Information about Essure and Fetal Deaths

A device designed to prevent pregnancy, Essure is causing quite a stir as thousands of women and families come forward with complaints of serious side effects, complicated pregnancies, and even death.  In this article, we will discuss Essure and fetal deaths, complications of pregnancy, and your rights as a patient.

Information about Essure

You may have heard about Essure, but may not know exactly what it is.  Essure is a small coil device made of a combination of Nickel-titanium and stainless steel.  Essure is inserted through the vagina into the fallopian tubes, which results in scar tissue blocking the fallopian tube thus preventing pregnancy.

Any time a foreign object is placed in the body, there is a risk of complications; Essure is no different.  Though it is approved by the U.S. Food and Drug Administration (FDA), Essure has a laundry list of potential risks that could affect you and your baby if you become pregnant.

According to the FDA, the risks associated with Essure include:

• Unintended pregnancy
• Increased risk of ectopic pregnancy or miscarriage
• Risk of migration of device into nearby organs
• Perforation of fallopian tubes or uterus
• Pelvic or back pain
• Persistent fever
• Muscle or joint pain or weakness

FDA Warnings and Literature is Inadequate

The FDA has listed Essure as a Class III device, meaning that there is not enough information to assure safety or effectiveness.  Even so, nearly one million women have been implanted with the device.  According to the FDA’s website:

“The risks to women and their fetus if pregnancy occurs after Essure placement are unknown.  However, the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement.  Women who have had the Essure placement procedure are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than women who have not had the Essure placement procedure.  At present, clinical studies and individual cases of Essure sterilization failure reported in the scientific literature have not demonstrated an increased risk of neonatal or pregnancy complications when pregnancy is in the uterus following Essure placement.”

Scientific literature may not demonstrate an increased risk of neonatal or pregnancy complications, but thousands of adverse events reports would certainly indicate that complications associated with Essure are a very real problem.

Delving Further into Fetal Death Reports

In February 2016, DrugWatch published an article discussing the dangers of Essure, and the public’s cry to have it banned.  According to the article, U.S.  Representative Mike Fitzpatrick and the CEO of organization Device Events, Madris Tomes, uncovered substantial evidence to support claims of the dangers associated with Essure.

The two provided data indicating as many as 10,500 adverse events related to Essure use, and over 300 possible fetal deaths.  This is a stark contrast to the numbers indicated by the FDA, and further proves that more information and monitoring is needed.

When questioned about the data, Bayer argued that it was “irresponsible” to link Essure use to fetal deaths when an unsuccessful Essure procedure results in the termination (miscarriage) of an undesired pregnancy.  Hardly a compassionate, caring reply for a company manufacturing a device marketed as offering a hassle free birth control experience.

Not Backing Down

Device Events CEO Tomes did not back down in response to Bayer’s reply, but rather continued to advocate for the data she had uncovered, and the families it represented.  Tomes indicated that, rather than relying on one of the few terms available in the FDA reporting system (death, injury, or malfunction), she searched through adverse event reports using keywords like “stillborn”, “miscarriage”, “stillbirth”, and “fetal death”.

The result of this intensive review was a plethora of records not previously made available by Bayer or the FDA.  Among these reports were hundreds of complaints, including:

• Fetal deaths
• Miscarriages
• Ectopic pregnancies
• Spontaneous abortion
• Hysterectomy required to remove Essure device

There have also been complaints made on behalf of several states claiming that Bayer gave doctors illegal “kickbacks” for prescribing Essure.

Advocating for Families Harmed by Essure

Madris Tomes is not the only one advocating for women and families, and calling for Essure to be banned.  Consumer watchdog group, Public Citizen, testified before the FDA Advisory Committee in 2015 calling for the FDA to withdraw approval based on a “lack of reasonable assurance of safety and effectiveness”.

This basis would seem to be in line with the FDA’s Class III status for Essure, yet it has not withdrawn approval.  Some members of Congress have stated their outrage, and have threatened to force the FDA to withdraw its approval of Essure.

Also fighting for justice of Essure victims is Erin Brockovich, who runs a website and petition to stop the FDA preemption protection that is keeping thousands of women from pursuing lawsuits against Essure manufacturers.  There are currently hundreds of women supporting this movement, in addition to the thousands who have filed complaints or lawsuits.

Defective Products and Infant Injury or Death

Defective products or medical devices have been linked to birth injuries and fetal deaths.  Just because a device has been approved by the FDA, does not mean that it is completely safe, or will not have negative side effects.  A variety of medical devices or products have been linked to infant injury or death, including:

• Medications like Topamax, Zofran, and Infant Tylenol
• Medical devices like CPAP machines and tracheostomy tubes
• Household items like cribs, formula, toys, and car seats

There are also a variety of maternal situations that can result in fetal death or birth injuries, such as maternal infections.

What about Wrongful Pregnancy?

Wrongful pregnancy is a legal term used to identify cases where a woman became pregnant after a sterilization procedure, and chooses to file a lawsuit against her doctor, a pharmaceutical company, or a manufacturer of a sterilization product.  While it is unclear whether current Essure lawsuits are being filed under the category of wrongful pregnancy, it is a relevant topic to consider.

Currently, 42 states have specific wrongful pregnancy lawsuit guidelines.  Thirty-one of those states do not allow damages to include costs of raising the child.  Some states allow plaintiffs to pursue punitive damages designed to punish the defendant.

The majority of states allow plaintiffs to pursue damages for:

• Maternal lost wages
• Emotional distress
• Pain and suffering (relating to the wrongful pregnancy)
• Medical expenses associated with the pregnancy
• Expenses associated with the failed sterilization procedure

After a sterilization procedure, there is no doubt that an unplanned pregnancy and subsequent fetal death would be distressing and traumatic.  As Essure lawsuits continue and the FDA continues to review claims of a link between Essure and fetal deaths, it will be interesting to see if wrongful pregnancy lawsuits emerge.

Written By Sam Uribe

Sam Uribe is a researcher and writer. She lends her expertise to the team at Birth Injury Guide to provide up-to-date and relevant content that clients can count on.