The U.S. Food and Drug Administration (FDA) recently announced that Bayer’s permanent birth control device, called Essure, will now be required to carry a black box warning on its label. The FDA reserves black box warnings for the most severe potential side effects of drugs and medical devices. This new box will warn consumers that Essure has caused serious adverse events in some women, including uterine perforation, severe pain, and the need for surgical removal of the device.

Essure as Permanent Birth Control

Essure is a medical device made by Bayer, which is designed to be implanted in the fallopian tubes for permanent birth control. It was designed to replace tubal ligation, a surgical procedure that fuses the fallopian tubes shut to prevent eggs from moving from the ovaries to the uterus. The Essure device is supposed to have the same effect, but it can be inserted vaginally and does not require surgical incision or anesthesia. In other words, it should carry fewer risks and require less recovery time.

The device works by causing scar tissue to form in the fallopian tubes. The device is a small metal coil with fibers inside of it. These trigger the formation of scar tissue by inflaming the fallopian tubes. After about three months, the scar tissue should block the tubes entirely, providing a permanent form of birth control.

Adverse Events Reported

Since Essure came on the market the FDA has received thousands of reports of adverse events related to it. Most women have experienced only mild side effects like minor pain, bleeding, or nausea, but others have had severe, sometimes debilitating consequences. These include perforation. The device may puncture the fallopian tubes and may even migrate and puncture other organs. This can cause severe pain and bleeding, as well as permanent damage.

Other reported adverse events include unwanted pregnancies, some of which were ectopic. Ectopic pregnancies are those that develop in the fallopian tubes and are very dangerous for the fetus and the mother. Some women have also had severe allergic reactions. Those women with the most severe reactions to Essure have had to undergo surgery to remove the device, some have had hysterectomies, and others have experienced incontinence, pelvic organ prolapse, and sexual dysfunction.

The FDA’s New Essure Warning

The FDA has not recalled the device over these issues, but it recently released a new requirement for a black box warning. The agency also issued statements explaining the importance of weighing the risks against the benefits of using Essure. In addition to the boxed warning, informing women of the adverse events that have been reported, the new labels will include a patient checklist to help women decide if the device is right for them.

Essure Lawsuits

Because of the very serious adverse events that some women have experienced after having Essure implanted, a number of lawsuits have been started against Bayer. The company insists that the device is not faulty, and that poor implantation by doctors is to blame for the issues. However, those women who have suffered because of the device believe that the company has not done enough to ensure that the device is safe or to warn women and doctors of the potential risks. In California, a judge recently remanded cases to the state, which is considered a minor win for the plaintiffs against the pharmaceutical giant.