A form of permanent birth control is under public scrutiny after being investigated by the FDA.
Essure has been on the market for almost 15 years. Now, women are asking Congress to investigate the device and the company that makes it.
Up until 2002, if a woman wanted a permanent form of birth control, she had one option: getting her tubes tied.
However, that all changed when Essure was brought into the market. It was offered as a non-surgical, effective alternative to tubal litigation.
The Henry family is surrounded by superheroes, but mom Samantha said she has needed to find a real life one for years.
“I had doctors making it sound like I just needed to give up, that bodies get sick, that doctors sometimes can't diagnose it, and that is what it is,” said Samantha.
Samantha is one of thousands of women who have the Essure device. It's a form of permanent birth control where metal coils are inserted into the Fallopian tubes to form scar tissue.
Common side effects
Samantha got the Essure device in 2008.
“(He) inserted them within five minutes and sent me home as if it was just a normal examination,” said Samantha.
Now, lawsuits about what women say are Essure’ s side effects are being filed in courtrooms around the United States.
In St. Louis, 92 women are listed on a complaint. In the lawsuit, the women say Essure caused them "abdominal pain, pelvic pain, bloating, weight gain, mental haziness, perforated organs, hair loss and tooth loss."
An FDA investigation found the most frequently reported problems were "abdominal pain, heavier periods, headaches, fatigue and weight fluctuation."
Samantha said she is familiar with all of those symptoms.
“I had this fatigue that I had never felt before. I had never felt my body give up and not want to do anything," she said.
"We have great sympathy of anyone who may have experienced problems following an Essure procedure, regardless of the cause of those problems."
Bayer, the company that now owns Essure sent the I-team a link to a YouTube video featuring Dr. Patricia Carney, Bayer's director of affairs for women's health in the United States.
“Bayer worked very closely with FDA as the agency considered the advice of the obstetrics and gynecology panel,” Carney said.
The FDA has put a black box warning on Essure and ordered Bayer to study the side effects.
“We see the FDA’s action today as an opportunity to continue to gather important data about Essure,” Carney said.
However, Dr. Charles Monteith, a sterilization reversal doctor, said the warning is about 15 years too late.
“I don't know how much of a difference that will make. Our patients are not always aware of that,” he said.
One question raised was if low-income women were encouraged to choose the device. So, the I-team reached out to 'Essure problems,’ a Facebook page viewed by thousands.
A study conducted by the British medical journal found that women who were on some sort of government health care program were slightly more likely to have Essure-over tubal ligation.
The I-team posted a survey on Essure problems. Within 24 hours, there were hundreds of responses. Within 48 hours, the I-team had almost a thousand women take the survey.
Fifty-two percent of the women who answered said they were on government health care when they got Essure. Of those women, 69 percent say they weren't given any other option when it came to permanent birth control.
Samantha is one of the women who was on Sooner Care when she got Essure.
“While all medical devices have risks, we sympathize greatly with any woman who has had issues with Essure,” said Carney.
Since 2005, Oklahoma has spent $1.5 million on Essure. U.S. Rep. Tom Cole (R-OK) is trying to end that by sponsoring a bill called the ‘E-free act," which would require the FDA to withdraw approval for Essure.
Samantha was able to be 'e-free' at the end of 2015.
“It was unbelievable. She's happy. She was dancing the other day, the first time in a while,” said Samantha’s husband, Sean.
Samantha said her symptoms have all but disappeared.
When the I-team spoke to Monteith via Skype, we asked him if he believed Essure should be taken off the market.
He said "no," because it has been effective for many women. But it needs to be studied and compared to regular tubular litigation to see if it is actually more effective, he said.