RICHMOND, Va. (WRIC) — Thousands of women, some right here in Virginia, have complained about the birth control device Essure.
On Thursday, they came from all over the country to voice their concerns.
“Within 12 months of placement I developed pain throughout my entire body,” said Kim Hudak, who had was part of the clinical trials for Essure.
Texas resident Christine Cervantes says, “both of my Essure implants migrated and were perforating my uterus.”
Crystal Donahue told an FDA panel, “I had an hysterectomy on my 37th birthday.”
Essure is a tiny nickle coil marketed as permanent birth control, but thousands of women say it has left them with permanent pain.
Calling themselves “e sisters,” they united at today’s rare FDA public hearing in Maryland. Their message, ban Essure.
“I really hope the FDA listens to patients’ stories over Bayer and seriously considers removing Essure from the market,” say Cervantes.
The panel of medical experts heard from patients, doctors and researchers. Many raised questions about the accuracy of the clinical trials conducted by Conceptus, which is now owned by Bayer.
Hudak told 8news, “The data that I have was absolutely altered; undeniably altered.”
Hudak says at first she was excited about participating in the trial. She was pleased there was a new birth control option, but within 12 months the pain started. Yet for some reason, her reports of pain were blacked out.
“A lot of my responses were crossed out responses where I had reported incredible pelvic pain, back pain, irregular bleeding, just crossed out,” claims Hudak, who shared her paperwork with the FDA panel.
But at the hearing, Planned Parenthood reported their patients had a low rate of complications and a Doctor with The American Congress of Obstetricians And Gynecologists says all medical procedures have sides effects and that Essure is less expensive and less invasive than having ones tubes tied. She urged the FDA to keep Essure on the market.
Dr. Roxanne Jamshidi told the panel, “ACOG considers this essential less invasive tubal ligation. Options like Essure must remain available to women because it is critical women have a choice when it comes to contraception.”
But for these “e sisters” it’s a choice they wish they never made.
“It was the worst decision I ever made in my life it caused me to have a hysterectomy,” said Amanda Susmisell.
8news planned to talk with the makers of Essure, Bayer, in an interview that had been in the works for three weeks. At the hearing on Thursday, Bayer suddenly backed out and canceled the interview.
After our 6 p.m. broadcast, however, Bayer issued the following statement to 8News:
“Patient safety is our highest priority and we sympathize greatly with any woman who has experienced problems with Essure. We have reached out to many women who have reported complications, listened to their experiences and provided any guidance we can. Bayer appreciates the opportunity to have an open and transparent dialogue about Essure. Hundreds of thousands of women have benefitted from Essure.”
