Essure Contraceptive Under FDA Review Following Complaints

| by Reve Fisher
Diagram of Essure device being insertedDiagram of Essure device being inserted

On Sept. 25, the Food and Drug Administration (FDA) held an all-day hearing on Essure, a method of permanent contraception currently undergoing thorough investigation after reports of safety concerns and unintended pregnancies.

The FDA approved Essure in 2002. From November 2002 through May 2015, more than 5,000 women complained to the FDA about the sterilization device, saying it caused problems such as unintended pregnancies, stillbirths, debilitating pain, and bleeding, CNN reports.

Kristina Burrell is one of the women who wants the FDA to hear her plea to take Essure off the market.

After giving birth to three children, Burrell decided to get the Essure contraceptive at her gynecologist's suggestion. Unlike tubal ligations (often referred to as having your "tubes tied"), the Essure procedure is done through the vagina. As the small contraceptive device can be quickly inserted in the doctor's office, with neither an operating room nor incisions necessary, it seemed ideal.

Burrell, who also has three stepchildren, told CNN that she became pregnant while using Essure, even though she was also using a back-up method of birth control. After her pregnancy ended in premature labor and a stillbirth, Burrell said her obstetrician blamed Essure for this outcome.

Part of the device's coil was exposed, which ruptured her amniotic sac and cut off the blood supply to the fetus. Burrell added that she now needs a hysterectomy because the device has perforated her uterus.

"I'm so angry and hurt and depressed," Burrell said. "We want the FDA to listen to us and take Essure off the market."

Bayer, which makes the device, said on its website that the device is 99 percent effective at permanently preventing pregnancy. The company said that Essure's high success rate is based on a study of 449 women, which was funded by Bayer.

In a recent report in the New England Journal of Medicine, doctors at the Yale School of Medicine disagreed with many of the claims of the Bayer-funded study. The authors of the Yale article are calling for a long-term study to be performed by an objective body.

"When the FDA approved Essure, they moved too quickly on a relatively incomplete set of data," Sanket Dhruva, a Yale researcher, said. "We don't really know how well it works."

Sources: CNN, WLOS / Photo credit: WikiCommons, MedPage Today