The Food and Drug Administration (FDA) is restricting sales of the permanent birth control implant, Essure, because of concerns it can cause severe injuries.
You will now only be able to get an Essure implant after a doctor fully informs you of risks associated with the device. Both you and your doctor will have to sign a form acknowledging you’ve been told about the risks.
Essure is a metallic implant with two small coils. A doctor inserts it through the vagina and cervix into each fallopian tube with the goal of causing scar tissue to form, permanently blocking the tubes. The implant is the only non-surgical form of female sterilization available in the U.S. and has been used by tens of thousands of women.
However, the FDA says the device can perforate the uterus and fallopian tubes, and may travel into the abdomen and pelvic cavity, causing pain and possibly requiring surgery. Some women have also complained the device resulted in irregular periods, headaches, bleeding, pain, unintended pregnancies, miscarriages, ectopic pregnancies and even death.
Thousands of women have sued Bayer, the implant’s manufacturer. The FDA said it’s received almost 27,000 complaints about the device since it was approved in 2002. It already carries a “black box” warning, but many women have said they were never informed about the risks.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable,” FDA Commissioner Scott Gottlieb said in a statement.
After the FDA’s announcement, Bayer issued a statement saying “The benefit/risk profile of Essure has not changed and remains positive.”
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