Essure complications and serious side effects have been experienced by women who have used this particular contraceptive device.

Injuries attributed to Essure have been the cause of action in thousands of lawsuits, many of which have been consolidated into multidistrict litigation. Essure has been banned in Australia, Brazil, and other countries.

However, the U.S. Food and Drug Administration, while having published an article covering the many injury risks associated with the device, failed to issue a similar ban, despite pressure from consumer groups and victims’ advocates.

Nonetheless, consumers have succeeded where regulators have failed, by voting with their pocketbooks: as of Dec. 31, 2018, Essure manufacturer Bayer Healthcare ceased all production and distribution of the Essure device, citing falling sales figures.

That said, there are Essure devices remaining on pharmacy shelves at U.S. hospitals, and they can still be used by the end of 2019. Here then is a brief summary of the history of Essure and the various risks that have been associated with the device.

Essure: a Brief History

The Essure contraceptive device was first approved by the FDA in 2002 by a company called Conceptus, which has since been taken over by Bayer. Unlike many new medical devices that are rushed to market through the controversial 510(k) Pre-market Notification process, Essure underwent rigorous clinical trials.

However, critics say this testing later proved to be inadequate. Over the 15 years following the device’s FDA approval, the regulatory agency received over 27,000 adverse event reports of Essure complications. These side effects included chronic pelvic and abdominal pain, heavy and painful menstruation, sudden weight loss and device migration. The latter has been the cause of serious, crippling injuries.

Essure Complications: Pelvic Pain

The most common Essure side effect, according to patient reports, is pain in the pelvic region. This can occur almost immediately following the implantation procedure. In many cases, this pain continues when the device falls out of place and perforates the fallopian tubes or uterus. In addition to painful menstrual flow, women have complained of dyspareunia and back pain.

Essure Toxicity

Women have also reported allergic reactions that include skin irritation and swelling. According to a class action lawsuit filed in Australia, this is caused by nickel poisoning from the material used to create the metal coil that was designed to cause a buildup of scar tissue in the fallopian tubes. Other potentially toxic materials include platinum and polyester fibers (polyethylene terephthalate, or PET).

Pregnancy

Approximately 6.6 percent of women who have used Essure report that the device fails its intended purpose altogether. Pregnancy usually occurs while using Essure because the coils were improperly placed, or the woman and her partner failed to use other contraceptives for the recommended three-month period after implantation.

An unexpected pregnancy is among the most serious Essure complications because these usually are ectopic (when fertilization occurs outside of the womb).

Additional Essure Side Effects

Other Essure complications that may be related to material toxicity include unexplained headaches, chronic fatigue, hair loss and psychological effects that include depression.