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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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IUD's: Are Women At Risk IUD's: Are Women At Risk Presentation Transcript

  • OB/GYN’s USING IUDs - WOMEN AT RISK DESPITE FDA WARNINGS & PRODUCT APPROVALFriday, October 15, 2010
  • 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.IUDLawyers.com www.IUDAttorneys.comFriday, October 15, 2010
  • MTMP - October 2010 Bellagio - Las Vegas Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • 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.comFriday, October 15, 2010
  • 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.comFriday, October 15, 2010
  • Usage and cost are on Follow up story to July 2010. the rise in the U.S. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • “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.comFriday, October 15, 2010
  • “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.comFriday, October 15, 2010
  • 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.comFriday, October 15, 2010
  • Disruption of natural meeting of sperm and egg. Read the MIRENA information again - emphasis on ‘may’ ParaGard Copper has impact on fertilization. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Safety of IUD Safe and effective if not contraindicated by health concerns or past medical history. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Safety of IUD 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. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Cost of IUD 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. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • What can we tell about the Women that use IUDs from how they are promoted to them ? Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • OB/GYN’s: Alternative to hormonal birth control Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • ParaGard Copper “T” PARAGARD IUD: Copper T380A Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Hormonal IUD MIRENA Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Know your audience. Who are they marketing too ? Look at these Gabriel F. Zambrano, Esquire Women. Do you see girls or Women ? IUDInjuries.comFriday, October 15, 2010
  • MIRENA is made by Did they target the same Bayer HealthCare audience of Females? Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • 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 awayFriday, October 15, 2010
  • 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.comFriday, October 15, 2010
  • Multiple Types of Contraception. Bayer HealthCare One Stop Shopping for Birth Control. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Internet,Social Media,SMS & TV YAZ & Yasmin are 800 Pound Guerilla promoted as Lifestyle Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Promotion of “Lifestyle” Choosing a way of Life. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • “No daily or weekly routines”. Small like a penny. Risk Free ? “Hassle-free”. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • No daily routine. Life is too complicated for you. Simplify Lifestyle. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • on ParaGard —the birth control that’s hormone-free and virtually hassle-free. You can also find out more about ParaGard® by: ParaGard Copper • Visiting www.paragard.com, or Welcome to • Calling the ParaGard® Info Line at • Promoted by World Health 1•877•ParaGard (727•2427) ParaGard ® Organization • Planned Parenthood & Family Planning Important Safety Information • Promoted as safe, effective and ParaGard® does not protect against HIV long term solutionheavier or longer or STDs. You may have for birth control spotting between periods, which periods or Like millions of other women, usually subsides after 2-3 months. you’ve chosen the birth control Complications may occur from placement. that’s hormone-free and • Utilized not use ParaGard® if you have You must up to 10 years with virtually hassle-free. push inflammatory disease (PID) or engage pelvic for 10+ years in behavior putting you at high risk for PID, See inside for information on have a history of certain reproductive cancers • Recent push for 12 years or might or infections, have Wilsons disease, getting started… be pregnant. Gabriel F. Zambrano, Esquire Please see product information at IUDInjuries.com • MERCK tied to 2010 study www.paragard.com.Friday, October 15, 2010
  • 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. MIRENA • Levonorgestrel-releasing intrauterine system • Try to not call it IUD Schematic drawing of Mirena • 32mm x 32 mm Inserter • “T” Shaped 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. • Hormonal Cylinder • 5 year placement Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • MIRENA • Already overpromoted • Already overhyped • Two (2) FDA WARNING LETTERS • Before July 2010 • Pattern of overpromotion: YAZ, Yasmin, MIRENA • Modus OperandiFriday, October 15, 2010
  • FDA WARNING 2009 DEPARTMENT OF HEALTH & HUMAN SERVICES "#$%&!()*%+,!-)./&)! ! 0112!*32!4.#5!627&3&8+.*+&13! -&%/).!-9.&35:!;4!<=>>?! TRANSMITTED BY FACSIMILE ! • March 26, 2009 (April 3, 2009) 0*2@*!6%7*3*A%B! ! 6881&*+)!4&.)+1.:!C%1$*%!D)5#%*+1.B!6EE*&.8! F*B).!()*%+,*.)!",*.7*)#+&*%8:!G31.91.*+)2! H!I)8+!F)%+JIK?! ! I*B3):!LM! =NON=! !! ! • YAZ Warning Letter (LEVITRA) RE: NDA No. 21-400 LEVITRA® (vardenafil HCl) Tablets NDA No. 21-676, 21-873, 22-045 YAZ® (drospirenone and ethinyl estradiol) Tablets NDA No. 21-225 Mirena® (levonorgestrel-releasing intrauterine system) MACMIS ID # 17307 ! • MIRENA Warning Letter 4)*.!;8P!6%7*3*A%BQ! ! ! R,&8!%)++).!31+&E&)8!F*B).!()*%+,*.)!",*.7*)#+&*%8:!G31.91.*+)2!SF*B).T:!*32:!$B!19B:! ! -,).&35!U1.91.*+&13!S-,).&35T:!@,&,!7*.A)+8!V)/&+.*!13!$),*%E!1E!F*B).:!+,*+:!*8!9*.+!1E!&+8! ! 713&+1.&35!*32!8#./)&%%*3)!9.15.*7:!+,)!4&/&8&13!1E!4.#5!;*.A)+&35:!62/).+&8&35:!*32! U177#3&*+&138!S44;6UT!1E!+,)!WP-P!0112!*32!4.#5!627&3&8+.*+&13!S046T!,*8!.)/&)@)2! ! ! • Directed at Internet Marketing F*B).X8!891381.)2!%&3A8!13!&3+).3)+!8)*.,!)35&3)8!S)P5P:!C115%)P17T!E1.!+,)!E1%%1@&35! 9.12#+8Q!VYZGRD6[!S/*.2)3*E&%!(U%T!R*$%)+8!SV)/&+.*T:!6][!S2.189&.)313)!*32!)+,&3B%! ! by Bayer Healthcare )8+.*2&1%T!R*$%)+8!S6]T:!*32!;&.)3*[!S%)/131.5)8+.)%J.)%)*8&35!&3+.*#+).&3)!8B8+)7T!S;&.)3*TP! ! R,)!891381.)2!%&3A8!&+)2!&3!+,&8!%)++).!*.)!7&8%)*2&35!$)*#8)!+,)B!7*A)!.)9.)8)3+*+&138! ! ! !! *32^1.!8#55)8+&138!*$1#+!+,)!)EE&*B!1E!V)/&+.*:!6]:!*32!;&.)3*:!$#+!E*&%!+1!177#3&*+)! ! 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*&%! ! ! ! ! • Actual search results on +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! ! ! ! ! GOOGLE were at issue S&&T!a!S)TSHTS&TP!!! ! .)5#%*+&138P!!See!<K!WP-PUP!?`<S*T!a!S3T:!?<KS3Tb!<K!U0D!<=KPK=S5TSKT:!<=<PKS$TSKT:!S)TS?TS&T:! ! ! Background ! Levitra • Failure to articulate any risk 61.2&35!+1!&+8!046J*99.1/)2!9.12#+!%*$)%&35!S"GT:!V)/&+.*!&8!&32&*+)2!E1.!+,)!+.)*+7)3+!1E! ).)+&%)!2B8E#3+&13P! ! ! ! Gabriel F. Zambrano, Esquire 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! ! IUDInjuries.comFriday, October 15, 2010
  • Google Organic Search “tiny T-shaped piece of plastic”Friday, October 15, 2010
  • October 2009: “Better Mouse Trap” Fills void created by Copper IUD October 2009: FDA approves MIRENA for additional use for HMB Gabriel F. Zambrano, Esquire IUDInjuries.com (Heavy Menstrual Bleeding)xFriday, October 15, 2010
  • MIRENA 2010 - HMB is promoted www.MIRENA-US.com Bayer HealthCare now pushing HMB benefit, emergency contraception Gabriel F. Zambrano, Esquire is ongoing and endometrial cancer benefits are next. IUDInjuries.comFriday, October 15, 2010
  • DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service FDA WARNING 2009 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 • December 30, 2009 Wayne, NJ 07470-6806 RE: NDA 21-225 Mirena® (levonorgestrel-releasing intrauterine system) MACMIS # 18166 • DDMAC review of a script 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 • Overstate the efficacy 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). • Presents unsubstantiated Background claims 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 • Minimizes risk 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. • Makes false and misleading 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 presentations infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.” 1 Gabriel F. Zambrano, Esquire 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. IUDInjuries.comFriday, October 15, 2010
  • July 2010 - FDA Consumer Health Information www.fda.gov/consumer • FDA warns OB/GYNS against FDA Cautions Against using ‘Black Market’ non-FDA Using Unapproved IUDs approved IUDs F   ederal health officials are warning medical practitioners around the country not to use unapproved intrauterine • Rhode Island - Ground Zero devices (IUDs). In a July 22 letter, the Food and Dr ug Administ ration (FDA) reminds health profes- sionals that using unapproved IUDs raises concerns about effectiveness and safety—as well as the potential for fraud • Several States and counterfeiting. “Federal law requires that IUD/IUSs (intrauterine sys- t e m s) b e F DA - a p pr o v e d pr ior to ma rket ing. T his law is designed to protect patients from products that are unsafe and ineffective,” Theresa Toigo, FDA’s liaison • Pandemic in the USA ? with health professionals, says in the letter. “The recent issue with patients in Rhode Island unknowingly receiving imported, unapproved IUD/ IUSs highlights t he unac- ceptable risk patients may be exposed to when a product’s identity, purity, source, han- dling, and storage cannot be • Possibly verified.” Still, patients can use their FDA-approved IUDs with con- fidence, Toigo says. FDA experts say women who received unapproved IUDs 1 / FDA Consumer Health Information / U.S. Food and Drug Administration J U LY 2 0 1 0 Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Consumer Health Information www.fda.gov/consumer July 2010 - FDA 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. • Involves both MIRENA & ParaGard Copper from practitioners in Rhode Island, the use of these unapproved prod- are licensed by the appropriate Massachusetts, and Kentucky could ucts in several states and is continu- state board of pharmacy and fol- be at an increased risk for unwanted ing to investigate. low laws and regulations of the pregnancy. FDA says doctors, nurses, mid- state where they operate. The small, T-shaped devices— w i ve s — a nd p o s sibl y pat ie nt s Legitimate Internet pharmacies often made of f lexible plastic or t hemselves—might buy unap- will also display a seal from the copper wire—are inserted into a proved produc t s f rom what National Association of Boards of woman’s uterus to prevent preg- appear to be Canadian or other Pharmacy—known as VIPPS seal or nancy. Some IUDs also deliver small foreign websites in a bid to save Verified Internet Pharmacy Practice • Both obtained via Internet amounts of hormone as added pro- money. Purchasing medical prod- Sites. VIPPS pharmacies are listed tection from pregnancy. ucts from websites that are out- at vipps.nabp.net/verify.asp. FDA says women should not try side of the U.S. may be illegal and FDA is also asking the public to to remove IUDs by themselves. The may increase the risk of receiving report information about the distri- agency is advising women who think a potentially harmf ul product, bution of unapproved IUDs. To con- they may have an unapproved IUD since many websites sell products tact the agency’s criminal investiga- to use another form of birth con- that are not FDA-approved and tors visit www.fda.gov/oci. trol—such as condoms, birth control could be manufactured in other pills, or the patch—and contact their countries. health care professional. Women “Unapproved produc t s br ing • Both involved non-FDA Find this and other Consumer may want to ask: a lot of u n k now n s i nt o t he Updates at www.fda.gov/ • What advantages are there for equation,” says FDA compliance ForConsumers/ConsumerUpdates keeping my IUD in? officer Kathleen Anderson. “An approved • Should I think about having my Internet ad may claim to sell IUDs Sign up for free e-mail IUD removed? made in Canada, but there’s no subscriptions at www.fda.gov/ • If I keep my IUD in, how long way to be sure. They might have consumer/consumerenews.html should I use another form of been made anywhere in the world birth control? and in unsanitary or undesirable • If I want my IUD removed, can I conditions.” get a new, FDA-approved one? • I don’t want to use condoms. Advice for Consumers Will other birth control products, F DA i nve st ig ator s rout i ne ly such as the pill, patch, or ring, be monitor the Internet for the sale • “Black Market” for both and equally effective? • Will this affect my ability to get pregnant in the future? of unapproved drugs and devices in an effort to protect the public, but the rapidly growing number of others of varying designs • What should I do if I think I’m websites trafficking in fraudulent pregnant? medical products means consum- ers must remain alert. Nationwide Problem E x per t s adv ise consumers to What started out as a Rhode Island learn how to buy health-related investigation has spread beyond the products safely over the Internet. state’s borders. The FDA is aware of Legitimate Internet pharmacies 2 / FDA Consumer Health Information / U.S. Food and Drug Administration J U LY 2 0 1 0 Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Limited US news coverage of July 2010 FDA action. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • 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 July 22, 2010 products. Patients who may have received an unapproved IUD/IUS have been instructed to Dear Colleague, 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 The U.S. Food and Drug Administration (FDA or the Agency) is seeking your help in products in several states; however, as the investigation continues, this issue may impact other communicating an important womans health safety message to your members. We hope you states nationwide. Information regarding the distribution of unapproved IUD/IUS products can will share this information with your members to ensure that they are obtaining and using only be reported to FDAs Office of Criminal Investigations at FDA-approved products. http://www.fda.gov/ICECI/CriminalInvestigations/default.htm, under “Report Suspected Criminal Activity.” 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 The FDA and other public health organizations continue to look into this situation, and will States. The violative products include unapproved versions of FDA-approved products such as update the medical community as new information of public health importance becomes Mirena, Implanon, Copper-T, and ParaGard; as well as products not approved for use in the available. The Agency is committed to promoting and protecting the public health by ensuring United States, such as T-Safe. that only safe and effective products are available to the American public. We appreciate your hard work and willingness in support of this effort. 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 Sincerely, negative public health impact from the import and use of unapproved IUD/IUS’s that can be Theresa Toigo, RPh, MBA from unknown sources or foreign locations, and may not have been manufactured, transported or Director, Office of Special Health Issues stored under conditions required as part of the FDA approval process; and (3) the use of and Food and Drug Administration 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. “Dear Colleague” Letter - July 2010 Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • 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 Gabriel F. Zambrano, Esquire • Pregnancy IUDInjuries.comFriday, October 15, 2010
  • Listed as Side Effects not risks Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Manufacturer’s Explanation Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • www.MIRENA-US.com Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • withdraw the inserter from the uterus. Be careful not to pull on the threads as this will displace Mirena. Mirena® • Genital bleeding of unknown etiology (4) • Untreated acute cervicitis or vaginitis or other lower genital tract (levonorgestrel-releasing intrauterine system) infections (4) • Acute liver disease or liver tumor (benign or malignant) (4) HIGHLIGHTS OF PRESCRIBING INFORMATION • Increased susceptibility to pelvic infection (4) Figure 5. Advancing These highlights do not include all the information needed to use • A previously inserted IUD that has not been removed (4) Mirena® safely and effectively. See full prescribing information for • Hypersensitivity to any component of Mirena (4) Mirena. • Known or suspected carcinoma of the breast (4) Mirena (levonorgestrel-releasing intrauterine system) Initial U.S. Approval: 2000 insertion tube until --------------------------WARNINGS AND PRECAUTIONS-------------------- • If pregnancy should occur with Mirena in place, remove Mirena. (5.2) flange is 1.5 to 2 cm ------------------------RECENT MAJOR CHANGES -------------------------- There is increased risk of ectopic pregnancy including loss of fertility, Indications and Usage (1) 10/2009 pregnancy loss, septic abortion (including septicemia, shock and death) and premature labor and delivery. (5.1, 5.2) from cervical os --------------------------INDICATIONS AND USAGE ---------------------------- • Group A streptococcal infection has been reported; strict aseptic Mirena is a sterile, levonorgestrel-releasing intrauterine system indicated technique is essential during insertion. (5.3) for: • Before using Mirena, consider the risks of PID. (5.4) • Intrauterine contraception for up to 5 years (1) • Bleeding patterns become altered, may remain irregular and amenorrhea • Treatment of heavy menstrual bleeding for women who choose to use may ensue. (5.5) intrauterine contraception as their method of contraception. (1) • Perforation may occur during insertion. Risk is increased in women It is recommended for women who have had at least one child. with fixed retroverted uteri, during lactation, and postpartum. (5.6)Step 6–Release the arms --------------------DOSAGE AND ADMINISTRATION------------------------ • Initial release rate of levonorgestrel is 20 mcg per day; this rate is • Embedment in the myometrium and partial or complete expulsion may occur. (5.8) • Persistent enlarged ovarian follicles should be evaluated. (5.9) While holding the inserter steady, release the arms of reduced by about 50% after 5 years; Mirena should be replaced after 5 years. (2) --------------------------------ADVERSE REACTIONS -------------------------- • To be inserted by a trained healthcare provider using strict aseptic The most common adverse reactions reported in clinical trials (> 10% users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea Mirena by pulling the slider back until the top of the slider technique. Healthcare providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion. (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic (2.1, 2.2, 2.3, 2.4) pain (12.8%) and ovarian cysts (12%). (6) reaches the mark (raised horizontal line on the handle) • Patient should be re-examined and evaluated 4 to 12 weeks after insertion; To report SUSPECTED ADVERSE REACTIONS, contact Bayer then, yearly or more often if indicated. (2.3) HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ------------------DOSAGE FORMS AND STRENGTHS -------------------- (Figure 6a). 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) ----------------------------------DRUG INTERACTIONS -------------------------- • Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the serum concentration of progestins. (7)Wait approximately 10 seconds to allow the horizontal ----------------------------CONTRAINDICATIONS ------------------------------ • Pregnancy or suspicion of pregnancy (4) • Congenital or acquired uterine anomaly if it distorts the uterine cavity (4) --------------------------USE IN SPECIFIC POPULATIONS ------------------ • Small amounts of progestins pass into breast milk resulting in detectable steroid levels in infant serum. (8.3)arms of Mirena to open and regain its T-shape (Figure 6b). • 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) • 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- • Known or suspected uterine or cervical neoplasia or abnormal Pap Approved Patient Labeling smear (4) Revised: 10/2009 9 FULL PRESCRIBING INFORMATION: CONTENTS* 7 DRUG INTERACTIONS 1 INDICATIONS AND USAGE 8 USE IN SPECIFIC POPULATIONS cm 2 DOSAGE AND ADMINISTRATION 8.1 Pregnancy 2.1. Insertion Instructions 8.3 Nursing Mothers 2.2 Patient Counseling and Record Keeping 8.4 Pediatric Use 2.3 Patient Follow-up 8.5 Geriatric Use 2.4 Removal of Mirena 8.6 Hepatic Impairment 2.5 Continuation of Contraception after Removal 8.7 Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 11 DESCRIPTION 4 CONTRAINDICATIONS 11.1 Mirena 11.2 Inserter 5 WARNINGS AND PRECAUTIONS 5.1 Ectopic Pregnancy 12 CLINICAL PHARMACOLOGY 5.2 Intrauterine Pregnancy 12.1 Mechanism of Action 5.3maSepsis 12.2 Pharmacodynamics rk 5.4 Pelvic Inflammatory Disease (PID) 12.3 Pharmacokinetics 5.5 Irregular Bleeding and Amenorrhea 13 NONCLINICAL TOXICOLOGY 5.6 Embedment 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.7 Perforation Figure 8. 14 CLINICAL STUDIES 5.8 Expulsion 14.1 Clinical Trials on Intrauterine Contraception 4 5.9 Ovarian Cysts 14.2 Clinical Trial on Heavy Menstrual Bleeding Releasing Mirena from 5.10 Breast Cancer Figure 6a. 5.11 Patient Evaluation and Clinical Considerations 15 REFERENCES 5 5.12 Insertion Precautions 16 HOW SUPPLIED/STORAGE AND HANDLING 6 5.13 Continuation and Removal Pulling the 5.14 Glucose Tolerance ADVERSE REACTIONS 17 Figure 6b. PATIENT COUNSELING INFORMATION 6 17.1 Information for Patients the insertion tube slider back 6.1 Clinical Trial Experience 6.2 Postmarketing Experience Releasing *Sections or subsections omitted from the full prescribing information are not listed 7 to reach the 1 the arms of mark Step 9–Cut the threads Mirena There is a routine and need for self inspection and regulation.Cut the threads perpendicular to the threadEsquire for • So, there Gabriel F. Zambrano, length,Step 7–Advance to fundal position is a routine. example, with sterile IUDInjuries.com leaving about curved scissors,Gently advance the inserter into the uterine cavity until 3 cm visible outside the cervix (Figure 9).he flange meets the cervix and you feel fundal resist- Friday, October 15, 2010
  • 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.comFriday, October 15, 2010
  • It pays to use our product line. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • www.MIRENA-US.com Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • ParaGard “IUC” ParaGard® IUC Reimbursement Checklist Reimbursement 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. To whom am I speaking today? (Name) (Phone no.) (Ext.) (Date) Be sure to get individual’s full name and extension. I am calling to verify whether has coverage for ParaGard®. (Patient’s name) Yes No Please confirm ’s deductible and co-pay. (Patient’s name) 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: Has insurance verification for ParaGard® been confirmed? Additional notes: Yes No For alternative payment options for your patients, please refer to the reverse side. Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • 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.comFriday, October 15, 2010
  •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`94&*?784 O#:a7*1+(847,#b)*17+1< TXS TXT E#]"W E#T"W G*1+%?784 O#: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 6th Best Selling Pharma Product in $462M 2009. 2nd Women’s Healthcare Product behind YAZ/Yasmin (DRSP/EE) Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Website: www.tevapharm.com 2009 Record Annual Sales Contact: Elana Holzman Teva Pharmaceutical Industries Ltd. 972 (3) 926-7554 Kevin Mannix Teva North America (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, Tevas 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.” Website: www.tevapharm.com Contact: Elana Holzman Teva Pharmaceutical Industries Ltd. 972 (3) 926-7554 Kevin Mannix Teva North America (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 -- Gabriel F. Zambrano, Esquire IUDInjuries.com Jerusalem, Israel, February 16, 2010 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today reported record results for the quarter and year ended December 31, 2009.Friday, October 15, 2010
  • Copper IUD embedded in bowel submucosa. “Copper IUD incidentally found during laparotomy embedded in bowel Gabriel F. Zambrano, Esquire submucosa”. IUDInjuries.comFriday, October 15, 2010
  • MIRENA IUD Uterine Perforation with adhesions. “Copper IUD incidentally found during laparotomy embedded in bowel Gabriel F. Zambrano, Esquire submucosa”. IUDInjuries.comFriday, October 15, 2010
  • IUD Cases: Any Women or Girl not on Hormonal OC • 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 Gabriel F. Zambrano, Esquire IUDInjuries.comFriday, October 15, 2010
  • Contact Me: Gabriel F. Zambrano www.IUDAttorneys.com www.IUDLawyers.com www.linkedin.com/in/gabrielfzambrano gabe@IUDInjuries.com Attorney At Law 707 S.E. Third Avenue Third Floor Fort Lauderdale, FLFriday, October 15, 2010
  • By Gabriel F. Zambrano www.RecallAttorneys.com www.IUDInjuries.com @gfzambrano gabrielfzambrano@gmail.com Attorney At Law 707 S.E. Third Avenue Third Floor www.IUDLawyers.com Fort Lauderdale, FL www.IUDAttorneys.comFriday, October 15, 2010