*THIS IS A MUST READ IF YOU ARE CONSIDERING ESSURE REMOVAL OR REVERSAL.
Information regarding Pathology:
If you would like your coils returned to you, ask your doctor to send written notification to the pathology department prior to surgery. Send one of your own as well. If your state or hospital does not allow specimens to be returned to the patient, request that pathology retain them indefinitely for litigation purposes. If you have retained an attorney, they can send a letter requesting your coils.
If the Essure devices are correctly positioned per the manufacturer, the coils span the utero tubal junction, and about 3-8 turns of the outer coil trail into the uterus. The devices should be removed intact, no cutting, or pulling, or stretching, to avoid breakage and fracturing. This means that in many situations, the uterus and tubes would need to be removed intact to get the devices out complete. There are specialists, however, who are skilled enough at removing the devices without breaking them, and might also be able to leave your uterus and or tubes, if you desire. But you MUST go to a specialist for this. Most OBGYN doctors are not familiar with this specialized removal process, and are most familiar with removing the uterus and tubes, (hysterectomy with bilateral salpingectomy). Leaving fragments of Essure behind is NOT desirable! Only removing tubes and "teasing" the coils out of the uterus, in most cases, will leave you with fragments or PET fibers. We have seen this happen over and over again in our Facebook group. Also, we have seen that with a vaginal hysterectomy, it is very very difficult to reach the entire tubes, and most often part of the tube and coil gets left behind. We have seen this happen to countless women in our support group, and do not want to see more women go through that scenario, which requires another surgery to retrieve the fragments. PLEASE, read as MUCH as you can on proper removal. You only get one chance at getting Essure out correctly the first time. Going back for a second or third or fourth surgery to retrieve fragments, or remove adhesions, is not fun! Trust me, I’ve personally been there, and so have many many others.
The manufacturer’s removal information can be found in their instructions for use, and or physician's manual. Ask your doctor to review these.
TAH- In a total abdominal hysterectomy, the entire uterus and cervix are removed (ovary and fallopian tube status is officially referred to separately). Total hysterectomy can be done abdominally with an incision most often made along the bikini line.
LAVH- Laparoscopic assisted vaginal hysterectomy, (ovary and fallopian tube status is officially referred to separately). The organs are visualized and manipulated through a laparoscope, and the uterus is removed either through the vagina or through a small incision in the stomach. ***If your doctor states your uterus will be removed thru a port, please question this, as you do not want a morcellator used. A morcellator is usually used to grind up your uterus and or /tissue so it can fit thru an abdominal port/ incision****** Depending on the doctor's skill or your particular medical needs, you can have one abdominal incision or three.
Total Vaginal Hysterectomy- TVH- is done with no abdominal incisions. An episiotomy- a cut to the perineum- the skin and muscles between the vaginal opening and anus - is often done to widen the opening of the vagina. This is often needed to allow the doctor the room they require to work and also to deliver the uterus vaginally. ***When you have Essure, this type of hysto can come with the risk of cutting the coils and leaving fragments. Most of the time, your doctor can not reach the top of your tubes from the vaginal only approach. The have to cut your fallopian tube and that usually means cutting thru a coil, depending on the location of your coil in each tube. If your doctor recommends this type of hysto for you, please ask how they will attempt to reach the top of your tube without laparoscopic assistance-ports/ incision in your abdomen.****
Supracervical (means above the cervix) hysterectomy, the cervix is not removed. Your uterus is removed but your cervix remains. This is usually done thru an abdominal incision. They cannot usually deliver the uterus thru the vagina if you do not remove your cervix. ****You do not want a morcellator used***
Oophorectomy- removal of an ovary
Bi-lateral oophorectomy- removal of both ovaries
Salpingectomy- removal of a fallopian tube
Bi-lateral salpingectomy- removal of both fallopian tubes
Salpingo-oophorectomy -removal of the Fallopian tubes and ovaries (bi-lateral being both sides)
These are separate medical procedures and are not included in a hysterectomy.
From Dr Shawn Tassone:
I feel the need to post because I am seeing some crazy things out there and with my experience in removing these things I want you guys to have the upper hand so you can get the things removed. Not only am I removing them at an alarming rate but I am reviewing legal cases across the country and I am seeing my colleagues (well meaning) doing some crazy things to remove these things that are causing more injury. Keep in mind this work-up is just what I do at my clinic and every doc is a bit different.
When I see a patient at the office for Essure removal this is my initial workup.
1). Vaginal ultrasound to look at the ovaries and uterus. Occasionally I will see the coils, but ultrasound is a poor method of location. I repeat ultrasound is a poor method of location
2). Pelvic exam to map out the areas of the pelvis that are causing pain
3). Hormone testing. I have been seeing that many if not all women with the coils are estrogen dominant and severely deficient in testosterone. This may not be due to the coils but I like to try and balance the hormones before we even go to the OR
4). Abdominal and Pelvic X-ray to locate the coils. I have seen many things like 3-5 coils, a coil up by the stomach, a coil in pieces and I like to know what I am getting into before I get in there.
5). Review of old medical records. Had one X-ray that showed the patient didn't have any coils in her pelvis before the surgery and review of her records showed she had the Adianna procedure not the Essure.
In reviewing cases I am seeing many sad things being done like cutting through the coils. Blatantly leaving the coils inside despite knowing it was there, damage to the colon with a coil that had perforated the back of the uterus, coils in the omentum, and coils stuck in the vaginal cuff because they were not removed at the time of hysterectomy.
I have been censured at times by the doctors in my group because they don't believe that I am doing something they agree with, but now some of them are stopping insertion. Point is this, have someone take the coils out that knows what they are doing or educated them before you have it done. Stand up for your rights as a patient and find someone you are comfortable with. If you have a legal case find an attorney that has a physician reviewing the records that has experience with the coils not a nurse that is unfamiliar with things.
Finally, don't stop fighting because the winds are a changin and I have seen three docs close to me stop placing them and some of these docs are referring patients to me for removal.
I can't answer medical questions but if you want to follow me and ask things I can answer you can find me athttp://www.facebook.com/womenhealthdocs
Below is a statement from Dr. Julio Novoa OBGYN
Hi ladies, I wish I could spend more time scanning your comments and answering, and I would recommend that the Administrators set up a general recommendation section on their Essure main page. But to answer your general question, if your periods are irregular following the placement of the ESSURE, it is probably due to the ESSURE. Most GYNs either don't believe or are unaware of the Post Tubal Ligation Syndrome which is associated with ANY surgery or procedure that affects the tubes, including the ESSURE, which leads to pelvic pain, irregular periods or changes in the menstrual cycle. Despite what your GYN may argue, even if the ESSURE is confirmed to be properly placed, you can suffer from a number of symptoms and side-effects. Also, if even a tiny portion of the ESSURE is allowed to stick out into the uterus, it can produce significant pain and uncontrolled chronic bleeding. So, again, the ESSURE can and must be considered as a cause for any side effect that occurs following its placement. Next, in my opinion, no attempt should be made to simply remove the ESSURE either from a hysteroscopic approach or laparoscopic approach. Imagine the ESSURE like a piece of industrial Velcro against a cotton ball, even if you separate the cotton ball from the Velcro, you will always have tiny pieces of the cotton ball left on the Velcro. In comparison, if you remove the ESSURE from the tube and coronua of the uterus, you may always have tiny pieces of the device embedded in the tube and uterus which act as a residual film of inflammation and which may explain why so many women still have complaints following the removal of the ESSURE. My recommendation is if you have problems with the ESSURE, it should be removed INTACT still covered and embedded in the tube and uterus; in other words, I would recommend a total hysterectomy bilateral salpingectomy, (THBS) aka, remove the cervix, uterus and tubes intact. Next, unless there is a real need to do it any other way, I would opt to do the THBS as a total vaginal hysterectomy bilateral salpingectomy or TVH/BSO or as a laparoscopic assisted vaginal hysterectomy bilateral salpingectomy (LAVH/BS). Next, I am very concerned with GYNs recommending the DaVinci robotic technique over the traditional LAVH/BS. In the hands of a skilled surgeon, only one or two laparoscopic ports need to be placed with the removal of everything through a vaginal approach. The use of the DaVinci rarely improves the technique or outcome of the procedure. On the contrary, the DaVinci most often increases the number of ports from 2 to 4 or 5 sites and increases the size of the ports from 5mm to up to 12mm. Also, the enlarged port sites tend to be extremely painful especially when placed far to the left or right hand side of the abdomen. Also, only a small % of GYN surgeons are experts at using the DaVinci with the majority of GYN surgeons being novices with this device and actually increasing the risk of complications in comparison to using the standard laparoscopic techniques. My recommendation for almost all patients is to find yourself an expert GYN willing to attempt to remove the ESSURE with the cervix, uterus and tubes through a vaginal approach and with a minor assistance or visual guidance from the laparoscope. REMEMBER that Minimally Invasive Surgery is the key and try to avoid the DaVinci. One last point, unless absolutely necessary, you should try to keep your ovaries as long as you can. Removing them before you actually hit menopause will lead to an almost immediately surgical menopause and a risk of a significant if not complete loss of libido or sexual drive which can be extremely hard if not impossible to correct. Please consider posting these points on a general screen. Again, it is just one GYN doctor's opinion, but as a doctor who specializes in Minimally Invasive Surgical procedures, management of surgical implants, and management of sexual disorders in women, I think I have a better understanding of the problems that exist with the ESSURE and how we as GYNs are not properly managing it ,as compared to most of my GYN colleagues. Sincerely, Dr. Julio Cesar Novoa. www.drnovoa.com
Hysterectomy is never an easy choice and, in general, should not be the first choice regarding the management of any of the aforementioned diagnoses. HOWEVER, the ESSURE is a unique situation that sets itself in a completely different category of management as compared to other problems. In women that are symptomatic due to the ESSURE, and based on our forum surveys, close to 90% have been shown to be at risk or currently have adenomyosis or endometriosis. These same women are at risk for post tubal ligation syndrome. And are at risk for eventual systemic effects due to the body's eversion to the chronic and permanent inflammatory insult that the ESSURE was intentionally designed to do. For a significant number of women opting for limited surgeries, such as only tubal removal, they end up needing 1-3 additional surgeries to correct their problems or until the ESSURE and the affected tissues around it are completely out. Unfortunately, for some women, even when the ESSURE is out, symptoms persist which may be due to a permanent effect or the triggering of a latent autoimmune condition that the ESSURE enhanced.
[essure is made up of parts including "PET" fibers]
Julio Novoa - Good evening ladies. Although we are focusing on the coils, the metallic nature of the coils and their impurities that cause inflammation are not as concerning as the PET fibers that the coils are meant to hold in place. The coils are designed to hold the PET fibers and allow the fibers to cause the scarring. It is the PET fibers that cause the most significant part of the autoimmune reaction and inflammation. The attempted removal of only the coils significantly increasing the chances of residual metal and Pet fibers being left embedded in the tissues. This is why patients may feel better for a short period of time as the majority of the implant is removed but relapse because not all of the implant and fibers were removed. Unfortunately, once the coils are removed, there is no way to scan for the fibers alone, and the patient is left with little choices except for a hysterectomy, which is why the LAVH is recommended as the initial and best choice.
Addition: Dr Novoa----- Julio Novoa Hey ladies. You may want to put this on the general forum. In review of the Commentaries, there are two very common complaints following Essure removal. These are severe postoperative bleeding and constipation. In regards to postoperative bleeding it appears that for some unknown reason patience with this device are prone to have postoperative bleeding occurring more often than in the general population. It is therefore recommended that your doctors place multiple independent sutures in the vaginal cuff in order to reduce the risk of postoperative bleeding. Second patient should be advised to make sure that there is no signs of constipation prior to their surgery and that they should be on stool softeners with a lot of hydration prior to the surgery and continue on stool softeners following their surgery
Good morning ladies. I have seen multiple questions and comments about the vaginal cuff.
Firstly, the vaginal cuff is the upper portion of the vagina that remains after the cervix is removed. This is most common following a total hysterectomy.
When the cervix is removed, the upper portion of the vagina is open, like a tube. This must be closed in order to prevent the internal organs from coming out of the vagina and being exposed outside your body.
Therefore, the once open end of the vagina is closed by sewing the open edges of the vagina closed, like a sock that has a big hole in it.
This upper part of the vagina that is sewn closed is called the vaginal cuff. In this scenario, it MUST BE created and is intentionally made.
The problem is that the vaginal cuff, or simply the open vaginal edges have blood vessels that can and do bleed if the vaginal cuff is not sutured closed correctly or if sutures break before the cuff can close correctly.
This leads to excessive vaginal bleeding following surgery or an occult hematoma, where blood collects on the pelvic side of the closed cuff which represents internal bleeding.
Because of this risk, PLEASE request that your doctors put an extra row of interrupted heavy sutures such as 0 or #1 Vicryl INTERRUPTED sutures in the vaginal cuff on top of whatever they normally use.
I am not sure if it is ESSURE related, since I have consulted on this on both Essure and non Essure cases, but it has become a relatively common complication of Essure associated postoperative hysterectomy.
Dr Julio Novoa
Good Evening ladies,
By this time many of you have heard about Lisa Johnston-Stolareks surgery to remove fragments that were left behind from her previous surgery six months ago.
In her first operation, Lisa agreed to have her uterus, tubes and the ESSURE coils removed believing that her Doctor would follow established guidelines and recommendations regarding the use the laparoscopic morcellator.
After her original surgery, Lisa continued to have problems and symptoms similar to those that required the surgery in the first place.
Although her complaints were dismissed by her GYN, she knew that something was wrong.
A few weeks ago, Lisa found out the FDA had sent out a warning that the use of the morcellator in the management of uterine tumors was associated with the spread of uterine cancer.
After discussing her concerns with the forum, it was recommended that she get an Xray of her pelvis asap.
Her CT scan revealed our worst fears.
Fragments of her Essure had been left behind and were very close to the iliac vessels which are responsible for blood flow to the lower extremities.
I advised Lisa that the morcellator was never intended to be used to cut through metal, especially not the coils of the ESSURE device which would risk fragmentation of the coils and the spread of the PET fibers into the pelvis.
After seeing several surgeons, it was agreed upon that she would have surgery today to remove the fragments.
Although very nervous and afraid that she may end up losing one of her legs if the case went badly, Lisa trusted her surgeon to remove the fragments.
Unfortunately, following the surgery, Lisa was shocked to learn that her surgeon did not confirm that she had indeed removed the fragments.
Her second surgeon explained that upon entering her pelvis with the laparoscope, she found a significant amount of scar tissue, inflammation and endometriosis.
Based on Lisa's description, the degree of adhesions is consistent with advanced endometriosis (probably Stage 3) which would explain, bowel or intestinal and pelvic pain, swelling, bloating, chronic fatigue, and a variety of autoimmune reactions.
Lisa's second surgeon operated on the assumption that by removing the adhesions and endometriosis that she had found, she would remove the fragments that had been left behind even though she could see the fragment or actually confirm that she had removed the fragments.
Lisa was sent home following her surgery, and, understandably very upset and scared about what is next with her health issues.
Lisa asked me to discuss my recommended management of this case in order to provide some guidance to other E-sisters that are having the same problems.
First, under no circumstances should a surgeon attempt to remove the ESSURE coils unless they can confirm that the entire coil is still covered by tissue. Attempting to pull, tug, "tease" or retract on the coil increases the risk of fragmentation and the spread of PET fibers into the pelvis.
Cornual resection and/or reversal should be advised with caution since only expert level surgeons should be attempting to manipulate the coils under these circumstances.
THE LAPAROSCOPIC MORCELLATOR SHOULD NEVER BE USED TO ASSIST IN THE REMOVAL OF THE ESSURE COILS.
As many of you are aware, a review of the data collected by the Essure Problems forum suggests a 3-8x increase risk of adenomyosis and/or endometriosis with the ESSURE. Although a cause and effect relationship has not been confirmed, I believe that this association will be confirmed in the near future.
In Lisa's case, the morcellator appears to have caused the spread of endometrial tissue and, of course, fragmentation and the spread of coils and PET fibers into the pelvis, leading to the implantation of endometrial tissue into the pelvis, which by definition is endometriosis, and at such an intense level that it caused the condition to develop to Stage 3 over a relatively short period of time.
This hypothesis is supported by the fact that Lisa's first surgeon saw no evidence of endometriosis in her original surgery, yet her second surgeon saw severe endometriosis.
Such a condition is unusual over a short period of time, especially with the removal of the uterus and the elimination of any endometrial tissue being naturally produced since the uterus was removed.
Second, in all cases of fragmentation, a surgeon should have preoperative films to identify the general location of the fragments and should use fluoroscopy X-ray and the assistance of Interventional Radiology to confirm that the fragments have been removed while the patient is still under general anesthesia.
Third, pathology should be consulted and on standby in order to review the tissue sent to the lab to confirm that fragments and/or PET fibers are present in the specimen.
Fourth, postoperative films should be done, either CT scan or MRI at a later date to confirm at all fragments have been removed.
The problem that Lisa and several other E-sister's are currently facing is the fact that my colleagues and I are working in uncharted areas of management. Basely, by trial and error, or, unfortunately, what the layperson commonly refers to as being someone's "guinea pig."
Believe me, we don't want anyone to consider that we are experimenting on them, but if a surgeon with no experience refuses to acceptance the recommendations of those with experience or at least, in my case, discussing the positive and negative treatment points that each patient has experienced, then we are absolutely doing an injustice to our patients.
I will follow Lisa's course and will continue to compile data in order to help the E-sisters make good choices and help their doctors form rational management plans in order to avoid the unfortunate problems that Lisa and those in similar situations have had to face.
Please pray for Lisa's speedy recovery.
Dr. Julio Novoa
Dr Charles Monteith Essure Problems
Initially I promised the group I would get back with my survey information about our experience with Essure removal. It has taken me sometime to compile this information. I have also added a more extensive "For Physicians" section to our website. A significant part of this section reviews our experience with both Essure removal and Essure reversal. I would encourage you to share this information on Essure removal with your doctors if they are open or willing to receive input.... I am not personally advocating one surgical approach over another. I think it is more important to have a doctor who is open, understands the variations in Essure coil insertion, and is motivated to remove the devices correctly and in a way that minimizes the risk of coil fragmentation. The information I am sharing with others can be seen here:
Here are 8 things to demand from your medical professionals, before you undergo an Essure removal procedure. Along with the advisement of your legal counsel, follow these steps to ensure that you keep all the evidence possible for your case:
Please consult your attorney about making these requests formal, by sending a “Preservation Request” to the hospital’s doctors, pathology department and risk manager (an employee who works to prevent situations that might open the hospital up to legal liability). Taking pro-active steps to preserve evidence can only strengthen a future case.
We also urge you to report your side effects directly to the FDA. To learn how, and raise your voice for women’s health, click here.