the Essure Birth Control Implant?
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Essure is a device sold as a permanent, non-surgical birth control solution for women. First approved for use by the FDA in 2002, the sterilization procedure permanently prevents a woman from being able to conceive. Essure is a soft, flexible pair of metal and fiber coils that are inserted into the fallopian tubes by a healthcare provider. After a three-month period, scar tissue forms around the coils of the implant, creating a barrier that prevents sperm from reaching the eggs. Essure was initially manufactured by Conceptus, Inc., which was later bought by Bayer HealthCare in 2013, but has spawned increasing reports of dangerous side-effects associated with the device.
Essure Sales Discontinued Amid Safety Concerns
In April 2018, the FDA restricted Bayer’s sales of Essure to health care providers that agreed to fully inform and review the device’s risks with patients. Two years prior, the safety regulator issued a “black box” warning on the product, the most stringent caution, outlining serious injuries that could result from using the device. In July 2018, Bayer announced that it would withdraw Essure from the market by the end of the year.
Essure’s Adverse Side-Effects
While Essure is marketed as a permanent method of contraception, many women are also finding that Essure is permanently debilitating. The FDA has received about 10,000 reports of severe complications and unwanted side-effects from patients implanted with Essure, mostly since Bayer’s takeover in 2013. These effects include pregnancy, ectopic pregnancy, miscarriage, perforation of the uterus or other organs, migration of the device or its components from the fallopian tubes to the lower abdomen and pelvis, severe menstrual cramps and abnormal and/or heavy bleeding, and even death, as some reports have claimed. Other reported effects include vaginal infection, bloating, fatigue, skin allergies, hair loss, chronic pain, headaches, weight gain and depression, among others. Several women have reported persistent side-effects so severe that they required invasive surgery to remove the implanted device — and many had or are having trouble finding a doctor that will perform the complicated removal surgery. Others experienced pain so severe that a hysterectomy was their only option for relief.
These complications have led to several lawsuits filed against Bayer. The first Essure lawsuit was filed in a Philadelphia civil court in 2014, alleging the pharmaceutical company intentionally misled women implanted with Essure and actively concealed negative reports about the device from the FDA. Another Essure lawsuit filed by a California woman in September 2015 similarly alleges that Bayer concealed adverse reactions to the device and claims that the nickel coil fractured inside of her fallopian tube, causing intense pain and heavy bleeding, requiring a total hysterectomy.
Study Finds Essure Causes Serious Safety Concern
A study conducted by Weill Medical College of Cornell University researchers published by the British Medical Journal in October 2015 suggests patients implanted with Essure have a more than 10-fold higher risk of undergoing re-operation with the first year of implantation as compared to patients that undergo surgical sterilization. The study also found that Essure was no more effective at preventing pregnancy— both methods of sterilization carried a 1% risk of unintended conception. Over 8,000 Essure patients and over 44,000 patients who received surgical sterilization were studied from 2005 to 2013.
What Does This Mean for You?
You may be legally entitled to compensation if you received an Essure implant and experienced adverse side-effects. It’s not too late to investigate your claim.
Want to Know if You Have a Valid Legal Claim?
Experienced attorneys are investigating the risks of Essure and are monitoring all developments. If you or a loved one suffered complications after receiving an Essure implant, please contact us by submitting the form or by calling us at 888-985-7228 for a confidential evaluation of your potential claim.