A Facebook group of more than 17,000 women who say they have suffered chronic pain, heavy bleeding, fatigue and skin allergies from a contraceptive device has prompted the Food and Drug Administration (FDA) to call for an expert panel to review the safety of the product.
The pharmaceutical and medical device maker Bayer AG produces the Essure brand contraceptive, a permanent intrauterine device (IUD) made of nickel-titanium coils that are inserted into the vagina to prevent pregnancy. Bayer says that about 750,000 devices have been sold, most of them in the U.S.
But after complaints from women who use the device, including from the Facebook group, the FDA this week made public its list of questions for a panel of outside experts, according to Reuters. The questions include possible issues about a product warning label and about further studies to review the possible side effects from the device.
One doctor suggested a stronger screening process to avoid using the device in women who might be susceptible to problems, such as women who have had a history of uterine fibroids. Another cautioned that doctors should counsel patients before they choose Essure, noting that they should warn patients that implanting the device is a surgical procedure and that some patients have reported complications.