FDA Added Black Box Warning for Essure in 2016

The FDA took the step of adding a Black Box FDA warning for Essure problems in 2016 as a result of a significant number of adverse event reports. Essure had already been on the market for 14 years, and more than 750,000 women had been implanted with the birth control device. Essure is no longer available in other countries; an ongoing FDA Essure investigation is underway in the United States. This page provides a detailed history on the regulatory history of the product, including Essure FDA warnings and Essure bans around the world.

Women and the family members of women who were harmed by side effects of the device before the FDA Essure warning was issued may be entitled to compensation by filing as Essure lawsuit. To learn about your legal rights, contact our firm for a free, no-obligation case review with an experienced Essure attorney.

FDA Essure Black Box Warning

In 2016, an FDA Essure warning was added to the product’s label, known as a Black Box warning. Intended to raise consumer awareness about severe risks posed by a medical device or pharmaceutical drug, the Black Box warning label now cautions women of the chance of chronic pain, bleeding, and device migration from Essure.

Essure risks and safety are the subject of ongoing FDA investigation, following reports from women indicating the device causes a host of unanticipated problems. Approved in 2002, critics say Essure was not adequately tested for safety or effectiveness. Instead, we have learned about Essure side effects through the experiences of consumers.

FDA Essure Side Effects Reports

As part of an ongoing investigation into Essure complications, the FDA recently provided information on adverse event reports filed through the FAERS system.

Between 2002 and 2015, more than 5,000 women reported Essure side effects to the FDA. As part of its investigation, the FDA has categorized Essure complaints:

  • 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

FDA Essure Investigation

In 2015, the FDA held an Obstetrics and Gynecology Devices Advisory Committee Meeting to examine the safety and risks of Essure. Bayer HealthCare officials testified on the safety of Essure, and patients, clinicians, researchers and safety advocates also provided insight on Essure side effects. The FDA also invited public comment on the subject for several months.

Essure Ban and Global Market Withdrawal

In the end, regulators deemed the benefits of Essure still outweigh its risks and the product remains available in the United States. In comparison, Essure was banned in Brazil and stringent Essure warnings were issued in Canada and the EU. Bayer HealthCare has recently retracted Essure for sale in every market around the globe except the United States, citing a change in consumer’s preferences. No doubt strong Essure warnings have play a role in this decline of Essure use.

American consumers filed a citizen’s petition to call for the ban of Essure in the United States, and more than 35,000 women belong to an Essure Problems group on Facebook. In 2015, a House bill, H.R. 3920, called for the FDA to withdraw approval of the device; the bill was not passed.

Let Our Essure Side Effects 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.

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.