Novasure VS HTA

I am a woman "$uffering" from heavy bleeding each month. I am a lowly second grade teacher, mother of three. Luckily I checked into MAUDE before having an ablation which my doctor strongly recommended two years ago. Still struggling with bleeding, but think I will stick with playtex.
Thanks to your chats I tell anyone who will listen to check for these types of blogs before any elective surgery. BTW: I opted for breast implants they were safer, checked those out too. My husband loves them and my in tact vagina. THANK YOU FOR ALL YOUR BLOG ENTRIES!!

 

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Wow, this blog clearly confirms that 99.9% of procedures are all about the 'ole mighty dollar and NOT a patient's safety. As with the lady's decision above, I'll sit tight with pain & bleeding for another 1-2 yrs when my body decides on its own to stop. Pretty scary that most women don't do the research before they trust their doctors recommendations, as sometimes you stumble across blogs such as these that display the truth about what is REALLY going on behind the scenes.

 

i would like to say ive been having pain since 06 from nova sure when i woke up i was coughing blood up i told nurse get my doctor antiastisalogy said shes fine came home still coughing up blood called hospital said come need to see if blood clot in lung sent to another hospital doctor calls says you didnt have a tube in throat i have pus in urine bad kidney infections right side pain that never goes away i feel like im on fire my vagina burns i lay on ice day night i once did 4 things at once now i cant do nothing i lay around been to 3 urologys 2 gyn several emergency rooms just to be asked did i come for the drugs i said no im in pain could you be pregnant i said no husbands been fixed have you been screwing around i said no i have noti have had 8 ct scans which showed nothing idont wish this on my worst enemy ive got white particles in urine i hate living this way ive tried to get help for my self my husband had a heart attack at 51 i cant help him pay the bills i ust to raise dogs once i could no longer do that i had to find them homes i had a 25 annversy when i woke up i had to lay on couch rest of the day felt like ihad an hours sleep everything wears me out my girls husband are here seeing me go threw allof this ive seen how the wand melts from novasure has shap end of it where it could put ahole uterus bladder or bowl they talked about it after complants to the fda i ts hard just to look up anything on there so how are women suppost to say anything there not getting any answers like me i believe there is alot of women like me trying to find out whats wrong and cant get any answers i know if i knew this would hurt someone so bad i could not keep doing oter novasures to women i have nothing to look forward to pain pain pain i have ice packs reddy i wish i would have never had this done i want to warn other women dont do it i heard in other countrys this is band also it closes off your uterus when you have your period blood cant come out goes up instead if you had tubes tied backs up in fallopullin tube and you coulld bleed in your belly they arent telling you the bad just how good it would be do your own research i thought id find a doctor that would help me i guess if i was there wife daughter they would sheila

 

Ma'am, if you had your Novasure done in America instead of f'in Mongolia perhaps your results would have been better. Too bad, if you had an HTA instead you could add a burned vagina to your incoherent list of adverse events. Tool! When you learn eanglish, c'mon back to CP.

 

The following is an except from Hughs v Boston Scientific, a 5th Circuit (federal) lawsuit, where the courtr allowed claims to go forward against BS for under-reporting the number of burn injuries from HTA procedures in the FDA Maude reporting:

"Hughes supports her argument that Boston Scientific failed to abide by these reporting regulations with evidence obtained during discovery that Boston Scientific developed an "algorithm" regarding reportable events caused by the HTA according to which Boston Scientific reported some, but not all, burns, as follows:

(1) First degree burns were not reportable.

(2) Second degree burns were reportable depending on the extensiveness and intervention required to treat the injury. A second degree burn was MDR reportable if any of the following criteria were met: (a) the burn was classified as extensive by the physician; (b) the burn involved both internal anatomy such as the vagina and cervix and external anatomy such as the vulva, perineum and buttocks; (c) the burn required intervention involving a medical or surgical procedure that cannot be administered by the patient (such as: systemic antibiotics, debridement, skin grafting, etc.).

(3) Other second degree burns that can be effectively managed by application of cream or ointment were not considered to be MDR reportable.

(4) Third degree burns were reportable.

Boston Scientific included this algorithm in its annual reports for the HTA from 2002 to 2008, required by FDA regulation to be filed with the FDA's Center for Devices and Radiological Health ("CDRH"). In response to a 2003 letter from the CDRH inquiring about Boston Scientific's criteria for reportable burns, Boston Scientific included the algorithm in a 2004 letter to the CDRH.

Hughes relies on the expert report of Charles Kyper, a former FDA official. Kyper has given his opinion that Boston Scientific's failure to report certain first and second-degree burns caused by leakage from the HTA device, pursuant to the algorithm, violated the MDR regulations. Hughes further asserts that the FDA itself disapproved of Boston Scientific's reporting practices, relying on the deposition of a Boston Scientific representative, Charles Montgomery, who testified that in 2008 an FDA official "directed" Boston Scientific by letter to abandon the algorithm and to begin reporting more burns caused by the HTA.

After this "direction" from the FDA in 2008, Boston Scientific began reporting more burns caused by the HTA device. Hughes produced evidence that this change in reporting resulted in a sharp increase in the number of reports to the FDA in 2008 and 2009. According to Hughes, evidence from the FDA's MAUDE internet database, which tracks device reports, shows that from 2002 until the time of Hughes's injury in 2006, Boston Scientific submitted 62 reports regarding the HTA, 53 of which involved leaks or burn-related injuries; but following the change in Boston Scientific's reporting criteria at the FDA's direction in 2008 through July 2009, Boston Scientific filed 495 reports, including 247 of which involved leaks or burn-related injuries..........."

I dont know about you, but i think BS was pulling the wool over the consumers eyes for the sake of the bottom line.

 

What to do now?

I am a 38 year old mother of four. I opted to have the Novasure in 2009 for heavy periods. Since then, every month during my menstruation I have been suffering with excruciating pain. At first I was told that the pain would decrease, but that did not happen. I decided that I did not want to go through surgery again, so tried to manage the pain with ibuprophen and narcotics. I had an MRI and 3 ultrasounds and nothing was found. In the Fall of 2011 I ended up in the ER for pain that made me sick to my stomach. The ER MD supposedly looked at my MRI and found nothing.

An ultrasound from a second opinion a month later revealed that I have hemorrhagic cysts & adhesions that are pulling my uterus & blood pooling in my uterus. Was this happening all along? How could this have been missed? All of this from a so-called simple procedure? Was it the fault of the device, the MD, or just one of those things?

I suffered for years-every month I feel like a drug addict. And now the options are surgery to correct surgery. Why couldn’t I have been grateful for life and heavy periods? Should I just be grateful for being a being alive suffering monthly with intractable pain?

 

I'm sorry you are going through this, this is something that is not uncommon to having a Novasure procedure - rergarding adhesions and blood pooling. Novasure causes what is called Asherman's Syndrome, where the walls of the uterus fuse together. If the walls of the uterus fuse together, it prevents blood from exiting during your cycle and can cause hematometra which is basically a small pool of blood/cyst at the top of the uterus. This can cause severe pain each month during your cycle. This pain can also be increased if you have also had tubal. Unfortunately, there is not much more that can be done now than to have a hysterectomy which relieve the pain.

 

Let's be clear, this can and does happen with all ablation devices, not just Novasure. Occurrence is low (<6%) and it is unfortunate.

 

I bet that posting an old case about HTA and it's vaginal burns felt good. Nothing like banking your argument on the old technology. Boston Scientific has made significant improvements to the safety of the equipment and unlike Hologic, the reps report every complication, including vaginal burns. That being said, less than 1 in every 1000 cases have had any type of vaginal burn and of those, the burns were mild and treated with cream.
NOW, feel free to ask the Hologic/Novasure advocates about the multiple BOWEL burns that have occurred over the past year, that were not reported. Then ask about the tragedy of the woman in California who just wanted to reduce her bleeding, had a Novasure on Friday and was dead on Tuesday. The procedure was done in the hands of an experienced Novasure doctor who did not perforate the uterus. As a patient, are you willing to risk a bowel burn or death just so that your doctor can save 8 1/2 minutes.The product is fast, but not safe! Period!

 

I had novasure done one week ago. I just discovered that my orgasms are gone! There is no uterine contraction whatsoever! I was told that the procedure destroyed the lining of the uterus. It seems that my entire uterine muscle is no longer working. I am devastated.

 

Sorry to hear about your troubles. I wouldn't get your panties all in a bunch just yet. You may just need some time for your body to heal. It's only been a week and you're already jockeying the one eyed pony? Might want to wait a bit. Not that this doesn't surprise me. This product is marketed as "safe" and "simple" but the reality is that this is a class III medical device - it sure isn't a band-aid, which is what that company would lead you to believe. There is nothing "safe" about surgery. There is always risk of injury and even death.

The sad fact is that NovaSure docs don't share with their patients all the risks and complications associated with the procedure because they are making money from the procedure. If they were more upfront with this information, less patients would opt for getting a NovaSure = less revenue for the surgeon. It's a big joke at company meetings. The busiest NovaSure surgeons will show up and pose with money in their hand, bragging about how much they make.

 

This is spot on. The sad thing is, if you search MAUDE, you won't see this death listed. Im not sure how they are getting away with this. We keep hearing about multiple NS deaths out in the field but when you search MAUDE, guess what? You never see them. I know the NovaSure rep. likes to talk about HTA vaginal burns (which are quite rare outright) but this is not KILLING patients. I've seen NS cases where the patient will just start shitting themselves once they start the energy.

 

Oh baloney... About 1.9 million novasures to date and the device dramatically improves a woman's life. BSCI endo rep here and I can say this procedure dramatically improved my QOL. Boiling water in my uterus? No thanks

 

Wow, I came here to get what I thought would be "inside information" and most of it is bickering, name-calling, and chest pumping; what a shame.

For those that came here for the same reason I did, Nova vs. HTA, I decided to go with HTA. I had my procedure 5 days ago. My doctor did not lead me to one decision or another, simply laid out the facts and let me make my own decision based on what I was more comfortable with. I chose HTA because I just felt like it was a more "organic" option (not that I'm a tree-hugger or anything-not that anything is wrong with that). I especially liked the fact that she had full view of what was going on during the entire procedure. If something goes wrong, she would have known immediately. I know there are knocks against HTA because it takes longer than Nova. Am I really going to complain about a 10 minute procedure? Besides, I'm knocked out the entire time, what do I care? I know that I spent extra time post-op in recovery for cramping, and was given pain meds via IV, but I only know this b/c my hubby told me-you are so out of it anyway you don't remember. They also sent me home with some extra strength Ibruprofen and Tylenol 3. The first 48 hours I took them regularly because I get migraines frequently and didn't want one coming on, but after that I've hardly taken anything. My tummy is swollen,dissented and I am aware of my uterus (not in a painful way), but doing any jumping jacks or a downward dog right now is definitely out of the picture. I am going to listen to my body and give myself ample time to heal. I asked my doctor about sexytime with the hubby and when can I stop wearing pads (hate them!) and she said to be safe, wait until we have our post-op check up, 2 weeks, and then she'd let me know. But when she talked about tissue, pink & yellow discharge, etc coming out, let's just say my hubby didn't look like he was ready to rip my hospital gown off!

Best advice I can give: if you love your doctor, put your trust in them. Make sure they have done the procedure many, many times. If they haven't, maybe there is another doctor in their practice that has? Keeping fingers crossed.... Good luck to you all!

 

Yes, your doctor could see what was going wrong with the HTA, unfortunately, there is nothing she could do about the 100 degree Celsius saline that rushed into your abdomen and burned your bowel if she perforated. Or better yet the boiling saline that would flow retrograde into your vagina when the HTA cervical seal became compromised....and that would be it for your "sexy time"' Mrs. Borat. BTW, you're and idiot and so is your doctor!

 

I seems pretty simple... hot water or RF energy. Both can burn you. One can kill you... id rather not risk the whole being killed thing. Just my 2 cents.