Product manufacturers are a for-profit business. Unfortunately, in the last decade, we have seen these companies put profits before people, and Bayer is no exception. In June 2016, federal lawmakers introduced a bill in the U.S. House of Representatives called “Ariel Grace’s Law” to help consumers fight for their right to file lawsuits against Bayer for the permanent birth control device called Essure.

Essure consists of a four-centimeter coil placed into each fallopian tube to prevent pregnancy by causing severe inflammation creating a total blockage of the fallopian tubes. The coil contains nickel, which some women are unknowingly highly allergic. The coil also contains polyethylene (PET) fibers, which irritate and inflame the tubes, causing scar tissue to form over the coils, blocking subsequent fertilization.

Unfortunately the PET fibers, which create the irritation to form the scar tissue, often cause the body to fight what it deems to be an infection or foreign body, creating a host of other problems from autoimmune disorders, neurological problems, kidney, adrenal and thyroid disorders and even cancer. The coils often become dislodged, perforating the fallopian tubes, uterus, colon or other internal organs.

Hemorrhaging and damage to fetus among risks for Essure users

There are many painful side effects associated with the Essure device. Some of the more common complaints are:

  • Pain or consistent abdominal pain
  • Hemorrhaging or prolonged heavy menstruation
  • Device migration leading to uterine or other organ perforation
  • Severe allergic reaction to the nickel in the device
  • More than 300 fetal deaths before and after it was approved
  • Device breakage and failure
  • Pregnancy
  • Perforated fallopian tubes
  • Extreme pain during intercourse
  • Severe bloating
  • Hysterectomy
  • Migration

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All the potential damages to the fetus of women who become pregnant while on Essure has not been determined. There have been approximately 10,000 complaints or adverse event reports forwarded to the FDA regarding Essure-related problems.

The manufacturer is now being accused of providing fraudulent data to the FDA during the premarket approval of Essure, which resulted in the device being approved and granted protected status from most litigation. Ariel Grace’s Law is one proposed measure in congress that would allow all women injured by the Essure device to seek compensation and redress for their injuries.

In 2013, the FDA conducted a safety review of the device after receiving nearly 1,000 adverse event reports from women who alleged that they had been injured by the device. The safety concerns lodged by patients and implanting physicians included a number of reports of hemorrhaging, migration or malpositioning of the device, product breakage, pelvic pain, abnormal menstrual bleeding, and the need for hysterectomies due to complications caused by the product.

In October 2015, the British Medical Journal published a study by the Weil Medical College of Cornell University concluding patients undergoing Essure had a 10 fold higher risk of undergoing a reoperation when compared with laparoscopic sterilization. 

On February 29, 2016, the FDA ordered Bayer to put a Black Box Warning on Essure and ordered Bayer to conduct a study of 2,000 women. 

Ennis & Ennis P.A. is among those law firms standing up for Essure injury victims across the country. Our attorneys work with clients to guide them through the physical, mental and financial anguish caused by these dangerous devices. Ennis & Ennis P.A. has filed lawsuits for Essure victims nationwide, in the state of California, Missouri, New Mexico and Illinois with more to follow.

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Nationwide Essure Injury Attorneys

If you or a loved one suffered injuries from an Essure device, you may be eligible to receive compensation for medical expenses, lost wages, pain and suffering and other damages. Contact one of Ennis & Ennis’ female Essure attorneys for a free case evaluation by calling one of our offices or by filling out the Essure lawsuit case evaluation form on this page.