There are several forms of permanent birth control available for those who want to either stop having children or not have them at all. One prominent choice for many is known as hysteroscopic sterilization, which uses a small device called Essure to block the fallopian tubes.

The Essure hysteroscopic sterilization device consists of two small metal coils lined with a thin fabric. The device is placed through the vagina and into the fallopian tubes.

Over the following weeks and months, the Essure coils expand in place, and the surrounding tissue also grows in around the device. After a few months, the Essure device can fully block the fallopian tubes, effectively preventing the patient from becoming pregnant.

The hysteroscopic sterilization process does not involve incision or anesthesia, and can actually be done in an outpatient procedure. By contrast, another form of permanent birth control, laparoscopic sterilization, involves an incision near the navel, and the fallopian tubes are closed off with either bands or clips.

A recent study published in the journal JAMA this month compared the risks of laparoscopic and hysteroscopic sterilization procedures, finding that hysteroscopic sterilization was more heavily linked with a risk of gynecological complications like device failure or requiring the sterilization a second time. This study did not find any particular medical risks affecting one sterilization option over the other, and noted that the choice between the two options is up to the physician and the patient.

The new JAMA study was prompted by the growing concern about potential risks of the Essure hysteroscopic sterilization procedure, especially given this birth control option’s popularity. In fact, around one million patients worldwide have undergone hysteroscopic sterilization.

Risk of Essure Side Effects

Essure was first approved by the U.S. Food and Drug Administration (FDA) in 2002. The FDA received more than 5,000 reports from patients implanted with Essure over serious complications, including stillbirths, severe pain, bleeding, fallopian tube perforation, and unintended pregnancies.

Some patients who have suffered from these kinds of problems with Essure hysteroscopic sterilization have required removal surgery to alleviate symptoms, but removal surgery can carry its own risks, such as infection, further injury, and of course the additional medical expense.

In response to these complications, the FDA added a new black box warning—the most intensive of FDA label warnings, indicating serious or life-threatening risks—to the Essure label.

The use of hysteroscopic sterilization with Essure has been banned in other countries, though the U.S. continues to sell the device. Essure’s manufacturer, Bayer Healthcare, maintains that the reason Essure has been discontinued outside the U.S. is “for commercial reasons only.”

Filing a Lawsuit Over Hysteroscopic Sterilization

According to a growing number of lawsuits, Bayer Healthcare failed to adequately warn patients and the medical community about major problems with Essure hysteroscopic sterilization, choosing to actively withhold this information. Plaintiffs allege that, had they been adequately informed of these problems with Essure, they would never have chosen to undergo the hysteroscopic sterilization procedure in the first place, and would have chosen a safer alternative.

If you or someone you love has suffered from serious side effects after being implanted with Essure, you may be able to file a Bayer lawsuit. While filing a lawsuit cannot take away the pain and suffering caused by problems with Essure hysteroscopic sterilization, it can help to compensate for the financial cost of medical expenses and lost wages.