The U.S. Food and Drug Administration (FDA) is reviewing safety concerns involving the permanent birth control implant Essure after mounting complaints from women who say they have been harmed by the device.

Essure, manufactured by Bayer Healthcare, was approved in 2002, and remains the only FDA-approved non-surgical permanent birth control method. Essure is a flexible coil that is permanently placed into each of the fallopian tubes where it works with the body to form a natural barrier that keeps sperm from reaching the egg, thus preventing pregnancy.

The FDA review was in large part prompted by the closed Facebook group, Essure Problems, which has more than 17,000 members and has logged more than 20,000 complaints from women who have been implanted with the device.

Those complaints involve cases in which the coils have migrated from their intended position in the fallopian tubes, leading to permanent perforation of the fallopian tube or uterine wall. In some cases, the coils have embedded into other organs. Many women have had to undergo surgeries to remove the device, including hysterectomies.

Essure side effects also include allergic reactions, severe pain, and infection. Some women have also reported metallic taste in the mouth, itching, tingling in the arms and legs, confusion, hair and tooth loss, flu-like symptoms, hallucinations, muscle weakness, bowel incontinence, severe fatigue, abscesses and various autoimmune problems.

Attorneys with Beasley Allan Law Firm are currently investigating injuries in women who have been implanted with the Essure permanent birth control. Device manufacturer Bayer is also facing lawsuits involving injuries in women implanted with its Mirena IUD contraceptive device.

New York Times

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