WINSTON-SALEM, N.C. -- No surgery, a faster recovery; thousands of women thought Essure was the perfect solution to a permanent birth control. But more and more women say the implant was a big mistake.
2 Wants to Know's Tracey McCain started investigating Triad women's problems and their complaints about Essure in 2014.
During the procedure, a doctor places two metal coils inside the Fallopian tubes. Over three months, scar tissue is supposed to amass around the coils, blocking conception. But according to reports filed with the Food and Drug Administration, thousands of woman complained about excruciating pain, extreme bloating and skin rashes. And in some cases, women say they've become pregnant.
We went to the FDA and Bayer for answers and so did Triad moms like Winston-Salem mother of two Monica O'Neal.
"I'll have to have a hysterectomy at 34," said an emotional O'Neal. She says she's forced to make that decision because the permanent birth control Essure, caused permanent damage.
"I didn't want to have any more kids, I wanted to have my tubes tied," said O'Neal. Her doctor told her Essure would be the perfect alternative to a tubal ligation. But what she got was even more pain then she could have ever imagined.
"I woke up in excruciating pain and I can remember feeling like, I'm having a baby," described O'Neal.
That was 2010, her first clue she made a big mistake.
"I'm cramping extremely bad. I'm hunched over. Each time I tried to stand up, it hurt more," described O'Neal.
The FDA's received more than 5,000 reports about adverse side-effects related to Essure since 2002. The FDA's done little about it, but this Triad mom is taking matters into her own hands. She's one of thousands to bring her complaints of excruciating pain, extreme bloating and headaches to the FDA and Capital Hill.
"There's women who suffer from the same complaint," said O'Neal, referring to the Essure Problems Facebook page. "I'm thinking well it's not just me then, this really needs to come off the market."
She's one of the first in North Carolina to sue Bayer, the company that makes Essure.
"Years later, you have all of these women having complications and no one wants to own up to it," said O'Neal.
Bayer says 900,000 American women have had the procedure and most are fine. But for the thousands who've reported unexplained symptoms you might wonder why they haven't filed suit. That's because of a special status it got when the FDA approved Essure in 2002. They can't sue Bayer for the device, but they can sue for failing to warn women about the health risks.
But for O'Neal it might be too little too late. She now has to make an incredibly difficult decision.
"If insurance will pay for it, then I'll have to have a hysterectomy at 34. It kind of makes me emotionally sad. I don't want to take my insides taken out due to someone else's failure."
She wants Essure off the market for good.
"If I can reach out and tell my story as well, maybe someone will believe us maybe something I share in my story will make a difference," said O'Neal. All the money in the world won't bring back my piece of happiness that I feel like has been taken away.
It could take years for these lawsuits to go in front of a judge. In September, the FDA held a panel to discuss the safety and effectiveness of Essure. It did not recommend banning the device, but it did release additional guidelines for use.
Bayer sent WFMY News 2 this statement:
Bayer stands by Essure as an important option for women who have completed their families and want a permanent form of birth control. The safety and efficacy of Essure is supported by more than a decade of science and real world clinical experience. Prior to Essure's FDA approval 13 years ago, tubal ligation, a surgical procedure requiring general anesthesia and incision, was the only option available for women for permanent birth control.Patient safety is Bayer's highest priority, and we sympathize greatly with any woman who has experienced problems following an Essure procedure, regardless of the cause. It is important to remember, however, that there are risks with all medical procedures and devices, and the communication between a woman and her physician is critical for understanding and navigating these risks.
