Delayed Scrutiny: Problems with Birth Control Device Expose Gaps in FDA Oversight

[…] More than 19,000 women—some of whom call themselves the “E-sisters”—have joined a Facebook support group called Essure Problems. Many have reported debilitating abdominal pain, heavy bleeding and large weight fluctuations. They claim these side effects were not disclosed to them by the manufacturer or their doctors, and that their complaints have been dismissed for years by the device manufacturer, physicians and the federal government. At least five women have filed product liability lawsuits against Bayer Healthcare, the product’s manufacturer, in connection with the use of Essure.Last month, the FDA issued an alert after a search of the agency’s Manufacturer and User Facility Device Experience, or MAUDE, database found more than 5,000 reports of adverse events related to Essure, some more serious than the risks listed on the warning label. The database includes reports of unintended pregnancies, complications during removal, and five fetal deaths after Essure failed to prevent pregnancy. An estimated 750,000 women worldwide have had the Essure device inserted. […]

The controversy over Essure is raising broader concerns about how the FDA reviews medical devices; lack of transparency in clinical trials; the adequacy of post-approval surveillance for safety and effectiveness issues; the amount of attention given to patient complaints; and the marketing and financial incentives to doctors aimed at boosting sales of new products.


Abdominal pain: 3,353
Heavy or irregular menstrual cycles: 1,408
Headache: 1,383
Fatigue: 966
Incompatibilities, like allergies:941
Weight fluctuations: 836
Device moving out of location:482
Broken device: 259
Bad positioning of the device:133
Note: Incidents reported through May 31, 2015
Source: Food and Drug Administration

[…] “Essure exemplifies the dangers,” said Dr. Sanket Dhruva, a clinical scholar at Yale University, who co-wrote a New York Times op-ed piece this month with Dr. Rita Redberg of the University of California at San Francisco warning about the risks of the proposed 21st Century Cures Act. “It has been on the market for over a decade despite serious safety concerns when there are other, safer, contraceptive options.”

Diana Zuckerman
“We have data that both companies provided, but we don’t have assurance that the data (are) an accurate representation of the truth.” Diana Zuckerman President of the National Center for Health Research

Essure could become a poster product for critics of the current regulatory process. Diana Zuckerman, president of the Washington, D.C.-based advocacy group National Center for Health Research, said her group heard Essure complaints from more than 900 women this year when it conducted an online survey. “If even half of what I’ve heard is true, there are still many problems,” Zuckerman said. The main issue, she added, is the questionable accuracy of the manufacturer’s clinical data about the product. […]

“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. […]


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