“Yes, there are risks. There are risks with any medical procedure,” said Dr. Elizabeth Hicks, an assistant professor of obstetrics and gynecology at the University of Washington. “Patients need to be properly counseled and providers trained to minimize complications and deal with them when they occur.”
But the National Center for Health Research's Zuckerman said it's not enough for physicians to provide counseling based on the existing clinical data about Essure. “It doesn't do any good to share data if the data you are sharing are inaccurate,” she said.
The MAUDE database includes reports from women who said they visited multiple doctors who offered varying approaches for removing the Essure device. The original labeling for the device noted the lack of data on the safety and effectiveness of surgery to remove the device.
Amanda Dykeman, 33, a stay-at-home mom who lives in Coal Valley, Ill., said she experienced many of the problems other women have reported, including bloating, heavy bleeding and pain in her abdomen. She said she asked doctors about having the device removed. But they “either didn't know anything about the device, or couldn't believe it could be the source of my problems,” said Dykeman, who is an administrator on the Essure Problems Facebook support group.
Bayer's Zampaglione acknowledged that there is no specific training for doctors on how to remove the Essure device. But he added that the product labeling includes directions about which patients should have the device removed and general guidance on how to do it.
This is hardly the first time an FDA-approved device or procedure has generated patient-safety and effectiveness concerns years after it has been approved. A recent study published in JAMA Neurology found that between 2005 and 2009, Medicare beneficiaries who underwent carotid artery stenting—a procedure that gained FDA approval in 2004—had a 32% mortality rate within two years of the procedure. That study concluded that more evidence is needed to support the use of the procedure outside of randomized clinical trials.
In their New York Times op-ed, Redberg and Dhruva warned that the 21st Century Cures Act would severely weaken the FDA's “already ineffective regulatory scheme for medical devices,” shifting the burden of evidence for safety and effectiveness to post-market studies. But such studies are often delayed months or years and many are never completed or published.
Yale's Krumholz said that what's needed is a national commitment to systematically collecting data to identify problems with medical products in general clinical use. “Small issues become large when millions of different kinds of people are exposed to them,” he said.
Others say the U.S. needs a better system for regulators, manufacturers, healthcare providers and researchers to hear and respond to reports from patients who experience adverse events. Dykeman said feeling unheard is one of the most common complaints of women on the Essure Problems Facebook page.
Tassone, the OB-GYN who used to insert a lot of Essure devices, said he stopped offering the procedure after dozens of his patients complained about adverse effects, asked for removal, or got pregnant. “As physicians, our responsibility is to listen,” he said. “You have to be open to that.”