The U.S. Food and Drug Administration is requiring a new Essure black box warning to be added to the label of the metal and polyester fiber birth control coils.

The FDA approved Essure coils in 2002. At the time, they were considered the safest method of permanent sterilization available, because implanting physicians could avoid the use of general anesthesia and surgery.

Essure coils are implanted hysteroscopically through the cervix and vagina and placed in the fallopian tubes. The process doesn’t take much time, which increased Essure’s appeal to women seeking sterilization when it first hit the market.

It was approved, however, through a short-cut method that did not require long-range studies of safety or efficacy. This method merely needs demonstrate that it is like something already on the market.

According to a CNN report, the FDA received complaints between November 2002 and May 2015 that numbered more than 5,000. These grievances ran the gamut from uncontrolled bleeding after implantation with the coils to pain, miscarriages, unintended and tubal pregnancies, miscarriages, and stillborn children.

Other sources have told of women experiencing coil migration, pelvic and bowel perforations, and horrific allergic reactions. These have led to the draft Essure black box warning that the FDA posted and sought public comment on from October to December 2016.

In addition to the new Essure black box warning that the FDA will have added, it is requiring that Essure’s manufacturing company, Bayer, start a new post-market study. This study should be designed in such a way as to provide data on the complications experienced by women implanted with Essure, so that the FDA can better compare the relative risks of tubal ligation and this non-invasive method of sterilization.

How Essure Works

Essure coils are implanted into the fallopian tubes through the vagina and cervix. The method is reliant upon the development of scar tissue around the coils. This scar tissue takes about three months to fully occlude the fallopian tubes. Once the scar tissue develops appropriately, the path for sperm and egg to unite is theoretically lost.

Part of the process of ensuring Essure coil functionality is to get an occlusion test performed at the three-month marker after implantation. The occlusion test is known as a hysterosalpingogram and involves the use of a contrast dye.

A radiologist performs and confirms whether the fallopian tubes are or are not completely blocked. Until they are completely blocked, the woman is advised to rely upon back-up methods of birth control in addition to Essure.

Essure Black Box Warning 

While the FDA is moving forward with the requirement of this new Essure black box warning and Bayer’s post-market study of the product, regulators in other countries have taken more assertive action.

The European Union has suspended the commercial license for Essure for three months as of Aug. 3, 2017. France and Ukraine have issued recalls of the product and the manufacturer has voluntarily pulled Essure from the market in Canada, United Kingdom, the Netherlands, and Finland.