Permanent birth control: A french exception?
Transcription
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