The FDA is facing harsh criticism from lawmakers and other stakeholders for not taking stronger action on the controversial birth control implant Essure, which many patients believe has harmed them.
Last week, the agency ordered Bayer — which manufactures the product — to develop and conduct a postmarket study intended to help the agency better understand the risks associated with Essure versus other birth control options, such as laparoscopic tubal ligation. Specifically, the agency wants data on the rates of unplanned pregnancy, pelvic pain and surgery to remove the device.
The FDA also issued draft guidance with labeling recommendations, including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients.
These actions have failed to appease Rep. Michael Fitzpatrick (R-Pa.), one of several members of Congress who called on the FDA to remove Essure from the market. He vows to continue his fight to revoke approval of the product.
“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,” he says.
More than 25,000 women reported symptoms — including extreme pelvic and abdominal pain, migraines, loss of teeth and hair, and the coil cutting into the uterus and other organs in the abdominal cavity — and 10,000 have filed formal complaints with the FDA, he points out.
“If the FDA is going to order another study, then at minimum they should take Essure off the market during that time. A 60-day comment period and another study while this device remains on that market only guarantees more women harmed,” he adds.
Rep. Rosa DeLauro (D-Conn.) says conducting a postmarket study and issuing labeling recommendations are positive developments, but the actions mean nothing unless the FDA is able to take action. She points out that a GAO report issued last year showed the FDA’s requests for postmarket safety studies often take a long time to be completed, and that companies lack incentives to find participants for their studies ().
“Now, the FDA is asking Bayer to do a postmarket study, all while there is no evidence that the FDA has remedied the issues found within the GAO report,” she says. DeLauro adds that the FDA should ensure that these manufactures complete these postmarket studies in a timely manner. She also wants to see the product off the market until the studies are concluded.
The FDA acknowledges that some women may be at risk for serious complications, but says the agency “believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.”
‘Not Scientifically Defensible’
Diana Zuckerman, president of the National Center for Health Research, took issue with the agency’s position, saying “it is not scientifically defensible to make that statement, given the lack of unbiased data on Essure.”
She adds that NCHR strongly supports a black box warning, although it needs to be very strong. Zuckerman says she is glad to see that the FDA is requiring new data and admitting that complications are a serious problem.
“The FDA also should work in tandem with CMS, because many women using Essure are on Medicaid. It is a big problem that women on Medicaid may be unable to find physicians skilled at removing Essure when there are serious complications,” she adds.
For its part, Bayer will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure, according to Dario Mirski, senior vice president and head of medical affairs Americas at Bayer. Essure is an important permanent birth control option with a positive benefit-risk profile, he adds.
The decision follows a September meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, during which several women testified about pain and other adverse events they had experienced after being implanted with Essure. The panel recommended that a patient registry be created to document these events ().