Essure, a popular permanent birth control device, has undergone a number of substantial Essure label changes updating its information.

There are three major Essure label changes for the public to be aware of.

The first of these Essure label changes is the boxed warning update. This boxed warning includes Essure’s most serious side effects.

The warning notes reports of the perforation of the uterus or fallopian tubes, and persistent pain. The updated warning also includes a warning about potential allergic or hypersensitivity reactions.

The boxed warning warns patients about the nickel, titanium, iron, and chromium metals that make up the device, noting that patients who are allergic to these metals may experience rash, itching, or hives in an allergic reaction to these metals.

The Essure label changes also warn patients that if Essure results in an adverse reaction that requires removal of the device, patients must undergo surgery for that removal.

The second of these Essure label changes is the inclusion of a patient decision checklist. This checklist highlights both the benefits and the risks of using Essure as a birth control.

One major factor that this label notes is that Essure is a permanent form of birth control, while other, non-permanent forms of birth control include oral contraceptives and condoms, which are another option.

Possible adverse effects of Essure included in the risk section of this warning include cramping, pain, nausea, vomiting, dizziness, and vaginal bleeding.

The third of the Essure label changes is a note about the importance of reporting any Essure adverse effects, from pharmacists to physicians to patients, to the FDA.

The U.S. Food and Drug Administration is requiring that Bayer Healthcare, the manufacturer of Essure, conduct a postmarket surveillance study in order to get a better grasp of Essure’s risks.

Essure Background

The Essure device consists of two metal coils which are implanted into a patient’s fallopian tubes. It takes months following the initial Essure procedure for the coils to become effective, expanding in place and allowing tissue to grow around them. Eventually, this is intended to completely block the fallopian tubes and prevent any pregnancy.

According to Bayer Healthcare advertising and marketing, the Essure device coils is a safe and effective method of permanent birth control.

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, lawsuits claim.

Essure Permanent Injuries

Essure complications that have thus far been reported include device migration, organ perforation, and severe pain.

Because of Bayer’s Essure birth control popularity, problems with the device could impact thousands of women. According to Bayer, around 900,000 women currently use the Essure coils.

Essure was approved by the U.S. Food and Drug Administration as a Class III medical device in 2002. By 2015, over 5,000 adverse event reports had been filed in its Manufacturer and User Facility Device Experience database.

These adverse event reports ranged from abnormal bleeding to device migration and organ perforation.

Essure Lawsuits

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