Sometime over the next few days, the FDA is expected to release its highly anticipated review of the controversial birth control Essure, and it could affect women across the country. Complaints about Essure have been piling up. Now, two local women share their nightmare.
Ashley Miranda and Melissa Dufour are best friends.
Miranda is a mother of two. Dufour, a mother of six. They’re depending on each other to cope with serious side effects they say were caused by their birth control.
“I was horribly sick,” said Miranda. “I was sick for a year straight.”
“Painful like stomach burning,” said Dufour. “Horrible cramps, it’s unbearable at times.”
Miranda said she got the implant Essure, which is made by Bayer, two years ago. With the procedure , metal coils are placed in the fallopian tubes to stop an egg from getting fertilized.
It was advertised as a non-surgical, easier permanent birth control method. But, Miranda said she only had the Essure in for about a month before she started experiencing complications.
“Horrible pelvic pain, migraines like you wouldn’t imagine!”
She finally decided to have it taken out. But, in order to do so, she also had to get her fallopian tubes out. A procedure known as a salpingectomy.
“I’m mad! I shouldn’t have had to lose any of my parts,” said Miranda.
She said Dufour was right by her side the day she had her surgery.
But now, Dufour is hoping it’s her turn to go under the knife.
“I want mine gone,” said Dufour. “I have had nothing but problems.”
Dufour said the side effects from the Essure are too much for her bear. However, she is having trouble getting clearance for removal.
“The doctor is not as eager to take them out as he was to put them in,” explained Dufour.
We spoke with several other women here in Connecticut who said they had to have a hysterectomy in order to get their Essure removed, and about a dozen who said they had problems with the side effects.
The FDA has received more than 5,000 reports about Essure. Among them, complaints that “describe symptoms not included on the labeling.”
Doctor Aileen Gariepy, of the Yale school of medicine said she and other doctors discovered unforeseen problems while implanting the device.
“I noticed that sometimes we couldn’t place the camera in the uterus. Sometimes we couldn’t place the coils. Sometime when women came back to get the X-ray dye test to make sure the tubes were blocked, sometimes they weren’t blocked. Sometimes the coils had fallen into the uterus,” explained Gariepy.
Gariepy also questioned the risk of pregnancy. Essure is advertised as 99% percent effective after three months of being inserted. But, the doctor published a paper in 2013 in which she said her research found the device to be less than that.
“That number is 85%,” said Gariepy. “That number was also reported to the FDA but it’s not what was advertised to physicians and advertised to patients, but I think that is the right number.”
She said the 99% effectiveness was reported to the FDA and others as a best-case scenario.
Gariepy also said there isn’t enough information about the removal of Essure. Sometimes it’s hard to take out and different surgical procedures are necessary.
“Some women probably require hysterectomy, but we don’t yet know how to identify who benefits from which of those procedures.”
Bayer’s data from clinical trials has also come under fire from Gariepy and others who question the methods they used to come up with the numbers they advertise.
“What has been published is an overly simplistic and overly positive view of the data,” said Gariepy. “And women that were having problems, women that didn’t successfully complete the procedure were taken out of the analysis.”
Bayer addressed the accusations saying it, “Strongly disagrees with any suggestion or allegation that the Essure clinical trial data collection was fraudulent or inappropriately altered,”
A Bayer spokesperson tells NBC Connecticut, they “Stand behind Essure as an important option for women whose families are complete.” Although, they did acknowledge there have been 12 deaths associated with it.
Congresswoman Rosa DeLauro wrote the FDA asking for an investigation of Essure. She thinks it should be taken off of the market until it’s complete.
“There were a lot of complaints that were made that were either glossed over or were not included in the review because during the trials in this effort.,” said DeLauro. “Women were making their complaints known.”
Bayer boasts more than 750,000 women have tried Essure. But that doesn’t impress Miranda or Dufour.
“It needs to be banned. It needs to be recalled,” said Miranda. “And I think every woman that wants it out should be able to get it out and not at their expense. I think it needs to be at the expense of Bayer and the expense of whoever is backing it.”
The FDA said it expects to release its review, and identify next steps for the product by the end of February.