Following complaints by thousands of women about complications associated with the Essure birth control system, the FDA will require its manufacturers to add a new “black box warning” to the product’s label.

CNN is reporting that that between November 2002 and May 2015, over 5,000 complaints were filed with the FDA alleging problems with the permanent birth control device.

Women reported suffering Essure problems such as pain, bleeding, and unintended pregnancies, some of which ended in miscarriages or stillbirths.

Essure is a birth control system designed to be an alternative to sterilization surgery for women seeking permanent birth control. It consists of a small coil that can be implanted within a woman’s fallopian tubes. Over the next few months, scar tissue forms around the implant, blocking the fallopian tubes and preventing pregnancy.

The purported advantages of Essure include that it provides near-100 percent effectiveness against pregnancy using a non-invasive procedure that can be performed in a doctor’s office in under 10 minutes, avoiding the potential complications and recovery time associated with surgical sterilization. Essure also works without the use of hormones.

But since Essure was made available in 2002, thousands of women have reported painful and damaging complications associated with these implants. In some cases, the implant perforated the fallopian tube. Other reports say the device broke or migrated out of place. Some women also reported autoimmune reactions, possibly related to the device’s nickel content.

New FDA Requirements for Essure

The FDA uses black box warnings to alert physicians and patients of serious or life-threatening risks, according to the agency’s website. While the FDA has not issued a final text for the warning, a draft text circulated by the agency states that some Essure patients have reported “perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions.”

The FDA will also require patients and doctors to sign off on a new “patient decision checklist” before allowing the device to be implanted. The checklist would require the patient to agree to a follow-up test three months after implantation to make sure the device was still in place and working properly.

In addition to the new warning and checklist, the FDA also will require manufacturer Bayer to conduct a new study to determine what further action might be necessary to protect public health. Over a period of three years, Bayer will be required to study the experiences of over 2,000 women, some using Essure and others relying on other forms of birth control, such as surgery.

Advocates for women who suffered complications of Essure expressed disappointment with the FDA’s announcement, saying the agency’s response to the issue didn’t go far enough. Congressman Mike Fitzpatrick of Pennsylvania said that evidence of “[t]ens of thousands of injured women and hundreds of fetal deaths” ought to be reason enough to take Essure off the market.

Congressman Fitzpatrick proposes to introduce new legislation that would address reports of Essure problems in other ways, such as by blocking the Department of Veterans Affairs from purchasing the device and by removing protections against civil liability that could prevent affected women from suing Bayer.