The controversy over Essure birth control continues as women claiming to have been harmed by the device call for an aggressive response.

Essure birth control has been available since 2002, when it first got FDA approval. It consists of a pair of implants, one for each fallopian tube, that are made of a nickel-titanium alloy coil.

The device was developed by Conceptus, who later sold the product to Bayer. Bayer now estimates around 750,000 women have received Essure birth control, most of them within the U.S.

The Essure procedure allows the implants to be placed via an outpatient procedure that’s usually over within 45 minutes. The physician inserts the implants into the fallopian tubes. About three months later, scar tissue will have developed around the implant, ultimately blocking the fallopian tube and preventing fertilization.

After three months, patients are advised to return for a test to confirm that the implants are preventing pregnancy like they’re supposed to. Patients are advised to keep using other forms of birth control until it’s confirmed that their implants are working.

One Patient’s Essure Birth Control Experience

At age 28, Angela O. of Texas had already had two children, and her last pregnancy had ended in complications. She decided then to get an Essure birth control implant. Five months later, she suffered a ruptured ovarian cyst that she believes was caused by her Essure implants.

Angela says the complications of her last pregnancy pale in comparison to the physical and emotional challenges she faced from her alleged Essure complications. She says her ovarian cyst rupture was so painful it felt like being stabbed with a metal rod.

She also reports living with constant fatigue, which she says is a major obstacle to parenting her two young children the way she would like to. She says that removing her Essure implants would require a complete hysterectomy.

Thousands of other women have reported their own Essure complications, many of which have been as painful and problematic as Angela’s. There have been reports that some Essure implants have fractured or migrated out of place.

Other patients report symptoms like fatigue, abdominal pain, bloating, irregular periods, fluctuation in weight, and problems stemming from allergic reactions to the nickel in the implants.

The FDA recently took action in response to reports like these, mandating a labeling change and further clinical studies.

After months of research and deliberation, the agency announced in March 2016 that it would require Bayer to conduct a new postmarket surveillance study to get a better idea of the risks and benefits associated with Essure birth control.

The agency also introduced two new labeling changes designed to increase patients’ awareness of the potential Essure complications. One change is a new boxed warning detailing some of the complications that have been reported by women who received Essure birth control.

The second change is a new “Patient Decision Checklist” that patients will be expected to review with their physicians before consenting to an Essure procedure. The checklist will cover points such as how the device should be used and its safety and effectiveness outcomes.

Many women protested, however, that any action by the FDA short of taking Essure off the market is inadequate.