Many women who have gone on to have complications from the permanent birth control device Essure are aware of the website and related social media hashtag #EssureProblems.

This group was created by several women who wished to raise awareness about the problems associated with the permanent birth control option.

In addition to raising awareness, this group has continued to lobby against the Essure device in court, and have aided in the most recent Essure FDA warning, which is now strictest of its kind.

The group celebrated its victory at the end of November but argues that there is still a long way to go to get the device permanently removed from the market and to save women from suffering in the future.

What is Essure?

Essure is a small device made of metal and polyester coils that is inserted through the vagina into a woman’s fallopian tubes. Once it is in place, the body mounts an inflammatory reaction to the foreign object, which causes scar tissue to form around the device.

The scar tissue grows and blocks the entire fallopian tube, preventing fertilization of eggs and thus rendering a woman sterile.

What Are the Complications of Essure?

The most common complication of Essure is severe pain. Women describe it as debilitating and chronic, and most are bedridden for some time due to the pain.

Others feel as if they have the flu constantly. Some women have excessive bleeding and cramping, pelvic and back pain, headaches, some autoimmune disorders, depression and suicidal thoughts.

Other complications can include organ perforation, especially if the coils migrate to other regions, metal allergies and metal poisoning due to the metal content of the device, unintended pregnancy, fetal disfigurement as a result of poisoning, ectopic pregnancies, stillbirth and more.

The women on the website argued that there complications resulting from the use of the device are much more severe than the current Essure FDA warning which includes side effects of “mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days.”

Essure FDA Warning

In February 2016, the FDA decided to add a more serious warning to the product label for Essure. This would include an updated “black box” Essure FDA warning, the strictest of its kind.

However, critics say that most women will not even see the warning on the product because the device is shipped directly to the physician or hospital and the patient would never see it.

In response, the FDA agreed to ask Bayer to supply a patient-doctor checklist that spells out the risks of the device, and patients and physicians sign the document before the procedure takes place.

However, as of this time, the checklist is not mandatory, and not all doctors may comply, rendering it intrusive or burdensome.

In addition to the latest Essure FDA warning and patient checklist, the FDA is also requiring Bayer to conduct new clinical trials on their device.

Prior trials were considered problematic because there was no control group. The new trials will compare 1400 women with Essure with another 1400 women who have laparoscopic surgery for their permanent sterilization.

The administrators at Essure Problems, along with their attorney, state that there are already thousands of women who have reported Essure problems, approximately 25,000 on their page, with another 7000 women that have undergone the procedure to remove the device.

The worry is that during the five to six years that these women will be followed in these studies, many more women will be harmed in the meantime.

The women of Essure Problems believe that the device should be pulled during the time that the clinical trials are taking place, and that Bayer should prove their product is safe.

Instead, they say Bayer will be able to sell a harmful device while it continues to conduct its own studies on the product.

Most people do not realize that the FDA does not test any products or drugs before it is approved. The FDA requires companies to do their own testing of the devices and drugs, which many feel is a huge conflict of interest.

Clinical trials of drugs and medical devices have huge critics because they say this research is biased and is not properly carried out by independent parties with no financial ties to the company.

Essure Problems has celebrated this victory but knows that there is a long way to go to have their ultimate mission fulfilled, getting Essure permanently removed from the market, but they say they will continue to fight on.