On April 9, 2018, the United States Food and Drug Administration issued an order restricting the sale and distribution of the Essure permanent contraception device.
The FDA took this step once it became aware that some women were not “adequately informed” of the risks that come with the device prior to its implantation, despite “previous significant efforts to educate patients and doctors” about the risks associated with the device.
Essure is the only permanently implanted birth control device for women on the market that does not require a surgical incision. Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression. It is unknown whether these symptoms are related to Essure. (Más)
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