FDA Investigates Safety, Side Effects of Essure Contraceptive

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Side Effects of ContraceptiveThe Food and Drug Administration (FDA) convened a panel yesterday to review claims relating to the Essure contraceptive device’s safety and efficacy. It heard from and questioned women who had used the device, doctors, and the implant’s German manufacturer, Bayer.

Essure is a small metal coil that is inserted into each fallopian tube to produce a natural barrier that prevents sperm from reaching the eggs. It is touted as the only non-surgical sterilization method for women and has been on the market since 2001. Since then, the FDA has received more than 5,000 complaints regarding the device, including claims it did not properly prevent pregnancy and caused long-term side effects, like irregular bleeding and chronic pain. These claims were echoed by some of the women who testified during the panel.

Bayer’s own presentation during the panel acknowledged the possibility of long-term complications, but stated that such risks were on Essure’s warning label and remain uncommon. The company acknowledged that no contraceptive is 100% effective, but also said its own investigations showed a third of the women who claimed Essure failed to prevent pregnancy never went to their doctors for the follow-up appointment needed to ensure the device was working properly.

The panel’s recommendations called for a mix of better education and the collection of more data. Doctors, it said, needed more training on how to properly insert and remove Essure. The panel also noted more data is needed for doctors to better determine if a woman is more likely to experience long-term complications after using Essure. Better visibility on the device’s risks for patients considering Essure was also recommended, such as having women who want the device review a checklist of possible side effects before its use.

While the FDA normally follows the suggestions of its advisory panels, the findings are still non-binding. It remains to be seen what action, if any, the agency will undertake next.

Sources for Today’s Article:
Cohen, E., “Essure Contraceptive Debated before FDA,” CNN web site, September 24, 2015; http://www.cnn.com/2015/09/24/health/fda-essure-contraceptive/index.html.
“Frequently Asked Questions About Essure,” Essure web site; http://www.essure.com/faq, last accessed September 25, 2015.
Perrone, M., “Experts Question Safety of Essure Device Linked to Pain,” ABC News web site, September 24, 2015; http://abcnews.go.com/Health/wireStory/women-urge-fda-pull-contraceptive-device-linked-pain-34011190.
Stein, R., “FDA Advisers Call For More Safety Data On Sterilization Device,” NPR web site, September 24, 2015; http://www.npr.org/sections/health-shots/2015/09/24/443233454/fda-advisors-call-for-more-safety-data-on-sterilization-device.