IUD's: Are Women At Risk

OB/GYN’s USING IUDs -
WOMEN AT RISK DESPITE FDA
WARNINGS & PRODUCT APPROVAL
Friday, 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.IUDAttorneys.comwww.IUDLawyers.com

MTMP - October 2010
Bellagio - Las Vegas Gabriel F. Zambrano, Esquire
IUDInjuries.com

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

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
IUDInjuries.com

Usage and cost are on
the rise in the U.S.
Follow up story to July 2010.
IUDInjuries.com

“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
IUDInjuries.com

“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
IUDInjuries.com

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
IUDInjuries.com

Read the MIRENA information
again - emphasis on ‘may’
ParaGard Copper has impact on
fertilization.
Disruption of natural
meeting of sperm
and egg.
IUDInjuries.com

Safe and effective if not
contraindicated by health
concerns or past medical history.
Safety of IUD
IUDInjuries.com

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
IUDInjuries.com

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
IUDInjuries.com

What can we tell about the Women that use
IUDs from how they are promoted to them ?
IUDInjuries.com

IUDInjuries.com
OB/GYN’s: Alternative to hormonal birth control

ParaGard Copper “T”
PARAGARD IUD:
Copper T380A
IUDInjuries.com

MIRENA
Hormonal IUD
IUDInjuries.com

Know your audience. Who are they marketing too ? Look at these
Women. Do you see girls or Women ?
IUDInjuries.com

MIRENA is made by
Bayer HealthCareDid they target the same
audience of Females? Gabriel F. Zambrano, Esquire
IUDInjuries.com

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

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
IUDInjuries.com

Bayer HealthCare
Multiple Types of Contraception.
One Stop Shopping for Birth
Control.
IUDInjuries.com

YAZ & Yasmin are
promoted as Lifestyle
Internet,Social Media,SMS & TV
800 Pound Guerilla
IUDInjuries.com

Promotion of “Lifestyle” Choosing a way of Life.
IUDInjuries.com

Small like a penny. Risk Free ?
“No daily or weekly routines”.
“Hassle-free”.
IUDInjuries.com

No daily routine.
Simplify Lifestyle.
Life is too complicated for you.
IUDInjuries.com

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
IUDInjuries.com

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
IUDInjuries.com

MIRENA
• Already overpromoted
• Already overhyped
• Two (2) FDA WARNING
LETTERS
• Before July 2010
• Pattern of overpromotion:
YAZ, Yasmin, MIRENA
• Modus Operandi

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(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
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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
IUDInjuries.com

Google Organic Search “tiny T-shaped piece of plastic”

October 2009: FDA approves MIRENA for additional use for HMB
(Heavy Menstrual Bleeding)x
IUDInjuries.com
October 2009: “Better
Mouse Trap”
Fills void created by
Copper IUD

Bayer HealthCare now pushing HMB beneﬁt, emergency contraception
is ongoing and endometrial cancer beneﬁts are next.
IUDInjuries.com
MIRENA 2010 - HMB is promoted
www.MIRENA-US.com

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
IUDInjuries.com

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
IUDInjuries.com

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
IUDInjuries.com

Limited US news coverage of July 2010 FDA action. Gabriel F. Zambrano, Esquire
IUDInjuries.com

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

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
IUDInjuries.com

Listed as Side Effects not risks Gabriel F. Zambrano, Esquire
IUDInjuries.com

IUDInjuries.com
Manufacturer’s Explanation

www.MIRENA-US.com
IUDInjuries.com

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.
IUDInjuries.com

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
IUDInjuries.com

It pays to use our product line.
IUDInjuries.com

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
IUDInjuries.com

Follow the Money:
TEVA & Bayer - Contraceptive Giants responsible
for YAZ, Yasmin, Ocella and generic progeny. They
are competing for pieces of the contraceptive
marketplace.
IUDInjuries.com

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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

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
IUDInjuries.com

“Copper IUD incidentally found during laparotomy embedded in bowel
submucosa”.
IUDInjuries.com
Copper IUD embedded in bowel submucosa.

“Copper IUD incidentally found during laparotomy embedded in bowel
submucosa”.
IUDInjuries.com
MIRENA IUD Uterine Perforation with adhesions.

• 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
IUDInjuries.com

Contact Me:
Gabriel F. Zambrano
gabe@IUDInjuries.com
Attorney At Law
Third Floor
Fort Lauderdale, FL
www.IUDAttorneys.com www.IUDLawyers.com
www.linkedin.com/in/gabrielfzambrano

By
Gabriel F. Zambrano
www.RecallAttorneys.com
www.IUDInjuries.com
gabrielfzambrano@gmail.com
Attorney At Law
Third Floor
Fort Lauderdale, FL www.IUDAttorneys.comwww.IUDLawyers.com
@gfzambrano

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