FDA Panel to Review Essure Contraceptive Device

Washington, DCBayer’s contraceptive device, Essure, will be reviewed by US health experts later this week, following an increasing number of complaints over potential Essure side effects. The review will determine whether or not the device should be restricted.

Approved in 2002, Essure contains two nickel-titanium coils that are inserted through the vagina into the fallopian tubes to prevent pregnancy. To date, nearly 17,000 women in the US who have had Essure implanted have complained that it has hurt them. They are members of the “Essure Problems” group on Facebook, run by Angela Lynch, who has herself experienced side effects. Those side effects include chronic pain, heavy bleeding, fatigue and skin allergies.

One gynecologist, Dr. Sebastiaan Veersema, Antonius Hospital Nieuwegein in the Netherlands, who was an early adopter of Essure and has implanted the contraceptive device in to nearly 1,400 women, now believes it requires further study. He says they need to establishe what, if any relationship exists between the side effects patients are reporting and the device itself. and the problems relayed by some patients.

The independent expert panel has come together at the request of the Food and Drug Administration (FDA) to discuss possible labeling changes to the product and whether additional clinical studies should be done. The panel will not be asked to formally vote on their recommendations.