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IUD's: Are Women At Risk

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IUD's, or Intrauterine Devices, have made a comeback as an alternative form of contraception. Their safety is not often emphasized. Rather, a tremendous focus is on their ease of use and claimed …

IUD's, or Intrauterine Devices, have made a comeback as an alternative form of contraception. Their safety is not often emphasized. Rather, a tremendous focus is on their ease of use and claimed 'lifestyle' benefits. This presentation explored this theme following an FDA investigation of "Black Market" IUD's raising issues and concerns in July 2010.

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  • 1. OB/GYN’s USING IUDs - WOMEN AT RISK DESPITE FDA WARNINGS & PRODUCT APPROVAL Friday, October 15, 2010
  • 2. Presented by Gabriel F. Zambrano www.RecallAttorneys.com www.IUDInjuries.com gabrielfzambrano@gmail.com Attorney At Law 707 S.E. Third Avenue Third Floor Fort Lauderdale, FL www.IUDAttorneys.comwww.IUDLawyers.com Friday, October 15, 2010
  • 3. MTMP - October 2010 Bellagio - Las Vegas Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 4. IUD, IUS & IUC - What is in a Name ? • INTRAUTERINE DEVICE • INTRAUTERINE SYSTEM • INTRAUTERINE CONTRACEPTION • “T’ SHAPED • PLACED INTO ENDOMETRIAL CAVITY BY TRAINED PROFESSIONALS • THE NAME IS “TABOO” BECAUSE OF THE “DALKON SHIELD” • SIMPLY A FORM OF BIRTH CONTROL Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 5. ACOG • American Congress of Obstetricians & Gynecologists - Estimates only 2% of American women use IUDs • However, IUD use is on the rise in the US and being aggressively promoted to all age groups • www.acog.org Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 6. Usage and cost are on the rise in the U.S. Follow up story to July 2010. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 7. “DALKON SHIELD” - Epic Legal Battle/Settlement • A.H. ROBINS (AHR) • CONTROVERSIAL AND LITIGATED IN 1974-1985 • ISSUES INCLUDED SPONTANEOUS SEPTIC ABORTION, SEVERE INFECTIONS RESULTING IN DEATHS, HIGH FAILURE RATE, A MULTIFILAMENT THAT PROMOTED BACTERIAL GROWTH • OTHER SYMPTOMS INCLUDED PERFORATION OF UTERUS, SEVERE CRAMPING, BLEEDING, ECTOPIC PREGNANCIES, PELVIC INFLAMMATORY DISEASE (PID), BIRTH DEFECTS IN CHILDREN CARRIED TO TERM • MANUFACTURERS TRIED TO ‘RE-BRAND’ AS IUS, IUC BUT IS THE SAME OLD IDEA - IUD • THE MONOFILAMENT OR ‘STRING’ IDEA CARRIED OVER INTO NEW GENERATION IUD Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 8. “DALKON SHIELD” • AROSE OUT SEARCH FOR ‘SIMPLE’ AND ‘SAFE’ ALTERNATIVE TO BIRTH CONTROL PILL • SETTLEMENT INVOLVED COMPLICATED TRUST, PAYMENT OPTIONS AND LONG TERM MANAGEMENT OF FUNDS • THE “DALKON SHIELD” EXPERIENCE PROVIDES A FACTUAL BACKDROP FOR PERCEPTION OF SIMILAR DEVICES MOVING FORWARD TO THE PRESENT DAY Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 9. IUD HISTORY & URBAN LEGEND • OB/GYN’S WILL TELL YOU THAT PRIMITIVE IUDS WERE ROCKS INSERTED INTO CAMELS TO PREVENT PREGNANCY DURING DESERT CROSSINGS • MONOFILAMENT OR FISHING LINE CONTINUE TO BE USED BY WOMEN IN UNDERDEVELOPED COUNTRIES AS IUDS TO PREVENT PREGNANCY • GENERALLY, IDEA IS DISRUPTION OF FIRM AND EGG MEETING Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 10. Read the MIRENA information again - emphasis on ‘may’ ParaGard Copper has impact on fertilization. Disruption of natural meeting of sperm and egg. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 11. Safe and effective if not contraindicated by health concerns or past medical history. Safety of IUD Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 12. Unique size and shape of woman’s uterus may preclude IUD as a birth control option. Unique profiles of Copper vs. Hormonal drive some safety considerations. Safety of IUD Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 13. Range from $500 - $1,000. Eliminates monthly cost and can last from 5-12 years. Yes, it says 12 years. MIRENA costs more than the ParaGard. Cost of IUD Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 14. What can we tell about the Women that use IUDs from how they are promoted to them ? Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 15. Gabriel F. Zambrano, Esquire IUDInjuries.com OB/GYN’s: Alternative to hormonal birth control Friday, October 15, 2010
  • 16. ParaGard Copper “T” PARAGARD IUD: Copper T380A Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 17. MIRENA Hormonal IUD Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 18. Know your audience. Who are they marketing too ? Look at these Women. Do you see girls or Women ? Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 19. MIRENA is made by Bayer HealthCareDid they target the same audience of Females? Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 20. Why sound the alarm ? IUDs are coming to an age group near you. • Having slowly eroded away at suspicion and taboo through IUS, IUC monikers they are now attempting to appeal to younger and younger women and girls • There is a push to use IUDs as ‘emergency contraception’ almost like a morning after pill from emerging literature and ACOG • There is a push to have insurers cover it • All under the umbrella of the idea that an IUD will simplify your life and one size fits all • Recent media attention negative but spun to positive highlight of benefits • Planned Parenthood type of organizations are practically giving them away Friday, October 15, 2010
  • 21. Two Types in US: MIRENA compared to ParaGard • Hormone releasing vs. Copper • “T” shaped design with variation • MIRENA new to market in Millenium in comparison to Paragard • MIRENA FDA approved for heavy menstrual bleeding (HMB) in October 2009 • ParaGard filled the “Dalkon Shield” void in marketplace earlier Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 22. Bayer HealthCare Multiple Types of Contraception. One Stop Shopping for Birth Control. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 23. YAZ & Yasmin are promoted as Lifestyle Internet,Social Media,SMS & TV 800 Pound Guerilla Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 24. Promotion of “Lifestyle” Choosing a way of Life. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 25. Small like a penny. Risk Free ? “No daily or weekly routines”. “Hassle-free”. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 26. No daily routine. Simplify Lifestyle. Life is too complicated for you. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 27. on ParaGard —the birth control that’s hormone-free and virtually hassle-free. You can also find out more about ParaGard® by: • Visiting www.paragard.com, or • Calling the ParaGard® Info Line at 1•877•ParaGard (727•2427) ImportantSafetyInformation ParaGard® doesnotprotectagainstHIV orSTDs. You may have heavier or longer periods or spotting between periods, which usually subsides after 2-3 months. Complications may occur from placement. You must not use ParaGard® if you have pelvic inflammatory disease (PID) or engage in behavior putting you at high risk for PID, have a history of certain reproductive cancers or infections, have Wilson's disease, or might be pregnant. Please see product information at www.paragard.com. Like millions of other women, you’ve chosen the birth control that’s hormone-free and virtually hassle-free. See inside for information on getting started… Welcometo ParaGard® ParaGard Copper • Promoted by World Health Organization • Planned Parenthood & Family Planning • Promoted as safe, effective and long term solution for birth control • Utilized up to 10 years with push for 10+ years • Recent push for 12 years • MERCK tied to 2010 study Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 28. vertical directions. The polyethylene of the T-body is compounded with barium sulfat which makes it radiopaque. A monofilament brown polyethylene removal thread is attached to a loop at the end of the vertical stem of the T-body. Schematic drawing of Mirena Inserter Mirena is packaged sterile within an inserter. The inserter, which is used for insertio Mirena into the uterine cavity, consists of a symmetric two-sided body and slider tha integrated with flange, lock, pre-bent insertion tube and plunger. Once Mirena is in p the inserter is discarded. MIRENA • Levonorgestrel-releasing intrauterine system • Try to not call it IUD • 32mm x 32 mm • “T” Shaped • Hormonal Cylinder • 5 year placement Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 29. MIRENA • Already overpromoted • Already overhyped • Two (2) FDA WARNING LETTERS • Before July 2010 • Pattern of overpromotion: YAZ, Yasmin, MIRENA • Modus Operandi Friday, October 15, 2010
  • 30. ! ! ! ! !! ! ! ! ! ! ! ! ! ! ! !! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !! ! ! ! ! ! ! DEPARTMENT OF HEALTH & HUMAN SERVICES "#$%&'!()*%+,!-)./&')! 0112!*32!4.#5!627&3&8+.*+&13! -&%/).!-9.&35:!;4!<=>>?! TRANSMITTED BY FACSIMILE 0*2@*!6%7*3*A%B! 6881'&*+)!4&.)'+1.:!C%1$*%!D)5#%*+1.B!6EE*&.8! F*B).!()*%+,'*.)!",*.7*')#+&'*%8:!G3'1.91.*+)2! H!I)8+!F)%+JIK?! I*B3):!LM! =NON=! RE: NDA No. 21-400 LEVITRA® (vardenafil HCl) Tablets NDA No. 21-676, 21-873, 22-045 YAZ® (drospirenone and ethinyl estradiol) Tablets NDA No. 21-225 Mirena® (levonorgestrel-releasing intrauterine system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any .&8A!&3E1.7*+&13!*881'&*+)2!@&+,!+,)!#8)!1E!+,)8)!2.#58P!!G3!*22&+&13:!+,)!891381.)2!%&3A8! E1.!6]!*32!;&.)3*!&3*2)_#*+)%B!'177#3&'*+)!+,)!2.#58X!&32&'*+&138:!*32!+,)!891381.)2! %&3A8!E1.!;&.)3*!1/).8+*+)!+,)!)EE&'*'B!1E!+,)!2.#5P!!0#.+,).71.):!*%%!1E!+,)!891381.)2!%&3A8!E*&%! +1!#8)!+,)!.)_#&.)2!)8+*$%&8,)2!3*7)P!!R,#8:!+,)!891381.)2!%&3A8!7&8$.*32!+,)!2.#58!&3! /&1%*+&13!1E!+,)!0)2).*%!0112:!4.#5:!*32!U187)+&'!6'+!S+,)!6'+T!*32!046!&79%)7)3+&35! .)5#%*+&138P!!See!<K!WP-PUP!?`<S*T!a!S3T:!?<KS3Tb!<K!U0D!<=KPK=S5TSKT:!<=<PKS$TSKT:!S)TS?TS&T:! S&&T!a!S)TSHTS&TP! Background Levitra 6''1.2&35!+1!&+8!046J*99.1/)2!9.12#'+!%*$)%&35!S"GT:!V)/&+.*!&8!&32&'*+)2!E1.!+,)!+.)*+7)3+!1E! ).)'+&%)!2B8E#3'+&13P! V)/&+.*!&8!*881'&*+)2!@&+,!*!3#7$).!1E!.&8A8:!*8!.)E%)'+)2!&3!+,)!U13+.*&32&'*+&138:!I*.3&358:! ".)'*#+&138:!*32!62/).8)!D)*'+&138!8)'+&138!1E!&+8!"GP! FDA WARNING 2009 • March 26, 2009 (April 3, 2009) • YAZ Warning Letter (LEVITRA) • MIRENA Warning Letter • Directed at Internet Marketing by Bayer Healthcare • Actual search results on GOOGLE were at issue • Failure to articulate any risk Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 31. Google Organic Search “tiny T-shaped piece of plastic” Friday, October 15, 2010
  • 32. October 2009: FDA approves MIRENA for additional use for HMB (Heavy Menstrual Bleeding)x Gabriel F. Zambrano, Esquire IUDInjuries.com October 2009: “Better Mouse Trap” Fills void created by Copper IUD Friday, October 15, 2010
  • 33. Bayer HealthCare now pushing HMB benefit, emergency contraception is ongoing and endometrial cancer benefits are next. Gabriel F. Zambrano, Esquire IUDInjuries.com MIRENA 2010 - HMB is promoted www.MIRENA-US.com Friday, October 15, 2010
  • 34. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Fadwa Almanakly, Pharm.D. Associate Director, Advertising and Promotions Bayer HealthCare Pharmaceuticals Inc. 6 West Belt Wayne, NJ 07470-6806 RE: NDA 21-225 Mirena® (levonorgestrel-releasing intrauterine system) MACMIS # 18166 Dear Dr. Almanakly: The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a script for a live consumer-directed program (program) entitled “Mirena Simple Style Statements Program” (150-74-0002-09) for Mirena® (levonorgestrel-releasing intrauterine system) (Mirena), submitted by Bayer HealthCare Pharmaceuticals Inc. (Bayer) under cover of Form FDA-2253. The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i). Background According to the DESCRIPTION section of its FDA-approved product labeling (PI),1 “Mirena® (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (T- body) with a steroid reservoir (hormone elastomer core) around the vertical stem.” The steroid reservoir contains the progestogen levonorgestrel, which is secreted slowly into the uterus over time upon the insertion of Mirena by a trained healthcare provider. According to the INDICATIONS AND USAGE section of its PI, Mirena is approved for the following indication: Mirena is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced. Mirena is recommended for women who have had at least one child. The PI for Mirena also includes numerous contraindications, including “[u]ntreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.” 1 The most current version of the FDA-approved PI as of the dissemination date indicated on Form FDA-2253 was the July 21, 2008, version, and that is the version referred to in this letter. We note that the PI for Mirena was updated on October 1, 2009. FDA WARNING 2009 • December 30, 2009 • DDMAC review of a script • Overstate the efficacy • Presents unsubstantiated claims • Minimizes risk • Makes false and misleading presentations Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 35. 1 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion JULY 2010 Consumer Health Information www.fda.gov/consumer FDA Cautions Against Using Unapproved IUDs  F ederal health officials are warning medical practitioners around the country not to use unapproved intrauterine devices (IUDs). In a July 22 letter, the Food and Drug Administration (FDA) reminds health profes- sionals that using unapproved IUDs raises concerns about effectiveness and safety—as well as the potential for fraud and counterfeiting. “Federal law requires that IUD/IUSs (intrauterine sys- tems) be FDA-approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective,” Theresa Toigo, FDA’s liaison with health professionals, says in the letter. “The recent issue with patients in Rhode Island unknowingly receiving imported, unapproved IUD/ IUSs highlights the unac- ceptable risk patients may be exposed to when a product’s identity, purity, source, han- dling, and storage cannot be verified.” Still, patients can use their FDA-approved IUDs with con- fidence, Toigo says. FDA experts say women who received unapproved IUDs • FDA warns OB/GYNS against using ‘Black Market’ non-FDA approved IUDs • Rhode Island - Ground Zero • Several States • Pandemic in the USA ? • Possibly July 2010 - FDA Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 36. 2 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion JULY 2010 Consumer Health Information www.fda.gov/consumer Federal law requires that IUDs be FDA- approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective. Find this and other Consumer Updates at www.fda.gov/ ForConsumers/ConsumerUpdates Sign up for free e-mail subscriptions at www.fda.gov/ consumer/consumerenews.html from practitioners in Rhode Island, Massachusetts, and Kentucky could be at an increased risk for unwanted pregnancy. The small, T-shaped devices— often made of flexible plastic or copper wire—are inserted into a woman’s uterus to prevent preg- nancy. Some IUDs also deliver small amounts of hormone as added pro- tection from pregnancy. FDA says women should not try to remove IUDs by themselves. The agency is advising women who think they may have an unapproved IUD to use another form of birth con- trol—such as condoms, birth control pills, or the patch—and contact their health care professional. Women may want to ask: • What advantages are there for keeping my IUD in? • Should I think about having my IUD removed? • If I keep my IUD in, how long should I use another form of birth control? • If I want my IUD removed, can I get a new, FDA-approved one? • I don’t want to use condoms. Will other birth control products, such as the pill, patch, or ring, be equally effective? • Will this affect my ability to get pregnant in the future? • What should I do if I think I’m pregnant? Nationwide Problem What started out as a Rhode Island investigation has spread beyond the state’s borders. The FDA is aware of the use of these unapproved prod- ucts in several states and is continu- ing to investigate. FDA says doctors, nurses, mid- wives—and possibly patients themselves—might buy unap- proved produc ts f rom what appear to be Canadian or other foreign websites in a bid to save money. Purchasing medical prod- ucts from websites that are out- side of the U.S. may be illegal and may increase the risk of receiving a potentially harmful product, since many websites sell products that are not FDA-approved and could be manufactured in other countries. “Unapproved products bring a lot of unknowns into the equation,” says FDA compliance officer Kathleen Anderson. “An Internet ad may claim to sell IUDs made in Canada, but there’s no way to be sure. They might have been made anywhere in the world and in unsanitary or undesirable conditions.” Advice for Consumers FDA investigators routinely monitor the Internet for the sale of unapproved drugs and devices in an effort to protect the public, but the rapidly growing number of websites trafficking in fraudulent medical products means consum- ers must remain alert. Experts advise consumers to learn how to buy health-related products safely over the Internet. Legitimate Internet pharmacies are licensed by the appropriate state board of pharmacy and fol- low laws and regulations of the state where they operate. Legitimate Internet pharmacies will also display a seal from the National Association of Boards of Pharmacy—known as VIPPS seal or Verified Internet Pharmacy Practice Sites. VIPPS pharmacies are listed at vipps.nabp.net/verify.asp. FDA is also asking the public to report information about the distri- bution of unapproved IUDs. To con- tact the agency’s criminal investiga- tors visit www.fda.gov/oci. July 2010 - FDA • Involves both MIRENA & ParaGard Copper • Both obtained via Internet • Both involved non-FDA approved • “Black Market” for both and others of varying designs Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 37. Limited US news coverage of July 2010 FDA action. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 38. July 22, 2010 Dear Colleague, The U.S. Food and Drug Administration (FDA or the Agency) is seeking your help in communicating an important woman's health safety message to your members. We hope you will share this information with your members to ensure that they are obtaining and using only FDA-approved products. The FDA has become aware of the purchase, use, and distribution of unapproved intrauterine devices (IUD) and intrauterine systems (IUS) by some medical practices throughout the United States. The violative products include unapproved versions of FDA-approved products such as Mirena, Implanon, Copper-T, and ParaGard; as well as products not approved for use in the United States, such as T-Safe. The FDA’s major concerns with the use of unapproved IUD/IUS’s are (1) the potential lack of safety and efficacy, and especially the risk of reduced efficacy for preventing pregnancy; (2) the negative public health impact from the import and use of unapproved IUD/IUS’s that can be from unknown sources or foreign locations, and may not have been manufactured, transported or stored under conditions required as part of the FDA approval process; and (3) the use of and subsequent billing for unapproved medical products, which raises the possibility of insurance fraud, particularly Medicaid fraud. To reduce the chance of receiving an unapproved or adulterated medical product, your internet purchases should be made from state-licensed distributors or pharmacies located in the U.S. Health care providers should be aware that purchasing medical products from web sites that are outside of the U.S. may be illegal and may increase the risk of receiving a potentially harmful product, since many web sites sell products that are not FDA-approved and could be manufactured in other countries. These products may or may not have been approved by regulatory agencies in other countries or may be counterfeit. For example, FDA is aware of several web sites that appear to be Canadian web sites but ship products from countries other than Canada. For this reason, the Agency does not recommend inserting IUD/IUS’s furnished by a patient who may have purchased the product on the internet, without first properly verifying that it is an FDA-approved product that was purchased from a licensed pharmaceutical or device supplier in the U.S. Federal law requires that IUD/IUS’s be FDA-approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective. The recent issue with patients in Rhode Island unknowingly receiving imported, unapproved IUD/IUS’s highlights the unacceptable risk patients may be exposed to when a product’s identity, purity, source, handling, and storage cannot be verified. Health care providers should be reassured, however, that FDA- approved IUD/IUS’s have gone through rigorous testing and review for safety and efficacy, and must meet specified storage and manufacturing practices. Providers can continue to use these FDA-approved IUD/IUS’s with confidence in their safety and efficacy. The FDA is asking that you communicate this information to your members so that appropriate steps can be taken, if necessary, to ensure that they are obtaining and using only FDA-approved products. Patients who may have received an unapproved IUD/IUS have been instructed to consult with their providers regarding next steps, including whether or not their IUD or IUS should be removed. So far, the FDA has been made aware of the use of these unapproved products in several states; however, as the investigation continues, this issue may impact other states nationwide. Information regarding the distribution of unapproved IUD/IUS products can be reported to FDA's Office of Criminal Investigations at http://www.fda.gov/ICECI/CriminalInvestigations/default.htm, under “Report Suspected Criminal Activity.” The FDA and other public health organizations continue to look into this situation, and will update the medical community as new information of public health importance becomes available. The Agency is committed to promoting and protecting the public health by ensuring that only safe and effective products are available to the American public. We appreciate your hard work and willingness in support of this effort. Sincerely, Theresa Toigo, RPh, MBA Director, Office of Special Health Issues Food and Drug Administration “Dear Colleague” Letter - July 2010 Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 39. General IUD Risks & Complications • Peforation of Uterine Wall. Claimed to only be 1.3 or 1.5 in every 1,000 • Migration into other parts of body • Pelvic Inflammatory Disease (PID) = synonymous with Dalkon Shield. • PID associated with sexually transmitted infections or diseases • Expulsion out of cavity • Infections in uterus, fallopian tubes resulting in scarring which diminishes fertility or ability to conceive • Pregnancy Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 40. Listed as Side Effects not risks Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 41. Gabriel F. Zambrano, Esquire IUDInjuries.com Manufacturer’s Explanation Friday, October 15, 2010
  • 42. www.MIRENA-US.com Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 43. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1. Insertion Instructions 2.2 Patient Counseling and Record Keeping 2.3 Patient Follow-up 2.4 Removal of Mirena 2.5 Continuation of Contraception after Removal 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Ectopic Pregnancy 5.2 Intrauterine Pregnancy 5.3 Sepsis 5.4 Pelvic Inflammatory Disease (PID) 5.5 Irregular Bleeding and Amenorrhea 5.6 Embedment 5.7 Perforation 5.8 Expulsion 5.9 Ovarian Cysts 5.10Breast Cancer 5.11Patient Evaluation and Clinical Considerations 5.12Insertion Precautions 5.13Continuation and Removal 5.14Glucose Tolerance 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 11 DESCRIPTION 11.1Mirena 11.2Inserter 12 CLINICAL PHARMACOLOGY 12.1Mechanism of Action 12.2Pharmacodynamics 12.3Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1Clinical Trials on Intrauterine Contraception 14.2Clinical Trial on Heavy Menstrual Bleeding 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1Information for Patients *Sections or subsections omitted from the full prescribing information are not listed 1 Mirena® (levonorgestrel-releasing intrauterine system) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Mirena® safely and effectively. See full prescribing information for Mirena. Mirena (levonorgestrel-releasing intrauterine system) Initial U.S. Approval: 2000 ------------------------RECENT MAJOR CHANGES -------------------------- Indications and Usage (1) 10/2009 --------------------------INDICATIONS AND USAGE ---------------------------- Mirena is a sterile, levonorgestrel-releasing intrauterine system indicated for: • Intrauterine contraception for up to 5 years (1) • Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception. (1) It is recommended for women who have had at least one child. --------------------DOSAGE AND ADMINISTRATION------------------------ • Initial release rate of levonorgestrel is 20 mcg per day; this rate is reduced by about 50% after 5 years; Mirena should be replaced after 5 years. (2) • To be inserted by a trained healthcare provider using strict aseptic technique. Healthcare providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion. (2.1, 2.2, 2.3, 2.4) • Patientshouldbere-examinedandevaluated4to12weeksafterinsertion; then, yearly or more often if indicated. (2.3) ------------------DOSAGE FORMS AND STRENGTHS -------------------- One sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged within a sterile inserter (3) ----------------------------CONTRAINDICATIONS ------------------------------ • Pregnancy or suspicion of pregnancy (4) • Congenital or acquired uterine anomaly if it distorts the uterine cavity (4) • Acute pelvic inflammatory disease (PID) or history of unless there has been a subsequent intrauterine pregnancy (4) • Postpartum endometritis or infected abortion in the past 3 months (4) • Known or suspected uterine or cervical neoplasia or abnormal Pap smear (4) • Genital bleeding of unknown etiology (4) • Untreated acute cervicitis or vaginitis or other lower genital tract infections (4) • Acute liver disease or liver tumor (benign or malignant) (4) • Increased susceptibility to pelvic infection (4) • A previously inserted IUD that has not been removed (4) • Hypersensitivity to any component of Mirena (4) • Known or suspected carcinoma of the breast (4) --------------------------WARNINGS AND PRECAUTIONS-------------------- • If pregnancy should occur with Mirena in place, remove Mirena. (5.2) There is increased risk of ectopic pregnancy including loss of fertility, pregnancy loss, septic abortion (including septicemia, shock and death) and premature labor and delivery. (5.1, 5.2) • Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion. (5.3) • Before using Mirena, consider the risks of PID. (5.4) • Bleedingpatternsbecomealtered,mayremainirregularandamenorrhea may ensue. (5.5) • Perforation may occur during insertion. Risk is increased in women with fixed retroverted uteri, during lactation, and postpartum. (5.6) • Embedment in the myometrium and partial or complete expulsion may occur. (5.8) • Persistent enlarged ovarian follicles should be evaluated. (5.9) --------------------------------ADVERSE REACTIONS -------------------------- The most common adverse reactions reported in clinical trials (> 10% users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%) and ovarian cysts (12%). (6) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ----------------------------------DRUG INTERACTIONS -------------------------- • Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the serum concentration of progestins. (7) --------------------------USE IN SPECIFIC POPULATIONS ------------------ • Small amounts of progestins pass into breast milk resulting in detectable steroid levels in infant serum. (8.3) • Use of this product before menarche is not indicated. (8.4) • Use in women over 65 has not been studied and is not approved. (8.5) See 17 for PATIENT COUNSELING INFORMATION and FDA- Approved Patient Labeling Revised: 10/2009 Step 6–Release the arms While holding the inserter steady, release the arms of Mirena by pulling the slider back until the top of the slider reaches the mark (raised horizontal line on the handle) (Figure 6a). Wait approximately 10 seconds to allow the horizontal armsofMirenatoopenandregainitsT-shape(Figure6b). Step 7–Advance to fundal position Gently advance the inserter into the uterine cavity until he flange meets the cervix and you feel fundal resist- withdraw the inserter from the uterus. Be careful not to pull on the threads as this will displace Mirena. Step 9–Cut the threads • Cut the threads perpendicular to the thread length, for example, with sterile curved scissors, leaving about 3 cm visible outside the cervix (Figure 9). Figure 5. Advancing insertion tube until flange is 1.5 to 2 cm from cervical os 4 5 6 7 Figure 6b. Releasing the arms of Mirena mark cm 9 Figure 6a. Pulling the slider back to reach the mark Figure 8. Releasing Mirena from the insertion tube There is a routine and need for self inspection and regulation. So, there is a routine. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 44. How does MIRENA work ? • It ‘may’ thicken cervical mucus • It ‘may’ inhibit sperm • It ‘may’ thin the lining of the uterus • It ‘may’ combine to do the above • Not really clear based upon their own materials and information how exactly it interferes to disrupt fertilization and prevent pregnancy • Cannot be comforting to know we do not know exactly how it works and it is being promoted as an option into younger and younger age groups Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 45. It pays to use our product line. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 46. www.MIRENA-US.com Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 47. To whom am I speaking today? Be sure to get individual’s full name and extension. I am calling to verify whether has coverage for ParaGard® . Yes No Please confirm ’s deductible and co-pay. Deductible Co-pay What is the payable J7300? If payable is less than the healthcare professional’s cost, consider requesting an increased reimbursement rate. Document response to request: Does this patient’s plan require submission of an invoice before we process reimbursement? Yes No Explanation: Additional notes: For alternative payment options for your patients, please refer to the reverse side. ParaGard® IUC Reimbursement Checklist (Patient’s name) (Patient’s name) (Name) (Phone no.) (Ext.) (Date) The following checklist is designed to assist you with the reimbursement process for ParaGard® . Use this checklist as a guide when speaking to your patient’s managed care organization (MCO) to ensure that you are asking all the required reimbursement questions. After completing the checklist, you may find it helpful to file it in your patient’s chart for future reference. Has insurance verification for ParaGard® been confirmed? Yes No ParaGard “IUC” Reimbursement Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 48. Follow the Money: TEVA & Bayer - Contraceptive Giants responsible for YAZ, Yasmin, Ocella and generic progeny. They are competing for pieces of the contraceptive marketplace. Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  •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`94&*?784O #:a7*1+(847,#b)*17+1< TXS TXT E#]"W E#T"W G*1+%?784O #:a7*1+(847,#b)*17+1< TWS TS^ #^"S #S!"W b(2*)7&(+O #:a7*1+(847,#b)*17+1< S^^ S^^ ]"] #SS"U Z7+c*9O #C#$&74(&O #:[%+%&*9#G%57,7+%< SWW SXW E#S!"^ E#SW"Y ,E=7? OPI-Q OPOI- R&SJ0 R&IJ/ $&(2(&47(+#('#$B*&)*,%047,*98#8*9%8 U!L UWL # # 2009 $490M 2008 $462M6th Best Selling Pharma Product in 2009. 2nd Women’s Healthcare Product behind YAZ/Yasmin (DRSP/EE) Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 50. Website: www.tevapharm.com Contact: Elana Holzman Kevin Mannix Teva Pharmaceutical Industries Ltd. Teva North America 972 (3) 926-7554 (215) 591-8912 For Immediate Release TEVA REPORTS RECORD FULL YEAR 2009 AND FOURTH QUARTER RESULTS -- Fourth Quarter Sales Total $3.8 Billion and Non-GAAP EPS of $0.94 – -- 2009 Sales Total $13.9 Billion and Non-GAAP EPS of $3.37 -- --Record Annual Sales in All Geographies -- Jerusalem, Israel, February 16, 2010 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today reported record results for the quarter and year ended December 31, 2009. Website: www.tevapharm.com Contact: Elana Holzman Kevin Mannix Teva Pharmaceutical Industries Ltd. Teva North America 972 (3) 926-7554 (215) 591-8912 For Immediate Release TEVA REPORTS RECORD FULL YEAR 2009 AND FOURTH QUARTER RESULTS -- Fourth Quarter Sales Total $3.8 Billion and Non-GAAP EPS of $0.94 – -- 2009 Sales Total $13.9 Billion and Non-GAAP EPS of $3.37 -- --Record Annual Sales in All Geographies -- Jerusalem, Israel, February 16, 2010 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today reported record results for the quarter and year ended December 31, 2009. Full Year and Fourth Quarter Highlights: Record quarterly and annual net sales of $3.8 billion and $13.9 billion, up 33% and 25%, respectively, compared to the comparable period in 2008. Quarterly non-GAAP net income and non-GAAP EPS of $847 million and $0.94, up 28% and 18%, respectively, compared with the fourth quarter of 2008. Quarterly GAAP net income and EPS totaled $379 million and $0.42, respectively, compared with a loss of $694 million and a loss of $0.88 per share in the fourth quarter of 2008. Annual non-GAAP net income and non-GAAP EPS of $3.0 billion and $3.37, up 22% and 11%, respectively, compared with the year ended 2008. Annual GAAP net income and EPS totaled $2.0 billion and $2.23, respectively, compared with $609 million and $0.75 in 2008. Quarterly non-GAAP operating income of $1.0 billion, up 41% compared with the fourth quarter of 2008. Quarterly GAAP operating income totaled $412 million, compared with a loss of $412 million in the fourth quarter of 2008. Annual non-GAAP operating income of $3.9 billion, up 35% compared to 2008. Annual GAAP operating income totaled $2.4 billion, compared with $1.1 billion in 2008. Record global in-market sales of Copaxone® of $2.8 billion in the year ended 2009, up 25% in the fourth quarter and for the full year compared to 2008. Copaxone® continues to be the leading MS therapy in the U.S. and globally. Record annual cash flow from operations of $3.4 billion. “2009 was a very good year for Teva, a year in which our company delivered record-breaking sales and profits across all our geographies and major businesses.” said Shlomo Yanai, Teva's President and Chief Executive Officer. “This was also a year of major strategic achievements, including the successful integration of Barr, a process which was completed less than a year after closing, and from which we expect to continue to derive significant synergies for many years to come.” 2009 Record Annual Sales Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 51. “Copper IUD incidentally found during laparotomy embedded in bowel submucosa”. Gabriel F. Zambrano, Esquire IUDInjuries.com Copper IUD embedded in bowel submucosa. Friday, October 15, 2010
  • 52. “Copper IUD incidentally found during laparotomy embedded in bowel submucosa”. Gabriel F. Zambrano, Esquire IUDInjuries.com MIRENA IUD Uterine Perforation with adhesions. Friday, October 15, 2010
  • 53. • Girls and Women have been targeted as viable users, a shift in marketing and market share • Prior failure of hormonal OC means they considered or used IUD • Socioeconomic factors through marketing, availability of insurance and exposure to social media marketing of simplicity • MIRENA now approved for HMB and claimed benefits for endometrial cancer via a very small limited study • “Black Market” vs. FDA Approved - injuries and no injuries • Promoted as “Emergency Contraception” alternative to morning after pills IUD Cases: Any Women or Girl not on Hormonal OC Gabriel F. Zambrano, Esquire IUDInjuries.com Friday, October 15, 2010
  • 54. Contact Me: Gabriel F. Zambrano gabe@IUDInjuries.com Attorney At Law 707 S.E. Third Avenue Third Floor Fort Lauderdale, FL www.IUDAttorneys.com www.IUDLawyers.com www.linkedin.com/in/gabrielfzambrano Friday, October 15, 2010
  • 55. By Gabriel F. Zambrano www.RecallAttorneys.com www.IUDInjuries.com gabrielfzambrano@gmail.com Attorney At Law 707 S.E. Third Avenue Third Floor Fort Lauderdale, FL www.IUDAttorneys.comwww.IUDLawyers.com @gfzambrano Friday, October 15, 2010