Permanent birth control: A french exception?

Permanent birth control:
A french exception?
Dr. Pierre Panel,
Service de Gynécologie-Obstétrique,
Centre Hospitalier de Versailles
Present contraception related to age
Contraception's choice: women's opinion, satisfaction and
profile. Results of a French national survey of a representative
sample of 5963 women.
Gynecol Obstet Fertil. 2014 Jun;42(6):415-21
Pill
Condom
Natural methods
Emergency pill
IUD
New generation contraception
Female sterilization
83%
72%
70%
55%
48%
31%
42%
35%
24%
10%
3%
2%
6%
8%
11%
5%
2%
9%
7%
3%
9%
3%
5%
9%
5%
2%
3%
Women from 15 Women from 18 Women from 25 Women from 30 Women from 35 Women from 40
to 17 years
to 24 years
to 29 years
to 34 years
to 39 years
to 45 years
(165*)
(1166)
(547)
(843)
(936)
(826)
Global satisfaction of present
contraceptive method
Average mark / 10
All
(4497)
8,4
Female
sterilization
féminine
9,7
IUD
(874)
8,9
ST Pill
(2728)
8,5
Implant
(Implanon,
Norplan)
Male condom
(362)
Natural methods
(88)
8,3
7,3
7,1
Base : Ens de femmes âgées de 15 à 45 ans et utilisatrices d’un moyen de contraception
Enquête TNS Sofres : P. Panel et col
*: base faible
Female sterilization: background and
ethics
!  Until 1999: Article 16-3 of the French Civil Code:
“The integrity of the human body shall not be violated except if
there is therapeutic necessity for the person.”
!  14 Nov 1975: Council of Europe’s resolution signed by
France
Surgical sterilization is admitted as medical service
!  Article 16-3 of the French Civil Code modified by article
70 of the Law 99-641:
“The integrity of the human body shall not be violated except if
there is medical necessity for the person.”
Voluntary sterilization: Legal aspects
!  Law n° 2001-588 of 4 July 2001:
o  «Art. L. 2123-1. (…) It may only be carried out if the interested
adult has expressed a free, motivated and deliberate intention
after considering clear and thorough information on its
consequences. (…) »
o  « (…) written informed consent (…) »
o  « (…) 4-month reflection period (…) »
o  « (…) written confirmation (…) »
Informed decision
French Law of 4 march 2002:
! 
o 
“In the light of information and advice provided by healthcare professionals
and in consultation with them, patients are entitled to make the decisions
concerning their health.”
Obligation of means
! 
o 
“The healthcare professional must provide all necessary means, considering
the available scientific data”
Obligation of information
! 
o 
Article 35 (article R.4127-35 of the French Public Health Code)
"The doctor owes the person he or she examines, treats or advises a loyal,
clear and relevant information concerning the patient’s condition, the
investigations and the treatments offered.”
7
HAS: 31 October 2007
!  ESSURE : “Adult women of childbearing age wishing a
permanent tubal sterilization as definitive and
irreversible contraceptive method.”
!  “ESSURE has a role in the prevention of unwanted
pregnancies which is of public interest.
!  “For women around or over 40 years old, ESSURE can
be offered as sterilization technique as first-line
treatment.”
Female sterilization in France
50000
45000
40000
35000
ligature coelioscopiques
30000
ligature par laparotomie
dont césariennes
25000
essure total
20000
essure sans anesthesie
total
15000
10000
5000
0
2007
2008
2009
2010
2011
2012
2013
Source: ATIH
SUCCES II
! 
! 
! 
! 
! 
! 
! 
! 
! 
Observational study
Prospective
National
Multi-centre
o (13 centres/14 investigators)
Phase 4
Beginning of study: 1st September 2008
End of inclusions: May 2011
Forecast end of study: 1st June 2016
Sample: over 2 500 patients
Permanent contraception in France and in Europe
SUCCESS II: Age
%%
14
12
10
Medianage = 41 years
Averageage = 41,1 years
Standard deviationage = 3,6
years
8
6
4
2
0
23 24 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
n=2573
Age
La contraception définitive en France et en Europe
SUCCESS II: Parity
n=2572
1 missing data
Averagefchildren = 2,46
Medianchildren = 2
Standard deviationchildren = 1,14
Permanent contraception in France and in Europe
SUCCESS II: Previous contraception
Before
28,69
%%
30
20
10
0,42
1,08
1,31
2,82
6,36
8,33
9,02
11,45
13,81
16,7
0
n=2593
After
%% 40
33,16
30
18,94
20
10
n=1695
0
0,35
0,88
1,42
2,48
4,96
9,32
3,95
9,73
14,81
Essure procédure : anesthesia
and technique
anesthesia
Oui
19%
sédation
17%
rachi/péridurale
7%
locale
2%
Non
81%
hypnose
25%
N=2565
NR=2
N=492
Technique
N=2561
NR=6
Spéculum
638
Pozzi
114
Bettocchi
1912
AG
49%
SUCCESS II: 3 months control
!  Included patients = 2575
o  procedure withdrawal after unilateral failure = 166
o  bilateral failures = 40
2369 patients scheduled for 3
months control
!  Controls done = 90.7 % (2149/2369)
!  Lost of follow-up despite multiple reminders 9.3% (220/2369)
SUCCESS II: Subjective effective
sterilization
!  Positive control tests = 97.7% (2099/2149)
Bilateral
procedure
Unilateral
procedure
Simple
Difficult
procedures
procedures
98.7%
93.5%
(1764/1787)
(259/277)
93.5% (43/46)
83% (5/6)
OR
OR=0.27;
IC=0.14-0.48;
p<0.0001
OR=0.24;
IC=0.07-0.82; p=0.02
16
5 years follow-up
Satisfaction of patients
Peu
satifaite
1%
Pas
satisfaite
2%
Satisfaite
13%
N=182
Très
satisfaite
84%
Complications, incidents et regrets
N
%
Migration
1
1%
Expulsion
0
0%
Grossesse*
0
0%
Infection**
2
1%
Regret
4
2%
Aucun
175
96%
Total
182
100%
•  1 patiente a eu un ménopause
•  5 patientes ont eu une hystérectomie
*Grossesses: 2 patientes ont déclaré une grossesse lors du suivi à un an, 1 à 2 ans
** Aucune infection de dispositif
Essure® permanent birth control
effectiveness: a seven-year survey
!  Questionnaire sent to the 1268 surgeon using ESSURE
!  Interventions between January 2003 and December
2009
!  Pregnancies between January 2003 and September
2010
!  Answers by e-mail, or mail.
!  53 003 interventions between 2003 and 2010
!  287 answers from 206 institutions, representing 63,4% of
the surgeons
!  Results combined with the pregnancies reported to the
laboratory
Eur J Obstet Gynecol Reprod Biol. 2013 Jun;168(2):134-7
Results: 58 pregnancies
!  One EUP
!  2 pregnancies happened before the 3-month control
(non luteal pregnancies): interval pregnancies
o  of which, one with HSG bilateral tubal obstruction
o  one with an intra-abdominal device
!  36 pregnancies reported /33 611 procedures
1,07/1000
!  58 pregnancies / nb of sold kits
= 1,09/1000
Tubal sterilization: pregnancy rates
after hysteroscopic versus laparoscopic
sterilization in France, 2006-2010
!  Assessment of the efficiency of sterilization techniques
based on PMSI data from 2006 to 2010
o  Efficiency assessed on the classic surgical technique by
laparoscopy and by Essure® tubal sterilization
o  Efficiency criterion: number of natural pregnancies post
sterilization
!  Characterization of regret ratios after tubal sterilization
based on PMSI data from 2006 to 2010
o 
o 
o 
o 
o 
Number of pregnancies carried through to full term
Number of medically assisted reproductions (MAR)
Number of repermeabilizations
Number of pregnancies post repermeabilizations
Number of successful pregnancies after MAR
Eur J Number Gynecol Reprod Biol. 2014 Sep;180:133-7
TIME LAPSE IT
GROSESSES
AGE REGRET
MAR
IDENTIFICATION
ETABLISSEMENT
AGE REGRET
RPT
Synthesis of regrets (MAR+RPT)
2006
ESSURE
Ligature tubaire
< 1 an
>1 an
TOTAL
< 1 an
>1 an
TOTAL
Ratio or MAR ESSURE :
0,8 ‰ versus 2,7‰ during the 4
years of observation
Ratio of MAR in 2009 :
0,11% versus 0,23%, whereas
ESSURE technique represents
49% of ligations
2007
1
2
3
17
71
88
2008
2
3
5
15
38
53
2009
0
4
4
12
30
42
Total
1
1
2
16
5
21
4
10
14
60
144
204
Courbes d'évolutions du nombre de regret auprès des patientes ayant eu
une IT entre 2006 et 2009
80
70
60
50
ESSURE <1 an
40
ESSURE >1 an
LT <1 an
30
LT >1 an
20
10
0
2006
2007
2008
2009