If you’re reading this, you may be considering having the NovaSure endometrial ablation done, or you may have already had it done. If you have, then I sincerely hope it went well for you. If you have not and are thinking about it, please read this and make an informed decision about it before going forward with it. I can understand a mistake, or a 'oopsie' once in a while, and there are risks associated with any medical procedure. However, once I saw the number of injuries as a direct result of this NovaSure endometrial ablation device, I just couldn't let it go. Not to mention, the suffering I personally went through, the horrible scar and the ongoing issues/pain that I still have to this day. 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 had the NovaSure procedure done for heavy bleeding, in September ’05, and I am still suffering residual effects from the injury sustained as a result of the NovaSure product. All seemed to go well during the procedure, then the following night I had the most excruciating pain imaginable. I called the OB (no longer my doctor) , she immediately said “it has nothing to do with what we did yesterday”. But she said, if I felt I needed to go in to ER, then go. Oh, she also said “it’s probably gas”… funny one. Basically, I felt I was bothering her. I had no choice but to go to ER, it was awful. I was begging my husband to just shoot me. I’d rather go thru days of hard labor pains than what I was dealing with then.
It turned out that the tool had burned my uterus and then burned my bowel, perforating it. This caused sepsis/peritonitis, which can be deadly. They did “emergency” surgery… about 14 hours later. All the while I was still in terrible, awful pain and asking my husband to just shoot me, kill me, whatever. I was then in the hospital for 13 days, 7 of them spent in ICU not knowing if I was going to make it or not. I had congestive heart failure (I was 43 at the time), needed blood transfusions, blood pressure was anything but stable the entire time, my organs were not doing well, etc… of course, according to the OB doctor, Sharon Washington, I was the picture of health. Almost everything she wrote in the medical records contradicted what was actually happening to me physically. Talk about CYA!
Had I known the number of injuries this device has caused, I never would have had the NovaSure procedure done. I would have researched other methods – had I been informed of other methods. The doctor (she is no longer my OB) only mentioned NovaSure. It appears this device is marketed very well. After deciding to go with the ablation, I was sent home with an educational video about the product. It was just a marketing tool, and I was gullible.
My purpose for sharing this info is that I’m hoping anybody considering having the NovaSure 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: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM Type the word NOVASURE in the ‘brand name’ field and modify the date range. It goes back thru March of ’03.
If you’re wondering if I have a lawsuit against all involved with this “adverse event”, I do. Although, apparently Cytyc is protected by some law as the device was approved by the FDA and is considered a Level 3 device. So patients that are seriously injured cannot sue them for compensation for their injuries and horrible experience. My guess is the families of the women that died cannot sue Cytyc either, due to this law, although I do not know that for sure. It’s a shame. I have never been involved in a lawsuit, ever. I feel there are many frivolous lawsuits from people simply trying to hit the “lotto” by suing . This, however, is warranted. I have a huge scar on my abdomen (up and down), still suffer from pain on the left side of my stomach – daily. Was put thru hell while in the hospital and during recovery, and I have a morbid fear of infections considering it was sepsis that almost killed me.
Cytyc’s only defense is this law, that they are protected and I, nor a judge can override this law. So basically, “sorry, but you can’t touch us”. 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. They are well aware of the injuries. In fact, on 6/9/06, Cytyc themselves uploaded appx. 19 “adverse events” all on the same day, which I thought was odd. Some of them were a few years old, yet they are supposed to report injuries within 30 days from the date they are aware of them. Seems somebody wasn’t doing their job, or they just didn’t want the additional adverse events to be public. Obviously they’re not playing by FDA’s rules.
Cytyc claim that the FDA’s approval process is “a rigorous one”. They indicate, “on average, the FDA spends more than 2800 hours reviewing each PMA over the course of one year.” Not quite sure how true that is when you consider the last paragraphs in the PMA (P010013) for this device… here they are:
CONCLUSIONS DRAWN FROM STUDIES
“The pre-clinical and clinical data provide reasonable assurance that the NovaSure System is safe and effective when used in accordance with the directions for use.”
“Pursuant to the provision if Section 515(c)(2) of the Federal, Food, Drug and Cosmetics Act(FD&Cact) as amended by the Safe Medical Devices Act of 1990, this PMA application was not referred to the Obstetrics and Gynecology Devices Panel, an FDA Advisory Panel Committee, for review and recommendation. FDA believes that previous panel reviews of related endometrial ablation devices provided sufficient guidance for the review of this PMA.”
Hmmmm, doesn’t sound like they spent an average of 2800 hours reviewing this device to me. Also, Cytyc tested a whopping 175 women in their studies and testing phase before this tool was approved. Doesn’t sound like much testing, granted I am not an expert on the making of medical devices.
I have previously had 2 ‘low-segment’ c-sections – in the PMA contraindications it mentions nothing about not being a good candidate if you’ve had low-segment c-sections. Although, if you’ve had the “up/down “ c-section, you’re not a viable candidate for this procedure. Why? Because your uterus would be compromised and susceptible to injury. So, what’s the difference, a c-section is a c-section, any previous surgery would compromise the integrity of the uterus. Although, if they were to exclude women that have had the low-segment c-section, that wouldn’t leave much of a market for them as c-sections are so common now and they no longer perform the “up-down” c-sections. Just more potential patients for their tool.
Basically, I went in for this procedure to treat very heavy bleeding. 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. This has happened to many other women, not just me. The company knows this and they are doing NOTHING to ensure the safety, nor are they accepting responsibility and being accountable for almost killing me. 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… almost dead. 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. Right now they are being morally unethical. 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. Did I get any response from Cytyc? 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. So, who protects the patients? Why should they be concerned with injuries and deaths of women as long as they’re protected? Real nice ethical way to do business… 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.
If you do decide to go with this product, I truly wish you the best for a good outcome. I wouldn’t wish what I went through on anybody. If you would like more info based on the research I have done and would like to contact me, you can email me at: firstname.lastname@example.org I can provide a copy of the letter I had written to the company. I can also provide the wonderful picture of my disgusting stomach post emergency surgery, all necessary from a “90 second” procedure, and provide any paper work, research info, whatever I have that may help you decide. If you have had this done, with a bad outcome, I’d love to hear from you as well.
Thank you and good luck!!!