Work With an Essure Lawyer to File a Birth Control Lawsuit
The birth control method known as Essure has been associated with many serious side effects that have resulted in lasting damage. To understand more about Essure’s effects on the body and how the manufacturer, Bayer, maybe be liable for your losses and damages, contact Parker Waichman LLP for a free consultation with a knowledgeable Essure attorney. We can evaluate your situation and help you determine whether to pursue an Essure implant lawsuit.
What Is Essure?
To understand Essure problems, we must first ask, “What is Essure?” Essure is a permanent method of birth control for women that consists of two tiny coils. The coils are placed in a woman’s fallopian tubes through a catheter via the vagina.
An incision is not necessary for the procedure. After insertion, scar tissue forms around the coils, which is meant to block the fallopian tubes and stop sperm from reaching an egg, causing permanent fertilization prevention.
The Essure procedure does not protect against sexually transmitted diseases, is not reversible, and does not impact menstruation. Also, some procedures may not be performed following implantation, such as some pelvic electrosurgical procedures, due to Essure inserts’ metallic components.
These devices, marketed by Bayer, received pre-market approval from the U.S. Food and Drug Administration (FDA) in 2002. According to Bayer, as of 2015, approximately 750,000 units of Essure had been sold.
Essure Linked to Serious Adverse Reactions
Thousands of women have reported significant Essure complications and health issues. Many of these women have gone on to file an Essure side effects lawsuit to seek compensation for these injuries. The FDA has received reports of more than 11,000 Essure injuries to date.
More than 40 deaths have been reported, including 15 adult deaths, 20 pregnancy losses, and five infant deaths following birth. The agency also received 2,230 reports of pregnancy from women implanted with Essure and 1,055 pregnancy losses by women implanted with Essure. If you or a loved one are one of those people, you should strongly consider filing an Essure birth control lawsuit.
What Are the Symptoms of Essure Implant Complications?
A total of 5,016 medical device reports involving Essure were made in 2016 and another 6,176 reports in 2015. Many of the reports indicate multiple side effects. These have included:
- Pelvic pain
- Heavier menstrual bleeding or irregularities
- Perforation of the fallopian tube or uterus
- Allergic reactions
- Weight changes
Researchers have found that women who were implanted with the Essure device had to undergo ten times as many operations to correct problems after the procedure compared to women who underwent traditional surgery on their fallopian tubes to prevent pregnancy. The risk of a second procedure was ten times greater in women implanted with Essure when compared to women who underwent laparoscopy. This study appeared in the online version of the British Medical Journal. Meanwhile, The Washington Post‘s reporting found a Facebook group that had 16,000 members who had experienced fatigue, tooth loss, weight loss, and bleeding after using Essure.
Federal Panel Investigates Essure
In response to some of these complaints, federal regulators convened a panel of health experts to review Essure’s safety. The panel also looked at adverse event reports and injuries related to Essure perforation and migration, device removal, chronic pain, allergic reactions, and unintended pregnancies.
During the public portion of the September 2015 panel discussion, dozens of patients spoke, discussing symptoms such as autoimmune disorders, bleeding irregularities, cataplexy, extreme fatigue, migraines, narcolepsy, painful sex, becoming pregnant after being implanted with Essure, perforation of the uterus, psoriasis, and severe abdominal pain.
Essure Lawsuit Update: What Actions Have Been Taken in Response?
On Feb. 29, 2016, the FDA announced actions it would take to address risks tied to Essure, including ordering Bayer to conduct a clinical study evaluating real-world side effects and complications associated with Essure. The FDA also planned to require a black-box warning, the strongest type of FDA warning, on the device’s label as well as a “Patient Decision Checklist” to inform patients about the benefits and risks of using Essure.
In 2018, Bayer announced that they would no longer sell Essure in the United States, citing decreased sales as the reason for discontinuing distribution.
Frequently Asked Questions in Essure Lawsuits
What Are Essure Coils Made Of?
Essure coils are made primarily from nitinol, an alloy of nickel and titanium. They also contain stainless steel as well as plastic fibers used to induce tissue growth in the fallopian tubes.
What Are the Long-Term Side Effects of Essure?
There are many serious side effects associated with Essure, but a few tend to have consequences that last much longer. Some of these side effects include:
- Abdominal and back pain
- Tear in uterus or fallopian tube
- Unintended pregnancy
- Allergic reaction
- Essure insert migration to abdominal or pelvic cavity
Is There a Recall on Essure Coils?
A recall of Essure was never issued, but Bayer pulled the product from the market in 2018.
Why Was Essure Discontinued?
Bayer claims that the decision to discontinue Essure in the United States was made because sales were dropping. Some people speculate that it’s actually because of the growing number of lawsuits against this product.
Is Essure Banned in the U.S.?
Essure is not technically “banned” in the United States. Bayer chose to remove the product from the market, which means you can no longer purchase the product in America. Some do question whether the company removed Essure by choice before it could be banned by the FDA.
How Much Are Essure Settlements?
Essure lawsuit settlement amounts can be quite high, reaching into the millions for plaintiffs who had serious side effects that will affect them for the rest of their lives. All of the responsibility for these damages falls on Bayer. An Essure lawsuit settlement amount is determined by the damages a plaintiff suffered, so the dollar amount awarded in an Essure class-action lawsuit or individual action can vary widely from case to case. A skilled Essure lawyer will seek compensation for damages including medical bills, lost wages, pain and suffering or the loss of a loved one.
Can Essure Coils Be Removed?
Yes, Essure coils can be removed. The removal process can vary depending on the state of your implants, though. In some cases, they can removed the way they went in, without incisions, but in others, surgical removal may be necessary. After surgical Essure removal, recovery time will vary depending on the procedure performed; laparoscopic incisions should only take a week or two to heal up, but if the implant has migrated, more extensive surgery might be necessary.
Does Essure Cause Weight Gain?
Essure may cause weight gain, but more patients reported that they lost weight while using Essure. Overall, weight changes were one of the least alarming side effects associated with Essure.
Find a Talented Essure
Attorney and Get Compensation
If you or someone you know wants to learn more about filing an Essure lawsuit, contact the personal injury attorneys at Parker Waichman today. We make it easy to find Essure lawyers near you by offering free case evaluations with no obligation, so you can learn more about your legal rights and make an informed decision about whether you should pursue a claim. For more information, fill out our online form or call 1-800-YOUR-LAWYER (1-800-968-7529).
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