Is Essure warning a game changer?

Dr. Aileen Gariepy began noticing about a decade ago that implanting a form of permanent birth control called Essure was more difficult than advertised, and that women frequently had to revisit her office to make sure it worked properly.

The OB-GYN said she's one to “trust, but verify,” so she began her own research. In 2011, she published a study in the journal Obstetrics and Gynecology that found Essure's success rate was lower than advertised, and lower than the alternative, surgical tubal ligation. The results led Gariepy, now an assistant professor at the Yale School of Medicine, to more aggressively emphasize the product's risks.

“Now, I may have only one woman a year who wants it,” she said. Before then, about 75% of her patients were opting for Essure.

Last week, the Food and Drug Administration recommended that labeling for Bayer's Essure should also highlight specific concerns. The agency gave it a black-box warning and a checklist for patients to initial indicating that they understand a suite of potential adverse events.

While the FDA says the device remains an appropriate option for the majority of women, the black box could be a game-changer for clinicians. By adding its most serious warning label, the FDA is saying “suggestive evidence is compelling and consequences are high,” said Dr. Terry Fairbanks, director of MedStar Health's National Center for Human Factors in Healthcare. Practitioners might decide the device is too difficult to justify or defend, he said.

Boxed warning regulations were first instituted in 1979 to call attention to drugs with serious or life-threatening risks. The FDA could not say how many regulated products include the warnings. “There wouldn't be much use from a regulatory standpoint to keep track of a number,” an FDA spokesman said.

Last year, Essure drew scrutiny when an FDA database found more than 5,000 reports of adverse events, including unintended pregnancies, complications during removal and fetal deaths.

Bayer later said that it had received more than 17,000 adverse-event reports from around the globe. The company estimated that about 750,000 women use Essure, and about 70% of them are in the U.S.

The FDA guidance recommends a warning that states the device's nickel coils have led to “perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reaction.” It also notes that some women needed abdominal surgery to have Essure removed.

Whether a black-box warning affects sales of Essure remains to be seen. While the associated risks are gaining attention, there are still benefits. It remains the only nonsurgical, non-hormonal permanent birth control on the market, and it does not require general anesthesia to implant, said Dr. William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health.

That's why the device rapidly gained popularity after its 2002 market approval. For years, patients and physicians waited for a non-surgical approach to sterilization.

By 2012, the original manufacturer, Conceptus, saw net sales top $140 million.

“It's a good example of how physicians allowed ourselves to be duped by information that we wanted,” Gariepy said. “We cannot rely on pharmaceutical representatives to tell us whether or not something is really beneficial for our patients.”

If fewer women opt for Essure, that could show that clinicians are better at communicating the risks, said Dr. Elizabeth Micks, a member of a panel that authored a 2013 practice bulletin on the benefits and risks of sterilization for the American College of Obstetrics and Gynecology.

A black box will be a strong reminder to physicians that the product is not right for everyone, and that the recommended three-month follow-up is critical, Micks said.

The FDA wants Bayer to conduct a new post-market observational study on the device's risks in a real-world setting. The study must include more than 2,000 patients, compare Essure to tubal ligation, and follow patients for at least three years.

The manufacturer said last week that it is cooperating with the FDA.