ-
ing mesh extrusion, dyspareunia, SUI, and recurrence
of POP were evaluated according to patient age and
preoperative stage of POP-Q. Recurrence of POP was
defined as POP-Q stage II or higher after the initial op-
eration. Patients were discharged 3 days after surgery
and monitored for postoperative complications in the
outpatient clinic at 1, 3, 6, and 12 months and then an-
nually after the surgery.
POP recurrence and mesh exposure were diagnosed
based on gynecological examination. De novo SUI was
determined based on the presence of both the patient’s
complaints and a positive stress test.
Statistical analysis was performed to determine sig-
nificant differences between the groups using the Chi-
squared test and the Fisher exact test with P < 0.05 in-
dicating statistical significance. The data were finalized
in December 2016.
RESULTS
The characteristics of the 195 patients who underwent
TVM surgery between January 2010 and March 2016
are shown in Table 1. The mean follow-up duration
was 12 ±15 (range 3 to 60) months. Regarding TVM
surgery, the combined AP-TVM was the most com-
monly performed surgery in patients with POP, and this
was performed in 128 women. The number of A-TVM,
P-TVM, and T-TVM surgeries were 34, 29, and 4, re-
spectively. Stage III was the most commonly diagnosed
POP-Q stage (n = 135), followed by stage II (n = 32) and
stage IV (n = 28). Also, the age distribution is shown in
Table 2. About 77% of women who underwent TVM
surgery were aged between 61 and 80 years; 13 wom-
Postoperative Outcomes of TVM surgery-Oride et al.
Table 1. Baseline characteristics of the 195 patients.
Age (at the time of surgery) 69.0 ± 8.5
Surgery
A-TVM, n (%) 34 (17.4)
AP-TVM, n (%) 128 (65.6)
P-TVM, n (%) 29 (14.9)
T-TVM, n (%) 4 (2)
POP-Q stage
II, n (%) 32 (16.4)
III, n (%) 135 (69.2)
IV, n (%) 28 (14.4)
Abbreviations: TVM: anterior TVM, P-TVM: posterior TVM,
AP-TVM: anterior and posterior TVM, T-TVM: total TVM
41-60 y 61-70 y 71-80 y 81-90 y Total (%) Mean of age (± SD)
TVM-A 11 10 9 5 34 (17.4) 67.9 (± 10.8)
TVM-AP 17 59 44 7 128 (65.6) 68.7 (± 8.0)
TVM-P 3 6 19 1 29 (14.9) 71.4 (± 8.0)
T-TVM 1 1 2 0 4 (2) 68.3 (± 6.0)
32 76 74 13 195 69 (± 8.6)
Table 2. Age distribution of patients.
Figure 1. Shape of mesh and a intraoperative picture of T-TVM.
(a)A-TVM mesh, (b) P-TVM mesh, (c) T-TVM mesh, (d) Inser-
tion of T-TVM mesh into a tunnel of vaginal stump
Female Urology 582
Vol 16 No 06 November-December2019 583
en were aged over 81 years, and 32 women were aged
below 60 years. Only 2 of the 195 patients had vaginal
hysterectomy due to uterine fibroid. No other patients
had undergone previous vaginal surgery.
Among 195 cases, only 1 intraoperative complication
occurred, wherein over 1800 mL of intraoperative
bleeding required transfusion in a patient. There were
no cases of bladder injury, rectal injury, or injury to the
ureters.
During postoperative routine follow-up examina-
tions, we found mesh exposure in 10 of the 195 pa-
tients (5.1%). Furthermore, 6 of these 10 patients were
asymptomatic, and 4 patients complained of abnormal
vaginal bleeding during follow-up hospital visits. Mesh
exposure was identified at various intervals following
surgery, between 6 months and 2 years and among pa-
tients whose age ranged from 49 to 79 (average age,
73.8 ± 11.0) years. The age distribution of patients with
mesh exposure demonstrated that younger patients who
underwent TVM surgery were more likely to have mesh
exposure postoperatively. When patients were divided
into two groups by age ≤ 60 years and > 60 years, we
noted that the occurrence of mesh exposure was signifi-
cantly higher in those aged ≤ 60 years of age (P < 0.007)
(Table 3). Among the 10 patients with mesh exposure,
only 1 patient underwent additional surgical treatment,
which included removal of the exposed mesh and re-su-
turing of the vaginal wall to control abnormal bleeding.
Among the 195 patients who underwent TVM surgery,
13 patients were diagnosed with recurrent prolapse
(6.6%). Recurrence was diagnosed based on physical
indications, not patient’s complaints. The time points
at which recurrence of POP was diagnosed varied from
3 months to 3 years postoperatively, and the average
time was 13.6 ± 10.3 months after the initial TVM sur-
gery. POP-Q stages at the time of initial operation were
compared among the recurrent cases. Overall, 8 patients
with recurrence were initially diagnosed as POP-Q
stage III (8/135, 5.90%), while the remaining 5 patients
had POP-Q stage IV (5/24, 17.90%). The recurrence
rate of POP was thus significantly higher in patients
with POP-Q stage IV than those with POP-Q stage III
at initial diagnosis. There was no significant difference
between age groups and POP-Q stage. Among these 13
Table 3. Age and POP-Q stage distribution of 10 patients with
mesh exposure.
Age (years) mesh exposure P value
Yes n (%) No n (%)
41-50 1 (50) 1 (50)
51-60 4 (13.3) 26 (86.7)
61-70 1 (1.3) 75 (98.7) p = 0.0071
71-80 4 (5.4) 70 (94.6)
81-90 0 (0) 13 (100)
POP-Q stage
II 3 (9.4) 29 (90.6)
III 6 (4.4) 129 (95.6)
IV 1 (3.6) 27 (96.4)
The percentage is the proportion of patients of the same age or at
the same disease stage who developed mesh exposure following
TVM surgery. The Chi-squared test was performed to compare two
groups divided by age ≤ 60 years and > 60 years. The incidence of
mesh exposure was significantly higher in patients over 60 years.
The percentage of mesh exposure did not differ between POP-Q
stages.
Age (years) Recurrent POP P value
Yes n (%) No n (%)
41-50 0 (0) 2 (100) 0.06
51-60 1 (3.3) 29 (96.7)
61-70 7 (9.2) 69(90.8)
71-80 5 (6.8) 69 (93.2)
81-90 0 (0) 13 (100)
POP-Q stage 0.66
II 0 (0) 32 (100)
III 8 (5.9) 127 ((94.1)
IV 5 (17.9) 23 (82.1)
The percentage is the proportion of patients of the same age or at
the same disease stage whose POP recurred following TVM sur-
gery. The Fisher’s exact test was performed to make comparisons
within each group. The recurrence rate was not related to the pa-
tient’s age and POP-Q stage.
Table 4. Age and POP-Q stage distribution of 13 patients with
recurrent POP.
Patients with SUI after TVM
Yes n (%) No n (%)
31 (15.9) 164 (84.1%)
Age (years) P value
41-50 0 (0) 2 (100) 0.200
51-60 1 (3.3) 29 (96.7)
61-70 14 (18.4) 62 (81.6)
71-80 15 (20.3) 59 (79.7)
81-90 1 (7.7) 12 (92.3)
POP-Q stage
II 7 (21.9) 25 (78.1) 0.29
III 22 (16.3) 113 (83.7)
IV 2 (7.1) 26 (92.9)
Yes n (%) No n (%)
Consultation to urologists 7 (3.6) 188 (96.4)
TVT surgery 2 (1.0) 193 (99.0)
Abbreviations: SUI: stress urinary incontinence; TVT: tension-free vaginal tape
The percentage is the proportion of patients of the same age or at the same disease stage who developed SUI following TVM surgery.
The Chi-squared test was performed to make comparisons within each group. The occurrence of SUI was not related to the patient’s age
and POP-Q stage.
Table 5. Occurrence of SUI after TVM surgery.
Postoperative Outcomes of TVM surgery-Oride et al.
patients who presented with recurrent POP, only 1 pa-
tient underwent a second surgery at her request (Table
4).
Finally, we analyzed the occurrence of postoperative
SUI in the 195 patients who underwent TVM surgery;
15 of 31 patients who developed postoperative SUI had
preoperative SUI. During postoperative follow-up, 31
patients (15.9%) received medication for complaints of
onset or worsening of SUI; These included transient or
continuous medication. The majority of patients who
complained of SUI following TVM surgery recovered
or did not consider the problem serious enough to war-
rant further treatment. However, 7 of the 31 patients
(22.5%) consulted a urologist to request further exam-
ination and treatment. Of these, 2 patients underwent
tension-free vaginal tape surgery for SUI (Table 5).
Patients’ symptoms associated with de novo SUI im-
proved after surgery. No patients complained of postop-
erative recurrent urinary tract infection or deterioration
of sexual function including dyspareunia and vaginis-
mus. There was no evidence of wound granulation or
infection at the postoperative examination.
DISCUSSION
In this study, we reviewed the records of patients who
underwent TVM surgery for POP and analyzed the
postoperative outcomes. As previously reported, we
concurred that TVM surgery can be performed safely
and that it is associated with a relatively low rate of
complications(6). We have not encountered severe com-
plications during the TVM surgeries that we have per-
formed so far, except in 1 case where blood transfusion
was required following heavy bleeding. This was our
24th case after starting TVM surgery in our institution,
and the unexpected blood loss probably occurred due to
poor surgical technique when opening the paravesical
space by blunt dissection.
As expected, this study revealed that mesh exposure
was one of the major postoperative complications of
TVM surgery. Our mesh exposure rate was 5.1%. The
occurrence of mesh exposure has varied significantly
among different studies. In 2007, Falagas et al. reported
that the incidence of mesh exposure ranged from 0%
to 33% (7). In 2016, Niu et al. reported a series of 195
patients in which the incidence of mesh exposure was
16.4% (8); they assumed that the number of concomitant
procedures and the operation times were risk factors for
mesh exposure. Indeed, a report by Heinonen et al. in
2016 demonstrated a mesh exposure rate of 23% and
noted that the complications in the first half and second
half of patients sampled revealed a reduction in mesh
exposure from 14% to 5%. Luo et al. reported that the
mesh exposure rate will be close to zero if TVM surgery
is performed using the anatomical implant technique (9).
We did not evaluate the cases of mesh exposure in de-
tail because our study had only 10 such cases; howev-
er, mesh exposure was more likely to occur in patients
younger than 60 years of age. Sexual activity may also
be a risk factor for mesh exposure as previously sug-
gested(10,11). However, several studies have shown no
significant difference in patient age between mesh ex-
posure and non-exposure groups(8,12). Considering that
more than half of the patients with mesh exposure were
asymptomatic and only 1 patient (0.5%) required reop-
eration due to repeated abnormal bleeding, which im-
plied that most cases with mesh exposure and abnormal
bleeding were easily cured by medical intervention with
local vaginal estrogen tablets), TVM surgery should not
be excluded based on patient age. Nevertheless, since
mesh exposure was noted as late as 2 years postoper-
atively, longer follow-up durations may increase the
incidence rate of mesh exposure in the future.
Recurrence of POP after TVM surgery occurred in 13
patients (13/195, 6.6%) in our evaluation. Of the 13 pa-
tients, only 1 patient underwent reoperation, while the
remaining 12 patients either did not notice POP recur-
rence or did not find it inconvenient. In 2008, Caquant
et al. reported a recurrence rate at 6-18 months of 6.9%
after TVM surgery(13). Sho et al. retrospectively re-
viewed 526 TVM operations in 2014 and indicated a
recurrence rate of 7.0%(14). Similar to our results, these
reports also described low rates of reoperation among
cases of recurrent POP. Since the recurrence rate of
POP was higher in patients with advanced stages of
preoperative POP, such patients should be followed up
carefully.
Although children might also develop SUI , SUI and
POP are common diseases in postmenopausal women.
Some reports state that SUI is observed in approximate-
ly 40% of women aged 51 or over. Changes in certain
neuropeptides such as vasoactive intestinal peptide and
neuropeptide Y, and neuronal nitric oxide in the vagi-
nal wall have been observed in SUI and POP patients
. Postoperative SUI is a well-known complication of
TVM surgery. We have previously reported that 47.3%
of patients without preoperative SUI experienced de
novo postoperative SUI after TVM surgery(3). In the
present study, not all women who complained of post-
operative SUI wished to receive medication, because
their SUI symptoms were not severe. Treatment was
prescribed to 31 of 195 patients for SUI using clen-
buterol hydrochloride and/or propiverine hydrochloride
after TVM surgery. In most patients, the symptoms re-
solved or subsided over time, and only 7 of 31 patients
were referred to the urologist for further expert exam-
ination and treatment. Ultimately, only 2 patients who
underwent TVM surgery underwent surgical treatment
for SUI by the urologist. SUI can result from resolution
of urethral obstruction by anatomical reconstruction.
Interestingly, TVM surgery can improve SUI in some
cases(3). Thus, even when postoperative SUI occurred,
most cases were transient. However, a small number of
serious cases may require surgery.
Limitations of our study are its retrospective and sin-
gle-center design. Additionally, although the study du-
ration was 3 years at the longest, the follow-up period
for some patients was too short for any complications to
have been observed.
Overall, we were satisfied with the outcomes of TVM
surgery performed in our institution in the past 6 years.
However, the US FDA has described increasing con-
cerns regarding complications after TVM surgery(15).
Furthermore, two recent studies from Scotland and the
UK took a stand against mesh surgery for POP because
their investigations revealed that vaginal repair with
mesh material did not improve outcomes for women
(16,17). Therefore, this surgical technique needs further
consideration, and patients undergoing TVM surgery
should be followed up carefully.
CONFLICT OF INTEREST
The authors declare that they have no conflicts of inter-
Postoperative Outcomes of TVM surgery-Oride et al.
Female Urology 584
Vol 16 No 06 November-December2019 585
est. No funding was received for this study.
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