German drug maker Bayer AG will be required to perform new safety studies on its Essure permanent birth-control device following a statement from the Food and Drug Administration on Monday.
The FDA took action after thousands of women complained of complications after inserting the implant, which has caused major controversy. In addition to the studies the FDA has recommended that a “black box” warning be placed on Essure packaging to warn consumers about potential side effects.
FDA action criticized by women’s groups
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, said in a statement. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
Women have reported side effects including pelvic pain, dizziness, stomach swelling, bleeding, cramping and fatigue. A group of affected activists have been campaigning to have Essure taken off the shelves, and criticized the FDA decision.
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market,” Rep. Mike Fitzpatrick (R-Pa.), who has pushed the agency to halt the device’s use, said 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.”
Bayer defends Essure record over side effects
Tens of thousands of women have joined a Facebook group called Essure Problems, whose administrators said that “FDA has dropped the ball again.” The FDA approved Essure in 2002.
“Essure is an important permanent birth control option with a positive benefit-risk profile, which is based on a comprehensive clinical development program,” Bayer said in a statement Monday. “Bayer will continue to closely work with the FDA to address their latest recommendations and to ensure the safe and effective use of Essure.”
A doctor inserts the small, flexible device into each Fallopian tube, and tissue is expected to form around the coil to block the tubes and prevent pregnancy. Women have reported painful side effects but Bayer says that the majority of patients are satisfied with the device.
New study will evaluate side effects and impact on quality of life
“Clearly, the data for Essure shows the benefits outweigh the risks,” Edio Zampaglione, the company’s vice president of medical affairs for women’s health, told The Post in an interview last year. “There’s nothing [we’ve seen] with the product itself that says we’ve got a defective product or something that needs to be taken off the market.”
The FDA apparently agrees, saying that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.” The agency recognized the risk of serious complications in some women, and proposed the black-box warning as a result.
Bayer will now have to conduct new studies which will “provide important information about the risks of the device in a real-world environment.” Over the course of the study, Bayer will be expected to monitor patients for adverse effects such as unwanted pregnancy, pelvic pain and other symptoms. The study will also have to evaluate how patients’ quality of life is impacted by these complications.