Following thousands of complaints over Essure birth control, a panel at the Food and Drug Administration (FDA) has recommended the federal agency review additional post-market information about the device.

The FDA’s Obstetrics and Gynecology Panel met in September 2015 to review the safety and efficacy of Essure in light of the many reports of Essure complications. The panel heard from patients who said they suffered complications that followed from their Essure use, and also from representatives of Bayer, the manufacturer of Essure.

Essure was designed as a non-surgical method of permanent female sterilization, offered as an alternative to tubal ligation surgery. The device consists of a small metal coil that is inserted into the fallopian tubes through the vagina, cervix and uterus. Once in position, Essure stimulates an inflammatory response from the body that causes the fallopian tube to be permanently blocked, preventing fertilization.

Unlike tubal ligation surgery, Essure implantation can be done in a doctor’s office on an outpatient basis. A Bayer representative who spoke at the panel’s meeting noted that Essure is the only non-surgical method of permanent female sterilization.

Essure Complications

But in the more than ten years that Essure has been in use, the FDA has received almost 5,100 reports of problems associated with the device. The agency says reports of Essure complications have been increasing dramatically, rising from 115 in 2011 to approximately 2,260 in 2014.

Essure patients have been reporting instances of pain, bleeding and other complications. In some cases, the Essure implant perforated the fallopian tube or uterus.

The device also contains a nickel alloy that Bayer notes could cause an adverse reaction in patients who are allergic to nickel. Some reports also show that when pregnancy occurs despite use of Essure, that resulting pregnancy is more likely to be ectopic.

At the panel’s hearing, most of the 43 Essure patients who spoke asked for the device to be removed from the market. Two women accused Bayer of falsifying the results of clinical trials.

Generally, members of the panel expressed interest in reviewing more post-market data regarding Essure complications. Members suggested that a randomized controlled trial would be an ideal source of information but that conducting such a study would not be practical now. Instead, the panel recommended creating a patient register that would track adverse events associated with the device.

The panel made a few specific but non-binding recommendations regarding many aspects of Essure use and marketing. Regarding patient selection, the panel said Essure may not be suitable for patients with a history of autoimmune disease, hypersensitivity to metal, abnormal uterine bleeding, or pelvic inflammatory disease.

The panel also stressed the importance of counseling candidates for female sterilization about the risks and potential adverse events associated with Essure. None of the panel’s recommendations were subject to vote, nor is the agency bound to follow any of them.

In February 2015, petitioners filed a formal petition asking the FDA to take Essure off the market. The petitioners alleged that Essure’s FDA approval in 2002 was based on manipulated clinical trial data. Bayer allegedly falsified or altered records and avoided reporting adverse events. The FDA opened an investigation into those allegations in April 2015.