Tens of thousands of women say they suffered painful and serious side-effects from. The device is the subject of nearly 27,000 complaints to the FDA since its approval in 2002. Women reported excessive pain, severe allergic reactions and, in some cases, perforated organs.
Essure is FDA approved, but the agency recently restricted sales of the device to physicians who provide their patients with a checklist outlining the risks, reports CBS News correspondent Anna Werner. The FDA also gave the device a mandatory black box warning in 2016.
Bayer, the device's manufacturer, admits there is no way to know who might develop problems. Women who have had problems told us the experience affected every aspect of their lives.
"The whole process was a very, very, very dark time for me," Amanda Rusmisell said.
Even now, Rusmisell feels the pain from the choice she made 10 years ago. It started after Rusmisell and her husband decided two children were enough. Her doctor recommended Essure, a newer method of permanent birth control.
"'You can go back to work the next day, it's not invasive, it will be no problem at all,'" Rusmisell said she was told.
Essure is a medical device designed to prevent pregnancy permanently, without surgery. A doctor inserts two small flexible coils in a woman's fallopian tubes where they're supposed to build up scar tissue and block the tubes. Bayer said Essure has been used in over a million women worldwide and advertises it as "surgery free, hormone free and worry free."
"It was the worst… pain I've ever been through," Rusmisell said.
The pain continued, along with heavy periods so debilitating, she started to miss work. Her doctor told her it was likely just her age. Then when the symptoms persisted said she'd need a hysterectomy. She was 38.
"I didn't have support of anyone who was dealing with this same things as me. And so it was very hard, and it was very -- I felt like my body was failing me," Rusmisell said.
It wasn't until she found a Facebook group that she realized she wasn't alone. Thousands of other women posted about problems they experienced including pain, severe bloating, rashes. Some posted images they say show the devices perforated a fallopian tube or their uterus.
Bayer declined to do an on-camera interview, but Dr. Edio Zampaglione, Bayer's vice president of U.S. medical affairs, told us in a phone interview: "We take all of this very seriously." He said the company's studies show the product has "low and acceptable rates" of adverse events. And he said, "We do not see anything that would indicate that the risks of Essure outweigh the benefits."
Illinois Dr. Brett Cassidy says at first he agreed, implanting Essure in 114 patients. But his opinion changed, he said, after a patient came back.
"She was having brain fog… migraines, joint pain in her knees arms wrists," Cassidy said.
"Those seem like strange symptoms to even be linked with a device like this," Werner said.
"My exact thoughts," he said.
He eventually determined she needed a hysterectomy, which removed the Essure devices along with the uterus.
"And what happened to her symptoms?" Werner asked.
"Gone. Completely gone," Cassidy said. "Within a week she was feeling 100 percent better."
That was three years ago. Since then, Cassidy said he's done over 100 hysterectomies for women with similar problems. He's since concluded Essure can cause reactions in some women.
"The coils are made of nickel and polyester fibers. And when they're placed in the tube, it creates an inflammation reaction… But this inflammation reaction continues in the body," Cassidy said.
"So you're basically saying that these two tiny little coils can make your whole body go haywire," Werner said.
"Yeah, it's hard to imagine or believe," Cassidy said.
Bayer said hysterectomy is not the only option for Essure removal. Their executive said the reason for the complaints is "hard to say." He told us "a lot of those symptoms can be hormonally-related and common as women go through reproductive life."
But the explanations aren't good enough for Rusmisell.
"We still want this product off the market… Everything we've done is because we have banged on people's doors and we don't go away," Rusmisell said.
One way those women have had an impact is on Essure sales. The company confirmed to us that sales have dropped. We also spoke with a doctor who is a paid consultant for Bayer, Dr. Peter Rothschild. He told us he has implanted Essure devices in more than 1,100 patients with no reported problems.
The FDA has ordered Bayer to conduct a post-market trial to compare Essure side effects with those of tubal ligation. The final report date is 2023.
After our report, Steven Immergut, Bayer's head of communications in pharmaceuticals, sent us an email in response. Among his points:
- "Essure has been tested in more than 200,000 women over about the last two decades and the conclusions of this scientific research show that its safety and efficacy are comparable to the only other form of permanent birth control, tubal ligation."
- "Women should consult with their physician about any medical decisions involving Essure."
- "Ms. Rusmisell has sued Bayer two times in cases involving Essure and has financial interests that are adverse to the company."
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