Thursday, December 29, 2005

Adiana Sterilization System


Adiana

Adiana, a new transcervical sterilization system, is performing well in phase III studies:


Adiana in situ
Photos via Ob.Gyn. News


The Adiana transcervical sterilization system appears to be easy to use, safe, and effective, according to phase III data, Alan Johns, M.D., reported at the annual meeting of the AAGL.

The Adiana Complete system is available only for experimental use, but U.S. Food and Drug Administration submission is anticipated in mid-2006, said Dr. Johns, one of the clinical investigators in the trial.

The FDA approved Essure, currently the only nonincisional approach to female sterilization, in November 2002. The Adiana system "is the next step in the evolution of hysteroscopic devices," Dr. Johns said in an interview. It may be better than the Essure simply because it doesn't require as much manipulation and the whole device is altogether shorter and easier to put in and cannulate, he said. "More importantly, in contrast to the Essure system, after the Adiana matrix has been deployed, nothing remains in the endometrial cavity."

This may be important in women who later choose to undergo in vitro fertilization or endometrial ablation, because these options can be limited by the presence of a portion of a device in the endometrial cavity, he said.

The Adiana system also differs from Essure in that it uses radio frequency energy before placement of the polymer matrix in the fallopian tubes. This process is designed to stimulate vascularized tissue ingrowth into the matrix material, said Dr. Johns of Fort Worth, Tex. He accepted payment to enroll and treat patients in the trial but said he has no financial interest in Adiana Inc.

As of Sept. 30, 2005, the Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women (EASE) study had enrolled 770 women at 16 sites. Almost half (47%) were aged 28‚–33 years. A total of 655 patients were taken for hysteroscopy, and 10 were excluded for hysteroscopic findings. The remaining 115 patients either withdrew from the study or were excluded from the study protocol.

Treatment was attempted in 645 patients and bilateral placement was achieved in 614 (95%).

This placement rate is comparable with that attained by Essure in its clinical trials, he said. Lateral location of the ostia is the most common reason for failure of placement of hysteroscopic sterilization devices.

The average procedure time from insertion to removal of the hysteroscope was 12 minutes. Local and oral anesthesia was used in 35% of patients, local anesthesia plus intravenous sedation in 48%, and local plus intravenous analgesia in 17%. Nine patients were lost to follow-up or are awaiting 3-month hysterosalpingogram (HSG).

Failure of tubal occlusion occurred in 26 (4.29%) women, and there were two pregnancies. One occurred after proper placement of the device and HSG confirmation of occlusion. The second occurred when a physician misinterpreted the HSG and retreated the patient but placed the device in the occluded tube instead of the patent tube. There were no device-related significant adverse events. One procedure-related incident of hyponatremia was reported. All other events were minor and included spotting, cramping, and headache.


Here is a good review, from 2003, of transcervical birth control methods in the U.S. pipeline.

Update: The Essure site.

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19 Comments:

At 12:49 PM, Anonymous Anonymous said...

I was scheduled for essure surgery but cancelled because I felt there isn't enough info about what happens if there's a problem and the microinserts have to be removed. Adiana seems better to me because there are no foreign objects left in a woman's body. I've waited a few years for it to be approved here in the U.S., but looking at the failure rate, I'm not sure if I would do it.

 
At 5:04 PM, Anonymous Anonymous said...

The first comment comparing Adiana to Essure is inaccurate. Adiana is also a permanent micro-insert that remains in the uterine wall portion of the oviduct. Not aware of any followup data on women who subsequently had the devices surgically removed, although it would seem unlikely they would have such an invasive procedure to undergo IVF. Remember, the initial sterilization procedure is intended to be permanent.

 
At 11:23 AM, Anonymous Anonymous said...

I am a participant of the study. I had my procedure done in November of 2003 and have found the experience to be 100% positive. I have had no complications from this procedure. It has been a little over 5 years since I had the procedure done and I am enjoying the fact that I will never have to worry about pregnancy again. I am hoping the FDA will approve Adiana in the near future. I have many friends that have decided to use Adiana as thier permanent form of birth control rather than having a tubal done.

 
At 9:34 PM, Anonymous Anonymous said...

I am an extremely satisfied participant of the Adiana study. The procedure was done in 2004 and I just went for my 5-year follow up appointment. I had absolutely NO pain or discomfort with insertion of the implants and was back at work the following day.

One aspect of the study that I really found reassuring was the "dye-test" done 3 months after insertion, which verified that my fallopian tubes were completely blocked. What a relief to see with my own eyes that I wouldn't have to worry about pregnancy ever again!

I encourage all women considering this procedure to speak with their doctors and get answers to your questions.

 
At 4:09 PM, Anonymous Anonymous said...

I have had a really bad experince with Adiana - firstly Surgeon could only place 1 insert - had to come back for the second one - the machine broke down on the second visit, then some 6 months later had the second insert placed, I then went for follow up at 3 months - HSG nasty didnt enjoy that much - they couldnt confirm if my Tubes were blocked - told to wait for another 3 months - came back again they werent sure but felt it had worked - Just had a termination - Thanks Adiana you suck and yes I will be suing the Surgeon - be acreful ladies very careful this product doesnt work

 
At 9:43 PM, Blogger P. said...

June 4, 2009
As a participant for the Adiana device I have to say I am 99% happy with it. The device works 100% as I am heading for my 5 years period - The only issue I have is that a year ago I started spotting between periods (2 weeks after to be exact) however because the device is "a test" I can't be 100% is the device or my own body going through changes.....To the person that said the device doesn't work, I'm sorry to hear you had a bad experience - I will recomend the device to every girl I know that's for sure!

 
At 2:36 PM, Anonymous Anonymous said...

I had it done and I love it!! Only thing is I was always on the pill then had a child then had this done. My periods are hellish!! I don't know if that is my own body but I am going to ask to be placed back on the pill just for the regulation!!!

I am finishing my 5 year study as well and I am 100% satisfied that it works to prevent pregnancy. Sorry to the lady that had to endure 2 procedures and equipement fail. Sorry about the termination too. Maybe God wasn't through with you! This wasn't 100% guarenteed and I felt if I did end up pregnant it was what God wanted to happen.

The failure was a total doctor issue. Sorry it was a bad tramatic experience for you!!

 
At 4:35 PM, Anonymous Anonymous said...

I'm going to look into a uterine ablasion to manage my periods after Adiana. I've had friends that have had it done with great results. One friend doesn't get any period after the ablasion.

 
At 6:00 PM, Anonymous Anonymous said...

I had Adiana done 9/2/10. I've had light to moderate cramping. Taking it easy the day after. After the 3-month hysterosalpingogram (HSG) I will have the Novasure procedure done. Hopefully this will eliminate my period.
I have not had children, however, my periods have been horrendous. I made the decision to do Novasure, but if I wanted to not be on BCP's I had to do Adiana. I'm happy with my decision. Feeling okay the day after surgery.

 
At 3:19 PM, Anonymous Anonymous said...

I had adiana done 3 days ago. Feeling good, mild cramping. My doc was part of the trials and stated most failures were due to doctor mistakes. He had no pregnancies or complications in his study. Recommend the adiana because nothing is left in uterus for future surgeries related to fibroids and heavy bleeding. Had a fibroid removed a year ago. Cannot wait for 3 month test! So far so good!

 
At 8:16 PM, Anonymous Anonymous said...

I had the Adiana done over 3 months ago. Just had my HSG test this week and found out that only one of my tubes is blocked/closed. The makers of Adiana are blaming the Dr and vice versa. I have had cramping everyday since my surgery 3 months ago. My Dr wants me to do the Essure now. I am very upset and do not want to go thru this again.

 
At 6:42 PM, Anonymous Anonymous said...

I had Adiana done 3 1/2 days ago. I'm still spotting, I feel gassy but nothing's there, my stomach is bloated, feeling stuffed and huge. My lower back is killing me. There was cramping the first 2 days but I'd rather have that than a large tight swollen stomach. I thought this would be better by day 4.
Is this normal? Will my stomach go down?

 
At 4:03 AM, Anonymous Anonymous said...

I had the adiana done yesterday. it was a little uncomfortable while Dr. was looking for the fallopian tubes. the procedure its self was not pain full at all. so a little cramping the day of.today no cramping and I went for a Hike.my experiance has been great!

 
At 4:44 PM, Anonymous Anonymous said...

I received the Adiana implant last October (2010). This past week, I found out I was pregnanat and suffered a terrible miscarrage. I was assured that the procedure was done properly. After the proper placement of Adiana, I waited 3 months as instructed than went for the HSG test of which had confirmed my tubes were blocked. I am still in shock and very upset of all I have gone through. My physician says he had two failures, me being one of them. And that he and other colleuges have stopped doing this procedure. I am afraid that all failures are not being reported to company as doctors are afraid of law suites. Well, I need some anwsers and no one is able to give them to me!! It's not over!!

 
At 4:48 PM, Anonymous Anonymous said...

I also had my adiana places in october of 2010 after the birth of my 4th child.My husband and i decided we were done having childeren. i went for the 3 month HSG test and one side was still open another 3 months later the HSG test confirmed both tubes were occluded. i just found out in june of 2012 that i am pregnant. the baby is in my uterus and everything seems "normal" my doctor also told me that i was his second patient with failure of this product.. i am very upset as i do not believe in abortion.. does anyone know of anything i can do? can we go after the company or the dr? or what? i mean to begin with i was talked out of having my tubes tied by the dr saying that this procedure was much more effective and less invasive! i think if i would have just had my tubes tied i would not be in this situation.. advice? anyone?

 
At 3:38 PM, Anonymous Anonymous said...

I just had the Adiana procedure three days ago (August 2012). I have had horrible cramps and backache. Returned to work the day after having procedure and it seems if i stand,walk, climb stairs etc..I bleed heavier. Also experiencing the horrible gassy feeling. Truely hoping this all passes very soon. Dr. simply says to take motrin for pain and inflamation...no relief at all!

 
At 5:02 AM, Anonymous Anonymous said...

I had mine done August 2012 . Had my 3 month hsg and everything wad great! What I have been noticing is that iv been cramping more frequent. (No bleeding) also, headaches/ migraines and tender breasts and nausea almost as if I were pregnant! ? Witch I'm not... does anyone els suffer similar after adiana placement?

 
At 1:22 AM, Anonymous Anonymous said...

Do not get Essure!!! The problem rate is sooo high, just google it! I never heard of this, but had Essure a year and three months ago. Major regret! Cramps are hell, I get pains where the coils are, and lots of fatique. I can't do ab work or any gym work outs that include involving the lower abdomen area.. tired of trying to pick up my kids just to double over in pain! Ugh. Live and learn I guess!

 
At 3:17 AM, Anonymous Anonymous said...

Had Adiana procedure in March of 2011. It is now June 2014 and I am 29 weeks pregnant with #4!

 

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