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.