The permanent contraceptive device Essure has been the center of the great deal of controversy for the last several years.

Critics have been pushing for increased safety regulations for the birth control coils in response to many adverse events reports that have been filed as a result of Essure side effects complications.

FDA Calls For Essure Boxed Warning

The latest recommendation from the FDA calls for an Essure boxed warning to appear on the label of the permanent contraception product.

In addition to the boxed warning, a patient checklist will be included that will serve to call attention to any potential adverse events that may be associated with the use of the device.

Essure is the only nonsurgical permanent sterilization method currently available on the market today and is an alternative to the traditional tubal ligation that was performed for decades.

The device consists of small metal coils which are planted into a woman’s fallopian tubes through a device inserted through cervix and uterus.

In time, tissue naturally grows around the coils and creates a physical barrier so that the sperm cannot reach the eggs to fertilize them, and this prevents pregnancy. The procedure is considered permanent and the devices are not intended to be removed from the body at any time.

Reports of Essure Complications

The FDA has received many reports of adverse effects related to the use of the device, including organ perforation, specifically of the uterus or fallopian tubes, persistent pain, allergic or hypersensitivity reactions to the materials included in the device as well as device migration.

Some women have had ectopic pregnancies and stillbirth babies despite having the Essure device in place.

As a result, a number of women have had surgery to remove the device, but many of these women who chose to go that route did not experience full relief of their symptoms following the surgery to remove the device.

Last September, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to gather more information. The committee heard expert scientific information, clinical opinions as well as experiences from patients themselves regarding the safety of Essure.

Following the meeting, the FDA reached a conclusion and said that many women are not receiving or understanding information related to the risks and benefits of the Essure device, and felt that an Essure boxed warning on the product label would help.

The label will also include a statement to the physician saying that risks and benefits should be discussed with the patient as they consider Essure sterilization.

FDA Essure Warning Includes Patient Checklist

In addition, the FDA says that Essure should contain a patient checklist that should be reviewed by the physician and both the patient and physician should sign the form indicating that they have discussed the device’s use, safety and effectiveness.

The FDA says that the boxed warning and patient checklist will “will help to ensure a woman receives and understands the benefits and risks associated with her contraceptive options so that she can make an informed decision as to whether a permanent hysteroscopically-placed tubal implant intended for sterilization is the right choice for her.”

Despite the FDA moving forward to move toward increased product safety, many advocates feel that the Essure boxed warning and patient guide does not do enough to reduce or eliminate the severe complications that can arise from the use of the device.

Some see the FDA’s move as a step in the right direction, while others feel that the only way to ensure the safety of the Essure device is to remove it from the market altogether.