The permanent contraceptive device Essure is being investigated by lawsuit attorneys over claims of adverse side effects including perforation, organ damage and dangerous breaks. If you have had the device implanted, you can read all about the research which has raised safety concerns, what investigating Essure attorneys are alleging, and what patient claims led to the FDA receiving over 9,900 medical device reports over the implant, the majority of which were voluntarily submitted by women who received Essure implants. The popular Essure micro-insert contraceptive is the subject of a number of alleged failure complaints and injuries. Ectopic pregnancies, perforations, expulsions and pain to name just a few of the claims, but that's just the personal injury lawyers, or is it. The following presentation shares the most important studies to date researching the risks of the device to women. All the information available about the contraceptive coil system is laid bare, then our legal opinion on the matter. If you have a potential Essure lawsuit claim and would like to learn more about your legal options, review the information below then visit our site to share what happened with a leading Essure lawsuit lawyer to learn your legal options and answer your questions.

1. [IMPORTANT]
Zofran Birth Injury Lawsuit
Information

2. The Essure Insert Device
Essure, non-hormonal, permanent
birth control.
Bayer purchased the original
manufacturer and is now responsible for
the product.

3. How Does The Essure
Procedure Work?
• A small, flexible device is inserted into
the (micro-insert) fallopian tube.
• Organic body tissue develops around
and into the micro-inserts over a 3
month period, for the purpose of
blocking the fallopian tubes.
• Like a river dam, the intent is to block
sperm from reaching the egg, and
thereby preventing fertilization.

4. Essure Complications
Complications: When an Essure
implant separates, migrates or
breaks - removal can require
multiple surgeries to ex-plant, in
some cases requiring removal of
the uterus entirely.

5. Damages In SCI
Medical Costs
Adverse Side Effect
Reports
Since November 4, 2002, through December 31, 2015, the FDA
received 9,900 medical device reports related to Essure.
Source: FDA’s Review of Reported Problems

6. Damages In SCI
Most Common Problems
Source: FDA’s Review of Reported Problems
Reported Patient Problems Number of Reports
Abdominal Pain 6989
Menstrual Irregularities 3210
Headache 2990
Fatigue 2159
Weight Fluctuations 2088
The most frequently reported problems:

7. Damages In SCI
Device Problems Reported
Source: FDA’s Review of Reported Problems
Reported Patient Problems Number of Reports
Patient-Device Incompatibility (like
nickel allergy, etc)
2016
Migration of the Device (or device
component)
854
Device Operating Differently Than
Expected
490
Device Breakage 429
Device Difficult to Remove 280
The most frequently device problems reported:

8. Reported Essure
Complications
FDA has received:
• 631 Essure pregnancies reported
(despite implantation)
• 294 reports of pregnancy loss by
women, 96 of which reported as
ectopic pregnancies
• 32 reports coded by the submitter
as death
Source: FDA’s Review of Reported Problems

9. Alleged Essure Side Effects
• Extreme abdominal pain
• Severe back pain
• Unexplainable fatigue
• Weight fluctuations
• Heavy menstruation blood flow
• Depression and suicidal thoughts
• Insert Device migration
• Organ perforation
• Device breakage
• Nickel allergy reactions

10. Damages In SCI
Medical Costs
Source: FDA Actions to Better Understand Safety of Essure
Essure Contraceptive
Device Recall?
There has not been a recall of Essure. So far, the FDA:
• Ordered Bayer in February 2016 to begin post-market surveillance
study of Essure’s benefits and risks.
• Require additional warnings to product labeling, including a Patient
Decision Checklist.

11. Damages In SCI
Source: PAS Study
Reported Patient Problems Number of Reports
Adverse events after the day of the
procedure
9%
Period pain & changes in menstrual
function
5%
Perforations 7
Expulsion 1
Unsatisfactory device location & a
retained micro-insert fragment
2
• Post-Approval Study (PAS) I: 5-year follow-up under Essure
What Research Is Being
Done to Study Risks?

12. Limitations of PAS I Study
• No comparison groups used
• The length to follow-up (5
years)
• Study designed to provide
pregnancy rate

13. Damages In SCI
Source: PAS Study
38 malfunctions in 27 cases (out of 514)
Problems included:
1. Detachment problems
2. Deployment issues
3. Thumbwheel retraction difficulty
4. Inner sleeve detachment
5. Failure of delivery catheter to retract
Post-Approval Study (PAS)
II: Safety Findings

14. Damages In SCI
Source: PAS Study
13 adverse events that included:
1. Perforation
2. Pelvic Pain
3. Bleeding
4. Light headed
5. Increased blood pressure & temporary decreased pulse
Post-Approval Study (PAS)
II: Safety Findings

15. • 10X risk in patients undergoing
hysteroscopic sterilization of
requiring reoperation as opposed
to patients who underwent a
laporascopic sterilization
procedure.
According to a study published in
the British Medical Journal:
Is More Research Required?

16. “The most common complications are
perforation, migration (toward the
uterine or peritoneal cavity), and
occlusion failure.
In hysterosalpingography, vascular
intravasation is the most common
cause of diagnostic error.”
According to a study published in
PubMed:
Hysteroscopically Inserted
Essure Study Findings

17. 52 of 610 cases reported adverse
complications:
• perforation
• proximal or distal migration of the
device
• device expulsion
A study published by the Journal of
Obstetrics and Gynaecology
Canada Found the following:
Another Essure Micro-Insert
Study
Source: Europe PMC Research

18. “This case illustrates that perforation
of an Essure device can result in a
serious complication leading to
ileocecal resection.”
Small bowel obstruction and
perforation case report found:
Perforation Study
Source: ScienceDirect Case Report

19. Damages In SCI
Medical Costs
Contraceptive Coil System
Study
“Imaging of Mechanical Tubal Occlusion devices & Potential
Complications”
• Migration of the coil device observed along with expulsion
and other complications
• Tubal expulsion found to be the most common complication,
ejecting the device into the uterine cavity (0.6% to 3%)
• Placing the insert device too near the uterus suggested as
cause for expulsion
• Tubal and uterine perforation experienced at 1% to 2%
Source: RNSA Study

20. Damages In SCI
Medical Costs
Essure Lawsuit Investigation
Source: Study “Imaging of Mechanical Tubal Occlusion devices & Potential Complications”
• Complaints being investigated by Essure attorneys include
unwanted pregnancy, peritoneum and bowel perforation,
migration and uterine expulsion of the device.

21. Legal Claims Alleged Against
Bayer
Claims
• Designed a faulty product
• Negligence
• Improperly training doctors on how to use Essure
Claims
• Failure to warn the public about health risks
• Fraud
Claims
• Breach of implied and express warranty
• Willfully concealing the dangers of Essure
• Misrepresenting the safety& effectiveness of Essure

22. Do I Have a Potential
Essure Suit?
• Adverse complications should
be brought to the attention of
a qualified mass tort attorney
immediately
• Injured women are being
encouraged to share the details
of what happened with a
lawyer who will be able to
review their case and advise
them of their potential lawsuit
options.

23. Essure Lawsuit Settlement
Claims are still being investigated
by law firms who handle medical
device liability cases.
A successful litigation however,
may be be able to recover
damages in the form of financial
recovery for injuries suffered.

24. Have More Questions?

25. Considering suing for compensation?
Connect with a qualified lawsuit attorney who will
make sure you are aware of your legal rights, and
ensure your voice and needs are not ignored.
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