Tuesday, March 1, 2011

Essure Reversal: Essure Problems Overcome

Is Essure Reversal Possible?

Essure Micro-insert
Essure sterilization was approved by the FDA for use in the US in 2002. Since then, hundreds of thousands of Essure sterilizations have been performed. The manufacturer, Conceptus Inc., states, “The Essure procedure is permanent and is NOT reversible.”


Essure Side Effects and Essure Complications


According to information provided by Conceptus, the most frequent adverse events and side effects reported upon insertion of Essure micro-inserts were cramping (29.6%), pain (12.9%), nausea/vomiting (10.9%), dizziness/hotheadedness (8.8%), and bleeding/spotting (6.8%). During the first year of reliance on the Essure micro-inserts for contraception (approximately 15 months after micro-insert placement), the following episodes were reported as at least possibly related to the Essure Micro-inserts: back pain (9.0%), abdominal pain (3.8%), dyspareunia [painful intercourse] (3.6%). [Source - http://www.essure.com/Portals/0/Skins/Conceptus_Skin/PDFs/CC-0366-01%2013Nov08F.pdf]


Internet Reports of Essure Problems


There are numerous web sites and blog sites where women have reported long-term complications they have had with the Essure inserts – most commonly excessive bleeding and pain. One blog site entitled "Essure Problems Continue Among Women" has over 400 women's comments about side effects and complications. In some cases, their doctors have recommended and performed hysterectomies, presumably because they thought the devices were not able to be removed.


Essure Reversal and Pregnancy


Despite the manufacturer’s statement that Essure is not reversible, the tubal reversal doctors at Chapel Hill Tubal Reversal Center have removed Essure devices and reversed Essure sterilizations with the technique of tubouterine implantation as outpatient surgery. Successful pregnancies have followed Essure reversals among women who regretted the sterilization operation and had the coils removed. Numerous medical studies have shown that approximately 10% of women who undergo surgical sterilization subsequently regret the procedure and want to become pregnant again. In some cases, women underwent Essure removal, but not tubouterine implantation, since they did not want to become pregnant but only wanted the Essure removed. The most frequent reasons for seeking removal of the Essure Micro-inserts were persistent pain, excessive and prolonged bleeding, and possible allergic reactions to nickel which is contained in the coils.


Post Marketing Surveillance of Essure Problems


The FDA maintains a reporting system for complications related to medical devices called MAUDE (Manufacturer and User Facility Device Experience). This is a voluntary reporting system for doctors. If a doctor reports a complication of a medical device to the manufacturer, it is required for the manufacturer to submit the adverse event report to the FDA. A search on Google for “FDA adverse events Essure” produced only a single adverse event report for Essure in MAUDE  as shown here:
CONCEPTUS, INC. ESSURE KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE      
Model Number ESS 205
Event Date 12/07/2007
Date FDA Received    01/08/2008
Event Type  Other   Patient Outcome  Hospitalization; Required Intervention
Manufacturer Narrative
Add'l info will be added if physician sends a pathology report info and any info from add'l post operative visits. 
Event Description
This physician reported on 12/6/07, that he was going to remove the essure micro-inserts the next day due to persistent pain, this pt experienced after having them placed in 2007. The physician evaluated the pain with pelvic examinations which were normal, and a ct scan which showed the micro-inserts to be properly located within the respective fallopian tubes. A white blood cell count was normal. The day after surgery, he reported both micro-inserts were removed laparascopically without difficulty; they appeared normal in the right location without any inflammation. There was no pathology he could find to explain the pelvic pain. He performed a d&c, hysterectoscopy and laparoscopy. He reported to conceptus on 1/7/08 via fax, that during her post operative visit 2 weeks later, her symptoms were much improved and pain seemed to be resolved, but he would continue to monitor her. This physician feels the pain was essure related as he could not find any other pathology to explain her symptoms.

With the hundreds of adverse events and complications women have reported on various internet sites, the single adverse event reported to the MAUDE database represents the tip of the iceberg. The actual long-term complication rate associated with Essure sterilization is unknown.


Essure Reversal and Essure Removal ARE Possible


Women who want to become pregnant after Essure sterilization should be informed that Essure reversal is possible. And women who experience persistent pain or bleeding following insertion of Essure coils should be informed that Essure removal is possible. It is very unfortunate for a young woman to have a hysterectomy to treat problems associated with Essure when a simpler, safer, and more conservative approach is feasible. For more information about Essure removal and Essure reversal, call (919) 968-4656 for a free consultation with a tubal reversal nurse at Chapel Hill Tubal Reversal Center.

45 comments:

  1. It is so important that women realize that Essure removal is possible. There are so many reports of women being told that this procedure cannot be reversed. Another thing that is scary is that women are being told that the only way to have the Essure coils removed is through a hysterectomy.

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  2. I had the HSG oct 21 2009 it was successful
    Since may 2010 I have been tracking my severe cramping it is march 2011
    I have had 200 Days and nights of severe on the couch with heating pad cramps
    I am a mom of two the ultrasound tech looked scared that the right esure coil was in my uterus I've since heard my obgyn not concerned

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  3. Hi Anonymous,

    I am sorry to hear that you are going through all of this. There are many experiencing problems like you.Have a look at the following blog and you can read what many have said.

    http://vervilledeb1.wordpress.com/2010/03/06/essure-problems-continue-among-women/

    Keep us posted on how you are doing! I wish you the best of luck.

    Deb

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  4. My name is Heather & I am 41 yrs old. I had the Essure coils implanted in Dec. 2008. The first try in Oct was unsuccessful & I had to go back a second time in Dec. Both times the insertion was incredibly painful, even barbaric! Worse than giving natural childbirth to a 9# baby. My OB/GYN also did Ablation immediately after the insertion in Dec. which I just found out yesterday according to Conceptus website is NOT to be done due to serious health risks to the patient when the coils are subjected to extreme heat!!! I have been to ER 4 x's in the last 10 days. A CT scan was done & it showed that even though the coils show up bi-laterally, there is a coil that is lodged at bottom of my colon near my rectum! The 1st & 2nd attempts to place the coils, the OB/GYN had said that a couple of the coils had broken & he had to start over. Obviously one of the broken ones was left to float around inside me until it lodged where it is now. I had no clue that there were any problems with these coils until the last week. The reason I kept ending up in the ER was due to extreme pain in abdomen, trouble breathing, white colored stool & diarrea, dizziness, fainting,headaches, a rash etc. Since finding out about the lodged coil I did some research online & found that blood poisioning from the nickel in these coils cause some/all of these symptoms. I am now scheduled for a colonoscopy in a couple days and have been told that i need to at least have the lodged coil removed & if tox screen shows nickel poisioning all of them will have to be removed. I am amazed that I was never told about the nickel & also that I was told that it is a simple procedure with mild discomfort when placing the coils, when in fact, it was pure hell! And now, 2.5 yrs later I am having all of these health problems. Not to mention, the OB/GYN performed the insertion & then the Ablation when Conceptus say it Ablation should NEVER be done when Essuer coils are in place! UNBELIEVABLE!!! After reading all of these complaints from so many women I can't believe that these coils are still being used. I've had no problem finding doctors that are "trained" in the placement of these coils but there are only the doctors at Chapel Hill Tubal Reversal Center that are specializing in the removal of them with out putting women through a complete hysterectomy. I will be calling these doctors tomorrow to discuss the removal. I have no desire to have any more children but also have no desire to have blood poisioning not to mention the fact that I have a coil lodged in my colon/rectum! These implants are obviously defective & are causing hundreds of women serious health problems & in my opinion, need to be re-called. Immediately!

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  5. I had the essure coils put in on Feb. 12, 2011. It was the most painfull experience I have ever had. After the procedure, and laying on the table drenched in a cold sweat, and not knowing wether or not I wanted too throw up or pass out.
    The next day I had abdominal cramping so bad I was doubled over crying. I had to call an ambulance to come get me. Even dispatch couldn't understand what I was say'n I was crying so hard. Since I had the coils put in, I cramp all month long every month. My periods are either very heavy, or just spotting. I get sharp pains in my left overy area, and I also have repeat BV infections every month. The OB/GYN that did the procedure assures me ( in her annoyed face) that IT IS NOT from the coils.
    I know all the stuff I have been going through is from these stupid coils, I have done my research, and have found other woman that have had the same problems I do. I can't seem to find anybody round here that knows anything about the procedure, or that doesn't say "it's not from the coils".
    I wish I would have never had them put in, and now I want them out.
    If you know somebody that is planing on getting the essure procedure done, I would highly recommend NOT not doing it. It's not worth it.

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  6. I am one of the women that is "thinking about" this procedure and now readin the stories of women going through so much pain and issues with the coils I am hesitant! I do not want any more children, do not want to bhe on the pill anymore, over 40 and just want to be free form the fear of pregnancy! Ladies, thank you for your stories, I am sorry you are in pain and suffering from this procedure that "sounds too good to be true!" Any one think it still is worth it? Am I better getting a tubal?

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    1. I'm 28 and am scheduled for a hysterectomy because of essure. I would do a tubal.. way less down time/ time off work than a hysterectomy down the line

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  7. Had the procedure in April. Had HSG done in july where I learned that I had two coils placed in my left tube. The last one inserted is in a complete ball curled up in my uterine cornua. My concern is whether or not I should leave this like this and will it cause any damage to my body. I should add I have been having pain almost immediately after the procedure on my left side. Any comments are appreciated. As I don't know what to do. If I have them removed my dr today told me that he would have to pull them out since they are in my uterus

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  8. Sorry ladies that you all experienced such difficulties .I had my procedure done I 2009 and I must say it was not painful at all. When I woke up I was vomiting but that was due to the anesthesia.. Sadly, now I found my soulmate and we plan to get married next year and he has no children so im looking to get it reversed. Praying that it will work..

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  9. I am another one thinking of getting the essure. I have the Marina this moment, but my 5 years are up. I don't want any more children and I just want to be protected. What is a women to do? I leaning more toward the essure than replacing the marina.

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  10. I have gone through hell with this procedure. I had to change doctors to get someone to listen, I had clotting, messed up my clothes at work twice, pelvic and back pain, BV infections, heavy bleeding, headaches and 3 surgeries. I had this done in 2008 and within a week I started having trouble. I ended up pregnant had to get an abortion(didn't want anymore children). The same doctor ended up removing both fallopian tubes in September 2009 and supposedly removed the coils. I still complained of severe pain before and after my cycle. I only had 1 good week a month. The doctor kept trying to give me more pills and we tried everything. He stated that it was not the Essure procedure. I didn't have any menstrual problems prior to the procedure. I changed doctors in February 2010 and I finally got him to approve a hysterectomy in June of 2010 but by them my insurance had been exhausted. I had to wait until 2011. In May 2011 I had my uterus and cervix removed leaving my ovaries. In July 2011 I started having painful periods again. Started complaining to my doc again and I just had another surgery on 10/11/11 to remove my ovaries. The doctor stated he found both coils still embedded in my body and that he removed one but would not touch the other since it is now attached to my bowel and and has grown into the tissue. I contacted a few lawyers and they all say nothing can be done unless a doctor states this will affect my health in the future and need to have it removed immediately. Then I have a case. If it's not going to cause any harm then I don't have a case. I think that's bullsh#*t! I wouldn't recommend this procedure for a lab rat!

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  11. Help! I had the procedure done 2 years ago and everything went great! 6 months ago, I started having horrible pains in my left lower stomach area. I have seen my GYNO, she assures me it is not the ESSURE coils. I have had such severe pain that I have been to the ER twice, seen my PCP and no one can tell me where the pain is coming from. I have had 2 CT scans, sonogram, xrays and now am having a colonoscopy before my OB/GYN will even think about proceeding further. I believe it is from the Essure coils. All the TECHS from the tests, xrays, CT scans that I have had all have commented to me "What is those THINGS in your tubes?" Does anyone have any suggestions on what to do next? Who to see? I am a healthy female and just wanted to get off the BC pill when I turned 40 so I had the procedure done. I can not live with this pain any longer. HELP

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    1. Wow....does this one sound ever so familiar. I had it done 2 yrs ago. Two weeks ago I had such severe cramps before my period and then I got my period and I thought I was having an appendicitis attack, gall bladder, all too low for that. I then thought with some of the stress going on in my life I was having an attack of an ulcer....Now after reading these, I am sure that this is what the problem is.

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  12. To have your Essure coils removed, call (919) 968-4656.

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    1. Dr. Berger, I called your office this morning and was told that you do not accept insurance and that you only accept payment in full at the time of the appointment. Is there any way that you could accept an insurance payment? I had this procedure done in Nov. 2011 and have found out that all of my pain and bleeding is because one of the coils has protruded into my uterus. I don't have $4,600 cash, plus expenses to travel to your office. I am not interested in having anymore children. I am being told that the only way to stop all of the pain is to have a hysterectomy. I just turned 30 and feel that I am a little too young for this. Thank you in advance for your response.

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    2. Hi Janet - We are unable to accept insurance payments at our surgical center. If your insurance would cover Essure removal for medical reasons, they would need to send the insurance check directly to you.

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    3. Do you know of any one in Michigan that does the removal? I don't want anymore kids however I don't want the pain and this type of lifestyle either.

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  13. Dr. Berger do you know of any one in the Florida area (Tampa) that does the Essure reversal?

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  14. I don't know of any doctors in Florida who perform Essure reversals.

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  15. I had this done in September of 2008. Since then I have has SEVER weight gain and I have tried everything! I have horriable migraines to the point I take medication daily and...I feel like I can feel them ....always. I try to not think about it and have bee ignoring them for a while but now I have Intestinal issues starting. I am scared to go to the doctors but I know if I don't it could get worse!
    Dr. Berger when removing the coils, have you seen anything abnormal?

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  16. It's going to be two years since I got Essure. After I got the procedure.my periods started coming later and later each month until it skipped, then I started with back pressure, when my period would come it was so heavy I have to make sure I have enough clothes, sanitary napkins, & tampons on deck. One time I woke up stood up & blood started dripping all down my leg. Now my period skips months at a time haven't had a real period since Aug. slightly in Sept now I am having severe pain on the left side & back pain its getting worse. Also I experience severe bloating & weight gain since have that procedure done. If I could get it reversed I would.

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  17. nice post dear blogger

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  18. I had the essure on dec 14,2011,loopy as a fruit loop from the meds i was given one day before procedure. The procedure was done in the OBGYNs office bout 1 hour an i was done,sent home to rest an back to work the next day. Im happy with my decision i made,hope it will last. I was told in three months to have the HSG done to make sure things are where they need to be. I hope an pray that i have no horror stories to tell.

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  19. i had the essure coils put in with an ablation done at the same time sept. 2010, my dr. put me under so i would feel any pain. the day of the procedure they sent me home with vicodin which did absolutely nothing for the pain and discomfort. i put a heat pad on my lower back and took ibprofen and within a half hr felt 90% better. the only complaint i have is for the first 6ish months i would get really sharp pains on my lower left abdomin around my time of ovulation which only lasted a day and that has slowly gone away and i now no longer have that at all .... all i can say is really discuss these procedures with your dr. and bring up all your concerns ...from my experience the more fears you bring up to your dr ( a good one) the more precautions they make to limit discomfort and fears

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  20. Would like to know the cost of an Essure removal.

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  21. Call (919) 968-4656 for the cost of Essure removal.

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  22. Hi i got the Essure pins put in, in June, Then in Dec i took what i believed to be my 1st menstrual cycle since the procedure, only problem is i have been bleeding every day since. I have been having constant cramping in my stomach and ovary area, and severe pains in my lower back, is this normal, it is driving me crazy,constantly in pain and not feeling clean.

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  23. My girlfriend had the essure procedure done. One side was done in January and the other had to be done a month later. The first coil was inserted so far that it couldn't be seen with the camera. But, it seemed to go well and she didn't seem to have any unusual or excessive symptoms during or after. The second one wouldn't go in as far. The doctor kept trying to jam it in there (on the first attempt she bent the coil). After getting a new coil, she eventually jammed it in as far as she could and left it. She said that it was within specs because she could see ten coils. She told us that Essure says you should see between three and thirteen coils (so, what's up with the first one?). The second procedure was a lot more painful and there was a lot more bleeding. My girlfriend had blood running down her leg and dripping on the floor (strange to me to have so much bleeding from a procedure that has no incisions). She almost passed out leaving the doctors office. Ever since the procedure she has been having irregular periods (used to know what day and how long -like clockwork), bleeding, pressure, stomach pain that goes all the way to her back, and nausea. The pain used to be just the side that was done the second time, but now it is all over and is getting worse. The doctor said that more severe symptoms are normal because she has never had kids. I have read many horror stories about this procedure. But, I haven't read any yet where a woman had it done and had really bad pain, bleeding, etc. and eventually got better. I would like to know if there have been any women that have had what they thought were excessive symptoms that eventually did get better. I would like to be able to give her some hope for the future. There doesn't seem to be much follow up on any of the blogs I've read. She is going to go for some tests to check for what they can check for. So, she's not going to just sit back and hope it gets better. Thank you for any help...

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    1. I will be having mine removed they struggled putting onside in. Symptoms does not get better. Lower back pains etc.. I would suggest removing them

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  24. dr berger, do you know of any doctors that do the removal of the coils in monterey california?

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  25. Kareninca - I don't know of any doctors in California who are performing Essure Reversals.

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  26. I tried to get the Essure today. This simple procedure turned into pain and cramping.. finally my doctor told me it could not be done. Apparently I have a significant right hand turn in both fallopian tubes making insertion impossible. $375 down the freaking drain! That was my co-pay of 15%, I guess I will have to wait and see if I get another bill from my gyno due to all the complications I experienced. I have a wonderful OB and know it was not her fault. Just a freak of nature, she had told me she had only known of one other patient with this problem. I have a very long, severly tilted cervix. Gave me fine babies but this procedure was a total flop. My only other choice is tubal ligation or my hubs gets a vasectomy. Bummer. Maybe going back to the IUD for another 10 years....

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  27. I suffer as well, bleeding for 7 months with only 16 days of not, severe cramping front to back, vertigo for 3 months, weight gain, ect, emotinal turmoil & moodiness, loss of enjoyment, lack of intimacy, doc still says it is a depo shot from over 8 months ago & back pain is now said to be musoskeletal...haha...never had prob before, all started 2 days after painful procedure...I am no sissy either, I usually camoflauge my pain because I am more embarassed to show it...but this... :(
    I want my life back; haven't found a new dr to take...most don't want to touch something someone else did

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  28. I have the essure for about a year and now Iam remarried and wanting to have a baby. What is the success rate on getting pregnant after removal?
    I have also had very bad pain in right pelvic area and cramping b4 periods.

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  29. The pregnancy rate after Essure reversal is 50% and depends in part on your age. Women younger than 35 have a high pregnancy rate while older women have a lower pregnancy rate.

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  30. I had my easier placed last Tuesday June 12 2012. I have complained about being nausea, back pain, vomiting since then, my period started that Tuesday and stop on Saturday. I went to the Dr office twice because of the pain and my symptoms. I had a sonogram done they said the coil are fine. When the vaginal sonogram was done, it cause me to bleed for a day. That was on June 19 2012. I had intercourse and that causes me to bleed. Like its hitting something and making me bleed. The bleeding will last for one day and it stops. I'm still in pain around my pelvic area and left side, nausea, lower back pain, diarrhea, I was placed on antibiotics. Yes I'm scare to death because I didn't have these problems before and it seems like its getting worse. And it does not sound normal to have something insert into your vaginal and cause it to bleed. Oh the Color of the blood is not like when your on your period. Its different. Anyone have any input on this. Something is not good, here. Please anyone know? Thank you.
    Mary

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  31. Dr.berger where are you located at what state? I would like to get my coils removed and would like to have another child!!

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    1. I am in Chapel Hill, North Carolina. You can get information about my practice at http://www.tubal-reversal.net or call (919)968-4656.

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  32. I actually had the procedure 5 yrs ago and feel that it is finally affecting my body in a very negative way. 6 months ago I began spotting all the time. This spotting lasted 5 to 7 days like a period. So now I bleed every 2 weeks. This is making me crazy! I want these thing out! My Obgyn has performed all the tests and can not find any reason for this. She too said it has nothing to do with the coils. I don't care about getting a reversal, I just want them removed.

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    1. We perform Essure removal at Chapel Hill Tubal Reversal Center and will be happy to help you.

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  33. Dr Berger, I had essure done 6 yrs ago. I had no issues but ended up divorced and with a man whom has no children. I am 29 and I think we will be getting married in the future. what are the chances of having a successful pregnancy in my early 30s if the only procedure i have had is the essure? i had 2 live births naturally previously without any complications. What are the chances of being able to have a natural birth or is the C-section mandatory after reversal?

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    1. After Essure reversal, it will be necessary to have a c-section delivery because there will be a scar in the uterus when the tubes will be implanted after removing the Essure devices.

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  34. I had essure done in Dec 2010. I haven't have any problems till now....July 2012. Only problems I just recently started having was last month i was a day late starting then after my period ended I started spotting a week later that lasted a few days. Then this month I was 4 days late finally started had a normal period...ended then started spotting again. Now my left side hurts very badly and is tender to the touch. I don't know what is going on.

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  35. I had essure done June 2009. I was very happy with it until about 8 months ago. I started having some sharp stabbing pains in my right lower pelvic area. I finally couldn't handle it any longer and went to the doctor today. Found out the the coil is stabbing into my uterus and I am being forced to have a hysterectomy next week. I have a heart-shaped uterus and the doctor who did the procedure (had to use a different one instead of my regular due to Catholic hospital regulations) told me that my condition would not affect Essure. My GOOD OB informed me today that I am the last patient in her office with the same condition who is having a hysterectomy due to Essure. Never thought I would be forced to have this done at 29!

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