Regulators at the Food and Drug Administration (FDA) have issued a so-called “black box warning” on a contraceptive device that has been the subject of investigations into its safety.
FDA officials also announced a new “decision checklist” that must be signed by a patient and doctor before implantable sterilization devices such as Essure can be implanted, according to a press release issued today by the agency.
The FDA edict also orders Bayer, the manufacturer of Essure, to conduct further studies on the product’s safety.
“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,” said Dr. William Maisel, M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, 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.”
Critics, however, said the action is nowhere near enough.
"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," Rep. Mike Fitzpatrick (R-Pennsylvania) said in a press release.
Fitzpatrick promised to introduce legislation blocking government agencies such as the Department of Defense and Veterans Affairs from purchasing Essure devices as well as eliminating blanket civil liability protections that non-life-saving devices like Essure now receive.
“Because the FDA is failing to act, I believe Congress must,” Fitzpatrick said.
Bayer officials sent a statement to Healthline, saying they will work with the FDA to "support the continued safe, effective and appropriate use of Essure."
"Patient safety and appropriate use of Essure are our greatest priorities," said Dr. Dario Mirski, senior vice president and head of medical affairs Americas at Bayer. "A woman's decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure."
Product Safety Questioned
The Essure device is a coil that is placed in a woman’s fallopian tubes.
Scar tissue then forms around the device to prevent sperm from reaching eggs and fertilizing them. That process usually takes about three months.
More than 5,000 women have filed grievances with the FDA about Essure since the device was put on the market in 2002, according to a CNN report.
The complaints included allegations of unintended pregnancies, miscarriages, and stillbirths as well as severe pain and bleeding.
In September, the FDA held a hearing in which women testified about what they went through using the device.
Last week, Fitzpatrick and Madris Tomes, a former FDA contractor, presented the FDA with raw data they said showed there have been 303 fetal deaths among women who used the device. The FDA has listed the number of fetal deaths at five.
"My hope was that they would recommend a recall,” Tomes told CNN. “How can we trust the FDA to make good decisions regarding safe and effective devices?"
Bayer has said Essure is 99 percent effective in preventing pregnancy.
What the FDA Ordered
FDA officials said Monday they are issuing the mandatory box warning and the patient checklist to “ensure women receive and understand information regarding the benefits and risks of this type of device.”
The warning label is "designed to call attention to serious or life-threatening risks," according to the FDA website.
The public has 60 days to comment on the draft guidance wording and what they feel should be included in the warning.
The checklist, FDA officials said, will help doctors communicate with patients and help ensure an informed decision. The list includes a recommendation of a “confirmation” test after three months to make sure the device is working properly.
FDA officials also ordered Bayer to conduct a “post-market surveillance study designed to provide important information about the risks of the device in a real-world environment.”
That data will include rates of complications, pelvic pain, and surgery to remove the Essure device.
The FDA will use that information to determine what, if any, additional steps need to be taken in relation to the Essure product.