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Hundreds of women are blaming Essure for ravaging their reproductive systems and causing so much pain, some say it forced them to get full hysterectomies. Essure consists of a pair of metal coils, implanted in a woman's fallopian tubes. The scar tissue builds around the coils, which is designed to block sperm and prevent pregnancy. But hundreds of reports of adverse effects from Essure have now surfaced on the FDA's website. Hetty Chang reports for the NBC4 News on Tuesday, Nov. 12, 2013.
Some women who turned to a birth control device called Essure had hoped it was the permanent solution that would close their child-bearing chapter in life, once and for all.
Instead, the women are blaming Essure for ravaging their reproductive systems and causing so much pain, some say it forced them to get full hysterectomies.
One of those women is Nicole Yadon, a nurse who said after three children, Essure seemed like the perfect option for her.
"It's very quick. It's in the office, there's minimal recovery time," she said of the procedure. "It seemed absolutely perfect."
It was anything but, Yadon said.
"It was 11 months of a nightmare. It was awful," she said.
Essure consists of a pair of metal coils, implanted in a woman's fallopian tubes. The scar tissue builds around the coils, which is designed to block sperm and prevent pregnancy. But hundreds of reports of adverse effects from Essure have now surfaced on the FDA's website.
Some women described "bleeding every day" and developing a "spiderweb" of scar tissue. Another said, "I felt my insides were on fire."
Yadon said she noticed she began "having some gynecological issues."
Those issues continued for Yadon and were compounded with health problems she would never have thought had anything to do with her Essure procedure. According to Yadon, her leg began to swell.
"It was horrific," she recalled. "It was to the point I couldn't walk."
To date, the FDA has received about 900 adverse event reports involving Essure, which is less than 1 percent of the total procedures performed.
But women who have had complications said it is not just the number of problems they're concerned with. It's the severity.
The complaints range from abdominal pain and swelling to forced hysterectomies to get the coils out.
There are at least two Facebook groups titled "Essure Problems," each with about 3,000 members. Many commentors are certain, like Yadon, that something in the coils is making them sick.
"I started reading that nickel allergies can cause recurrent infections, so at that point, the light goes off," Yadon said.
Essure coils are made partially of nickel. In 2011, the FDA approved changing the language around the nickel warning on Essure's packaging.
There is still a warning on the label, but there is no requirement to test patients for nickel allergies before performing the procedure.
"That is one of the questions that you are asked in your pre-op (conversation) with your doctor," Yadon said. "'Are you allergic to nickel?' 'Nope.' 'Moving on.'"
The FDA approved Essure in 2002 under the conditions the birth control-maker complete two post-approval studies, including a five-year study on safety and effectiveness.
The question some are asking now is, Was the product studied long enough?
Dr. Diana Zuckerman has worked as a congressional investigator and currently runs a nonprofit FDA watchdog group. She believes more should have been done.
"You're looking at those side effects for those few years," Zuckerman said. "But you don't know what's going to happen to her five or 10 or 15 or 20 years down the road."
Doctors who stand by Essure, including Dr. Steven Rabin, argue every medical device has its risks.
"In my experience, I haven't had a single patient that's had a complaint afterwards," Rabin said.
A spokesperson for Pharmaceutical giant Bayer, which now owns Essure, said there have been about 750,000 Essure procedures performed.
The company points to an FDA finding: “[a]lthough 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.”
Nicole Yadon has since undergone surgery to remove the coils. According to Yadon, her health issues went away virtually overnight.
"I think for some women (Essure) is the right thing and for me it absolutely wasn't," she said. "I think there needs to be more in-depth screening and testing."
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