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TYPICAL REASO NS FO R REM OVAL O F CO PPER- AND HO RM O NE-RELEASING INTRAUTERINE DEVICES
ESC, Budapest, May 2018
Luis BahamondesProfessor of Gynaecology
Department of Obst & GynaecolUniversity of Campinas, Medical SchoolCampinas, SP, Brazil
PREMATURE DISCONTINUATION OF IUCs IS A BIG CONCERNS AMONG HCPs AND
USERS
REMOVALS COULD END IN AN UNNPLANNED PREGNANCY
• BLEEDING AND LOWER ABDOMINAL PAIN ARE THE MAINCAUSES OF EARLY DISCONTINUATION BOTH FOR CU-IUD ANDTHE LNG-IUS;
• ACNE AND BREAST TENDERNESS ARE RARE COMPLAINTS• OVARIAN “CYSTS” AMONG LNG-IUS ARE RARE AND MUST
ONLY DESERVED OBSERVATION;• WEIGH INCREASE IS A COMPLAINT AMONG LNG-IUS;
HOWEVER, IT IS A COMPLAINT ALSO AMONG CU-IUD USERSWHICH INDICATE THAT WEIGHT INCREASE OCCURS ONLY BYAGE INCREASE;
• PID AND UTERINE PERFORATION ARE RARE COMPLAINTS;
• COUNSELING IS THE MOST IMPORTANT ISSUE TO REDUCE EARLY REMOVALS OF IUCS.
BLEEDING AND PAIN ARE THE MAIN CAUSES OF EARLY DISCONTINUATION FOR
THE COPPER IUD AND THE LNG-IUS
REASON 12 m. 36 m. 60 m.
N O V A -
TL N G -IU D
N O V A -
T
L N G -
IU DN O V A -T
L N G -
IU D
P R E G N A N C Y 3 .0 0 .4 4 .7 0 .4 5 .5 0 .4
B le e d in g / p a in 3 .0 6 .1 1 1 .0 9 .0 1 7 .1 9 .8
A m e n o rrh o e a 0 .0 2 .5 0 .0 1 1 .6 0 .0 1 1 .6
52-mg LNG-IUS vs Cu-NOVA T IUD: CUMULATIVE RATES/100 WOMEN
Contraception. 1986 Feb;33(2):139-48
WHO STUDY. SELECTED CUMULATIVE DISCONTINUATION RATES (PER 100 WOMEN) BY DEVICE IN ALL CENTRES
Contraception. 2016 Jun; 93(6): 498–506.
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LOWER ABDOMINAL PAIN REPORTED (%) BY 100 WOMEN EUROPEAN STUDY. 52-mg LNG-IUS
Anderson et al., Contraception, 1994
3 months 60 months
LNG-IUS Nova T LNG-IUS Nova TLower abdominal pain 10.5 1.8 2.0 2.7
E v e n ts
5 2 -m g L N G -IU S T C u 3 8 0 A IU D
R a te a t 5 y e a rs R a te a t 5 y e a rs
A b d o m in a l p a in1 1 .4 8 .0
B le e d in g p ro b le m s5 .6 1 8 .0
U n k n o w n re a s o n s2 9 .8 3 9 .0
COMMON REASONS AND RATES OF DISCONTINUATION OF 52-mg LNG-IUS AND TCu380A IUD UP TO 5 YEARS.
Philips et al. Am J Obstet Gynecol. 2017; 217: 57.e1–57.e6.
COMMON CAUSES OF EARLY DISCONTINUATION FOR THE 52-mg LNG-
IUS
AMENORRHOEA, INFREQUENT BLEEDING, FREQUENT BLEEDING, PROLONGED BLEEDING AND IRREGULAR
BLEEDING RATES OVER 2 YEARS OF 52-mg LNG-IUS USE
Eur J Contracept Reprod Health Care. 2018
DISCONTINUATION FOR BLEEDING-RELATED COMPLAINTS OVER 3 YEARS FOR WOMEN USING A 52-MG LNG-IUS.
D is c o n t in u a t io n fo r
b le e d in g c o m p la in t
D is c o n t in u a t io n a s %
o f w o m e n e n te r in gt im e p e r io d
0 to 6 m o n th s 6 0 .4 %
7 to 1 2 m o n th s 1 1 0 .7 %
1 3 to 1 8 m o n th s 9 0 .6 %
1 9 to 2 4 m o n th s 4 0 .3 %
2 5 to 3 0 m o n th s 4 0 .3 %
3 1 to 3 6 m o n th s 1 0 .1 %
Eur J Contracept Reprod Health Care. 2018
Reason Rate per 100 women/years
Abnormal bleeding 2.8Pelvic infection 1.4Pain 1.3
Mood changes 1.3Pregnancy 0.2
CUMULATIVE RATES AND REASONS OF REMOVALS UP TO FIVE YEARS OF 52-mg LNG-IUS. FINLAND. N=23,885 WOMEN
Backman et al. EJCRHCare 2001;6:23-6.
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SELECTED STUDIES. GROSS RATES OF DISCONTINUATION UP TO 5 YEARS/100 WOMEN. 52-mg LNG-IUS
A U T H O R n P re g n a n c y E x p u ls io nB le e d in g /
p a in
A n d e rs s o n e t a l. (1 9 9 4 ) 4 1 8 2 1 0 .5 5 .8 1 3 .7
L u u k k a in e n e t a l. (1 9 8 6 ) 5 2 8 1 0 .8 2 .0 8 .3 a
S iv in e t a l. (1 9 9 0 ) 6 1 1 2 4 1 .1 1 1 .8 1 5 .4
C o x e t a l (2 0 0 2 ) 6 7 8 1 .0 5 .9 1 6 .7
The Journal of Family Planning and Reproductive Health Care 2002: 28(2): 73-77
R E A S O N S
Y E A R S O F U S E
1 -2 3 -5
P re g n a n c y 0 .1 0 .3
A m e n o rrh o e a 5 .5 3 .5
B le e d in g / p a in 5 .1 2 .4
In fe c t io n 0 .9 0 .5
52-mg LNG-IUS UP TO 5 YEARS. GROSS RATES OF DISCONTINUATION/100 WOMEN
Sivin et al, Contraception. 1991;44(5):473–480
ReasonMeses 61-84
N 776
Pregnancy 0
Bleeding/pain 0.2 (0.0–0.6)
Infection 3.2 (0.7–5.6)
Removal due to menopause 0.4 (0.1–0.7)
WHAT ABOUT EXTENDED USE? CUMULATIVE RATES/100 WOMEN POST 60 MONTHS OF USE,
52-mg LNG-IUS, CAMPINAS, BRAZIL.
Bahamondes et al. / Contraception 2018;97:205–9.
ACNE, LOWER ABDOMINAL PAIN AND BREAST TENDERNESS ARE RARE
COMPLAINTS
EVENTS REPORTED (%) BY 100 WOMEN EUROPEAN STUDY. 52-mg LNG-IUS
Anderson et al., Contraception, 1994
3 m o n t h s 6 0 m o n t h s
L N G - I U S N o v a T L N G - I U S N o v a T
L o w e r a b d o m in a l
p a in
1 0 . 5 1 . 8 2 . 0 2 . 7
H e a d a c h e 2 . 8 0 . 8 1 . 6 1 . 0
M o o d c h a n g e s 2 . 5 0 . 4 0 . 6 0 . 3
A c n e 3 . 5 0 . 4 1 . 8 0 . 3
B r e a s t t e n d e r n e s s 3 . 1 0 . 2 1 . 0 0 . 7
RELATED ADVERSE EVENTS WITH INCIDENCE ≥ 2% IN 52-mg LNG-IUS USERS OVER 3 YEARS [N (%)]
1 6 – 3 5 y e a rs o ld
(n = 1 6 0 0 )
3 6 – 4 5 y e a rs o ld
(n = 1 5 1 )
To ta l
(n = 1 7 5 1 )
A c n e 1 0 1 (6 .3 ) 4 (2 .7 ) 1 0 5 (6 .0 )
D y s p a re u n ia 4 8 (3 .0 ) 1 (0 .7 ) 4 9 (2 .8 )
B re a st te n d e rn e s s 3 0 (1 .9 ) 5 (3 .3 ) 3 5 (2 .0 )
Contraception. 2015 Jul;92(1):10-6.
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REMOVALS DUE TO WEIGH INCREASE IS UNCOMMON; HOWEVER, IT IS COMMON THE COMPLAINT BOTH AMONG Cu-IUD
AND LNG-IUS
Years
Kg
WEIGHT VARIATION THROUGH 10 YEARS OF USE. Copper-IUD vs LNG-IUS. BRAZIL
Modesto et al, 2015
5 6
5 7
5 8
5 9
6 0
6 1
6 2
6 3
B as e lin e 1 2 3 4 5 6 7
WEIGHT VARIATION THROUGH 7 YEARS OF USE. Copper-IUD. BRAZIL
Hassan et al, Contraception. 2003 Jul;68(1):27-30.
OVARIAN “CYSTS” AMONG LNG-IUS; NO INTERVENTION IS NEEDED
P re v a le n c e o f 1 9 % u p to
o n e y e a r o f u s e
P le a s e d o n ’t ta k e fu rth e r
a c t io n , th e y d is s a p e ra e ds p o n ta n e u s ly
PID AMONG Cu-IUD AND LNG-IUS
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LOW INCIDENCE OF PID WITH AUC
Inci
denc
ia d
e EP
I
2
0
3
4
5
S T U D Y, A U T H O R A N D Y E A R
Sufrin et al, 2012
1
Birgisson et al, 2015
Genzell-Danielsson et al, 2015
0.54%(n=57,728)
0.46%(n=4,371)
0.42%(n=2,884)
Incidence of PID (%)
Farley et al, 1992
0.36%(n=22,908)
Datos de Farley et al (1992)
0
2
4
6
1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58
C u -N O VA T
5 2 -m g L N G -IU S
60
Rat
e/10
0 w
omen
/yea
r
Months
CUMULATIVE RATE OF PID/100 WOMEN DURING USE OF Cu-IUD AND 52-mg LNG-IUS
Luukkainen et al, 1999
PERFORATION AMONG Cu-IUD AND LNG-IUS
INCIDENCE OF UTERINE PERFORATION/1000 INSERTIONS (95% IC) STRATIFIED BY IUC AND BREASTFEEDING
K. Heinemann et al. / Contraception 91 (2015) 274–279
WHAT ABOUT THE LOW DOSE NEW LNG-IUS AND FEMILIS?
E v e n ts
N u llip a ro u s w o m e n P a ro u s w o m e n
nR a te (S E ) 9 5 % C I
a t 5 y e a rsn
R a te (S E ) 9 5 % C I
a t 5 y e a rs
B le e d in g / p a in 7 6 .1 (2 .2 ) [2 .5 , 1 2 .6 ] 1 0 4 .3 (1 .3 ) [2 .1 , 7 .9 ]
W o m e n -m o n th s 7 6 0 4 1 9 6 6 5
CUMULATIVE DISCONTINUATION RATES/100 WOMEN/YEAR IN 356 PAROUS AND NULLIPAROUS.
FEMILIS 20-mg LNG-IUS USERS AT 5 YEARS.
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MOST FREQUENTLY REPORTED EVENTS (REPORTED BY ≥ 3% OF PARTICIPANTS). 13.5-MG LNG-IUS (JAYDESS)
EventsN= 304, n (%)
Pelvic pain 45 (14.8)
Dysmenorrhea 37 (12.2)
Acne 20 (6.6)
Ovarian cyst 13 (4.3)
Headache 4 (1.3)
Contraception. 2016 Jun;93(6):507-12
IN CONCLUSION• BLEEDING AND LOWER ABDOMINAL PAIN ARE THE MAIN
CAUSES OF EARLY DISCONTINUATION BOTH FOR Cu-IUD ANDTHE LNG-IUS;
• ACNE AND BREAST TENDERNESS ARE RARE COMPLAINTS• OVARIAN “CYSTS” AMONG LNG-IUS ARE RARE AND MUST
ONLY BE OBSERVED;• WEIGH INCREASE IS A COMPLAINT AMONG WOMEN;
HOWEVER, THE DATA INDICATES THAT WEIGHT INCREASEOCCURS ONLY BY AGE INCREASE;
• PID AND UTERINE PERFORATIONARE RARE COMPLAINTS;
• COUNSELING IS THE MOST IMPORTANT ISSUE TO REDUCE EARLY REMOVALS OF IUCS.