Women forced to have hysterectomies to remove Essure device
Patients report adverse reaction to permanent birth control
Nikki Morris has three very busy little girls at home in Haines City. Her husband works full-time and she stays home and home-schools the oldest while looking after the little ones.
Her pregnancy and delivery with her third daughter was a rough one, so she spoke to her doctor about permanent birth control options.
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The Essure procedure sounded like a convenient option, because it could be done in the office and had no recovery time, as opposed to tubal ligation which is more invasive.
The device works by inserting flexible coils into the fallopian tubes. Eventually tissue will grow around the coils causing a permanent barrier that blocks sperm from reaching the eggs for fertilization.
Morris said within four months of having the device implanted she couldn't sleep, couldn't eat, couldn't stand and was in debilitating pain.
"I remember telling my husband every night before bed to please check on me and make sure I keep breathing, cause I would go to bed every night scared to death I wasn't going to wake up the next morning," she said in an interview with Local 6's Lauren Rowe.
During a phone call with her mother, Morris discovered she had experienced a childhood allergy to nickel and wasn't even able to have pierced ears.
The Essure coils contain nickel alloy, and a warning is even given in the product's information for use, or IFU, provided to doctors.
Morris believed the coils were poisoning her body and contacted her doctor.
"He said there was not enough nickel to be causing those problems," she said.
After more months of pain, she ended up at Florida Hospital Celebration in the office of gynecological surgeon Dr. Steven McCarus. Dr. McCarus felt the coils had to be removed from her body to get her feeling normal again.
The only way to do that was to perform a hysterectomy and remove Morris' fallopian tubes and uterus.
"I was 25 years old and had to have a hysterectomy, I don't think that’s acceptable at all," said Morris.
She is not alone. Thousands of women across the country say they’ve had to get hysterectomies after having the Essure device implanted. They have joined together on Facebook, and have the help and attention of consumer advocate Erin Brockovich.
Heather Hare, a 44-year-old mother from the Tampa area, is among those women.
She chose to have a hysterectomy in October and said the minute she woke up from the surgery she felt better.
"My body and my mind was that of an 80 year old and I just thought to myself everyday that I couldn't imagine living another day like this," said Hare.
Like Hare, many women who’ve had the procedure talk about getting a ‘brain fog’ where they cannot remember daily tasks.
Trish McFarlan, a 34-year-old mother of two from Orlando, has had that fog along with nagging pain for over four years and blames the device.
However, she said she is not quite ready to give up her organs to have Essure removed and is looking for a doctor who will remove the coils themselves.
Dr. McCarus does not think that is an option.
"It's a device that can't be removed easily so patients need to know that. Patients that have a nickel allergy or who are on steroids, patients who are not sure whether or not they are ready to be sterile or not should not have the device," he said.
Morris, Hare and McFarlan said they were never asked if they had an allergy to nickel prior to getting the Essure implants.
When Essure was first approved by the FDA in 2002, nickel was listed as a contraindication in the information for use.
But in 2011, the FDA removed that contraindication and stated in an email, "there was no evidence from laboratory (bench) testing data, literature, market history information, and clinical trials to support a contraindication for nickel sensitivity."
The FDA spokesperson also wrote that the sensitivity to the device was found to be less than one percent.
After the FDA removed the nickel contraindication, the maker of Essure said it would be aggressively marketing that change to doctors.
Conceptus, Inc., the maker of Essure in 2011, boasted about the change in a press release and claimed they would be informing the OB/GYN community about the new expanded amount of women who would be able to have the procedure.
Despite the change in the contraindication material, nickel allergy information still appears on the website for Essure and the IFU material.
In the last line of the warnings section it states, "Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies."
Dr. McCarus said he informs his patients about the potential nickel allergy before performing the procedure, and so far he has not had any patients who he implanted with the device experience problems.
However, Dr. McCarus said he has had to perform several hysterectomies on other doctor’s patients for reasons other than a nickel allergy.
"The insert was either improperly placed and can perforate through the uterus, or through the tube, or it migrates into the end of the tube or it falls out," he said.
The US Food and Drug Administration provided figures regarding the types of complaints it had received on Essure.
In the FDA’s adverse reporting database, from 2002 through the end of October 2013, the agency reported 943 complaints related to Essure.
Of those adverse events, 606 related to pain, 140 were for hemorrhaging, 130 for headaches, 95 for menstrual irregularities, 88 for fatigue and 77 for weight malfunctions.
In an email, a spokesperson for the agency wrote, "The most frequent device problems reported were the migration of the device or device component (116), patient device incompatibility (113) (e.g., possible nickel allergy), device operating differently than expected (73), malposition of the device (46), and device breakage (37)."
Another complication that is apparently not present in the FDA data is pregnancy.
Women who have joined forces with Brockovich have shared stories of unwanted pregnancy after getting Essure and shared their stories online.
Leila Cruz, a 29-year-old mother of three from Jacksonville, is pregnant with her fourth child despite having Essure implanted in 2007.
This is the second time Cruz has gotten pregnant on the device, she miscarried once in 2011.
The FDA said its adverse event reporting data alone cannot be used to figure out just how often certain events, like pregnancy, are occurring.
Bayer purchased Essure from Conceptus, Inc. in 2013 and has stood by the safety and effectiveness of the product.
In written and video statements, the company points out that nearly 750,000 women worldwide have chosen Essure as their permanent birth control method.
Bayer pointed to the results of a five-year Essure study completed by the FDA, that overall "did not demonstrate any new safety problems or an increased incidence of problems already known."
In a summary of that five-year-report, the FDA writes, "To date, we have found no evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement."
Local 6 filed a Freedom of Information Act request to receive the full five year study completed by the FDA, but the request has not been returned at this time.
Meanwhile, Dr. McCaurus said he will continue to have honest conversations with his patients about the device and the potential problems.
"There's a lot of stakeholders in this process, we all have to collaborate, get the information to the patient, answers the patients questions and concerns and try to make a good decision," he said.
Women who believe the product is causing their medical problems are encouraging others to file complaints with the FDA to try to get the agency to recall the device.
"I would love for them to pull this off the market so that no one has to go through this," said McFarlan.