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