The FDA recently issued an order to restrict sales and distribution of the Essure permanent birth control, to help curb the rising number of injury reports linked with this device.

The Essure permanent birth control device is currently the only nonsurgical form of female sterilization in the United States and has been on the market since 2002.

The Essure permanent birth control consists of two metal coils, each of which is implanted into each fallopian tube. When these coils are implanted, the surrounding tissue eventually swells and ultimately prevents sperm to egg fertilization.

Even though the Essure permanent birth control device has helped numerous women, there have also been many reported instances of serious device complications. Thousands of women have reported suffering adverse side effects in conjunction with the Essure permanent birth control device including incidents of unplanned pregnancies, miscarriages, and ectopic pregnancies.

With these serious injuries reported, the FDA has taken several steps to help protect women against potential Essure complications.

Overview of Essure Permanent Birth Control Problems

The new FDA restrictions of the sale and distribution of the Essure permanent birth control device be exclusive to certain facilities and healthcare providers that complete a set of precautions.

These healthcare providers must review, complete, and sign a brochure they reviewed with patients entitled “Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgment.”

The point of this checklist is to ensure that both the patient and their healthcare providers understand the risks and benefits of the Essure permanent birth control, which will hopefully prevent new instances of device complications. It is important to note that these new restrictions must be carried out by Bayer HealthCare and that the company could face “criminal and civil penalties” from the FDA.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Dr. Scott Gottlieb stated, according to a CNN article.

According to the FDA, over 5,000 Essure injury reports were submitted to the FDA between November 2002 and May 2016. The sheer number of injury reports had prompted to the FDA to order Bayer to conduct a post-market study to evaluate the risks and benefits of the device.

The FDA also required Bayer to add a black box warning label to the Essure permanent birth control’s warning label, to further emphasize the potential device complications.

While these new restrictions are good news for consumer advocates, the majority of these members who believe the Essure permanent birth control should be taken off the market. However, consumer advocates are pleased that these FDA requirements hold Bayer to some level of accountability.