After months of consideration, FDA has revealed next steps in its oversight of Essure permanent birth control. The agency is requiring maker Bayer to add a boxed warning and patient decision checklist to Essure labeling, as well as run a new postmarket surveillance study of the device. Patient activists, who have campaigned for a ban, expressed their displeasure Monday at FDA's decision to leave Essure on the market.
The Essure system, owned by Bayer following its 2013 acquisition of Conceptus, received FDA approval in 2002. The system involves hysteroscopic placement of nickel-titanium alloy inserts into the fallopian tubes, which, with tissue ingrowth, block the fallopian tubes and result in permanent birth control.
In a press release Monday, FDA acknowledged that some Essure patients may be at risk of serious complications such as "persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions."
The agency published draft guidance, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization," detailing a mandatory warning that will be added to the Essure product box, as well as language that explains the potential for serious adverse events. Also included in the draft document is a checklist that is intended to be discussed and signed by patients and physicians before undergoing Essure or any other permanent hysteroscopic sterilization procedure. FDA wrote, "Each separate item in the body of the checklist should be accompained by a line for the patient to initial her acknowledgment and understanding of that individual piece of information."
This draft guidance is open to public comment for 60 days. FDA's actions follow a meeting of the Obstetrics and Gynecology Devices panel in September 2015.
FDA is also requiring Bayer to design and run a post-market surveillance study "to help the agency to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation." These study results will be reviewed by FDA to decide if any other steps are necessary.
“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 William Maisel, MD, MPH, deputy director for science and chief scientist at CDRH in the press release. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies. Clearly Essure's PMA should be revoked and the device should be pulled from the market. These studies could take several years, and leaving the device on the market will only put more women's lives at risk. We have provided the FDA with enough relevant data to prove that Essure is unsafe. Take the device OFF the market and revoke PMA. Do not continue to allow more women to be harmed . . . "
In a statement, Bayer said it "will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure." Dario Mirski, MD, senior vice president and head of medical affairs of Americas at Bayer, said in the company's statement, "Patient safety and appropriate use of Essure are our greatest priorities. 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."
Rep. Mike Fitzpatrick (R-PA), who introduced the E-Free Act on the House floor last fall to take Essure off the market, also expressed disappointment with FDA's actions. "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 said in a release. He added, "Frankly, I'd contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering."
Fitzpatrick said he plans to keep pushing for Congress to pass the E-Free Act, will try to prevent government agencies "from purchasing this unsafe device," and will introduce a new bill to get rid of "blanket civil liability protections that device manufacturers like Bayer currently receive for a non-life-saving device like Essure because those harmed deserve a voice in court."