After a five-month safety review of thousands of complaints from women, the Food and Drug Administration (FDA) announced it will place its strictest warning on the label of the permanent birth control method Essure and order more safety studies. But women who claim they have been injured by the device – they call themselves E-sisters – say the agency did not go far enough. They want Essure to be banned from the U.S. market so that other women are not harmed by the device.
“We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies,” the E-sisters said in a statement on their website.
“Clearly Essure’s PMA (pre-market approval) should be revoked and the device should be revoked and the device should be pulled from the market. These studies could take several years, and leaving the device on the market will only put more women’s lives at risk.”
Essure, made by Bayer Healthcare, was approved by the FDA in 2002 and remains the only non-surgical permanent birth control method on the market. It consists of two nickel coils that are implanted in each of the fallopian tubes, creating a barrier to prevent sperm from reaching the egg.
The FDA has received thousands of Essure side effects reports including allergic reactions, chronic pain and autoimmune disorders. The device can also migrate and perforate the fallopian tubes or uterine wall. Some women have undergone hysterectomies and other surgeries to have the device removed.
E-sisters and a Facebook group called Essure Problems have helped bring problems with Essure to the forefront, leading the FDA to launch an investigation into the safety of the devices. Rep. Mike Fitzgerald also introduced the “E-free” act to Congress in an effort to ban the contraceptive. His probe uncovered hundreds of fetal deaths linked to Essure when the FDA only reported a handful.
“We have provided the FDA with enough relevant data to prove that Essure is unsafe,” the Essure Problems Facebook group said in a statement. “Take the device off the market and revoke PMA. Do not continue to allow more women to be harmed. Unless the FDA takes those steps, we intend to push for Congress to force the hand of the FDA. We will not be stopped or silenced.”