Women Suffering from Essure Side Effects: Essure Complications and Who is Eligible to File an Essure Lawsuit
Essure, a medical device that serves as the only non-surgical form of female sterilization available in the United States, has been fraught by reports of severe side effects and complications. According to the FDA, Essure complications and problems include persistent pain, perforation of the uterus or fallopian tubes, intra-abdominal or irregular bleeding, allergic and hypersensitivity reactions, and ectopic pregnancy. Some patients who have suffered from Essure complications have required surgery to remove the device.
How Essure Works
Essure consists of flexible coils, made of a nickel titanium allow and a polyester-like fiber known as PET (polyethylene terephthalate). One of the benefits of Essure is that the procedure to place the device is short and non-invasive. A physician or gynecologist inserts the coils through the vagina and cervix into the fallopian tubes. Once the coils have been inserted, tissues develop around the inserts, and within three months, most women’s fallopian tubes are sufficiently blocked as to keep sperm from reaching the ovaries, thus preventing pregnancy.
There is no incision, anesthesia is not required, and the procedure takes only 10-20 minutes. The device offers permanent birth control, or female sterilization, without the use of hormones. The lure of these benefits have resulted in approximately 750,000 American women having Essure implanted since the device was approved by the FDA in 2002, according to Bayer HealthCare. Essure was originally developed and marketed by Conceptus. Conceptus was acquired by Bayer in June of 2013. In 2013, the product label was updated to reflect new Essure injury information, noting the side effects of chronic pain and device migration.
Understanding Essure Complications
Critics of the Essure system say this method of birth control was not subject to enough pre-market testing to ensure its safety. The many Essure side effects – chronic pain, internal organ injury, bleeding, and allergic reactions – could have been the subject of Essure warnings from the start.
An article published in the New England Journal of Medicine on October 8, 2015 took this stance, stating that Essure problems might have been "detected sooner or avoided altogether" if more thorough pre- and post-market evaluations had taken place, and if the Essure risk information had been disseminated in a "more timely and transparent" way.
Adverse Event Reports of Essure Side Effects
The FDA recently took stock of Essure problems reported through the Federal Adverse Event Reporting System (FAERS). Between the time the device was approved in the United States on November 4, 2002 and May 31, 2015, 5,093 incidents of Essure problems were reported. The reports were categorized to determine the frequency of each kind of Essure side effect:
- 3,353 reports of pain or abdominal pain
- 1,408 reports of heavier or irregular menses
- 1,383 reports of headache
- 966 reports of fatigue
- 936 reports of weight fluctuation
The reports were also categorized by type of Essure device problems:
- 941 reports of nickel allergy or other device incompatibility
- 482 reports of migration of the device
- 301 reports of the device operating differently than expected
- 259 reports of device breakage
- 133 reports of device malposition
Let Our Essure Injury Lawyers Help You
Our attorneys specialize in holding large corporations accountable when they've placed profits ahead of safety. Through settlements and winning verdicts, our attorneys have obtained millions for our clients. Let us help you today.
Essure Complications Lawsuits
Filing a lawsuit will allow you to hold the pharmaceutical company accountable for damage it has caused you or a loved one, while also providing real compensation for your medical expenses, suffering and loss. Contact us today for a free consultation.