The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction.

A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation.

[3] Initial trials found about 4% of women had tubal perforation, expulsion, or misplacement of the device at the time of the procedure.

[citation needed][9] In 2017, the CE marking in the European Union, and thus the commercial license for Essure was suspended for at least three months.

Authorities in France and Ukraine recalled the implants, and the manufacturer withdrew the product voluntarily in Canada, the UK, Finland, and the Netherlands.

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

[15] Because of the stainless steel medical staff need to be notified before magnetic resonance imaging (MRI) can be performed.

[25] Once in place, the ingrowth continues over a period of three months, resulting in blockage in the Fallopian tubes; the tissue barrier formed is supposed to prevent sperm from reaching an egg.

[citation needed] The small, flexible inserts are made from polyester fibers, nickel-titanium, stainless steel and solder.

Some women had coils break and perforate their internal organs, or conceived and gave birth to a child, at a number well above what Bayer has been reporting.

[5] In 2013, the product made news in North America, with women complaining of severe side effects leading to surgical extraction.

[4] 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).

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.

[30] Recruitment of patients receiving Essure into the postmarket surveillance study has ceased as the device is no longer available on the US market.