LNG-IUS: heavy
meNStrUaL
bLeedING
What IS NeW???
Dr. Sharda Jain
Dr. Jyoti Agarwal
Dr. Jyoti Bhaskar
1 Int J Women’s Health. 2011;3: 207–21; 2. J Midlife Health. 2013;4(1):8–15; 3. Open Access J
Contracep. 2013; 4:21–28; 4 ...
Options AvailableOptions Available
Mirena /
Endometrial Ablation
Drug therapyDrug therapy
Hysterectomy
LNG-IUS first designed in Finland – 1990
• From the concept of contraception, the
spectrum of indications broadened
• In s...
NatIoNaL eSSeNtIaL LISt
of medIcINe (NeLm) 2011
Out of 348 drugs Govt. of India has
included LNG-IUS as hormonal IUD
in NE...
• Progestin releasing
intrauterine system
• T shaped polyethylene
frame
• Contains 52 mg
levonorgestrel
• Releases 20 µg L...
Mirena :‘Local is logical’
local mode of action
• Prevents endometrial
proliferation
• Thickens cervical mucus
• Inhibits ...
usage
4
CHALLENGES
MOTIVATION
INSERTION
POST INSERTION
COST
Motivational Facts …….
• Over 60% of women diagnosed with
HMB ended up having a hysterectomy
within 5 years from the diagn...
MOTIVATION
Your words can
change their
world
MIRENA
Inspired by : Prof.Osama Showki
Magic Stick
International Guidelines recommend
LNG-IUS as first line Rx in HMB
Data on file
Recent guidelines place
more emphasis on
improvement of QoL of
the patient
Data on file
Efficacy of LNG - IUSEfficacy of LNG - IUS
“The results are in line with NICE
recommendations 2007, as they show
that wome...
Efficacy of LNG IUS in
Idiopathic Menorrhagia
97% Reduction in Menstrual Blood Loss
over 1 year of therapy
Significant increase in Hemoglobin and Serum Ferritin
level
Comparison of Rx Modalities
Progesterone or LNG IUS
LNG IUS reduces menstrual blood loss more
effectively and has a higher...
Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing
Intrauterine System in Primary Care against Standard Tr...
COCs= Combined OC pills; LNG-IUS – Levonorgestrel Intrauterine System; GnRH – Gonadotrophin Releasing
Hormone agonists
Fin...
Finnish trial
(multicentric RCT 236 pts)
• Mirena improves the quality of life as
effectively as surgical treatment at 1 y...
LNG IUS versus Hysterectomy
24
When patients were given the option of mirena
a significant percentage of women cancelled
t...
Objective: To evaluate the efficacy, acceptability,
and possible side effects of a
levonorgestrelreleasing
intrauterine sy...
• OBJECTIVE : To evaluate the efficacy of an
intrauterine system releasing levonorgestrel (LNG-IUS,
Mirena) in the treatme...
Bleeding pattern in the first 5-year period
Rönnerdag M, Odlind V. Acta Obstet Gynecol Scand 1999;78:716–21
Infrequent
3.7...
2nd
challenge
How to insert Mirena
properly???
It has been seen
that properly
placed Mirena
rarely gets
displaced
3rd
challenge
Practical tips for
post insertion
success
COUNSELLING
Is it not very costly as
compared to oral
medication?
Doctor, I am spotting
daily? What do I do?
I have not ha...
Counselling !!!
• Spotting after insertion
• Amenorrhea in 25 % of women
Irregular Bleeding or spotting
May last for 3 - 4 months
COC
Progesterone
GnRHa are used to tide over this period
Sevista
...
4th
challenge
COST EFFECTIVENESS
LNG IUS
• Cost- Rs 8205/-
• Insertion cost – Rs.
2000 - 5000
Covered by Insurance
ORAL
PROGESTERONE
1 m...
Emerging new
indications for use
of mirena
Endometriosis it provides long
term relief of chronic pelvic pain
Obstet gynecol 2012;119:519-526
FIBROIDS
Significant reduction in
both the uterine volume and
Endometrial Hyperplasia
• Beneficial effects are observed by1
year.
• Treatment should be reliably
monitored through regul...
Early-stage Endometrial Carcinoma
May have a role in selected patients
willing to preserve fertility
• Endometrial protect...
How long ?
NICE GUIDELINES : If inserted > 45 yrs of
age and has complete amenorrhea may
continue to use it until menopaus...
Are there any drugs that interact
with mirena ?
• Women using mirena
may be reassured that
• No drugs are known
to interac...
Health Benefits
No significant change in
• Blood pressure
• Lipid profile
• Coagulation factors
• Carbohydrate metabolism
...
Sonographic Evaluation
Routine use of ultrasound is not indicated
Our Experience
with
MIRENA in
Heavy Bleeding
Used in 300 cases
INCLUDING FIBROIDS AND ENDOMETRIOSIS
(July 2014)
Expulsion in 3
(UBT , hysterectomy , reinsertion )
• It...
Mirena
Positive Side
• Effective after 4 month
• Major Surgery is saved – Mortality
- Morbidity
Cost Effective
To conclude …..
HYSTERECTOMY
as Treatment
Should be last resort
LNG - IUS
Its not simply a
Pregnancy
Hormone.
But in true sense,a
Mother
Hormone.
ADDRESS
11 Gagan Vihar, Near Karkari
Morh Flyover, Delhi - 51
CONTACT US
9650588339, 011-22414049,
WEBSITE :
www.lifecarec...
LNG-IUS: heavy menstrual bleeding What is new??? Dr. Jyoti Agarwal / Dr. Sharda jain / Dr. Jyoti Bhaskar
LNG-IUS: heavy menstrual bleeding What is new??? Dr. Jyoti Agarwal / Dr. Sharda jain / Dr. Jyoti Bhaskar
LNG-IUS: heavy menstrual bleeding What is new??? Dr. Jyoti Agarwal / Dr. Sharda jain / Dr. Jyoti Bhaskar
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LNG-IUS: heavy menstrual bleeding What is new??? Dr. Jyoti Agarwal / Dr. Sharda jain / Dr. Jyoti Bhaskar

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  • Ghazizadeh S. A randomized clinical trial to compare levonorgestrel-releasing intrauterine system (Mirena) vs. transcervical endometrial resection for treatment of menorrhagia. Int J Women’s Health. 2011;3: 207–21
    Magon N, Chauhan M, Goel P, et al . Levonorgestrel intrauterine system: Current role in management of heavy menstrual bleeding. J Midlife Health. 2013;4(1):8–15.
    Bitzer J. Women’s attitudes towards heavy menstrual bleeding, and their impact on quality of life. Open Access J Contracep. 2013; 4:21–28
    National Collaborating Centre for Women’s and Children’s Health. Heavy Menstrual Bleeding Clinical Guideline. London: RCOG Press for NICE; 2007.
    Roy SN, Bhattacharya S. Benefits and risks of Pharmacological Agents used for treatment of menorrhagia. Drug Safety 2004; 27(2): 75-90
    In the past, over 60% of women diagnosed with HMB ended up having a hysterectomy within 5 years from the diagnosis, with 80% having an anatomically normal uterus removed
    National Collaborating Centre for Women’s and Children’s Health Clinical Guideline on Heavy Menstrual Bleeding. January 2007 available at : http://www.nice.org.uk/CG44 accessed 4 Dec 2008
  • Mirena
  • Data on file
  • 2007
  • 2005
  • challenge
  • LNG-IUS: heavy menstrual bleeding What is new??? Dr. Jyoti Agarwal / Dr. Sharda jain / Dr. Jyoti Bhaskar

    1. 1. LNG-IUS: heavy meNStrUaL bLeedING What IS NeW???
    2. 2. Dr. Sharda Jain Dr. Jyoti Agarwal Dr. Jyoti Bhaskar
    3. 3. 1 Int J Women’s Health. 2011;3: 207–21; 2. J Midlife Health. 2013;4(1):8–15; 3. Open Access J Contracep. 2013; 4:21–28; 4 NICE 2007; 5. Drug safety 2004 Major impact on a woman’s quality of life
    4. 4. Options AvailableOptions Available Mirena / Endometrial Ablation Drug therapyDrug therapy Hysterectomy
    5. 5. LNG-IUS first designed in Finland – 1990 • From the concept of contraception, the spectrum of indications broadened • In sept 2009 , the US FDA approved mirena as a treatment for heavy menstrual bleeding Obstet gynecol 2009;1104-1116
    6. 6. NatIoNaL eSSeNtIaL LISt of medIcINe (NeLm) 2011 Out of 348 drugs Govt. of India has included LNG-IUS as hormonal IUD in NELM 2011 Source: Union Health Ministry of India From Research to Practice – Long Way to Go
    7. 7. • Progestin releasing intrauterine system • T shaped polyethylene frame • Contains 52 mg levonorgestrel • Releases 20 µg LNG daily What is Mirena - LNG IUS
    8. 8. Mirena :‘Local is logical’ local mode of action • Prevents endometrial proliferation • Thickens cervical mucus • Inhibits sperm motility serum levels are 4 times lower than after oral ingestion
    9. 9. usage 4 CHALLENGES
    10. 10. MOTIVATION INSERTION POST INSERTION COST
    11. 11. Motivational Facts ……. • Over 60% of women diagnosed with HMB ended up having a hysterectomy within 5 years from the diagnosis • About 1/3 rd of hysterectomies for HMB result in removal of anatomically normal uterus
    12. 12. MOTIVATION Your words can change their world
    13. 13. MIRENA Inspired by : Prof.Osama Showki Magic Stick
    14. 14. International Guidelines recommend LNG-IUS as first line Rx in HMB Data on file
    15. 15. Recent guidelines place more emphasis on improvement of QoL of the patient
    16. 16. Data on file
    17. 17. Efficacy of LNG - IUSEfficacy of LNG - IUS “The results are in line with NICE recommendations 2007, as they show that women should be offered Mirena first to avoid more invasive treatment”
    18. 18. Efficacy of LNG IUS in Idiopathic Menorrhagia
    19. 19. 97% Reduction in Menstrual Blood Loss over 1 year of therapy Significant increase in Hemoglobin and Serum Ferritin level
    20. 20. Comparison of Rx Modalities Progesterone or LNG IUS LNG IUS reduces menstrual blood loss more effectively and has a higher likelihood of treatment success than oral medroxyprogesterone acetate. Obstet Gynecol. 2010
    21. 21. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial 21 Improvements in MMAS scores were significantly greater (lesser score= more severity) Gupta J, Kai J, Middleton L, Pattison H, Gray R, Daniels J for the ECLIPSE Trial Collaborative Group N Engl J Med 2013;368:128-37 Daily routine work, social and family life, and psychological and physical well-being Menorrhagia Multi-Attribute Scale (MMAS)
    22. 22. COCs= Combined OC pills; LNG-IUS – Levonorgestrel Intrauterine System; GnRH – Gonadotrophin Releasing Hormone agonists Finnish Survey:: Among 75 Obstericians/ gynaecologists working at the Helsinki University Central Hospital (2013) Pre congress course on heavy menstrual bleeding, 10‐ th Congress of European Society of Gynecologists, Brussels Belgium September 18-21 2013 In your opinion what is the most effective medical treatment for HMB?
    23. 23. Finnish trial (multicentric RCT 236 pts) • Mirena improves the quality of life as effectively as surgical treatment at 1 year. • Women ranked their satisfaction with a mean score of 7 / 10. • Less than 5% of women required subsequent operative treatment • Mirena is more cost effective than hysterectomy in the short term
    24. 24. LNG IUS versus Hysterectomy 24 When patients were given the option of mirena a significant percentage of women cancelled their hysterectomy Pekka Lähteenmäki et al. 1998 316: 1122 (6)
    25. 25. Objective: To evaluate the efficacy, acceptability, and possible side effects of a levonorgestrelreleasing intrauterine system for menorrhagia. Method : Sixty-three women with menorrhagia but without uterine enlargement, endometrial hyperplasia, or endometrial carcinoma were enrolled in this prospective, open, nonrandomized clinical trial and LNG-IUS was inserter in post menstrual period to these women Result : Menstrual pattern, number of bleeding days, and subjective and objective estimation of menstrual blood loss using a pictorial blood loss assessment chart (PBAC) were recorded before insertion and at specific intervals for 4 years. Conclusion: Using the LNG-IUS is an effective and well-accepted option overall for the medical management of menorrhagia. Mirena is an effective and well-accepted option for the medical management of menorrhagia in India : An AIIMS Study 2007
    26. 26. • OBJECTIVE : To evaluate the efficacy of an intrauterine system releasing levonorgestrel (LNG-IUS, Mirena) in the treatment of women with menorrhegia . • METHOD(S) : This was a prospective, non- comparative study. Twenty patients who had Menorrhagia due to non-malignant causes were included in the study (age range 20-42 years). However patients of fibroid uterus with uterine size more than 12 weeks and those with submucous fibroid were excluded. A LNG-releasing-intrauterine system was inserted on any day during bleeding or within a week of cessation of bleeding. Menstrual blood loss was assessed, before LNG-IUS was inserted, and after 3, 6, and 12 months of use. • RESULTS : The most common bleeding pattern at 3 months after insertion was spotting and after 6 and 12 months the majority of women presented with amenorrhea or oligomenorrhea. One woman requested removal of the LNG-IUS because of continuous spotting even after 4 months of insertion. The remaining women continued the use of LNG-IUS beyond 1 year. • CONCLUSION: LNG-IUS is an effective treatment for Menorrhagia due to benign causes and could be an alternative to hysterectomy. Mirena is an effective treatment for Menorrhagia and could be an alternative to hysterectomy: An Indian Study 2005
    27. 27. Bleeding pattern in the first 5-year period Rönnerdag M, Odlind V. Acta Obstet Gynecol Scand 1999;78:716–21 Infrequent 3.7% Regular 70.3% Ammenorhea 26%
    28. 28. 2nd challenge
    29. 29. How to insert Mirena properly??? It has been seen that properly placed Mirena rarely gets displaced
    30. 30. 3rd challenge Practical tips for post insertion success
    31. 31. COUNSELLING Is it not very costly as compared to oral medication? Doctor, I am spotting daily? What do I do? I have not had periods since 6 months? Am I in menopause?
    32. 32. Counselling !!! • Spotting after insertion • Amenorrhea in 25 % of women
    33. 33. Irregular Bleeding or spotting May last for 3 - 4 months COC Progesterone GnRHa are used to tide over this period Sevista Acceptance depends on good pre insertion counselling
    34. 34. 4th challenge
    35. 35. COST EFFECTIVENESS LNG IUS • Cost- Rs 8205/- • Insertion cost – Rs. 2000 - 5000 Covered by Insurance ORAL PROGESTERONE 1 mnth – Rs. 3000 6 months Rs. 18000 1 Yr Rs. 36000 No insurance
    36. 36. Emerging new indications for use of mirena
    37. 37. Endometriosis it provides long term relief of chronic pelvic pain Obstet gynecol 2012;119:519-526
    38. 38. FIBROIDS Significant reduction in both the uterine volume and
    39. 39. Endometrial Hyperplasia • Beneficial effects are observed by1 year. • Treatment should be reliably monitored through regular 6-montly outpatient follow up Eur J Obstet Gynecol Reprod Biol. 2008
    40. 40. Early-stage Endometrial Carcinoma May have a role in selected patients willing to preserve fertility • Endometrial protection for women on tamoxifen • Women With Clotting Disorders Or Under Anti Thrombotic Treatment Conservative treatment of early endometrial cancer: preliminary results of a pilot study. Gynecol Oncol. 2011; 120(1):43-6
    41. 41. How long ? NICE GUIDELINES : If inserted > 45 yrs of age and has complete amenorrhea may continue to use it until menopause. It can be removed at mid 50s as long as it controls the bleeding HRT Change it after 4 years “licenced” Contraception < 45years…..5 years > 45 years ….7 years
    42. 42. Are there any drugs that interact with mirena ? • Women using mirena may be reassured that • No drugs are known to interact with mirena • Can be used safely with ATT • No effect on BMD Not to be used as Emergency Contraceptive
    43. 43. Health Benefits No significant change in • Blood pressure • Lipid profile • Coagulation factors • Carbohydrate metabolism • Liver function • Bone mineral density
    44. 44. Sonographic Evaluation Routine use of ultrasound is not indicated
    45. 45. Our Experience with MIRENA in Heavy Bleeding
    46. 46. Used in 300 cases INCLUDING FIBROIDS AND ENDOMETRIOSIS (July 2014) Expulsion in 3 (UBT , hysterectomy , reinsertion ) • It can replace the need of hysterectomy in 50 % of cases. • Especially useful when future fertility is desired
    47. 47. Mirena Positive Side • Effective after 4 month • Major Surgery is saved – Mortality - Morbidity Cost Effective
    48. 48. To conclude …..
    49. 49. HYSTERECTOMY as Treatment Should be last resort
    50. 50. LNG - IUS Its not simply a Pregnancy Hormone. But in true sense,a Mother Hormone.
    51. 51. ADDRESS 11 Gagan Vihar, Near Karkari Morh Flyover, Delhi - 51 CONTACT US 9650588339, 011-22414049, WEBSITE : www.lifecarecentre.in www.drshardajain.com www.lifecareivf.com E-MAIL ID Sharda.lifecare@gmail.com Lifecarecentre21@gmail.com info@lifecareivf.com & Thank You

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