(April 8, 2016) – A popular birth control device has run into some serious criticism, and a growing group of users stepped forward to call on the FDA to evaluate it.
Ten women have formed a group called the “E-Sisters.” They’re focused on Essure, saying the birth control device has caused them pain and bloating. In one case, a woman had to have a hysterectomy.
The FDA approved Essure in 2002. The procedure involves inserting metal coils in the fallopian tubes. The women claim that the nickel and titanium coils are making them sick. They’ve talked about the issue to the FDA and on Facebook.
“If you ask my 2-year-old right now, he would tell you Mom is broke,” said Essure patient Jackie Stuby, who says she went from being a thin, active mother to someone who’s swollen and in constant pain.
"You don't want to move, you just want to curl up and die and I mean sometimes if I wouldn't have had my kids I would have wished to be dead with some of the pain I went through,” Stuby said.
The FDA’s website shows more than 5,000 complaints. Women who testified during FDA hearings in September want Essure banned.
The women have been told that they can’t sue because Essure is protected under federal preemption, which makes personal injury lawsuits difficult to win.
While Essure certainly has its critics, some women swear by the birth control device.
“No problems at all,” said one supporter who asked that her identity be concealed. “A little cramping the first morning, but nothing held me back at all.
The woman had her Essure inserted in 2011 and is completely satisfied with the result.
“I am part of the 98 percent that is very happy with it and if someone asks me for a recommendation or should they do it, I would say absolutely,” she said. “Honestly, it’s the best thing I’ve ever done.”
We reached out to local doctors to get their opinion on the device.
“I see Essure as a valid option for women,” Dr. Kristin Bolin told CBS4. “My patients have had a good response with Essure. I am concerned about the nickel in the device, but generally my patients have done well.”
“What I like is, it’s a way for women to take control of their fertility without going to the operating room,” Dr. Elizabeth Nowacki said. “It’s not for everyone. You have to weigh the risks and the benefits and discuss all your concerns with your physician.”
A North Carolina physician who says he’s doing three to four Essure removal surgeries a week said he’s seen both good and bad from the device.
“I am willing to say there are a lot of women who have Essure and don't have problems, but I don't think we truly know what the magnitude of the problem is,” said Dr. Charles Monteith.
Meanwhile, the women who’ve had problems wait and hope their stories encourage other women.
“Our story is real, we are all real, despite what everyone tells you that it can’t be true, that’s it’s not Essure. Trust yourself,” said Latasha Newton, a member of the E-Sisters.
CBS4 reached out to Bayer, the company that makes Essure. While Bayer didn’t respond specifically to this story, it said in a past statement that patient complaints are “not representative of the hundreds of thousands of women who have relied on Essure since FDA approval in 2002.”
In February, the FDA placed a “black box” warning label on the device and asked Bayer to conduct more studies on the risks and side effects of Essure.