WASHINGTON, D.C. (WRIC) — Hundreds are in attendance for the Food and Drug Administration’s public hearing to re-evaluate risks and benefits of the birth control device Essure.
The review comes after thousands of woman, including some here in central Virginia, complained of severe abdominal pain, bloating, hair loss and hives.
The FDA is now presenting reports submitted to them. It included 11 deaths possibly related to Essure, five of them were fetal deaths.
8News investigator Kerri O’Brien is in D.C. for today’s meeting and says women in attendance have traveled from all over the country to testify to serious complications from the device. Several women Kerri talked to say they have had pain and bleeding so severe that they had to have a hysterectomy.
The maker of the device, Bayer, says research for the device spanned over a decade and data has been gathered from 10,000 women. They say complications are rare.
Bayer is also accused of altering clinical trials. One woman who was part of the clinical trials told 8News that her data was altered.
Bayer has maintained Essure is safe and tells 8News that hundreds of thousands of women have had the device successfully implanted.
The panel could consider potential changes to the product’s label and call for more clinical studies, though a formal vote is not expected.
Get a full recap from Kerri O’Brien tonight on 8News at 5 and 6.
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