Essure Birth Control: Frequently Asked Questions

This website provides the answers to the most frequently asked questions regarding Essure, including injuries, recalls, warnings and litigation.

What is the Essure Birth Control Device

The Essure System was designed and intended to be a form of permanent contraception. The device consists of a small metal coil, which is implanted in the Fallopian tube. Once implanted, the metal coil causes scar tissue to form, blocking the tube and preventing the egg from descending into the uterus.

According to the manufacturer, the primary advantage of Essure is that it can be implanted without the need for invasive surgery. The procedure can be done in a physician’s office within an hour. Women who have the Essure device return for a follow-up visit 90 days later and undergo a brief x-ray procedure (known as a hysterosalpingogram, or HSG) in order to confirm that it is working as intended.

Between its FDA approval in 2002 and 2015, an estimated 750,000 women have received Essure contraceptive implants.

What are the Concerns with Essure

The FDA approval of Essure was based on only two limited, short-term studies. Originally, only 745 women participated in the initial premarket studies; only one-quarter of them were followed up after 24 months.

Since the device went on the market, the FDA has received more than 1,000 adverse event reports, half of which were received in 2013 alone. Among the numerous symptoms reported by women who have had the Essure device implanted are chronic pain, unusual bleeding, unexplained headaches, disruption of the menstrual cycle and weight gain. These injuries have been attributed to an allergic reaction to nickel, one of the metals used in the manufacture of the Essure device.

Additionally, The device is known to fall out of place, causing serious injuries as it migrates, including perforation of internal organs. Women have also reported nausea, skin rashes, hair loss, cognitive difficulties, and psychological reactions such as anxiety and depression.

What is the FDA’s Position on Essure

In 2015, the U.S. Food and Drug Administration ordered the manufacturer to conduct a postmarket study in order to get additional information about the risks and benefits of Essure. The study was approved in September 2016. Based on the results of that study, the FDA now requires a stronger, boxed warning that includes more detailed information on safety concerns, as well as a checklist of issues of which doctors and patients should be aware.

What Does the Scientific Literature Say about Essure

In October 2015, an article in the New England Journal of Medicine reported that the “device offers clear advantages,” with no need for invasive surgery; however, the authors also highlight concerns about the limited scope of initial premarket studies and the lack of long-term patient follow-up. The authors conclude that based on long-term adverse event reports, Essure is not as effective or safe as the early premarket studies indicated.

Among other concerns is a 5.7% failure rate. It is recommended that additional studies be performed focusing on patient outcomes – including unintended pregnancies and other symptoms outlined above.

Has the Essure Birth Control Device Been Recalled

In early 2015, the FDA received a petition signed by over 2,100 individuals, alleging that the manufacturer had engaged in fraud concerning the clinical trials and calling on the agency to issue a recall of the Essure device.

In its response, the FDA determined that the petition was a “trade complaint,” and that its Office of Compliance would investigate and “pursue actions as deemed necessary.” However, to date, no recall has been issued, and the manufacturer continues to maintain that the device is safe and effective.

Have Lawsuits Been Filed Involving Essure

Despite the overwhelming number of complaints received by the FDA and the manufacturer (40,000 as of the end of 2016), only about 1,000 Essure lawsuits have been filed. The major reason for this is a legal loophole, known as “pre-emption.”

Because Essure was approved through the 510(k) Pre-Approval Process, it is difficult to hold the manufacturer liable for any harm resulting from the product. Because of this, as well as the lack of assertive action on the part of the FDA, victims of the Essure device have turned to the legislature for a remedy.

H.R. 5403, also known as “Ariel Grace’s Law” (for an infant who died because of complications due to the Essure device), was introduced during the 114th Congress by Representative Michael Fitzpatrick (R-PA). The law would amend the Federal Food, Drug and Cosmetic Act, allowing victims to sue medical device manufacturers and drug makers even if the product had received Pre-Market Approval (PMA).

Who Manufactures the Essure Birth Control Device

Essure was developed in the late 1990s by a California firm, Conceptus, Inc. In 2013, German-based Bayer AG acquired Conceptus for $1.1 billion. Today, Conceptus is a wholly-owned subsidiary of Bayer. Although Bayer was not directly involved in the development, manufacture and early marketing of Essure, it took on Conceptus’ liabilities when it purchased the company.