the device was approved, and another postmarketing study had not been published as of 2015. FDA The product was approved by the 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 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% reporting pain and 10% with abnormal bleeding 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 into the postmarket surveillance study