Dr Helen Pymar MD, MPH

Associate Professor, Department of Medicine,

University of Manitoba
April 16, 2015
Speaker Disclosure

 Have given talks for Bayer around Mirena, IUDs

 Have been a principal investigator for the University of
Manitoba site for IUS study sponsored by Bayer
 I use and promote a lot of IUD/IUS in my patients
 As a fellow in 1999-2001 I was involved in study of Caya
Diaphragm
Overview
 Copper IUD available in Canada
 Size, copper amounts, cost,
coverage
 Jaydess IUS
 Emergency contraception IUD now
that weight is an issue with Plan B
 Caya Diaphragm
Copper-releasing IUCD
 CuT380A (“Paragard”)
 FlexiT380+, Liberté TT380 (Standard &
“Short”), Mona Lisa 10
 CuT380 (no cuffs on T arms)
 Liberté UT 380 (Standard & “Short”),
Mona Lisa 5
 Copper devices with less than 380 mm2
Cu
 Flexi T 300, Flexi T 300+, Mona Lisa N
 Nova T 200
Paragard-
Size- 32 mm
horizontally
by 36 mm
vertically
176 mg copper
wire stem,
68.7 mg
copper collar
on each side
 Dimensions of IUCs Available in
Canada
Company, style Length(mm) Width(mm)
Bayer, Nova T-200 32 32
Prosan,
(mm) Flexi-T 300 28 23
Flexi-T 300+ 32 28
Flexi-T 380+ (cuffs on T arm) 32 28
7-Med Industrie, Liberte UT380 Standard 35.4 32
Liberte UT 380 Short 28.4 32
Liberte TT 380 Standard (cuffs) 34 29.9
Liberte TT 380 Short (cuffs) 29.5 23.2
Mona Lisa NV, Mona Lisa 10 (CuT380A,cuffs) 35.85 31.85
Mona Lisa 5 (NT 380, no cuffs NovaT) 31.9 31.8

Mona Lisa N (Flexi T 300) 29 23

References: (all resources accessed 2012 Oct 28, updated Mar 2014)
1. Mirena Product Monograph July 2013 http://www.bayer.ca/files/MIRENA-PM-ENG-15JUL2013-164011.pdf?#
2. Nova T info at manufacturer site http://www.bayer.ca/files/ENG-NOVT%20DEV%201%20PI%2081527628%20130214%20(2).pdf?#
3. Flexi-T Package Insert http://www.trimedic-inc.com/pdf/InsertionInstruction.pdf
4. Liberte info at distributor web site: http://medisafecanada.com/medi_products/liberte-brand-iuds/
5. Mona Lisa info at distributor web site: http://pacepharma.ca/en/physician-prescribing-information-10.html
 380 mm2 300 mm2 200 mm2

Copper - square
“Long” “Short”mm of surface area
Width
28 to 32 mm 23 to 28 mm 23 to 28 mm 32 mm

FlexiT380+
(28 x 32)
Size

T380A Liberte TT380 Liberte TT380

(Cuffs) (30 x 34) Short
(23 x 30)

Mona Lisa 10
(32 x 36)

Flexi-T300
Mona Lisa 5 (23 x 28)
380/300/200 (32x32)
(No Cuffs) Nova T
Mona Lisa N (32X 32)
(23 x 29)
Liberte UT380 Liberte UT380
(32 x 35) Short Flexi-T300+
(32 x 28) (28 x 32)
Websites for the Recommended
Copper IUDs
 http://medisafecanada.com/products/liberte-
iuds/ For Liberté UT and TT 380
 http://www.pacepharma.ca/en/mona-lisa-
iuds.html
For Mona Lisa 10, and N
 http://www.trimedic-inc.com/about_flexi-
t_iud.html For Flexi T 380, 300
Uterine size important?
Ultrasound study of width normal uterus
(n=210, 91 G0)

 Nulliparous women avg 27 mm

 Multiparous women avg 32 mm
 No relationship to cesarean section or
patient age

Benacerraf et al, Obstet Gynecol 2010;116:305-310

3D imaging
ultrasound
width
Uterine size important?- Part 2
Width Ut Embedded(n=29) Nonembedded(n=132)
(width±SD ) 25 ± 8 mm 32 ± 10 mm

In USA where all IUDs (Paragard and Mirena) are 32 mm

4 patients with embedded IUD had a uterine width of

over 32 mm
No information about parity, gravidity in this study

Shipp et al J Ultrasound Med 2010;29:1453-1456

Size of uterus and malposition
Show Me The Money!
 Nova T- most expensive $177 5 yr
 Flexi T 380 $87 10-12 yr
 Flexi T 300 $80 5 yr
 Mona Lisa 10 $75 10-12 yr
 Liberte TT 380- short and standard $74 10-12 yr
 Liberte UT 380– short and standard $74 5 yr
 Mona Lisa 5 $59 5 yr
 Mona Lisa N $59 5 yr
Covered by Social
Covered by NIHB Assistance
1 every yr
Costs Provided by Grand Medicine Pharmacy email April 9, 2015

Pymar Picks for Out of Pocket Patients

How Long Can You Leave Your
Copper IUD/IUS In the Uterus?
 Recommendations based on device type and age at
insertion.
 Paragard like- inserted age 35 or older good to
menopause, and 25 or older good for 12 years
 Mirena IUS inserted age 25 or older good for 7
years (some prefer 35 or older)

Wu et al. Contraception 2014;89:495-503

What is the Best Choice?
 Copper- 380 “Paragard- like” best

 Size- based on nulliparity, cesarean

only, or previous vaginal delivery,
acutely retro/anteverted uterus?

 Need to consider cost/coverage by

health plan if applicable
 The smallest LNG-IUS
available
 Contraception up to 3
years
 Silver ring
– Allows it to be
distinguished on
ultrasound from other
uterine devices
Jaydess®
 Highly effective
– Pearl Index (0.33)
– Typical use = Perfect use
IUS, intrauterine system Jaydess® Product Monograph, November 21, 2014
LNG-IUS, levonorgestrel-releasing intrauterine system Gemzell-Danielsson et al. Fertil Steril 2012; 97: 616-622
Jaydess®
with
EvoInserter®

• Few preparatory steps with EvoInserter®:

o Simplified loading by pushing the slider forwards to its furthest
position
o IUS pre-loaded in the correct horizontal orientation in the
package
o Threads inside handle - handling of threads no longer necessary
o Ergonomic design of handle and slider
o Double-sided centimeter scale
o Not reloadable once IUS fully released
IUS, intrauterine system Jaydess® Product Monograph, November 21, 2014
 Jaydess®1 Mirena®2
T-frame dimensions
28 × 30 mm 32 × 32 mm
(horizontal x vertical)
Insertion tube diameter
3.80 mm 4.40 mm

Initial in vivo LNG release rate* 14 μg/day 20 μg/day

(24 days after insertion)
Maximum duration of use 3 years 5 years
Total LNG content 13.5 mg 52 mg
Silver ring for differentiation Yes No
on ultrasound
Inserter EvoInserter® EvoInserter®

*Jaydess® is also known as LNG-IUS 13.5 mg (total content) or LNG-IUS12, which comes from the initial
predicted in vitro release rate while Jaydess® was in development. Release rates between Jaydess and Mirena
should not be directly compared because they were measured at different time points and using different
calculations.
LNG-IUS, levonorgestrel-releasing intrauterine system 1. Jaydess® Product Monograph, November 21, 2014
2. Mirena® Product Monograph, October 9, 2014
Emergency Contraception and
Weight
 Emergency contraceptive pills to carry warnings for reduced
effectiveness in women over a certain body weight
 Report a Concern
 Starting date: March 26, 2014 Posting date: March 26, 2014 Type of
communication: Information Update Subcategory: Drugs Source of recall:
Health Canada Issue: Important Safety Information Audience: General Public
Identification number: RA-38701
 Issue
 Emergency contraceptive pills, also known as the “morning after” pill, will soon
carry new warnings about reduced effectiveness in women weighing over 165
pounds.
 Health Canada has asked companies to add new warnings to product packages
advising that these pills are less effective in women weighing 165 to 176
pounds (75-80 kg), and are not effective in women over 176 pounds (80
kg). Women who weigh 165 pounds or more are advised to ask a health
professional, such as a doctor or pharmacist, for advice on alternative methods
of emergency contraception.
SOGC Recommendations
 Should not discourage pts over BMI 30 from using Plan
B if they don’t want IUD
 Recent publications from WHO have recommended
insertion of copper IUD most effective if done within 5
days of unprotected sex
 (Can still go to 7 days)
 Future- consider 30 mg Ulipristal Acetate- approx $80

http://sogc.org/wp-content/uploads/2013/01/gui280CPG1209ErevB.pdf
NEW Program Copper IUDs for EC
 Working with the Pharmacists
 Newsletter
 Linking them up with the website at Womens Health
Clinic http://womenshealthclinic.org/
 Will have OPD and CPU listed on the sites
(eventually) for patients to self refer within 7 days
 Providers available Monday, Wednesday in CPU 204-
787-1961, and Friday in OPD 204-787-1781 to self-refer
Caya Diaphragm
 Fits most women
 No fitting required
 No prescription required
 Made of silicone/nylon
 Use with Caya diaphragm
gel- Containing Water,
Lactic acid, Sodium
lactate, Cellulose, Sorbic
acid
 View the Caya Video at:
http://www.caya.eu/en/
Overview
 Copper IUD available in Canada
 Size, copper amounts, cost,
coverage
 Jaydess IUS
 Emergency contraception IUD now
that weight is an issue with Plan B
 Caya Diaphragm
Giving Thanks!
 Wendy V. Norman- Many Slides on Copper IUDs
MD, CCFP, FCFP, DTM&H, MHSc
 CIHR- Chair, Family Planning Public Health Research, Dept
of Family Practice, UBC
 Bayer- Jaydess slides
 Trimedic for Caya info- Paula Gelbfarb
([email protected])
 [email protected]