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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.