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HarrisMartin’s MDL Conference:                                   MIRENA IUD, Tylenol,Granuflo,                             ...
Gabriel F. Zambrano                       gabe@pathtojustice.comFriday, March 15, 13
www.MirenaLawsuits.com                       My Collection & Display of Photos from - WIRED: Contraceptive Comeback: The M...
Friday, March 15, 13
Friday, March 15, 13
www.AdverseEvents.comFriday, March 15, 13
Friday, March 15, 13
Have a different opinion? Concurring comments?                       E-mail a Letter to the Editor to toby.hindin@qhc.com....
Department of Health and Human Services                                                                      Public Health...
June 2011Friday, March 15, 13
Friday, March 15, 13
September 2012Friday, March 15, 13
October 2012Friday, March 15, 13
October 2012Friday, March 15, 13
Friday, March 15, 13
2013 - And Now We Have - SKYLAFriday, March 15, 13
Gabriel F. Zambrano                       gabe@pathtojustice.comFriday, March 15, 13
Gabriel F. Zambrano                       gabe@pathtojustice.comFriday, March 15, 13
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MIRENA LAWSUITS - The Future 2013

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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.

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MIRENA LAWSUITS - The Future 2013

  1. 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 LEGACYFriday, March 15, 13
  2. 2. Gabriel F. Zambrano gabe@pathtojustice.comFriday, March 15, 13
  3. 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 2011Friday, March 15, 13
  4. 4. Friday, March 15, 13
  5. 5. Friday, March 15, 13
  6. 6. www.AdverseEvents.comFriday, March 15, 13
  7. 7. Friday, March 15, 13
  8. 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 39Friday, March 15, 13
  9. 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: 3046415Friday, March 15, 13
  10. 10. June 2011Friday, March 15, 13
  11. 11. Friday, March 15, 13
  12. 12. September 2012Friday, March 15, 13
  13. 13. October 2012Friday, March 15, 13
  14. 14. October 2012Friday, March 15, 13
  15. 15. Friday, March 15, 13
  16. 16. 2013 - And Now We Have - SKYLAFriday, March 15, 13
  17. 17. Gabriel F. Zambrano gabe@pathtojustice.comFriday, March 15, 13
  18. 18. Gabriel F. Zambrano gabe@pathtojustice.comFriday, March 15, 13

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