The US Food and Drug Administration (FDA) calls for the strongest warning for Essure's birth control device.

The FDA issued a new requirement for German drug maker, Bayer AG, to create a new clinical study for their permanent birth control implant Essure in order to determine its effects on women who use it. Furthermore, the government agency is requiring the company to include a black box warning and a "Patient Decision Checklist" on the product's label.

Essure has been around for 14 years since it was released in 2002. The postmarket study will include more than 2,000 women who will be followed for at least three years. The results of women who have used Essure's birth control implant will then be compared to those who have undergone tubal ligation.

"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," said Dr. William Maisel, FDA's Center for Devices and Radiological Health director for science, in a press release. "They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications."

According to Reuters, Essure is marketed as an alternative to ligation in women. It is a small coil that is inserted into the fallopian tubes that will prevent sperm from reaching or fertilizing the eggs. It is considered to be a permanent form of birth control.

There have been numerous complaints against Essure. Some women have reported that the device has broken or moved, therefore resulting in unwanted pregnancies. Others have complained of chronic pain, lupus and psoriasis. The Washington Post reports that Bayer is being sued over the device failing, but they maintain that it is "effective at preventing pregnancies."

The outlet reports that a Facebook group of women called "Essure Problems" has criticized the FDA's decision to have Essure still be available on the market.

"These studies could take several years, and leaving the device on the market will only put more women's lives at risk," the group said. "We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device."

In the agency's press release, the FDA believes that Essure is still a viable alternative for women who are looking for other forms of birth control. However, they added that women may experience some complications from using Essure, including "persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions."

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