MIRENA LAWSUITS are on the rise across the US in 2013. This is a result of over 45,000 adverse events being reported to the FDA from use of the hormone releasing IUD. This is a presentation I prepared to give in San Diego, California in March 2013 as part of a panel of faculty discussing the growing litigation.

1. HarrisMartin’s MDL Conference:
MIRENA IUD, Tylenol,Granuflo,
Byetta & Januvia
March 20, 2013 - San Diego, CA
The Westin San Diego
History of IUDs & Female Contraception - BAYER’S LEGACY
Friday, March 15, 13

2. Gabriel F. Zambrano
gabe@pathtojustice.com
Friday, March 15, 13

3. www.MirenaLawsuits.com
My Collection & Display of Photos from - WIRED: Contraceptive Comeback: The Maligned IUD
Gets a Second Chance by Jennifer Couzin-Frankel, July 15 2011
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4. Friday, March 15, 13

5. Friday, March 15, 13

6. www.AdverseEvents.com
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7. Friday, March 15, 13

8. Have a different opinion? Concurring comments?
E-mail a Letter to the Editor to toby.hindin@qhc.com. VIEWPOINT
A Professional Opinion Article
LNG-IUS: First-Line Therapy for
Idiopathic Heavy Menstrual Bleeding
Anita L. Nelson, MD
Treatment for heavy menstrual used as first-line therapy for women with
bleeding with the levonorgestrel heavy menstrual bleeding, it was cost-effec-
tive.6 The rate of hysterectomy has dropped
intrauterine system is effective in England since the introduction of the
and cost-efficient. The FDA LNG-IUS and endometrial ablation.7
The LNG-IUS has been approved by
approved this treatment in
health authorities in 111 countries for con- FOCUSPOINT
women who use an intrauterine traception and in 107 countries for the treat- Systematic
device for contraception. ment of menorrhagia/heavy menstrual literature reviews
bleeding. In addition, health authorities in have consistently
97 countries have approved the LNG-IUS as
demonstrated that
H
a source of progestin for women with intact
eavy menstrual bleeding (formerly uteri who use postmenopausal estrogen the LNG-IUS is the
called menorrhagia)1 is one of the therapy. most effective
most frequent reasons women seek Systematic literature reviews have consis- medical therapy
gynecologic care and is the justifica- tently demonstrated that the LNG-IUS is the
for idiopathic
tion for 10% to 30% of the hysterectomies most effective medical therapy for idio-
and virtually all of the 500,000 endometrial pathic heavy menstrual bleeding. It is supe- heavy menstrual
ablations performed each year in the United rior to NSAIDs, tranexamic acid, oral con- bleeding.
States. Chronic excessive blood loss invari- traceptives, and danazol.8,9
ably leads to anemia, which in turn can lead
to serious medical problems. More predict- EARLY LNG-IUS EXPERIENCES
ably, heavy menstrual bleeding diminishes In the clinical trials studying the efficacy of
a woman’s quality of life and her productiv- the LNG-IUS for contraception, blood loss
ity.2 Ten percent of reproductive-aged was reduced by 70% to 90% in the first 12
women suffer blood loss heavy enough to months of LNG-IUS use by women with
put them at risk for anemia.3 However, be- normal menses. In earlier studies of Finnish
cause of the significant impact heavy flow women with idiopathic menorrhagia, the
(even temporarily) can have on quality of LNG-IUS normalized menstrual blood loss
life, 30% of women consider their menstrua- for virtually all patients within 6 months.10
tion heavy.4 Among women with excessive menstrual
The levonorgestrel intrauterine system blood loss due to underlying coagulation
(LNG-IUS) was found in an early Cochrane defects, all women were effectively treated,
review to be as effective as endometrial ab- and 56% became completely amenorrheic
lation in reducing heavy menstrual bleed- within 3 months.11
ing after 12 months.5 The LNG-IUS has also The impact of these reductions in blood
been shown to reduce the need for hysterec- loss has been so impressive that an interna-
tomy by 58% among women with idiopathic tional special expert consensus panel re-
menorrhagia, demonstrating that when cently endorsed the use of the LNG-IUS as
first-line therapy for women with clotting
Anita L. Nelson, MD, is Professor, Department of disorders who are not seeking pregnancy.12
Obstetrics and Gynecology, Harbor–UCLA Medical The 2008 National Heart, Lung, and Blood
Center, Torrance, CA. Institute guidelines also listed the LNG-IUS
Follow The Female Patient on and The Female Patient | VOL 35 NOVEMBER 2010 39
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9. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Surveillance and Epidemiology
Drug Use Review
Date: November 17, 2011
Reviewer(s): Stephen H. Chang, PharmD
Drug Use Data Analyst
Division of Epidemiology II
Office of Surveillance and Epidemiology
Acting Team Leader: Grace Chai, PharmD.
Division of Epidemiology II
Office of Surveillance and Epidemiology
Deputy Director: Laura Governale, Pharm.D., MBA
Division of Epidemiology II
Office of Surveillance and Epidemiology
Drug Name(s): Mirena® (levonorgestrel) Pediatric Post Marketing Drug
Utilization Review
Application Type/Number: NDA 21-225
Applicant/sponsor: Bayer Healthcare
OSE RCM #: 2011-2688
**This document contains proprietary drug use data obtained by FDA under contract.
The drug use data/information cannot be released to the public/non-FDA personnel
without contractor approval obtained through the FDA/CDER Office of Surveillance and
Epidemiology.**
Reference ID: 3046415
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10. June 2011
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11. Friday, March 15, 13

12. September 2012
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13. October 2012
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14. October 2012
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15. Friday, March 15, 13

16. 2013 - And Now We Have - SKYLA
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17. Gabriel F. Zambrano
gabe@pathtojustice.com
Friday, March 15, 13

18. Gabriel F. Zambrano
gabe@pathtojustice.com
Friday, March 15, 13