[IMPORTANT]

Zofran Birth Injury Lawsuit

Information

The Essure Insert Device

Essure, non-hormonal, permanent

birth control.

Bayer purchased the original manufacturer and is now responsible for the product.

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.

Essure Complications

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

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

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:

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 devicecomponent)

854

Device Operating Differently Than Expected

490

Device Breakage 429

Device Difficult to Remove 280

The most frequently device problems reported:

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

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

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.

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?

Limitations of PAS I Study

• No comparison groups used• The length to follow-up (5

years)• Study designed to provide

pregnancy rate

Damages In SCI

Source: PAS Study

38 malfunctions in 27 cases (out of 514)

Problems included:1. Detachment problems2. Deployment issues3. Thumbwheel retraction difficulty4. Inner sleeve detachment5. Failure of delivery catheter to retract

Post-Approval Study (PAS)

II: Safety Findings

Damages In SCI

Source: PAS Study

13 adverse events that included:

1. Perforation2. Pelvic Pain3. Bleeding4. Light headed5. Increased blood pressure & temporary decreased pulse

Post-Approval Study (PAS)

II: Safety Findings

• 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?

“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

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 GynaecologyCanada Found the following:

Another Essure Micro-Insert

Study

Source: Europe PMC Research

“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

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

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.

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

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.

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.

Have More Questions?

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.

www.LawsuitLegal.com

Connecting people with legitimate legal claims to attorneys nationwide who can help, Lawsuit Legal

makes it simple and easy to acquire award-winning legal assistance when it's needed most.

About LawsuitLegal.com

401 E. Las Olas Blvd, Suite 130-484, Ft. Lauderdale, FL 33301Phone (Toll Free): (888) 713-6653 | Connect with Us on Facebook

Source: https://www.lawsuitlegal.com/class-action.php