RICHMOND, Va. (WRIC) — The Food and Drug Administration will hold a meeting on September 24 to review the data, safety and effectiveness of the birth control device Essure.
The device is supposed to be less invasive than having your tubes tied to prevent pregnancy. However, more than 4,000 women have complained to the FDA of complications that include severe cramping to a perforated uterus to an allergic reaction.
“My hair started falling out in immense quantities… I woke up in the middle of the night covered head to toe in hives,” one woman who has taken the device told 8News.
Seven deaths have been possibly linked to the device.
The FDA announced the meeting on Wednesday, along with this message:
While scientific evidence shows that Essure is a highly effective means of sterilization when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100% effective.
The Agency has received reports of fetal complications including miscarriages in women who became pregnant following Essure placement. Women who have had the Essure placement procedure are more likely to have a pregnancy outside the uterus (ectopic pregnancy). At present, clinical studies and individual cases of Essure sterilization failure reported in the scientific literature have not demonstrated an increased risk of neonatal or pregnancy complications when pregnancy is in the uterus following Essure placement. The FDA will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks.”
Stay with 8News for the latest updates in this developing story.