Essure is a permanent contraceptive device for women. Physicians may recommend it as an alternative to surgical female sterilization to prevent pregnancy. Essure devices may contain defects that can cause serious abdominal injuries. If you have been affected by a defective Essure device, we can help. Contact the New York City Essure injury attorney at Sullivan Papain Block McGrath & Cannavo, PC for a free and confidential case evaluation.
Essure is a medical device manufactured by Bayer, that is used as a permanent form of birth control by way of implantation into a woman’s fallopian tubes. The device is made up of two nickel alloy coils and expands to about an inch and a half once inserted. The goal is for enough scar tissue to build up around the device, that eventually, sperm will be blocked from getting through the tubes and fertilizing an egg. Physician’s placed Essure by using a catheter to reach the uterus after passing through the vagina and cervix. The contraceptive device was once thought of as revolutionary, as the insertion procedure did not require surgery or even an incision and typically took only 10 to 15 minutes in a doctor’s office.
Essure birth control injuries are often serious. Reported cases have involved serious autoimmune reactions, serious bleeding, and intense pain at the implant site. Some devices have even broken apart and migrated inside the patient, causing internal injuries and organ damage. Autoimmune reactions have included tooth decay, weight gain, fatigue, hair loss, and joint pain. Serious allergic reactions can occur in women who are allergic to nickel. Some women have also gotten pregnant after receiving the Essure implant, with complications during their pregnancies. It is extremely difficult to remove the device. Removal often requires hysterectomy.
The many reported adverse events led to the FDA taking action in 2016, requiring Bayer to add a black box label warning—the most serious type of alert. The warning label was intended to notify women of the risks of perforation of the uterus or fallopian tubes, migration of the devices to other tissues, and persistent pain, some of which can requires additional surgery. Two years later, the FDA restricted Bayer from selling to anyone except doctors and healthcare facilities which utilized the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.” Agreeing to this stipulation, meant that the doctors and facilities which had access to Essure were required to speak to patients regarding this checklist and obtain their signature before moving ahead with the procedure to implant the device.
The lawsuits against Bayer for Essure related injuries and wrongful death claims have mounted quickly. Individual cases have been filed throughout the U.S., however there are no class actions or consolidated federal cases as of yet. Additionally, there have been no settlements or jury verdicts to date, but some courts have begun selecting cases and dates for trial.
Since the device’s approval in 2002, approximately 750,000 women have been implanted with Essure. Also within that time period, there have been more than 26,000 reported adverse events in relation to Essure and 26 fatality reports. Factors in their deaths included uterine perforation, infection, suicide, and air embolism. Eighteen of the fatality reports were related to 15 incidences of loss of pregnancy, and the last two reports were in regards to two infants who died after live birth.
It wasn’t until December 2018, that Bayer finally announced that Essure would no longer be sold in the U.S, shortly before a Netflix documentary was released, discussing this medical device litigation. Though the company is not admitting to any wrongdoing, Bayer’s decision to stop selling the device may result in even more lawsuits.
A lawsuit against the manufacturer of Essure, Conceptus, as well as Bayer, the company that now produces Essure devices, can be hard to win on your own. Going up against major manufacturing companies and their insurance providers can be difficult if you do not have a legal background. Hiring a lawyer, on the other hand, can allow you to focus on yourself while an attorney with experience handles your claim. A lawyer will use aggressive negotiations tactics to fight for justice for your serious Essure-related injuries.
If you received an Essure contraceptive device and subsequently suffered unusual, unexplained, or severe side effects, keep a record of your experience. Keep copies of medical records from your initial complaint to a physician. If you needed surgery to remove the device, keep track of your treatment and its costs. Write down how you are feeling, the side effects you experienced, and how the defective device has impacted your life. As in cases involving many people who claim to have been injured by the same product, such as with Essure litigation, there are things called Plaintiff Profile Forms or Plaintiff Fact Sheets that will need to be filled out. You as the plaintiff, will be required to complete these documents, which provide information regarding your use of the product, health history, injuries and damages you claim the product has caused. The more information you can gather about your Essure disaster, the better for your claim.
Then, contact our law firm and ask to speak to a New York City Essure injury attorney. A lawyer will listen to your story and let you know if you have a viable claim.
Our attorneys want to help you hold the manufacturer responsible for a defective and dangerous Essure birth control device. Call us right away if you have suffered persistent pain, an allergic reaction, uterus perforation, or device migration after receiving the Essure implant. We can meet you in your home or hospital if you cannot make it to our NYC office. Call us today at (212) 732-9000.