FDA to hold hearing on permanent birth control
Women who have complained about the potential side effects linked to Essure permanent birth control will keep an eye on a day-long public hearing in the nation’s capital to be held by the US Food and Drug Administration (FDA).
In June, the FDA made an announcement regarding the public meeting of its Obstetrics and Gynecology Devices Panel, together with adding patient information, serious risks, and physician information to website of the agency in relation to Essure.
Essure is promoted as permanent birth control without the need of a surgery. However, several women say that they have experienced side effects of the device, and their number has increased to over 20,900.
During the Essure procedure, two metal coils are implanted inside fallopian tubes of a woman, and scar tissue is formed that blocks conception. According to the FDA, over 5,000 adverse effect reports have been filed regarding Essure since it was given green signal by the agency nearly 13 years ago.
Bloating, chronic pelvic pain, severe rashes, extreme bleeding and auto-immune disorders are included in the complaints. Many women reported that they were told to get their reproductive organs removed in a hysterectomy procedure in order to remove the device.
In June, the FDA admitted that some serious risks linked to Essure consist of ectopic pregnancy, unintended pregnancy, pelvic pain, rash and itching as a result of a possible nickel allergy. It has been warned by the FDA that the coils can come out of the fallopian tubes or uterus and enter the lower abdomen and pelvis.