The FDA has placed new restrictions on the sale of Bayer AG’s Essure permanent birth control device. On April 9, 2018, they announced that only doctors and medical centers that agree to review with patients a “discussion checklist” will be allowed to sell and distribute the device.
This marks one of many actions taken by the FDA in response to the thousands of adverse events associated with Essure devices.
Women Suffer from Essure Side Effects
Essure is a small, spring-like device made of metal that is placed inside a woman’s fallopian tubes to help prevent pregnancy. It is the only permanent form of birth control that can be implanted without an incision. Once it is placed in the tubes, it creates an inflammatory reaction that encourages the formation of scar tissue. After about three months, the scar tissue creates a blockage in the tubes, preventing sperm from reaching the eggs.
The device received FDA approval in 2002, but since then it has been associated with thousands of adverse event reports. Between 2002 and 2017, the FDA received 26,773 reports related to the device, with women complaining of side effects like abnormal bleeding, abdominal pain, menstrual irregularities, and weight fluctuations.
Problems reported with the device include allergic reactions (typically to the metal materials), device migration and breakage, dislocation, and malpositioning. The FDA received reports of over 1,800 women becoming pregnant after implantation of the device, with many of those suffering from life-threatening ectopic pregnancies.
FDA Gathers Data About Risks Associated with Essure
In 2016, after examining all the data associated with Essure, the FDA required Bayer to add a black box warning to the product—the most serious warning—to alert doctors and patients to the potential for serious side effects and complications. They have also required Bayer to conduct additional studies to help the FDA understand the potential risks associated with the product.
Back in 2015, the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel. During the meeting, the members of the panel listened to scientific and medical experts, and to women who claimed to have been injured by the device. Following that meeting, they issued a new guidance for patients in October 2016.
The new guidance included a decision checklist for patients with information about the device, its use, and its safety and effectiveness, including its possible side effects and complications.
FDA Requires Doctors and Medical Centers to Discuss Essure Risks with Women
After the release of that guidance in October 2016, however, the FDA determined that some women were still not receiving the information concerning Essure’s potential risks. So they took action and issued an order restricting the sales and distribution of the device only to those healthcare providers and facilities that provide information to patients about the risks and benefits.
Specifically, prior to prescribing Essure, doctors were required to give women the Essure patient brochure, which includes the patient-doctor discussion checklist. The patient must review the information in the brochure and sign it, and the physician must also sign it, before implanting the device.
“Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device,” said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process.”
In June 2018, Bayer announced that it would stop selling Essure birth by the end of the year. So far, more than 15,000 Essure lawsuits have been filed against the manufacturer.
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