FDA to Announce Next Steps in Essure Review
Posted 25 November 2015 | By
The US Food and Drug Administration (FDA) says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety.
In an update posted to FDA's website Tuesday, the agency says it is reviewing information, including testimony made at a recent advisory panel meeting, medical literature and recent adverse event reports to "identify appropriate next steps."
The agency is also considering a recent MDEpiNet study published in the BMJ that found women who received Essure had a "more than 10-fold higher risk of undergoing reoperation," when compared to women who had laparoscopic sterilization.
What is Essure?
Essure is a permanent birth control device, originally developed by Conceptus and currently marketed by Bayer after buying Conceptus in 2013. Essure was first approved in the US in 2002 under FDA's premarket approval (PMA) process and is CE marked for sale in the EU.
The device consists of a small metal (nickel titanium allow outer, medical grade stainless steel inner) coil, which is covered by polyethylene terephthalate (PET) fibers. The device is placed in the fallopian tube, prompting tissue growth into the coils which should prevent pregnancy.
In recent years Essure has been surrounded by controversy as patients and activists have claimed the device has caused serious and debilitating side effects such as pain, inflammation, menstrual irregularities and fatigue. Others have claimed the device is not as effective as it claims, with numerous women reporting pregnancies and miscarriages.
However, a 2013 review by FDA concluded that Essure was an effective alternative to surgical sterilization options.
Two months ago, FDA began a new review of the device. On 24 September, FDA's Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to hear patient and expert testimony on Essure in light of mounting reports of serious adverse events concerning the device.
While the panel said that Essure should remain an option, especially for "women who are not good candidates for laparoscopic or general surgery," it did recommend that FDA continue to review the safety of the device, especially relating to potential allergic reactions and metal sensitivities.
Since then, two members of congress have called for Essure to be pulled from the market.
In October, Representative Rosa DeLauro (D-CT) wrote a letter to FDA Acting Commission Stephen Ostroff saying the device should be withdrawn until future studies can prove the device's benefits.
Then in November, Representative Mike Fitzpatrick (R-PA) introduced a bill titled the E-Free Act directing FDA to pull Essure's PMA within 60 days of the bill's passage. So far the bill has four co-sponsors, including Reps. Marsha Blackburn (R-TN), Christopher Smith (R-NJ) and Lou Barletta (R-PA).
FDA Update on Essure