Questions abound about birth control device Essure as many women report suffering from complications
1:24 PM, Nov 4, 2013
5:58 PM, Nov 5, 2013
Questions have surfaced about whether a birth control device implanted in thousands of women is actually making some of them sick.
Essure's manufacturer boasts it's safer, less expensive and less invasive than going through surgery for tubal ligation - what most call 'having their tubes tied.' But now - women across the country are saying - they want it off the market.
"My doctor recommended Essure for me about a year ago," said Cassandra Cooper-Stewart. "Quick recovery time. I could have it done on Friday be back at work on Monday."
Within months of having Essure birth control implanted last year, Cassandra started having problems, and pain.
"At its worst, it was like somebody stabbing me with an ice pick from the inside out," she explained.
The mother of three kept telling her doctor something was wrong. When he wouldn't listen, she began researching the device online. She soon discovered she is not alone.
"And there's a FB page just for women who are having problems with Essure," Cassandra said.
A woman named Crystal told the Scripps News investigators, "It's a constant pain that doesn't go away." Another woman, Tera, said, "It felt like barbed wire inside of me."
Essure is marketed as permanent birth control without surgery. Coils are placed inside the fallopian tubes blocking conception. It's been around since 2002. According to the manufacturer, about three quarters of a million women have had it implanted.
Scripps News investigators found 838 women and doctors filed complaints with the Food and Drug Administration since 2004. There were 150 complaints where the coils broke or miss-fired. And even more where the device moved or punctured the fallopian tube. Eighty women became pregnant and 91 reported having hysterectomies to remove the device.
"Scar tissue forms around it and because it grows into the tubes and the uterus they have to take both of them to get the device out," Cassandra said. Her new doctor told her that a hysterectomy was her only option to remove the device and end her pain.
"I'm 29. I was scared to death. It's drastic surgery. What are you supposed to think?" she said. "I'd done this procedure not to have surgery - to not have to deal with the recovery time!"
Thousands of women, like Cassandra, are now sharing their experiences on Facebook -
http://on.fb.me/1ebkXkA. This page is dedicated to issues with Essure. On it, you see woman after woman, many with the exact same symptoms, telling nightmare scenarios.
Most of the comments and photos detail side effects from an allergy to nickel - which is a component of the coils. Originally, women were required to test for that allergy, but the FDA removed that requirement a few years ago.
This group has some significant backing - famed activist, Erin Brockovich.
"These women didn't sign up to have hysterectomies," said Erin Brockovich. Scripps News investigators flew to Los Angeles to talk with Brockovich.
"You have to look at the numbers of women in front of you, all presenting with the same type of symptoms - from excess bleeding to hysterectomies to getting pregnant." Brockovich added.
The FDA approved Essure after two years of clinical trials. Brockovich says they "fast-tracked" it through and it shouldn't be on the market.
"Women are being harmed, somewhere we're not being informed appropriately or truthfully."
She blames the manufacturer for not completing the full study and the FDA for not enforcing it.
"If you think there's a problem, get it off the market until you fix it," Brockovich stated.
In 2011, the Supreme Court ruled you can't sue the manufacturer of an FDA approved device. So, Brockovich set up another way for them to tell their stories. She started an online petition, and Cassandra signed it in her Nowata home weeks ago.
She noticed the number of signatures had jumped from 1,900 when she signed it - to 2,700 members now. She hopes others will show their support and sign the petition, too.
"It's not fair. And there's a lot of women suffering - and have suffered for years because they can't get it taken care of," Cassandra said. "They don't have insurance, they don't have the money and there's nothing we can do other than fight."
The U.S. Food and Drug Administration recently received a new report of a patient with Essure who developed complications and died. We contacted Bayer and the company sent this statement:
"CONCEPTUS DEVELOPED ESSURE. THEY CONDUCTED THE ORIGINAL TRIALS AND ASKED THE F-D-A TO REMOVE THE NICKEL ALLERGY TESTING REQUIREMENT."
Bayer healthcare bought Conceptus last June. Bayer refused an interview. But sent a statement saying they, "...take the safety of [THEIR] products very seriously."
Also, "Bayer is developing the next generation Essure..." But the company would not go into detail.
When asked about the removal of the nickel allergy testing, Bayer noted:
"The use of a nickel titanium alloy in Essure remains as a warning in the product label."
We reached out to the Tulsa doctor who recommended Essure to Samantha. He never returned our call. The doctor who removed the device for Samantha declined to comment.