In mid-November, the FDA issued approval for a new black box warning label to be added to the permanent birth control device Essure.

Following reports of 13,800 women getting sick and hundreds of deaths due to Essure adverse side effects, the FDA is now requiring Bayer, Essure’s manufacturer, to conduct a new clinical trial to look at the long-term effects of the device.

The clinical trial will begin in 2017 and will look at the outcomes of 1400 Essure patients and compare them to women who underwent tubal ligation surgery for permanent sterilization.

As of now, the FDA has decided not to issue a recall on the Essure device, saying after considering the Essure adverse side effects in light of the product’s benefits, the scientific reports and related medical findings point to the device’s safety and efficacy.

The FDA issued the following statement in response to the reported Essure adverse side effects reported by so many women:

“After significant review and analysis of available information, the FDA has concluded that Essure is safe and effective for many women but also that some women experience very serious and sometimes debilitating problems…[b]anning Essure device from the market for all patients and would limit the options available to physicians and patients. The FDA will continue to consider regulatory options that appropriately balance benefits and risks for the Essure device.”

Women Call On Congress over Essure Adverse Side Effects

Women who have suffered from Essure adverse side effects feel that the FDA has failed to protect them and other women and are now taking the matter into their own hands by contacting Congress and by filing product liability lawsuits in the court system.

Hundreds of plaintiffs currently have lawsuits pending against Bayer, claiming the manufacturer neglected to warn them about known risks and Essure adverse side effects that were associated with the use of the device.

Doctors tell their patients that Essure is a 10 minute-office procedure that does not require surgery and is more than 99% effective. A doctor inserts coils into the fallopian tubes and an inflammatory process causes scar tissue to build up around the coils, blocking the fallopian tubes and preventing fertilization.

Women have complained of metal allergies to the device components, the triggering severe autoimmune disorders, hair loss, extreme pain, bloating, rashes and more. Some have had pregnancies and complications related to these unplanned pregnancies while being implanted with the device.

In addition to the black box warning required by the FDA, a patient list is also required. Doctors must go over the information on the checklist with the patient and both must sign indicating the information was covered in consultation.

One particular situation a woman became pregnant after having the Essure device implanted, and one of the coils from the device punctured the amniotic sac. The baby, named Ariel Grace, was delivered at 27 weeks and died after only five days.

The baby was the inspiration behind a proposed law called Ariel Grace Law. The law is seeking to remove federal protection on medical device lawsuits.