Women who rely on Essure for birth control claim that the device has caused severe side effects and other problems. Some of these side effects include cramping, persistent pain in the pelvic cavity, nausea and vomiting, dizziness, irregular periods and bleeding, bloating, constant feelings of discomfort, itchy skin, and more.
Essure has also been associated with more severe side effects, including device migration, perforation of the uterus and fallopian tubes by the device, severe allergic reactions, unplanned pregnancies, dangerous ectopic pregnancies, and even death.
Patients who have suffered injuries from an Essure birth control device will be actively looking for a product liability law firm for legal representation. Broughton Partners connects personal injury law firms with Essure lawsuit leads and other defective medical device leads. The leads we deliver to law firms are case-ready and pre-qualified. Your law firm can get Essure lawsuit leads delivered with relevant case documents by contacting our team at (912)-304-4444 or fill out a quick online form for a free consultation.
Essure Birth Control
With the emergence of modern birth control, women can choose when they want to start a family and when they do not. As medical technology advanced over the years, more birth control options were made available, giving women the chance to choose which birth control method was right for them.
Just because there are more options, doesn’t mean women have all the necessary information about each technique to make an informed decision. The number of lawsuits piling up against Bayer, the manufacturer of the birth control Essure, highlights the fact that women, and in some cases their health care providers, are not getting the necessary information they need to choose what’s best for them.
What is Essure?
Essure is a permanent birth control device designed to prevent pregnancy without the need for surgery. Essure is the only type of birth control device on the market designed to permanently prevent pregnancy without surgery. This makes it an attractive option for many women because they can get back to their normal daily activities almost immediately. Essure is made of two small coils that are placed into the fallopian tubes and is intended to cause inflammation and scar tissue that forms and blocks the tubes, preventing pregnancy.
The maker of the Essure device claims it is effective and safe with an easy insertion procedure
Essure is a permanent, non-surgical birth control device designed to prevent pregnancy in women. It is the only one of its kind on the market intended to avoid pregnancy without a surgical procedure permanently. For this reason, Essure is an attractive option for many women, as they can return to their regular activities almost immediately after insertion.
How Does the Essure Birth Control Device Work?
Essure consists of two metal coils placed inside the fallopian tubes. The Essure coil is designed to cause scar tissue, thereby closing the tubes and preventing pregnancy. The Essure procedure, conducted in a doctor’s office, usually takes less than an hour. During the procedure, doctors use a small tube to insert the coils into the fallopian tubes through the vagina and cervix.
After the procedure, women still need to use another form of birth control because it can take months for the scar tissue to form and close the fallopian tubes completely. Typically, about three months after the initial procedure, women must go back to their doctor to take the Essure confirmation test, during which doctors use dye to see whether or not the tubes are completely closed. If they are not, women may be at risk for pregnancy because sperm is still able to enter the tubes and fertilize an egg.
Bayer markets Essure as a safe alternative to tubal ligation, which is the only other option women have for permanent birth control and requires surgery. Bayer claims its Essure implant is over 99 percent effective, but women who use it have argued otherwise. There have been reports of unintended pregnancies in women using Essure, along with thousands of other complaints against the device. Women have reported adverse events including abdominal pain, severe cramping, allergic reactions and more severe side effects. Now, women are choosing to file lawsuits against Bayer to hold the company accountable for the costs they’ve endured.
Essure Birth Control Causes Problems in Thousands of Women
Thousands of complaints have been reported to the U.S. Food and Drug Administration by women who rely on Essure for birth control and have suffered from pain and other side effects. Some of these side effects include cramping, bloating, nausea and vomiting, persistent pain in the pelvic cavity, dizziness, bleeding and irregular periods, constant discomfort, skin itching, and much more.
The device has even more severe side effects, including migration of the device, perforation of the uterus and or fallopian tubes by the device, device breakage, severe allergic reactions, unintended pregnancies, ectopic pregnancies, and even death.
The FDA has received tens of thousands of adverse event reports documenting these side effects. Since Essure is a permanent birth control device, many women who suffer from side effects choose to have hysterectomies to remove the device.
Can Essure Be Removed?
The Essure device was not designed to be removed, however, due to the large number of women experiencing severe injuries and pain, gynecological surgeons have developed removal procedures. There are two main options available for women looking to remove their Essure device:
- Hysteroscopic removal
- Laparoscopic removal
Hysteroscopic removal is only possible within the first 3 months after Essure is implanted. This procedure is done without any incisions. To remove the Essure coils, surgeons will use a camera to look at the coils within the uterus and then simply pull out the device through the cervix. It is ideal for patients to attempt this removal procedure first.
A laparoscopic removal is done after a 3 month period has passed. During this procedure, surgeons will make small incisions to the wall of the uterus to remove the Essure device. Patients are usually sent home the same day with a full recovery time of approximately 2 weeks.
Surgeons performing this procedure may have different techniques for removal and it is highly recommended for patients looking to remove their Essure device to speak with an experienced and certified gynecologist.
FDA Issues Black Box Warning For Essure
Because of the number of side effects reported, the FDA announced in February 2016 that it would be adding a black box warning to the product’s label. In November 2016, the FDA approved the black box warning and every new Essure device sold now includes this warning. Black box warnings are the strongest warnings given by the FDA, short of removing the device from the market. For many women, the warning wasn’t enough. They are fighting alongside their advocates to get Essure off the market.
On top of the boxed warning, Bayer was also required to include a patient-doctor discussion checklist to be signed by women and their doctors before getting an Essure device. The checklist contains important safety information about Essure’s potential risks and possible side effects.
Despite these changes, the FDA continues to take action regarding Essure. In April 2018, the agency announced it would begin restricting sales of Essure in the United States because women were still not getting enough information about the device’s risks before they went through with the procedure. The FDA’s latest action limits the sale of Essure to only those health care providers who read and sign the patient-doctor discussion checklist with their patients.
Even before the FDA’s announcement, sales of Essure were down about 70 percent in the U.S. Those sales could drop even further now that the restrictions are in effect.
On July 20th, 2018, Bayer announced it would stop selling Essure Birth Control Implants. “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” Bayer said in a statement.
History of Essure Birth Control Device
November 2002 – The FDA approves Essure as a Class III medical device and markets the device as a promising and safe option for female birth control.
2011 – Angie Firmalino, now an advocate for women’s health, has her Essure implant removed after it caused severe injuries and constant bleeding. Firmalino began an “Essure Problems” Facebook group and has been featured in the Netflix documentary, The Bleeding Edge, which showcases the fight against Essure.
September 2015 – FDA advisory committee examines Essure’s post-market data and peer-reviewed research. The FDA also receives reports of women claiming they suffered injuries from Essure.
October 2015 – Research from The BMJ finds that women with the Essure implant are 10x more at risk of repeat procedures compared to women with tubal ligation.
February 2016 – The FDA orders Essure manufacturer, Bayer, to conduct a new clinical trial based on adverse event reports filed.
November 2016 – The FDA requires Essure to be labeled with black box warnings to indicate the dangerous health risks associated with the device.
September 2017 – Bayer announces that they will end all Essure sales outside of the United States.
April 2018 – Between 2002 and 2017, there were more than 26,700 complaints filed with the FDA about Essure. The large number of adverse event reports the FDA received forced the agency to restrict Essure sales in April 2018.
Increasing Number of Essure Lawsuits Against Bayer
Modern birth control has given women the freedom to start a family on their terms, allowing them to choose when they get pregnant and when they don’t. Advances in medical technology have opened up a number of birth control options for women, meaning they can find the type of birth control that is right for them. This freedom of choice rests on the idea that women are given all the facts they need to make informed decisions about their ideal birth control. But the number of lawsuits mounting against healthcare giant Bayer and it’s birth control Essure shows that women—and even health care providers—are not receiving the full information they need to choose what’s right for them.
Bayer is facing an increasing number of lawsuits involving its permanent birth control Essure. Women who were harmed by the device first began filing lawsuits in late 2015 and early 2016. The number of lawsuits continues to rise as more and more women come forward. There is one major obstacle that lawyers and attorneys have had to fight to overcome when it comes to filing an Essure lawsuit: federal preemption.
When the FDA approved Essure in the early 2000s, it passed through the agency’s Premarket Approval Process. This “fast-track” approval process meant it was subject to more rigorous clinical testing before it could go to market, but the validity of those studies remains in question.
Through the PMA process, Essure was granted federal preemption, which effectively shields it from product liability lawsuits. Attorneys across the country have been fighting to overcome those obstacles and bring Essure claims to court. Since 2016, significant progress has been made in state courts, and has allowed those lawsuits to proceed. Women harmed by Essure deserve to see their cases play out in court.
What Claims Are We Looking For With Essure Lawsuit Leads
Broughton Partners will only deliver quality Essure Lawsuit leads that are pre-qualified and match the case criteria specified by your law firm. Our team of trained specialists will be examining the eligibility of cases and whether or not a patient’s claim qualifies for an Essure lawsuit. Our case intake system is built upon unique parameters and algorithms that allow us to dynamically improve case quality and conversion. We do this by running potential plaintiffs through specialized questions and a qualification process based on your law firm’s desired criteria. The Essure lawsuit leads that your law firm will receive will be questioned and examined to ensure that they are quality retained plaintiffs.
Our team will be examining Essure lawsuit leads for the following claims:
- Essure has forced a patient to undergo additional and/or revision surgery beyond the implantation
- Essure was improperly placed during the procedure
- Essure caused tearing or perforation of the fallopian tubes or nearby organs
- Essure has moved or migrated after implant surgery
- Bayer did not give adequate warnings to patients and doctors of the dangerous Essure side-effects
- Essure was defectively designed and led to severe complications
- Essure has caused allergic and immune reactions and recurring pain
Our Essure Lawsuit Leads Are Case-Ready
Broughton Partners’ goal is to provide law firms with retained Essure plaintiffs. However, we don’t stop there. We go further by providing Essure lawsuit leads pre-packaged with all the necessary case documents, such as hospital files and drug history, so you can start working the case immediately. The Essure lawsuit leads that are provided by Broughton Partners are real victims who have legitimate Essure cases.
It can be difficult to find Essure lawsuit leads, especially leads that are high-quality with retained plaintiffs. Save time and let us perform the work to find the Essure lawsuit leads your law firm needs.
Broughton Partners Can Help Your Law Firm Find More Essure Cases
Our case generation marketing firm can help you reach your goals by delivering prequalified Essure cases to your law firm. Broughton Partners provides you with plaintiffs who are fully qualified and meet your unique case criteria. Let us focus on what we do best, generating legal leads and delivering you signed cases, so you can spend more of your valuable time fighting winning cases.
Call Broughton Partners today at (855) 463-1735, or contact us for your free consultation. Together we can ensure there is No Claimant without a Claim.
- Shelia Kaplan. “Essure Birth Control Implants”, The New York Times, https://www.nytimes.com/2018/07/20/health/bayer-essure-birth-control.html. Accessed April 14, 2019.
- FDA. “Essure Permanent Birth Control: Information for Patients”, U.S. Food and Drug Administration, https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452251.htm. Accessed April 14, 2019.
- FDA. “Essure Permanent Birth Control”, U.S. Food and Drug Administration, https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/default.htm. Accessed April 14, 2019.
- Laurie McGinley. “FDA restricts sale of Essure contraceptive device, requires that women be informed of risks”, The Washington Post, https://www.washingtonpost.com/news/to-your-health/wp/2018/04/09/fda-restricts-sale-of-essure-contraceptive-device-requires-that-women-be-informed-of-risks/?noredirect=on&utm_term=.493b04ce0c07. Accessed April 14, 2019.
- Shannon Firth. “History of a Device: Essure”, MedPage Today, https://www.medpagetoday.com/obgyn/generalobgyn/69288. Accessed May 30, 2019.
- Devin Namaky, MD. “Should I have an Essure Removal?”, DailyHealthWire, https://www.trihealth.com/dailyhealthwire/living-well/womens-health/should-i-have-an-essure-removal. Accessed May 30, 2019.