essure failure

**ashisbaby17** · 09-24-2009 01:27 AM

The risks that I listen were directly from the website and expulsion is listed on there. It also includes the results from the clinical study;

Two clinical trials were done to check the safety and effectiveness of the
Essure system. A total of 745 women had the Essure micro-inserts
placed. Certain problems with the micro-inserts were reported during
these trials. These were:
• Failure to place both micro-inserts during the first procedure (14%)
• Tubes not becoming blocked at 3 months after placement (patency) (3.5%)
• One or both micro-inserts not staying in the body (expulsion) (2.2%)
• One or both micro-inserts poking through wall of tube or uterus (perforation)
(1.8%)
• One or both micro-inserts outside the tube or not in the correct place
in the tube (0.6%)

When compared to standard tubal litigations this is fairly minor. I'm not saying to proceedure is perfect but it's not productive to try and fear people from one proceedure to another which obviously has even greater risks. Making comments such as, "Don't ever get this proceedure" or "if you want to get pregnant get the essure" isn't productive for anyone. Share your experience and if you encounter a risk let everyone know what to expect in case it happens to them. Don't use the forum as a way to get back at the proceedure. As for the doctors, don't assume that because they are the head of the department they are the best at that particular proceedure. If the hospital first started doing the proceedure they may still be new at doing it. Look at reviews for the doctors. Look at their credentials, where they've worked. If they've worked the same hospital for years they may not have encountered a lot of specieal circumstances. It's more than just the position it's the knowledge and a lot of times they don't go hand in hand.

**karoper** · 09-24-2009 07:46 AM

Ashisbaby17,

I disgaree that the complications are minor. You may be able to say that because you have not experienced any complications. I can tell you that the problems that I had for 9 weeks were not minor, and I don't feel the percentages cited on the essure website are accurate. Thanks for the information on how to pick a good doctor, but I am actually an insurance defense attorney, and I spend 85% of my time talking to doctors, reading medical records, and deposing doctors. So, I am very aware of how to check out whether I have a good doctor. I am not telling anyone not to get Essure. I am simply telling my story and hoping that people will do their own research before just relying on the doctors and the Essure website. I hope you don't have any future problems, but I think some of your comments are a stretch. To think that the problems with Essure that have occurred are simply due to inexperienced or incompetent doctors simply is not true. I am sure that has accounted for some of the probelms in some cases but not all. I went to numerous doctors who were professors at Medical schools and corresponded with a doctor at Harvard. The doctors are seeing problems with properly placed coils.

**ashisbaby17** · 09-24-2009 09:06 PM

I wasn't saying the problems themselves are minor but when you compare them to that of standard tubal litigations the risks are minor. Perhaps I should have used the term "not as life threatening." Plus, I never said the only reason there are problems is because of the doctors themselves nor did I refer to anyones specific situation. I It's just that I've noticed a lot of people who aren't getting support from their doctors, having questions answered, or seeing proceedures done at strange places such as a day spa. Obviously not all these doctors are doing adequate jobs and if there are people considering getting any procedure done they need to research their doctor prior to and find one that isn't just in a position that is to be admired but specializes in their particular situation. You may not believe the statistics are accurate but people have a tendency to share the bad stuff more than the good and even though there are quite a few people on here who have encountered the problems listed on the website there are a lot of people out there who had successful experiences and probably don't think about sharing them.

**kym4** · 09-24-2009 10:15 PM

You cannot compare the metal coils to the tubal ligations. Tubal ligations have been performed on millions and essure has only been done on about 290,000 women worldwide according to the companys latest reports. I wouldn't call the experience that I had minor. This procedure cost me a lot of money and a lot of down time. It also required me to have further surgery to remove them. (edit). I had so much pain that I actually trembled and by night I would be shaking. That was with taking percocet which is pretty stout. It took at least two to kill the pain. Not only that the emotional turmoil of being told the pain was in my head because this procedure is so great nothing can go wrong.

**LWatson** · 09-24-2009 10:44 PM

I read some of these, but right now I'm really not feeling my best so I stopped.

I had my procedure 2wks ago. I didnt want to do this procedure simply because it has not been around long enough, but I agreed to it since I didnt want another abdominal surgery this year (had my gallbladder removed...emergency surgery). I started having serious 2nd thoughts about it right b4 hand, but again went through with it. The day of the procedure I went in and took the 3meds like I was supposed to and then the procedure started an hour later. The 1st side (right) went in fine, but the 2nd side did not. It took forever to get it in. They tried and tried and tried. It took almost an hour to complete the procedure. While in there one of the things that inserts it broke after they finally got it in. All 3 docs in there were in shock they were having problems, and because the thing broke. They thought originally that it didnt go in because they thought they saw it in the part of the inserter that broke, but the camera showed it in (not all the way, but she said it was far enough in to work). I had horrible pain the rest of the day and was very emotional. I ended up w/ pain constantly for over a week, and bleeding...well, it still hasnt "stopped" I'm still spotting daily 2wks later. I still have pain off and on a lot during the day on the left side. I feel like I'm daily taking Aleve or Motrin at night to help me relax. I called last week and they said it was because I had not had a "BM" in a few days. I did finally go, and still the pain is there and is strong. I dont know if I should give it more time because they did have problems, or if I should call and see the doc. I am not one to have really bad cramps at all, but these hurt.

**LWatson** · 09-24-2009 10:48 PM

Oh and the reason I'm not taking my percocept is because my husband is deployed right now, so I am caring for my 2 boys by myself. I have to be able to care for them, so i cant take them (lord I wish I could though).

**CHANDLERS WISH** · 09-25-2009 04:16 PM

Taken by Wikipedia:-

Essure procedure

The reported insertional failure rates are "failure to place 2 micro-inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)." Following successful insertion and occlusional response, the Essure procedure is 99.80% effective based on 4 years of follow-up. The Essure procedure has been demonstrated in a small portion of the women undergoing clinical studies to be 99.74% effective based on 5 years of follow-up. Five year follow-up of all patients in clinical trials is ongoing.

The micro-inserts do not prevent the transmission of sexually transmitted deceases. The procedure takes about 35 minutes for a trained physician to perform and can be performed in a physician's office. General anethesia is not required. Unlike many temporary methods of birth control, the Essure micro-inserts do not contain or release hormones.

The micro-inserts are made from polyester fibers,nickel-titanium and stainless steel and are safe to use with MRI equipment. There is no data on reversing Essure and any attempt would require major surgery and likely be unsuccessful. Additional birth control must be used for 3 months after procedure.
Risks

Perforation, expulsion, or other unsatisfactory location of the micro-insert
Pregnancy and increased risk of ectopic pregnancy
Pain, cramping, vaginal bleeding, menstrual pattern changes, light periods at first then longer, heavier periods lasting up to 6–8 weeks.
Nausea/vomiting, or fainting
Vasovagal response
Allergic reaction to the materials

Tubal ligation (informally known as getting one's "tubes tied") is a permanent form of female steralization, in which the fallopian tubes are severed and sealed or "pinched shut", in order to prevent fertilization Hormone production, libido, and the menstrual cycle can be affected by a tubal ligation.

Another form of permanent birth control is the non-surgical Essure procedure that has been in use since 2002. In this procedure within the fallopian tubes by means of catheter and Hysteroscopy.

The micro-inserts produce eventual occlusion of the fallopian tubes by causing the in-growth of tissue.

Tubal ligation is approximately 99% effective in the first year following the procedure. In the following years the effectiveness may be reduced slightly since the fallopian tubes can, in some cases, reform or reconnect which can cause unwanted pregnancy. Method failure is difficult to detect, except by subsequent pregnancy, unlike with vasectomy or IUD. If pregnancy does occur it carries a 33% chance of being an ectopic pregnancy.

Usually there are two remaining fallopian tube segments—the proximal tubal segment that emerges from the uterus and the distal tubal segment that ends with the fimbria next to the ovary. The procedure that connects these separateds of the fallopian tube is called tubal reversal or microsurgical tubotubal anastomosis.

In a small percentage of cases, a tubal ligation procedure leaves only the distal portion of the fallopian tube and no proximal tubal opening into the uterus. This may occur when monopolar tubal coagulation has been applied to the isthmic segment of the fallopian tube as it emerges from the uterus. In this situation, a new opening can be created through the uterine muscle and the remaining tubal segment inserted into the uterine cavity. This microsurgical procedure is called tubal implantation, tubouterine implantation, or uterotubal implantation.

Tubal reversal, if done by a specialist microsurgeon, has a high success rate and few complications. Successful repair of the fallopian tubes is now possible in 98% of women who have had a tubal ligation, regardless of the type of sterilization procedure

Tubal ligation is a more major surgery than vasectomy, and carries greater risks. Postoperative complications are more likely than with vasectomy, and more costly.For instance, in industrialized nations, mortality is 4 per 100,000 tubal ligations, versus 0.1 per 100,000 vasectomies.

Wikipedia is the best sorce for information as other sites can in-deed be selling the concept or a product. However, more than often people post a thread with concerns and ask for opinions based on personal experience.

The Administrator and Moderators watch carefully for spammers and are aware of "advertising" on this site and delete same.

In addition each person is different in how it has worked for them, or whether it has not worked for them. We are not all the same.

Debating is welcome on the forum...however, directing comments personally as an attack is not tollerated, directing a question or debating over an issue pertaining to personal opinions should be done in a respectful manner.

It is important to know that the Administrator "Little" allows opinions only on this site, we are not Doctors.

Simply put, I would ask for a referral to a Doctor that has performed this method more than once and discuss one on one with that Doctor the pros and cons and personal situations of past problems.

In addition, thank you to all who have posted their personal experiences, it allows people to make their own judgement call as to which method may be best for them, or to make further enquiries if they are not sure.

CW

**se73** · 09-25-2009 06:26 PM

Originally Posted by LL123

I had the Essure procedure done in April. It was more painful than I had ever imagined!!! I cried the whole time. I just had the 3 month dye test yesterday, which also hurt, and it showed that neither tube is blocked!!! In fact the coils aren't even in my tubes. When I asked where they were she told me that they are probably in my Uterus but we will have to wait until I talk to the doctor on Wednesday to know for sure. How am I supposed to wait 5 days to talk to someone??? Has anyone ever heard of this? I have been crying all night and I am not sure who to call or ask. Can they be taken out now? To make it even worse..... my husbands work is changing insurance companies real soon, so I am not going to be covered under the new insurance because this will be a preexistion condition.
Has anyone ever had them removed from the uterus? Is it even possible to do without a major surgery? Any advice or suggestions would be greatly appreciated!

I also had the Essure procedure done in April 09. The procedure was very painful, our stories sound so similar. After it was done was was shaking, room was spinning, I had to drink juice, and stay for awhile until I stopped shaking. After I relaxed more, I just felt cramping, nothing too major, slept alot that day, but after about the 2nd day felt fine, some bleeding. The next 3 months I felt great. At the HSG test in July, which was only slightly uncomfortable, not painful at all and very easy, however, it was determined that my right tube was not blocked. I never did get an answer as to where it was, but I could see on teh x-ray that it was twisted, and not really in the tube.
I was scheduled for a repeat Essure procedure on the right side just last week. It went better, had some more muscle relaxants, but it still hurt quite a bit. It was then noted that the first coil was in my uterus. My Dr seemed unconcerned about where it was and said this 2nd one went in great and thinks this one will work. Sooo I find out in December now if this one is blocked now....but my question now is what about the one in my uterus? I guess with everything on my mind, I did ask him where the 1st one was, but then never asked about it's location--- can it stay in my uterus, without problems in the future. It will be my main question at the HSG. I am doing fine after this 2nd procedure as well, no pain afterwards, just slight cramps for 2 days, and tired, but now feel fine.

Have you heard any more about a insert being in the uterus, can it just stay there, my Dr didn't seem concerned that it needs to be taken out, but then I never asked specificly the why's? So far so good and I hope this 2nd attempt works.

**karoper** · 09-26-2009 04:42 AM

As far as this site goes, I just wanted to saying that reading information from people like Kym4 helped me a lot. When I had problemns and needed removal of the coils, I was very stressed out. There is very little information out there about removal. So, it was nice to have this site to hear about how others had it done, and that there was successful removal with a hysterectomy. That gave me hope. So, I am glad that people tell their stories.

Sorry, that post should have said without a hysterectomy.

**LWatson** · 09-26-2009 02:39 PM

Well, my doc called me back and put me on stronger meds (tramadol), but said that if I'm still feeling the pain on Tuesday I should come back in for her to see what is going on and make sure it didnt perforate anything. Here is to hoping!!!

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