Effective December 31, 2018, Bayer will end all U.S. sales of Essure birth control devices. The U.S. Food and Drug Administration (FDA) has received more than 26,000 reports of serious health issues, including organ perforation, device migration, chronic pain, internal bleeding and ectopic pregnancy. Thousands of women who have experienced these side effects have filed Essure lawsuits for damages. Women who have done the procedure claim that Bayer failed to warn about the risks of adverse side effects.
If you or a loved one has suffered serious injury or illness after being implanted with the Essure birth control device, you may have grounds to file a lawsuit against the device’s manufacturer, Bayer. The reputable Portland defective medical device lawyers at Rizk Law can review your claim and determine the legal options available to you. Your consultation is free and there is no risk or obligation to you.
Adverse Side Effects Reported
Essure birth control devices are flexible metal coils made of nickel alloy and nylon fiber that are inserted into the fallopian tubes. Over the course of three months, a natural barrier is formed from scar tissue around the coils which blocks the eggs from reaching the fallopian tubes, preventing conception. The non-surgical procedure can be performed in a doctor’s office or medical clinic.
For years, Bayer has maintained its views of Essure’s safety and effectiveness, even though the company has already stopped selling the device in Canada, Europe, South America, South Africa and the United Kingdom.
Following an Essure procedure, many women have reported adverse side effects, such as:
- Perforation of the uterus or fallopian tubes
- Chronic abdominal or pelvic pain
- Allergic reactions to nickel in the device
- Device migration and expulsion
- Migraine headaches
- Internal bleeding
- Miscarriages after unintended pregnancies
- Heavy and irregular menstruation
- Risk of ectopic pregnancy
- Fetal death
Essure is intended to remain in place as a permanent birth control solution. However, in the event of a complication, removing the device may require extensive surgery if the device migrates or breaks and goes into the abdomen or pelvis, which can result in significant organ damage and blood loss.
The FDA has also reported at least 40 deaths linked to the Essure device, including the deaths of eight adults, 20 pregnancy losses, four infant deaths after live birth and two ectopic pregnancies.
If you experienced side effects from an Essure birth control device, contact our trusted defective medical device lawyers for a free consultation. We may be able to file an Essure lawsuit on your behalf for the medical complications you have experienced.
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FDA Action Against Essure
Essure is a Class III medical device initially developed by Conceptus Inc., an American medical products manufacturer and developer, and was first approved by the FDA in November of 2012. By 2013, Essure was acquired by Bayer, a multinational pharmaceutical company based in Germany that also manufactures Mirena (an intrauterine device) and other birth control products such as Yaz and Yasmin.
Since hitting the market, the FDA has been actively monitoring the growing number of adverse reactions associated with the use of Essure. Bayer has been required to regularly submit reports concerning the safety and effectiveness of the birth control device. However, the company has been cited numerous times in the past several years for not following protocol.
The FDA has launched the following actions concerning Essure:
- November 2013 – The FDA required Bayer to update Essure’s label to include the risks of chronic pain and device migration after implantation.
- September 2015 – The FDA organized an advisory council to discuss Essure’s safety and effectiveness after receiving thousands of reports from women suffering health complications.
- February 2016 – The FDA required Bayer to perform a new mandatory clinical study of the Essure device to better understand the women who may be at risk of adverse side effects.
- November 2016 – The FDA required Bayer to update Essure’s label to include a black box warning notifying patents about the risk of organ perforation, device migration, chronic pain and allergic reactions. A black box label is the strongest warning issued by the FDA.
- February 2018 – The FDA Commissioner met with women implanted with the Essure device who suffered adverse side effects. At this time there was growing concern over women not being properly educated on the risks associated with the birth control device.
- April 2018 – The FDA decided to restrict the sale and distribution of Essure and order all health care professionals to properly inform patients of the risks involved with the device. This includes reviewing a brochure with patients that outlines the pros and cons of having the procedure.
- July 2018 – Bayer notified the FDA that it will discontinue sales and distribution of the Essure birth control device in the U.S. by the end of the year. The company insisted the decision was based on declining sales and not due to serious adverse reports over the device.
Schedule a free, no-obligation case evaluation today by calling 503.245.5677.
Essure Lawsuits Filed
Bayer continues to stand behind the product’s safety and efficiency, despite the thousands of Essure lawsuits already being filed by women who have suffered severe injury or illness. These lawsuits make several claims against the company, including failing to:
- Report Essure’s adverse side effects and trying to conceal these risks
- Report serious risks to the public of organ perforation, device migration and breakage
- Properly train physicians on how to use the device
- Safely sell and distribute Essure to qualified physicians
If you were implanted with an Essure device and have experienced adverse health complications or side effects, you may be entitled to recover compensation for past and future medical bills, surgical expenses, lost wages, loss of earning capacity and loss of enjoyment of life.
During a free consultation, our attorneys can review your claim and discuss when you received your Essure implant and the severity of complications you have suffered. We can then use this information to determine an accurate value of your damages and losses.
Fill out our Free Case Evaluation form to get started.
Contact Our Defective Medical Device Lawyers
Learn more about your rights by contacting our defective product lawyers in Portland to see if you may be able to file an Essure lawsuit to obtain the justice and compensation that you deserve.
At Rizk Law, we have years of combined legal experience advocating for the rights of victims impacted by dangerous and defective products. Manufacturers such as Bayer have a duty to ensure their products are safe and effective to use. When this duty of care is breached, we will fight to hold them accountable for negligence.
Request a free, no obligation consultation with our firm to discuss your case. We work on contingency, so there are no upfront legal fees unless we help you reach a fair outcome.
Contact our office right now by calling 503.245.5677.