Birth Control Battle: Local women have a warning for you
WASHINGTON (WJLA) -- There’s a battle brewing over a popular birth control device that’s billed as a safe, effective alternative to having your tubes tied. It’s called Essure and the company says more than 750,000 of the devices have been sold around the world. But a small percentage of women who’ve used it say Essure has caused them major health problems. And they want it pulled from the market.
They are women on a mission on the streets of Capitol Hill, taking their taking their call for a recall to the halls of Congress. Amanda Dykeman, a mother from Iowa, was among the group.
“They're relying on us to be their voice,” she said.
The group of women who visited Washington on a frigid January morning say they’re acting as the voice of nearly 14,000 women, including Alexandria's Elizabeth Turley, a former Essure user.
“As soon as it was placed, it changed my life,” Turley told ABC7.
Turley is part of a Facebook group brought together by Essure, an FDA approved permanent birth control device that uses metal coils placed in the fallopian tubes. It’s been on the market since 2002. Fairfax County Ob-Gym Dr. Leonard Rosen has placed close to 1,000 of them at his practice. He says, “The risks are incredibly small and in my practice I haven't seen maybe a handful or less that I've had to go back in. Most people love it.”
But not everyone is happy with the device. Turley is among them, telling the ABC7 I-team, “There's not a single day that you're not in pain or having some kind of illness.”
And she’s not alone. The Seven on your Side I-team found complications in large numbers in an FDA database. The agency lists nearly 1,000 adverse reports related to Essure on its website through the end of October 2013. A search of adverse reports turns up at least 500 more since then. The complaints range from pain to hemorrhaging, movement of the device and worse. The seven women we followed through DC all indicated they’d had hysterectomies as part of getting the coils removed.
But no matter the complications they claim, Essure patients can’t sue. Washington, DC-based attorney Seth Price explains it’s because of something called an FDA exemption.
“You get hurt, you're kind of powerless,” Price said.
The exemption is part of the pre-market approval process for devices entering the market. Price says, “The idea here is that if companies comply with certain facets, that will allow products to come to market and they have a safe harbor. So if they do certain things and comply with FDA requirements then they would cannot be sued for economic damages.”
But a Philadelphia law firm is trying. It's suing Bayer, which in 2013 bought the company that originally made Essure. It’s a case Price says attorneys across the country are watching.
Some patients, including Ohio’s Kim Hudak, think the device shouldn’t have gotten approval in the first place. In those meetings with congressional staffers, she alleged the answers she gave in Essure’s clinical trials 15 years ago, were changed. That was long before Bayer owned the company that made the device.
“This is huge,” Hudak said, “Because we can present this to the FDA. And we will. It will happen.”
The leaders of the “Essure Problems” Facebook group hoped to make that happen during a meeting with the FDA during their trip to DC. They showed us emails indicating they had spoken with top brass about getting an hour while the group was in town. They even had a potential date on the calendar, but as Dykeman asked if media could attend, the plans were dropped.
“They couldn't make time for us,” Dykeman said.
The Seven on your Side I-team asked Bayer to make time to answer our questions. But after the company cancelled interviews set up in DC and New York, it sent us a video statement, which indicates Essure's side effects are long known and advertised. In the statement, Dr. Edio Zampaglione says, “This fact has been confirmed by the FDA whose review of our five-year safety data for Essure did not demonstrate any new safety problems or any increased incidence of problems already known.”
But when it comes to problems with the device, the women in the Facebook group could talk for days. They’re now looking to Congress to help get the product off the market.
“We can’t stop until somebody that can do something about this listens,” Dykeman said.