Home » Blog » - New FDA Safety Alert for Essure Birth Control Device

When it comes to permanent birth control, there are only a handful of options for women. There is a surgical procedure called tubal ligation and intrauterine devices (IUD). The two most popular IUD devices on the U.S. market are Essure and Mirena products.

Essure IUD uses coils which are placed in the fallopian tubes. The device forms scar tissue within the fallopian tube, which prevents pregnancy. Many women choose Essure as a permanent contraceptive because no surgery or anesthesia is needed. The device is implanted in a doctor’s office, allowing the patient to return home and resume regular activities. Essure is also very effective, with just a 0.1 percent risk of pregnancy.

However, implantation of the Essure device carries risks. Essure patients have reported serious and even life-threatening side effects, including pseudotumor cerebri, device migration causing uterine perforation. Some deaths, while rare, have even been linked to Essure usage.

To ensure that women are aware of the risks of Essure, the Food and Drug Administration (FDA) issued a safety alert on April 9, 2018. The FDA is restricting the device in a unique way. Essure can only be implanted by health care providers who guarantee that patients have been informed of the risks involved.

Providers must take the time to review a brochure with the patient. The brochure lists the possible risks of using Essure. After reviewing the brochure, both the patient and doctor must sign it.

The FDA is being especially strict with this new requirement. Bayer, the manufacturer of Essure, must implement this protocol right away, without delay. The company must also ensure that health care providers comply with the requirement. If Bayer does not follow through, the FDA promises to impose civil and criminal penalties on the manufacturer.

The reason for this unusual requirement is that women in the past were not being adequately informed of Essure’s risk. By making the checklist mandatory, the FDA seeks to ensure that every woman is made aware Essure’s risks prior to implantation.

Essure has faced other FDA restrictions in the past. In 2016, after a growing number of women came forward to complain about the device, the FDA ordered Bayer to add a black box warning to the label, as well as to conduct a new safety study.

Nadrich & Cohen is currently investigating Essure & Mirena IUD device claims, where the patient has been diagnosed with a pseudotumor cerebri condition. Pseudotumor cerebri is also referred to as idiopathic intracranial hypertension, which causes pressure to increase inside the skull. This condition can cause serious side effects and even death, if not promptly addressed.

Call our Essure Complications attorneys today, if you believe that you or a loved one received a  a pseudotumor cerebri diagnosis while using Essure. We offer a free and confidential consultation. Let us answer all of your questions and advise you of your legal options. Call us at 1-800-718-4658. We are accepting these cases nationwide.