Problems with Essure, women experience severe symptoms

Preferring not to have surgery involving general anesthesia and a laparoscopy, Amanda opted for the only non-surgical permanent contraceptive method approved by the FDA, Essure. She says it changed her life completely.

 

"Physically, it has permanently ruined my body inside and out," she said "Mentally I've never been stronger. You have to force yourself to be, or you'll never make it."

 

The Essure device is a device implanted into the fallopian tubes of women between the ages of 21 and 45. It is a soft, flexible metal alloy. One is inserted into each fallopian tube, and during the following months scar tissue growns around them hence blocking the tubes and preventing the fertilization of eggs, or their arrival in the uterus. After the first 3 months, women must have an x-ray to check that the tubes have been fully blocked, and at this point the contraceptive method is considered to be 99.83% effective.

 

The priblems for Amanda started in September 2010, when she started to experience a range of symptoms. She experienced; migraines, joint pain, chronic fatigue, heavy periods with lots of clots, back pain, digestive issues, abdominal pain; difficulty concentrating, tooth deterioration, hair loss, depression and severe bloating to the point where she felt like she looked pregnant and refused to leave here house.

 

At first she thought this was all due to aging, until she missed a period and found a facebook group of women (18,000) who were experiencing similar problems after having the Essure device inserted. These women now call themselves the “E-sisters”. Many have had to have the device removed despite it being considered a permanent contraceptive method and are extremely frustrated with their doctors and the Essure’s manufacturer Bayer who for years have dismissed the concerns.

 

Bayer said that the product had passed all FDA analysis before it was brought to market.  

 

"Essure was reviewed through the premarket approval process for Class III medical devices, the most stringent type of device marketing application, according to the FDA," said a Bayer spokeswoman Tara DiFlumeri.

 

However, Dykeman said, "We don't understand, if all of these women are reporting the same symptoms, why aren't we being taken seriously?"

 

The FDA are now taking action and taking the concerns seriously. On their website they have updated the long and short term risks that they list and have scheduled a public advisory meeting of its Obstetrics and Gynecology Devices Panel. This will bring experts together to with patient and industry advocates to review the data and hear what the women have to say.

 

It is possible that the labeling of the product could be amended, or additional studies could be needed, but the decision won’t be made until after the meeting.

 

"I'm anxious to attend the hearing and demonstrate everything we've learned about Essure and its safety and efficacy over the years," Dykeman said. "If the right people are in attendance and they really listen to what we have to say, I believe they will have no choice but to take some kind of disciplinary action."

 

The main question that is being asked is, whether Essure is the cause of these problems, and how common they actually are.