Essure Birth Control Safety Alert Overview

Have You Suffered Severe Side Effects from Essure Permanent Birth Control?

Essure is a form of permanent birth control that works by creating scar tissue in a woman’s fallopian tubes to stop eggs from descending into the uterus and sperm from entering the fallopian tubes. The Essure medical device is a coil made from stainless steel, nickel titanium and polyethylene fibers. The coil is inserted through the vagina into the fallopian tubes, where it expands and anchors into the walls of the tubes. During the months following insertion, scar tissue builds up to seal the fallopian tubes.

Bayer markets Essure as the only FDA-approved form of permanent birth control available to women without a surgical procedure. Essure is promoted as being over 99% effective at permanently preventing pregnancy with a quick recovery after insertion. However, many women report severe and debilitating side effects as a result of Essure, including severe pelvic pain, autoimmune problems, migraines, hair loss, and even perforation of the fallopian tubes or other organs. These reports are significant as over 750,000 women and their doctors have chosen Essure as a method of permanent birth control.


Essure is a form of permanent birth control that was first approved by the U.S. Food and Drug Administration (FDA) in 2002. Essure was originally manufactured and marketed by Conceptus, Incorporated, and was later acquired by Bayer in 2013. Essure is classified by the FDA as a Class III device, a category of devices that “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” As a result, Essure was required to undergo the FDA’s most stringent review prior to being offered on the open market: the Pre-Market Approval (PMA) process.

The FDA’s original PMA approval for Essure required Conceptus to conduct two post-approval studies. First, Conceptus was required to obtain follow up information on participants from the two premarket clinical trials for period of five years. Second, Conceptus was required to evaluate the bilateral placement rate for newly trained physicians. According to some news reports, several participants in the clinical trials claim that the side effects they suffered were not properly reported. One of the trial participants even filed suit against Bayer because she suffered from side effects such as sharp pains, migraines, fatigue and joint pain, interfering with her ability to work.

In order to monitor the safety and effectiveness of medical devices such as Essure, the FDA relies on a variety of postmarket surveillance data. For example, one type of postmarket surveillance data is the adverse event reports that are submitted to the FDA by patients or their health care providers. From November 4, 2002 to December 31, 2015, the FDA received 9,900 reports that were related to Essure. The most frequently reported side effects were pain/abdominal pain, heavier menses/menstrual irregularities, headaches, fatigue, and weight fluctuations, with most reports listing multiple problems. The most frequent device problems reported to the FDA were patient-device incompatibility (e.g., nickel allergy), migration of the device or device component, device operating differently than expected, device breakage, device difficult to remove, malposition of the device, and device difficult to insert. Furthermore, there were 26 correctly-coded reports of death, with 4 being adult deaths; 15 incidences of pregnancy loss; and two incidents of a death of an infant after live birth. It appears that in certain instances Essure fails to prevent pregnancy, as the FDA has received 631 reports of pregnancies in patients with Essure.

In 2015, the FDA convened an Advisory Committee comprised of panel of experts to evaluate Essure in response to widespread safety concerns in postmarket surveillance data. As part of its investigation, the FDA reviewed alleged clinical trial misconduct, including that “clinical trial participants’ medical records were altered to reflect more favorable data about participants’ experiences, and that the sponsor violated the terms of the PMA approval order and violated laws that relate to the manufacturing and marketing of Essure.” The FDA identified modifications to case report forms but found that the modifications were not intentionally made to reflect more favorable data for Essure.

As a result of the FDA Advisory Committee’s investigation and analysis, the agency announced a requirement for a mandatory postmarket clinical study “to determine heightened risks for particular women.” Furthermore, the agency has now required that Essure carry a black box warning, the agency’s most severe warning, and a Patient Decision Checklist designed to inform women of the risks. Bayer maintains that Essure is safe and effective for the majority of women who want permanent birth control. However, thousands of women have reported side effects such as severe pain and even organ performation after insertion of Essure. Because Essure was approved through the stringent PMA process, patients suffering serious debilitating side effects from Essure have had difficulty suing Bayer. However, the newly-required black box warning and recent state court rulings indicate that women suffering serious consequences from Essure may now be able to seek relief in the courts.

If you or a loved one have been injured by Essure, contact our team of lawyers to help assert your legal rights.

Risks and Side Effects

Essure is a form of permanent birth control that works by creating scar tissue to seal a woman’s fallopian tubes. Although some women do not experience serious adverse side effects after implantation of Essure, a wide range of serious side effects have been reported to the U.S. Food and Drug Administration. Research shows that some women suffer from perforation of fallopian tubes or other organs, meaning the device, or a broken segment of the device, pokes through the fallopian tubes or other organs. Other side effects include autoimmune problems, migraines, hair loss, fatigue, severe or other pelvic pain, allergic reaction, neurological damage, and even death.

Often times removal of Essure can alleviate the symptoms. However, in certain cases, a normal Essure removal is not possible because the fallopian tubes and uterus are too damaged. In these cases, surgeons often opt to perform a complete hysterectomy. A hysterectomy has serious potential long-term effects such as incontinence, bowel dysfunction, pelvic organ prolapse, sexual problems and the formation of scar tissue in the pelvic organs. A hysterectomy may be performed by a technique called power morcellation, in which the surgeon uses an electric drill-like device to chop up and remove the uterus from the pelvic cavity. This may be problematic as morcellation can spread uterine cancer if not previously diagnosed. Some of the life-long side effects of a hysterectomy may necessitate the implantation of vaginal mesh, another medical product that has been found to cause complications such as organ perforation and severe pelvic pain. Therefore, women may face additional complications and problems associated with Essure removal.

If you or a loved one have been injured by Essure, contact our team of lawyers to help assert your legal rights.


Explanation of the history uses and risks associated with Essure

FDA website with information regarding Essure, including regulatory history and labeling information for patients and health care providers.

The U.S. Food and Drug Administration activities in reviewing the safety concerns regarding Essure.

Comments from the American Congress of Obstetricians and Gynecologists to the FDA regarding Essure.

Articles regarding the U.S. Food and Drug Administration’s requirement that Essure carries a black box warning.