Mesh crisis in Japan

Urogynecology Center, First TowakaiHospital

Masami Takeyama
 Selamat siang !
saya Sammy
I came from Takatsuki city, Japan

Kyoto

Takatsuki

Osaka

Osaka
Our hospital and the members
of our urogynecology center
 Number of Operation /a year (2017)

operation No
TVM 385
POP LSC 158
NTR 17
MUS TVT 105
TOT 0
Hydrodistention 8
VVF 2
other OP 23
Total 697
 Today’s agendas
As a matter of fact, we experienced no serious crisis
regarding mesh in TVM.
However, we experienced major two crisis where
TVM could disappear if things turn out bad.

(1) Short history of self –cut TVM in Japan

(2) The 1st mesh crisis in 2012

(3) The 2nd mesh crisis in 2019

 Background
 Despite negative opinions worldwide, I believe that TVM
is safe and effective procedure for POP repair if we follow
the basic precautions as follows.
 (1) The mesh must be spread without wrinkles.

 (2) The mesh must be anchored in the correct position.

 ProliftTM TVM was born in France (TVM group)

J. Berrocal Rouen
H. Clavé Nice
M. Cosson Lille
P. Debodinance Dunkerque
O. Garbin Strasbourg
B.Jacquetin Clermont-Ferrand
C. Rosenthal Brive
R. Villet, D. Salet-Lizée Paris

Since June 2000

In ProliftTM, mesh supports the pelvic floor
by plane

Using PP mesh ,mesh replaces the visceral fascias 、lines the both vaginal walls,
bridging both ATFPs with 4 mesh arms in TVM-A and
mending the DeLanceys levelⅠ with 2 arms in TVM-P
Introduction of POP repair with mesh
in Japan

In2005, trans vaginal mesh (TVM) operation for

POP was introduced by Prof. Shimada and
Dr.Takeyama.

In June, 2005, I invited Dr.D.Robinson as a trainer

for TVM to the hospital where I was working at.
At that time, he taught me the basic techniques of
mesh surgery for POP.
My first TVM operation with Capio
in 2005

(Posterior lift)
 First attempt of Trans- obturator TVM
with Gynemesh PS (15x10cm)

Self-cut mesh with 4 arms is made from 15x10cm

mesh.
Special needles were made for the operation
First operation was performed in October,２００５.
 Osaka Central Hospital’s special
Prolift

My original Prolift type mesh

 Hands-on by Prof. M.Cosson
Ｌｉｌｌｅ（Ｆｒａｎｃｅ）Ｍａｙ ２００６

Completion of the procedure

GynemeshPS XL（２５x２５cm）became availiable in Feb. 2006

Hands-on training by Prof. Cosson in Lille university in May 2006
TVM with GynemeshPS XL(25x25cm)
 TVM has been uniquely developed in Japan

 TVM operation prevailed rapidly nationwide

 In order to prevent critical complications, we established
Japanese TVM association (Japanese society of POP Surgery
now) in 2007 in order to give lectures to the beginners.
 In couple of years, TVM procedures became more and more
popular.
 Fortunately, we had very few serious complications related to
mesh, supposedly because no TVM kit such as ProliftTM had
not been available and only proficient surgeons performed
TVM in Japan.
 At last, health insurance came to cover TVM in 2010.
 Fresh cadaver session
Repeated procedure verification
with fresh cadaver dissection

Sapporo medical university 2005-present

My paper on the TVM was accepted to publication
 The first mesh crisis

FDA’s hard alart in 2011had a seismic effect on TVM in Japan.

FDA Public Health Notification: Serious Complications

Associated with Transvaginal Placement of Surgical Mesh in
Repair of Pelvic Organ Prolapse and Stress Urinary
Incontinence For updated information about Surgical Mesh
for Pelvic Organ Prolapse, see: Update on Serious
Complications Associated with Transvaginal Placement of
Surgical Mesh for Pelvic Organ Prolapse, released July 13,2011.
 Aftermath of the FDA alert

After the alerts from FDA, most of the TVM devices

were withdrawn from the market.
Then we also faced a predicament in Japan..
ETHICON Co. was going to stop supplying
Gynemesh PSTM , only one mesh available in Japan.

Through much hard negotiation with the authority, we

came to be able to use PoliformTM20x15cm for the TVM
instead.
 Safety, efficacy and limitation of
TVM for POP
Two-years outcome of TVM
operation performed by a single
surgeon revealed the safety, efficasy
the limitation of TVM procedures
 Materials and methods
 Materials are consecutive 625 patients underwent TVM
by a single surgeon between from Nov.2009 to Dec.2012
 Procedures: highly accurate anchored Prolift-style TVM
using self-cut mesh

TVM-A TVM-P
TVM-C

TVM-EP TVM-UP
Number of the patients in each procedure

術式 症例数 年齢
TVM-A 261 67.1±7.3
TVM-P 47 67.3±9.7
TVM-AP 234 67.5±7.9
TVM-C 75 69.8±7.3
TVM-UP 1 84
TVM-EP 7 69.3±7.0
 Perioperative complications
TVM-A TVM- TVM-AP TVM-C TVM-UP TVM-EP
n=261 P n=234 n=75 n=1 n=7
n=47
Ope time(
(min.) 43.9±14.4 45.0±10.5 81.1±17.6 76.2±21.6 51 52.6±7.2

Blood loss
（ml） 19.4±32.8 20.4±11.8 39.2±38.7 36.4±38.1 19 20.7±12.4

complication hematoma 2 none hematoma １ none none none

Bladder injury 10 Bladder injury 8
（3.8%) (3.4%)
Vaginal wall injury Vaginal wall injury
2 2
Blood loss (>300) Blood loss (>300)
3 1

Incidence rate（30 cases）4.8％

 Mesh extrusion and recurrence and SUI
needed MUS within 24m after TVM
Mesh extrusion Recurrence in the Recurrence in the mid-urethral sling
same side opposite side afterward
TVM-A 2 5 48 TOT 4
(n=261) (0.8%) (1.9%) (18.4%) TVT 11
TVM-P 10
TVM-P 0 3 8 TVT 1
(n=47) (6.4%) (17.0%)
TVM-P 1 TVM-A 1
TVM-AP 1
TVM-AP 4 30 TOT 2
(n=234) (1.7%) (12.8%) TVT 14
Manchester 1 ー
TVM-P 1

TVM-C 1 5 TVT 7
(n=75) (1.3%) (6.7%) ー
TVM-UP 0 0 0 0
(n=1)
TVM-EP 0 0 0 0
(n=7)

Incidence rate of mesh extrusion 1.1％ ＊Definition of recurrence= POP-Q StageⅡ or more
total recurrence rate 16％
recurrence in the same side 6.9％
Recurrence rate of TVM-AP (preserve uterus) within
24m after surgery
-stratified analysis for C value before surgery-
Number of reccurence
C value Number of cases
（％）
（n=227）
(n=27)
C<-1 34 0
=0 9 0
1~2 23 0
2~3 36 3 (8.3%)
3~4 41 3 (7.3%)
4~5 30 6 (20%)
5~6 26 7 (26%)
6~7 12 3 (25%)
7~8 11 4 (36%)
8~9 2 0
9~10 2 1（50％）
 Interpretation and conclusion

TVM with self-cut mesh is safe and efficient

procedure for POP repair.

Uterus preserving TVM has limitation for high stage

uterine prolapse.
 What is the most important point to avoid
mesh extrusion or recurrence of POP

 Anchoring to the firm tissue to

expand mesh well without
wrinkle
 Anchoring points for anterior
TVM are (1)distal part of
anterior vaginal wall, (2)uterine
cervix, and (3)firm tissue around
both ischial spine or
sacrospinous ligament (SSL)
 Anchoring points for posterior
TVM are (1) distal part of
posterior vaginal wall. (2)uterine
cervix, and (3)both SSL
Less-accurate TVM triggers mesh contraction
and chronic pain

Cord-like structure : mesh

the patient complaint of worsening pubic chronic pain

contracted mesh
We came up with TVMA2 for the anterior
POP repair from the concept of LSC

The fact that LSC

repairs cystocele well
indicated that we can
omit the first arms
TVM A2 from the anterior mesh
of Prolift TVM.
Needle insertion point for TVM-A2

clit base
Anchoring points for TVMA2
(1)distal part of anterior vaginal wall(A point),
(2)uterine cervix (C point), and
(3)firm tissue around both ischial spine(B point)
 perioperative complications
TVM-A2 TVM-A
n=250 n=34

intraoperative bladder injury bladder injury

complications 3cases（1.2%） 1case（2.9%)

CIC due to
none 1 case （2.9%)
dysuria

supplemental TVT 11cases(4.4％） TVT 3 cases(8.8%)

operation TVM-P 1 case（0.4%） TVM-P 1 case(2.9%)
 Recurrence and late complications

Outcome of TVM-A2 n=62

objective success rate at 24M 95.2%

Mesh extrusion rate 0%

 The 2nd mesh crisis in Japan
 TVM has been banned in UK, Australia, Ireland,・・・・・.
 Japanese government started to doubt the efficacy and
safety of trans-vaginal mesh operation in 2018.
 TVM has been banned in US.

 Boston scientific co. decided not to supply polyformTM

which is used in many medical institutions in Japan.
 Fortunately, we have a Japanese-made
polytetrafluoroethylene(PTFE) mesh “ORIHIME”
available for POP repair.
 Through persistent negotiations with the government
agency, TVM using “ORIHIME” has been permitted as
one of the operative measures for POP.
PTFE mesh for POP repair
“ORIHIME”
 Material of “ORIHIME”

PTFE（poly-tetra-fluoro-ehylene)
polymer of tetrafluoroethylene
non-absorbable
chemically stable and inactive
heat-resistant, low friction coefficient.

As a medical material, it has been used in artificial blood vessels,

sutures, and so on. for a long time.
Magnified Image of ORIHIME
ORIHIME Polyform Gynemesh PS
Shape of “ORIHIME” self-cut for TVM-A2

3.5cm

many cuts are put

on both sides of arms
 Is TVM with ORIHIME feasible
for anterior POP repair?

Safety and efficacy of TVMA2 with ORIHIME

-Reference is TVMA2 with Polyform-
 Methods

Materials are 100 POP patients scheduled to undergo

TVM.
 Patients were randomly divided into two groups, one
is ORIHIME® group and the other is Polyform®
group, both composed of 50 patients.
Operative procedure was TVM-A2. The shape of the
mesh used is as follows and the anchoring points and
the needle insertion points have been shown.
 Summary of the patients
（ORIHIME n=50） median range

Age 73 59-85

Parity 2.2 1-5

BMI 24.7±2.84 18-31.3

（Polyform n=50） median range

Age 74 60-88

Parity 2.1 0-5

BMI 25.5 ±3.7 17.8-34.1

 TVM−A２ with ORIHIME

disection of anterior vaginal wall

mesh is stitched to the anterior vaginal wall

 TVM−A２ with ORIHIME

mesh is stitched to the anterior vaginal wall

TVM−A２ with ORIHIME

mesh is anchored appropriately and

introduced without too much tension
 Summary of the operation
ORIHIME Poluform
n=50 n=50

ope time（min.） 28.6±4.5 (22-45) 28,3±4.4 （21-42）

blood loss（gr.） 18.4.0±14.0 (5-80) 22.7±14.2 (5-100)

posterior vaginal
Surgical plasty 2 cervical adhesion
procedure added cervical polyp detachment 1
resection 1
 Perioperative Complications

ORIHIME Polyform
n=50 n=50

intra-operative
none none
complications

dysuria after OP 1
（needed CIC more none (needed CIC up to
than a week) 4weeks)
Objective success rates, mesh extrusion
and SUI needed operation afterwards
Objective success rate of ORIHIME® group and
Polyform® group were 94% and 98% at 3 month after
operation, 94% and 96% at 6 month after operation
and 91.7% and 95.7% at 12 month after operation.
There were no cases of mesh extrusion in either
groups up to 12 months.
The number of cases with stress incontinence
requiring surgery were 11 and 10 cases respectively
up to 12 month after TVM operation.
 There was no case of difficulty urinating for more
than one month.
 Conclusions

TVM-A2 using minimal ORIHIME® mesh is

effective and safe procedure for the reconstruction
of anterior vaginal prolapse.
 Current status of TVM in Japan

We can perform TVM with ORIHIME

We must register all the case of TVM

Data must be accumulated to investigate

the safety and efficasy of TVM with
ORIHIME
LSC and TVM using ORIHIME

LSC

TVM(UPHOLD)
 Terima kasie !
Thank you for your attension!