I was whole and intact when I went in for this “90 second” procedure.I came out with a thermal injury to my uterus and a perforated bowel, which then caused a very, very deadly condition called sepsis.It may have been a combination of the device and the doctor, maybe the doctor was not trained enough and along with an unstable (self automated thermal tool), you end up… But when you look at the history and high number of injuries, I think the company needs to step up to the plate and do something about it. I did write a letter to the CEO of Cytyc, it does provide more details and if you’d like to read it, please let me know. I did receive a call from them, of course, not accepting responsibility, just to call and discuss it.Then they filed court documents to dismiss the lawsuit based on the fact that this pre-emptive law protects them. Why should they be concerned with injuries and deaths of women as long as they’re protected? it makes me sick, it’s all about the money and marketing the products to keep the money coming in, not about the safety of the people being treated with the devices.I would have researched other methods – had I been informed of other methods.The doctor (she is no longer my OB) only mentioned Nova Sure. After deciding to go with the ablation, I was sent home with an educational video about the product. My purpose for sharing this info is that I’m hoping anybody considering having the Nova Sure ablation done, will at least be able to make an informed decision based on some of my research and my horrible experience.Just don’t assume (like I did) that medical products and devices are safe and have been thoroughly tested, and that doctors are well trained in using them.The FDA has a link to information listing all “adverse events” related to devices, here it is: MAUDE/search.
Although, if you’ve had the “up/down “ c-section, you’re not a viable candidate for this procedure. Because your uterus would be compromised and susceptible to injury.
There needs to be some form of retribution made to me, and I certainly hope to anybody out there that was injured from this device. I’d rather go thru days of hard labor pains than what I was dealing with then.
I had the Nova Sure procedure done for heavy bleeding, in September ’05, and I am still suffering residual effects from the injury sustained as a result of the Nova Sure product. It turned out that the tool had burned my uterus and then burned my bowel, perforating it. All the while I was still in terrible, awful pain and asking my husband to just shoot me, kill me, whatever.
Cytyc’s only defense is this law, that they are protected and I, nor a judge can override this law. I incurred medical bills due to this, was off of work for 3 months, and just the trauma of almost dying, does, in fact, deserve some form of compensation.
They are not at all concerned with the fact that women are being injured regularly with this device. In fact, on 6/9/06, Cytyc themselves uploaded appx.
If you have not and are thinking about it, please read this and make an informed decision about it before going forward with it.