Essure health problems are being reported across the country, with numerous women opting to file legal action against manufacturer Bayer HealthCare.

Ever since its approval in 2002, there have been thousands of Essure health problems reported and public outrage regarding the device’s approval. This concern has recently spurred the FDA to investigate the long term health complications associated with the Essure birth control product.

A study recently underway by Bayer HealthCare is supposed to observe any Essure health problems that may occur over a seven year period, which will follow approximately 2,800 women. Half of these women will receive the Essure birth control device, while the remaining 1,400 will receive traditional tubal ligation.

Bayer HealthCare initiated the study at the FDA’s mandate, after receiving public outcry regarding Essure long term side effects. According to Virginia ABC News affiliate ABC8, the results of the study will not be ready until 2023 and two intern reports are set to be published sometime in 2017.

Even though consumer advocates had been calling for this for years, this long term investigation will not be assessed for years to come.

Overview of Essure Health Problems

The Essure birth control device is meant to be a permanent contraceptive choice for women who do not wish to undergo traditional hysterectomy. After it entered the market, the Essure device quickly became popular as a quick and convenient method of female sterilization.

Ever since its approval in 2002, over 750,000 women have opted for the Essure birth control device. However, up to 5,000 patients have reported long term Essure health problems, with other studies suggesting long term side effects could be a significant possibility for prospective patients.

One study observed Essure patients for five years, and found that one in eight women experienced very painful menstruation and that 3% of the women experienced Essure coil perforation in their fallopian tube.

A second study in a series had examined only 366 patients out of the original 518 subjects, and found that 38% of subjects experienced abnormal heavy menstrual bleeding, with 5% of patients experiencing pelvic pain, and 7% experiencing menstruation on regular basis.

At this time, the Regulatory Affairs Professionals Society reports a number of complications related to Essure failure, including: four adult deaths, 15 fetal deaths, and 631 pregnancies. While the Essure device is meant to guarantee female sterilization, there are reported instances of the device moving out of place and causing unwanted pregnancies.

The Essure device consists of two metal coils that are directly implanted into each of the fallopian tubes, with the inner tissue swelling around the coils to prevent sperm to egg pregnancy. So when the coils perforate and migrate out of place, it leaves the possibility open for unplanned and potentially ectopic pregnancies.

Even though these complications can be potentially fatal to patients, these Essure health problems were reportedly not mentioned on the device’s warning label. Many of these women and their families have opted to file legal action against Bayer HealthCare, for allegedly failing to warn them against potential Essure complications or for injuries incurred.