UPDATE: The FDA spent Thursday discussing the controversial birth-control device Essure. No action was taken.
A growing list of patients say Essure -- advertised as a fast and permanent, non-surgical form of birth control for women -- has ravaged their bodies, causing years of pain and suffering.
Jenny Jones decided her family was big enough. She and her husband were both active duty and already had two kids at home.
“Two is good number,” Jones told News4. “That way we weren't outnumbered."
In 2008, Jones decided to get Essure, a quick but permanent form of birth control where small, metal coils are placed in the fallopian tubes to block sperm. Three years later, a trip to the doctor for problems with her periods ended with a surprising diagnosis.
"They asked me if I could be pregnant, and I said, ‘Well, no, I had the Essure,’” Jones recalled. “Why would I be pregnant? That's over."
Six months later Jones delivered Ruby via emergency C-section. She calls Ruby an unexpected blessing and nicknamed her “e-baby.”
Health
So, what happened?
"The Essure didn't stay where it was supposed to," said Jones.
Doctors told Jones her coils had migrated, one perforating the fallopian tube, rubbing against her colon. They removed that one. The other remains outside the tube, according to Jones. "It's over here in my abdomen somewhere."
Ruby isn't the only “e-baby” out there. At least 50 women on the Facebook page "Essure Problems" say they got pregnant after being implanted. Hundreds of others complain of migrating coils, inflammation, fatigue and chronic pain.
Both Krystal Donahue and Meribel Zurita told News4 they’ve had chronic pain after getting Essure, problems they said they did not have before being implanted with the coils.
“My whole life revolves around pain,” said Donahue, who got the device in September 2011. “The pain started radiating into my hips and my back and my thighs, and it just became very debilitating."
Zurita got Essure in September 2009. Describing the pain she said, “Some of them were dull, and it felt like they radiated from front to back, and another was just a sharp pain deep inside."
The Food and Drug Administration approved Essure in 2002 after clinical trials were conducted by the manufacturer Conceptus. Those trials mainly followed patients up to two years. Abdominal pain was found in almost four percent of participants in the first year. Back pain was found in nine percent.
FDA documents reviewed by News4 showed the company acknowledged at the time, "The risks of long term implantation are unknown."
"It is safe and very effective," said Dr. Mark Levie, an OB-GYN and paid consultant for Essure. Dr. Levie said he hasn't seen any more of an increase in complications with Essure than other birth control procedures. He said all possible risks are clearly documented on the label and should be discussed between physician and patient.
"We've done over a thousand procedures and we would expect if this was really a pervasive problem we'd be seeing women come in here all the time with these complaints, and we're just not seeing it," said Dr. Levie.
The FDA agrees. A spokesperson told News4 there have been 943 complaints about Essure since 2002, mainly about pain, compared to 750,000 procedures done worldwide. The agency did require a five-year follow-up study with patients looking at safety, effectiveness and training after it approved Essure.
Bayer, the company that bought the maker of Essure earlier this year, told News4 the FDA reviewed the results of that five-year study and found "although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known." Neither the FDA nor Bayer could provide specifics from that study to News4.
"We really have no idea what the long term risks are," said Diana Zuckerman, who heads the National Research Center for Women and Families, which studies the effectiveness of medical products. She said even five-year studies aren’t long enough for a device meant to remain in the body forever. "It could well be that women have a pretty good reaction to it for the first year or two, but after it's been in their body for 10 or 20 years it could wreak havoc," Zuckerman said.
Some women aren't waiting to find out what happens. Meribel Zurita had both her coils removed last year.
"After surgery it was the best I had felt in years," she said. Zurita said most of the pain went away, but she still has some discomfort. Both she and Krystal Donahue, along with dozens of other women, have opted for hysterectomies to stop the pain.
“In a month, I really hope that I will be on the path to being pain free,” Donahue said. “I really do.”
The FDA told News4 no birth control is 100 percent effective, but the agency said it takes these complaints very seriously and will continue to review them. As for the complaints, federal law generally prevents consumers from suing medical device manufacturers if it had FDA approval.
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