The U.S. Food and Drug Administration is recommending that pharmaceutical giant Bayer Healthcare place a black box warning on Essure, a form of birth control it manufactures that has led to thousands of adverse event reports, including some deaths.
Bayer must also conduct a new post-market surveillance observational study on the risks of the device in a real-world setting. Within the next 15 days, the company must present to the FDA a design for a study that includes more than 2,000 patients who will compare the Essure device to tubal ligation. The manufacturer must follow the patients for a minimum of three years.
Essure now must also carry a checklist for clinicians to use when talking to patients about the pros and cons of the device. […]
Some who viewed the FDA’s draft guidance are already expressing concern.
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market,” said Rep. Mike Fitzpatrick (R-Penn.) in a statement Monday. “If the FDA is going to order another study, then at minimum they should take Essure off the market during that time.”
While National Center for Health Research president, Diana Zuckerman strongly supports a black box warning, she says warning language will be crucial. She was concerned by FDA statements that the device remains safe for the majority of women. “It is not scientifically defensible to make that statement, given the lack of unbiased data on Essure,” she said.
Zuckerman said perhaps Bayer is not the best entity to do a study. Their previous attempts “have not been appropriately conducted,” she said. […]
To read the original article, click here.