.- The FDA announced Monday that it will add its strictest warning to the label of Essure, a sterilization device in the form of flexible metal coils inserted into the fallopian tubes.
But the decision still comes as a blow to thousands of “E-sisters” – women who have experienced the often debilitating side effects of the device and who have been pushing to get Essure completely removed from the market.
“We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies,” the group said in a statement on their website.
“Clearly Essure's PMA (pre-market approval) 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.”
A so-called “black box” warning has been recommended for the device, which is “designed to call attention to serious or life-threatening risks” of the device including “persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions,” according to an FDA statement.
Touted as the only form on non-surgical permanent birth control, implanted Essure coils are supposed to stay in the fallopian tubes, where they create a chronic infection causing scar tissue to form, effectively closing the tubes and rendering the woman sterile. The device was first manufactured by the group Conceptus and pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.
In addition to the “black box” warning, the FDA asked Bayer to include a “patient decision checklist” in Essure's packaging, “to ensure women receive and understand information regarding the benefits and risks of this type of device,” and is accepting the public’s input on the device for 60 days.
The FDA has also ordered Bayer to conduct a three-year clinical study in which they will follow 2,000 women who have been implanted with Essure, and compare them to women who’ve had different sterilization procedures. The FDA expects Bayer to submit a study protocol within 30 days and the company is required by law to begin the study within 15 months, CNN reports. If Bayer does not comply, the FDA can declare the device misbranded.
The Facebook page “Essure Problems” is over 27,000 members strong (up from 14,000 just last year) and serves as a place where the “E-sisters” women band together for support and protest the device. They tell their stories to women considering the device and provide the names and locations of doctors who won’t dismiss women’s Essure complaints.
“We have provided the FDA with enough relevant data to prove that Essure is unsafe,” the group said in a statement following the FDA’s latest announcement.
“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.”
Rep. Mike Fitzpatrick, a Republican from Pennsylvania, introduced the “E-free” act to Congress in November, a bill calling for the device to be pulled from the market. He said the latest move from the FDA is unacceptable in the face of all the women who have already suffered because of Essure.
“It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market,” he said in a statement following the announcement.
“It's been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths.”
On the “Essure Problems” Facebook page, women log complaints about chronic pain, allergic reactions, perforated organs, migrating coils, and fetal disfigurement caused by the device.
Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a news briefing Monday that the agency has received 631 reports of women becoming pregnant while using the product, and 294 reports of pregnancy losses.
“Like all forms of birth control, Essure is not perfect and women may become pregnant despite use of the device. The lack of an Essure confirmation test is the most common factor contributing to unintended pregnancies in women with Essure,” Maisel said.
The FDA has received about 10,000 complaints of adverse effects since the device’s approval in 2002. Instructions for how to file a complaint about Essure can be found on the Essure Problems website.
For 60 days, patients and doctors can submit their feedback to the FDA on the device, which will be taken into consideration before the addition of the new warning labels.