KANSAS CITY, Mo. - More than 750,000 women worldwide use a device called Essure to prevent pregnancy. The makers of the device boast it is safer, less expensive and less invasive than going through surgery to have their "tubes tied" (known medically as a tubal ligation).
However, hundreds of women across the United States said the device has changed their lives for the worse. They contacted the 41 Action News Investigators to look in to the product.
After the birth of her fourth child, Joleen Fuller and her husband searched for a permanent form of birth control. Fuller didn't want the long recovery time associated with surgery for a tubal ligation, so her doctor suggested Essure.
Essure is a spring coil inserted in the fallopian tubes during an office visit. The devices cause the fallopian tubes to scar over and produce the same end result as a tubal ligation. However, patients avoid the expense and downtime associated with surgery.
"We did research it. We didn't find anything bad on the product, so we thought it was OK to do," Fuller said.
However, two weeks after the procedure, Fuller said she continued to suffer from severe pain. She said her doctor did not take her complaints seriously.
"He showed us. Put it in his hand, the Essure coil, and showed my husband and me. Wiggled it in our face and said there is no way this can be causing you this amount of pain," Fuller said.
Fuller said the pain grew worse, and her stomach started swelling out as if she was pregnant. She took pictures of her stomach at its worst.
"I was terrified because I didn't know what was going on internally," Fuller explained.
FINDING OTHER WOMEN ON ESSURE
Confused and terrified, Fuller searched for answers online. She discovered a Facebook page devoted to women concerned about their Essure implants.
The page contained hundreds of other women describing problems with the device and posting pictures, X-rays and other information about the product.
Through the page, Fuller met Jeanie Esther from Weston, Mo. Esther is a mother of three and told 41 Action News she noticed problems with her Essure implants almost immediately after they were inserted.
She said she regularly has cysts burst and once hemorrhaged from one of the cysts. Esther said before Essure, she never had problems with cysts.
"My problem big time is the cysts. That's my number one, on top of the cramping. It's non-stop. I'm always in pain," Esther said.
FDA LOGS HUNDREDS OF COMPLAINTS
The complaints on the Facebook page range from unintended pregnancy, to sever pain, to the device migrating and perforating organs.
We searched the FDA database of adverse events to see if the government agency had received similar complaints.
We found since 2004:
- More than 838 adverse reactions reported to the FDA from both patients and doctors
- 150 complaints from doctors about the device misfiring or breaking while trying to position coils
- 80 complaints where a woman ended up pregnant
- Two cases where women reported pregnancies with twins
- More than 150 case where the device moved and punctured the fallopian tubes or uterus
- 91 cases where women had hysterectomies to remove the device.
When the swelling became unbearable, Fuller returned to her doctor. X-rays revealed the devices had moved into her uterus.
"I was told they had never seen anything like this before and it may mean a hysterectomy," Fuller said.
The Pleasant Hill mother was just 26 years old when doctors performed a full hysterectomy.
Fuller said after surgery, she immediately felt better and a photo taken afterward showed her stomach returned to normal.
THE RIGHT DEVICE FOR THE RIGHT WOMAN
Doctors told 41 Action News Essure can be a great option for the right woman.
Dr. Danielle Staecker, at the University of Kansas Hospital, was involved in the clinical trials of Essure when she worked in Baltimore.
"It actually has the lowest rate of failure of all the different ways we tie a person's tubes," Dr. Staecker said.
Staecker believes the device is safe and can be an affordable permanent birth control method for the right woman. She said women who are good candidates for Essure are finished having children, have healthy reproductive organs and are not allergic to nickel.
"They are made of titanium steel with a little nickel so (that's) another important thing to tell your doctor if you are interested in this. Nickel allergy is very common," Staecker said.
However, our investigation found some women may be receiving a mixed message about that nickel warning.
When the FDA approved the device in 2002, the government agency told Conceptus, the makers of the device, to include a label warning women to undergo a skin test before getting the device implanted.
However, in July of 2011, Conceptus asked the FDA to remove that skin test warning. The company presented studies showing there was too little nickel in the product to cause an allergy.
The FDA approved removing the skin test warning and
replacing it with a different warning.
Following that decision, Conceptus sent out a press release about the change which stated the device now "could be an option for women with nickel sensitivity."
READ | Conceptus press release: http://bit.ly/1aEZH15
The CEO quoted in the press release said, "The upgraded label change significantly diminishes the biggest competitive selling point of our competitor's hysteroscopic sterilization product against Essure, which was the nickel hypersensitivity contraindication."
The release goes on to say, "We will be aggressively marketing this IFU change to the OB/GYN community, and especially to those physician accounts that are trialing the competitor's product primarily because of potential nickel allergy in patients."
However, in the FDA database, we found doctor after doctor reported allergic reactions to the device to the FDA.
In each case, we saw Conceptus responded by saying the device should not be implanted in women with a nickel allergy or without a skin test.
MANUFACTURER RESPONDS TO ALLEGATIONS
Conceptus, the original manufacturer of Essure, was acquired by The Bayer Group in June 2013.
A spokeswoman for Bayer told us the device has been reviewed by more than 400 peer-reviewed publications that support Essure's safety, efficacy and cost-effectiveness.
"At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause," Bayer spokeswoman Rosemarie Yancosek wrote in an email.
She told 41 Action News the device has always contained a warning telling women with nickel allergies to speak with their doctors.
Women like Fuller and Esther told 41 Action News their doctors downplayed the chance of allergy. They said they are facing large medical bills trying to fix the problems they say Essure caused, yet they are not able to file litigation to recoup that money.
A 2008 Supreme Court ruling decided a previous law did exempt medical devices approved by the FDA from litigation. In their decision, the justices said it would be up to lawmakers to change the law.
That leaves women with complaints with no legal avenues to pursue. However, famed consumer advocate Erin Brockovich has taken up the task of trying to change the law.
"I was just astounded at what I was reading and even more angered that there was just going to be no recourse for these women," Brockovich said.
She has started a website for women to share their stories and has drafted a petition to get lawmakers to change the law.
"I find it very, very, very bothersome that thousands of women have been harmed in this way and very very, very, very bothersome that there's no recourse," Brockovich said.
Both women we spoke with are upset they are facing large medical bills to have the device removed.
"I mean in science it says you cannot have so much of this and there not be some sort of common denominator. There is a common denominator. We all have Essure," said Esther
The women we interviewed, Bayer, and Dr. Staecker all expressed the same advice to women: Talk to your doctor and thoroughly research which birth control method is right for you.
For instance, Dr. Staecker advises women who are finished having children and seeking a permanent birth control solution to consider having their partner undergo a vasectomy. Dr. Staecker said it is far less invasive and can be done in an office visit.
If you have had problems with Essure or any medical device or pharmaceutical, you can make a report to the FDA here: http://1.usa.gov/18eqK4H
You can search for problems with a device here: http://1.usa.gov/1gEM1rP