Essure Lawsuit: What You Need to Now
More than 500,000 American women use Essure, a permanent sterilization device to prevent pregnancy. While the device is advertised as a non-invasive form of permanent birth control that is 99% effective, thousands of women have reported experiencing severe complications including:
- Chronic pelvic pain;
- Fatigue, rashes, hair loss, and weight gain;
- Organ perforation from the device shifting;
- Severe migraines and allergic reactions;
- Life threatening ectopic pregnancy; and
- Fetal death.
The Strom Law Firm, LLC is currently accepting Essure Lawsuit cases in all 50 states. If you or someone you love underwent the Essure procedure and suffered from any of these side effects, you could be entitled to compensation. Give one of our Essure Lawyers a call today to schedule your Essure Lawsuit consultation.
Essure Lawsuit Complaints
The Food and Drug Administration (FDA) has received 9,900 reports from physicians and women stating that Essure has resulted in severe side effects, including 11 deaths. In June 2015, the FDA updated the number of reports involving the Essure system including the long term risks. The FDA also issued a black box warning in February 2016 and ordered Bayer to “to conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment.”
Most recently, on November 15, 2016, the FDA announced label changes for the Essure device. The new labels include “the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure.”
The lawsuits involving the Essure birth control device claim the company hid evidence from the FDA to obtain pre-market approval. The Essure lawsuits also claim that the company failed to warn doctors and patients of the potential dangers of the medical device.
Essure Injuries and Side Effects
From 2002 to 2015 the FDA received thousands of reports involving complications related to the Essure birth control device. The most frequent problems include:
- Moderate to severe pain;
- Vaginal bleeding;
- Heavier menses/menstrual irregularities;
- Pelvic or back discomfort;
- Weight fluctuations;
- Device shifting;
- Device not operating as expected; and
- Faulty manufacturing.
Essure Lawsuit Long Term Risks
There are other health complications that result from the nickel-titanium alloys, a material that causes many women to have allergic reactions. In addition to the allergic and reactions, there are long term risks associated with the Essure device including:
- Severe pelvic pain;
- Organ perforation;
- Rashes; and
- Unintended pregnancy including ectopic pregnancy
What is the Essure Birth Control Device?
Essure is a non-surgical permanent birth control device developed by Conceptus, Inc., a company owned by Bayer. It was approved by the FDA in 2002. It is made of a nickel-titanium metal coil coated in polyester fibers. The procedure does not require anesthesia and generally takes ten to fifteen minutes to perform in a physician’s office. The doctor will insert flexible coils through the cervix into the patient’s Fallopian tubes. Once inserted, tissue will grow around the device and form a blockage in the tubes, creating a barrier to prevent sperm from reaching the eggs.
A few months after the device is inserted, a radiologist will see if the patient can rely on the Essure device to prevent pregnancy by testing whether the Fallopian tubes are completely blocked. The radiologist will inject dye, and then take an x-ray to ensure that there are no leaks past the device.
Can I Remove the Essure Birth Control Device From My Body?
For years, the Essure device was believed to be non-reversible. Now, physicians state the device can be removed. Surgeons will make an incision into each Fallopian tube and carefully remove the coils. The procedure will generally take 30-45 minutes and is conducted under general anesthesia.
Essure Complications: What Should You Do?
If you underwent the Essure procedure and you are currently experiencing any of the previously mentioned side effects, you should see a medical professional immediately. The doctor will be able to confirm whether the pain or discomfort is a result of the Essure device and will provide treatment to manage your symptoms.
Essure Lawsuit Information
On April 4, 2016, U.S. District Judge John R. Padova of the Eastern District of Pennsylvania allowed five lawsuits filed against Bayer to proceed with failure to warn and negligent misrepresentation claims. He also allowed the complaints to be amended. The five lawsuits pending before Judge Padova will continue with the following claims:
- Negligent manufacture;
- Negligent risk management;
- Breach of express warranty;
- Negligent training; and
- Fraudulent manufacturer.
Angie Firmalino an administrator and co-founder of Essure Problems said in a statement she has been fighting to expose the truth about the dangers of the Essure device.
“To finally hear that we will have our day in court was cause for celebration. The order could not have come at a better time, as we recently were let down, yet again, by our FDA.”
Why You Need an Essure Lawyer
The Strom Law Firm, LLC is currently accepting Essure Lawsuit cases in all 50 states.
If you or someone you love had the Essure birth control device implanted and suffered any of the side effects discussed in this article, give us a call today. You could be entitled to compensation.