Tuesday, February 26, 2013

FDA Preventing Legal Action Against Dangerous Sterilization Procedure

Hello, my name is Linda, I’m trying to get the word out about how the FDA has prevented legal action from being taken against a dangerous sterilization procedure, and how that has affected my life for the last two years.

In March of 2011 I decided, after careful consideration to have the Essure procedure done, which is form of permanent birth control that involves an implant within the fallopian tubes. My selection was based upon the assurances of the doctor that it would be simple, painless and have a short recovery time. Well it’s been two years and I’m still recovering, and it has been far from painless.

I was told that the implants were copper coils, which I have recently discovered was untrue. They are made of nitinol, a nickel-titanium alloy and I have a sensitivity to nickel. Had I known the device contained nickel I wouldn’t have had the procedure done.

I was told that the coils would irritate my fallopian tubes and cause scar tissue to grow around them thereby blocking the tubes and preventing pregnancy. What I wasn’t informed of is that once the scar tissue is in place the coils still inflame and irritate the tubes. Again, had I been informed of this, I wouldn’t have selected the procedure.

This has been a source of daily pain and occasionally restricts my abilities due to the pain and exhaustion that accompanies it. The pain is a stabbing and sometimes fiery in my lower right abdomen. It also is much worse during my period or when I am aroused. Another symptom has been a much heavier period which worsens a trouble that is bad enough naturally. I have also noticed that despite healthy changes in diet and exercise I have become more easily fatigued than I was previously. I’m an otherwise a healthy 24 year old weighing less than 130 lbs.

I’ve had several other tests looking for the source of my fatigue, but nothing has been found. The coincidence of the symptoms beginning shortly after the Essure device was implanted and no other causes found by my doctor points to the Essure device as the cause. With my nickel sensitivity this is no surprise.

In late September into October in 2012 I had chronic pain for two weeks. The doctors took an external and internal ultrasound but could not find anything and told me that it would probably just go away. The pain is still present, though it has diminished since that two week period, so I decided to do some research and see if any other women have had issues I’ve experienced in conjunction with the Essure procedure.

Not only are there other women but there are women who are describing the exact same symptoms as mine! There are some who have had even worse stories. Needless to say these women have gone to extreme lengths to have this implant removed. The most common way is to have a hysterectomy! There are women in their twenties having hysterectomies because Conceptus, the manufacturer of Essure, refuse to recognize that these symptoms are caused by their product. Yet if you go to their official website looking for possible and reported side effects nothing is listed!

I am tired of being in pain everyday and I hate not having the energy to play with my two little girls the way I used to. I do what I can but everyday is a battle and somedays it feels like a war. My body is fighting against itself and I’m afraid either way I will lose.

My husband and I are looking into our legal options, but the FDA has given Conceptus Pre-emption, which not only allows them to remove from their label that the product has nickel in it, but also precludes them from most legal action for harm caused by their device. We definitely have an uphill battle. I have no ill will against the doctor, she got her information from Conceptus and there was no way for her to know of it’s side effects or true composition.

I’m not looking to receive a massive settlement from Conceptus. All I want is for them to cover the removal of the Essure device. A hysterectomy is an unacceptable solution to this, especially when there is a reversal procedure now available that leaves all of my parts intact and functional. At this point the reversal procedure is is beyond our ability to pay, and not covered under insurance.

I wanted to bring this to your attention in hopes that spreading the word about the effects this product has on a woman’s body would allow women looking into the procedure to be adequately warned, and to let other women know that they are not alone in their suffering.