According to the U.S. Food and Drug Administration (FDA), almost 10,000 Essure adverse events have been reported since the birth control device was first released.

The FDA is currently conducting a safety review of the Essure birth control device, which has revealed thousands of these reports of Essure adverse events.

The complications reported are often severe and dangerous, according to the FDA.

Essure Background

Essure birth control coils have become an increasingly popular method of permanent birth control, implanted in at least 750,000 women since the device’s release. Essure was first released onto the market by Bayer Healthcare in November 2002.

The Essure device consists of two metal coils which are implanted into a woman’s fallopian tubes. After initial implantation, it takes several months for the coils to effectively prevent pregnancy.

During this time, the tissue around the coils grows, eventually blocking access to the fallopian tubes altogether and preventing pregnancy.

However, despite the increasing popularity of these Essure coils, and despite Bayer’s marketing of the product as safe and effective, thousands of women have reported severe Essure adverse events.

The Essure adverse events reported in these complaints include:

• Device migration
• Uterus perforation
• Severe allergic reactions
• Infections
• Abdominal pain

These are only some of the Essure adverse events being reported by thousands of women across the country.

FDA Advisory Committee

The FDA advisory committee met back in September 2015 to discuss the safety of the Essure device in light of these Essure adverse events.

At this advisory hearing, dozens of women spoke about their own serious Essure injuries and complications.

The nearly 10,000 Essure adverse events found in this review included a variety of major problems.  Specifically, the review found:

• 6,989 of these Essure adverse events involved pain or abdominal pain
• 3,210 involved unusually heavy menstrual bleeding or other menstrual abnormalities
• 2,990 included headaches
• 2,159 fatigue reports
• 2,088 reported weight fluctuation
• 2,016 patient-device incompatibility

Some less common but still concerning Essure adverse events included 854 reports of device migration, 429 broken Essure coils, 280 problems with Essure removal, 280 reports of incorrectly positioned coils and more.

Many women suffered from more than one of these Essure adverse events at a time.

Though these were the most common complications in the reports, the FDA also noted four cases of adult deaths, 15 lost pregnancies and two infants who died after a live birth.

In addition, a whopping 631 women reported unwanted pregnancies, 96 of which were ectopic, which can be dangerous or even fatal.

Filter migration and organ perforation are two of the most dangerous Essure procedure side effects. If the Essure device migrates from its placement, it can perforate nearby organs, leading to some very dangerous complications.

Filing a Lawsuit Over Essure Adverse Events

These lawsuits allege that neither the public nor the medical community were adequately warned about the potentially severe Essure adverse events linked with the device.

Instead, Bayer Healthcare has continuously marketed Essure as a safer, simpler and more effective method of permanent birth control than other options currently available to women, the lawsuit claims.

Thousands of women who have undergone the Essure birth control implantation procedure have later filed adverse event reports over a variety of serious side effects.

Plaintiffs involved in these lawsuits allege that, had they been adequately informed of these complications, they would never have been implanted with an Essure birth control device and avoided these risks altogether.

If you or someone you love has suffered from any of these Essure adverse events or others after being implanted with the Essure birth control device, you may be able to file an Essure adverse events lawsuit.