KNOXVILLE (WATE) – A new “black box” warning label is now required by the FDA for the birth control implant Essure after more than 5,000 women filed grievances complaining of all kinds of health issues.
During an interview with WATE 6 On Your Side Anchor Lori Tucker, OB-GYN Dr. Michael Fields explained the Essure device is a blended titanium-nickel device that was released by the Bayer company in 2002 and is implantable. The device is designed to scar a woman’s tubes over time and prevent pregnancy.
“Right after I had it implanted, I really didn’t have a whole of of issues. We were told to go home, you’re fine, you can be up walking around that night. And that certainly happened, but probably a year after – horrible cramps, everything they said wouldn’t happen happened,” said Bridget Williams who had received an Essure implant. “Since then for the past seven years, medical issue after medical issue – pain, back pain, pelvic pain, hair loss. It’s really too much to list.”
Williams said she didn’t put it all together until everything else had been ruled out. Jessica Aikens had similar issues.
“Fatigue, three strokes, no energy,” she said.
“The problems are twofold. The first is the physical manifestation of the device itself’ That’s the cramping, the abnormal bleeding and the pain with intercourse. And the other, which may be more significant, is that a significant portion of the population is sensitive to the nickel in the device. The nickel is right up against a very vascular area. It leeches into the bloodstream, so we see everything from hair loss and skin changes and that type of thing, all the way to chronic fatigue syndrome, memory loss and some worse conditions,” said Dr. Fields.
Dr. Fields says in certain populations, there is also an increased risk of pregnancy, miscarriage and ectopic pregnancy. He says he’s been getting complaints about the device since 2007 from across the country and logging them into a national database.
“There really are only two procedures to fix the problem. The first is to remove the actual device by removing the tubes, but this also requires removing a fairly large portion of the muscle this thing traverses on the inside,” he said. “A lot of times doing that procedure to conserve the uterus actually a lot of times leads to cramping and problems afterward.”
He said most women end up choosing to have a hysterectomy instead.
Williams and Aikens are members of a Facebook group called Essure Problems for the discussion of issues caused by the device.
The FDA has required Bayer to do a study following 2,000 women for three years to assess the risk. Bayer issued a statement saying: “Essure is an important birth control option with a positive benefit-risk profile. Bayer will continue to work closely with the FDA to support the continued safe, effective and appropriate use of Essure.”