User:Lukascolashop/Essure sandbox

Adverse effects

Serious side effects may include persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.

Because the inserts contain stainless steel, medical staff needs to be notified before an MRI can be done. However, the inserts were found to be safe with MRI using a 3-Tesla magnet and is considered MR-conditional.

Risks

Procedural Complications

• Inability to place inserts (4%)
• Cramping (30%)
• Pain (13%)
• Nausea/vomiting (11%)
• Dizziness/light headed (9%)
• Bleeding/spotting (7%)
• Vasovagal response (fainting) (1.3%)

• Perforation, expulsion, or other unsatisfactory location of the insert

Long-Term Complications

• Abdominal pain (3.8%)
• Back pain (9%)
• Menstrual cramps, severe (2.9%)
• Pelvic or lower abdominal pain, severe (2.5%)
• Gas/bloating (1.3%)
• Headache (2.5%)

• Heavier menstrual bleeding (1.9%)
• Vaginal discharge or infection (1.5%)
• Pregnancy (0.48%) and increased risk of ectopic pregnancy
• Nausea/vomiting
• Allergic reaction to the materials
• Heightened allergic response to other allergens
• heavy metal toxicity
• itchy, raised rash
• brain fog
• Autoimmune disease (0.99%)
• weight gain
• anxiety/depression
• hair loss
• severe anxiety
• numbness of extremities
• joint pain
• Suicide attempt (0.55%)

Regulatory history

A Facebook group called Essure Problems which had 33,140 members (as of 04/03/2017) called the method "E-hell" and mentioned mostly pain, bleeding, bloating and other side effects from the device. Some women had coils break and perforate their internal organs, conceived and gave birth to a child, at a number well above was reported in the original studies submitted to the FDA. Erin Brockovich became involved in the controversy and hosts a website where women can share their stories after having the procedure. Since then Bayer provided two toll-free telephone numbers for patient complaints, has advised that women reporting adverse effects are "consistent with clinical trials and consistent with what the FDA is seeing", and further insisted that it wanted to hear from any women experiencing problems with Essure.

In April 2015, a group of six delegates from the Essure Problems group, including a doctor with Essure experience, spoke before 36 members of the FDA and the Congressional HELP committee regarding a citizen's petition filed with the FDA. The FDA began investigating the claims of then over 16,000 members of the group as well as the legalities of the approval process that Essure went through.^{[citation needed]}

United States

The product was approved by the United States Food and Drug Administration (FDA) in 2002. In 2013, the product made news in North America, with women complaining of severe side effects leading to surgical extraction. According to one article, women who have gotten pregnant are naming these children e-babies.

In October 2013 the FDA stated that since the product was approved in 2002 it had received 943 reports of adverse events related to Essure, mainly for pain (606 of the complaints). An additional 1,000 more complaints have been sent to the FDA in a voluntary reporting system, but physicians are not obliged to report complaints.

In June 2015, the FDA reported an investigation into Essure and its over 5000 complaints, seven reported deaths, and many additional side effects, all linked to Essure, its specific chemical composition, its improper placement and its insertion. The agency announced that its Obstetrics and Gynecology Devices Panel would conduct an evidence-based review of Essure's safety in September 2015 due to the rise in adverse event reports from only 950 reports between 2002 through October 2013, to more than 4,150, or 81 percent of the total, from October 2013 to June 2015.

In February 2016, the FDA issued a "black box" label to warn the public about the harmful complications associated with the use of this device and requested Bayer to conduct a new postmarket surveillance to follow 2,000 women for at least three years, comparing the effectiveness and safety of the device with other surgical contraceptive methods. Women and doctors were required to sign a decision checklist before Essure implantation, and to give consent to a test three months later to ensure the device was properly placed and functioning.

In July 2020, Bayer published interim data from the FDA-mandated postmarket surveillance study comparing patients who received Essure to those who receiving a laparoscopic tubal ligation. The interim data reported the incidence of several reported side effects in each group. In Essure, patients, chronic lower abdominal or pelvic pain occurred in 9% and abnormal bleeding in 16%, compared to 4.5% and 10% in the tubal ligation group. It also reported new allergic or hypersensitivity reactions in 22% of patients and no reports of new autoimmune disorders, although blinded independent verification was pending. Recruitment of patients receiving Essure had ceased as the device was no longer available on the US market.