Essure Problems 

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Julio Novoa Dear ladies. The reason I posted my comment regarding Dr. Nutis and myself willing to remove the ESSURE is that once other GYNs begin to see that the ESSURE is being removed by GYNs for the management of chronic pain, autoimmune systems and dysfunctional uterine bleeding, you will begin to see a fast turn around by those GYN doctors insistent that it is not associated with the aforementioned problems. I had failed to post this very important point about malpractice. There is a term known as Failure to Diagnose and a delay in management. Doctors are afraid to get sued so many times they deny that there is a problem. HOWEVER, we can become just as afraid to get sued for improper or delayed diagnosis. SO, if patients with the ESSURE start getting them removed by doctors who agree that there MAY be a problem, other GYN doctors will become afraid that by not removing them, they are allowing patients to suffer and have themselves Failed to Diagnose and failed to treat their patients. The problem is that the vast majority of doctors are unaware of problems with the ESSURE. Once a few patients start promoting how well they feel after the removal of the ESSURE, then GYN doctors will still removing them just as fast. I saw this same problem with vaginal meshes. I use to put them in and found an incredibly high number with complications (similar pain as with ESSURE). At the time I put them in, there was no literature to support a significant problem. I eventually recommended that they all be removed or not put in at all. The vaginal mesh companies still deny that their products are unsafe. It took me a couple of years of intensive research to confirm my suspicions that there was a problem but once I did, I told my colleagues and they stop putting in meshes and followed my recommendations to remove them when they caused problems. You can do the same with ESSURE. Sincerely, Dr. Julio Novoa

 

 

 

Another important post  regarding a patient who has been having painful intercourse. From Dr. Novoa,

 

Julio Novoa Ladies. This is extremely frustrating for me to watch what is going on. YOU DON'T HAVE TO HAVE A CONFIRMED CAUSE TO HELP A PATIENT.!!! If a patient were to come to me and she were to tell me that having sex caused severe or unbearable pain and it was not there before the Essure was placed, it would be a no brainer. GET IT OUT! If a patient were to come to me and I were to examine her and if I pressed on her cervix or uterus and was able to duplicate the pain she was feeling, AGAIN, No BRAINER, something is wrong with either the cervix or uterus causing DYPAREUNIA. This would be my diagnosis to get the cervix and uterus out, OH, and by the way, the darn ESSURE that was probably part of the problem. WHY are you ladies being made to suffer? Why are you being made to wait? Most GYNs understand that DYPAREUNIA doesn't have to have a confirmed cause, the pain itself when the cervix and uterus is moved or duplicated with Cervical Motion Tenderness during a physical examination is a sufficient explanation to warrant a hysterectomy. Or at least that is what I was taught, long before the ESSURE came out. So, again, what is the problem? Are you supposed to wait until your whole life and your marriages Teeter on the brink of divorce before a doctor will show enough compassion to want to help? I say we should be ashamed of ourselves for not wanting to help sooner. I'm really disgusted with what I'm seeing with the behavior of my colleagues. I can only imagine how each of you must feel. Sincerely, Dr. Julio Novoa.

 

More from Dr. Novoa

 

Good evening ladies,

I wanted to address the concerns I have about all the testing that is being done by my colleagues and the follow-up management of pain and abnormal bleeding.

First, many of you are displaying scans of the ESSURE devices. The diagnoses are that the devices are in the tube and appear to be normal, even though X rays are not being done in a lateral view; apparently only in a frontal view, and ultrasounds are not being done to assist in the diagnosis. HSG, although painful, is very sensitive to determine the position of the ESSURE in relation to the tubes and uterus.

My point is that even if the CT scans, ultrasound, X-ray and MRI appear to show that the ESSURE is positioned properly, this CANNOT and DOES NOT rule out the presence of pain. These tests are all indirect diagnostic tools and cannot distinguish problems with adjacent tissue to the tubes and uterus, such as scar tissue, because it all looks alike in CT, US, X-ray and MRI pictures.

None of these tests are as accurate as the human eye or laparoscope, which is why many surgeons are shocked when they actually get into the pelvis with a scope and see where the ESSURE actually is and all the damage it has caused to the surrounding tissue with scarring, etc....

Further, even in cases where tissue looks normal to the human eye, that doesn't mean that you can't have pain.

For example, have you ever bent you finger back too far, pulled a muscle or bumped your knee without leaving a mark and yet you feel pain for days???

My point is that everything can look normal and yet produce pain.

In the case of the ESSURE, just because everything looks normal on scans doesn't mean that a patient is not in excruciating pain day in and day out.

This is what many of my colleagues are forgetting or ignoring and it is delaying the proper management of their patients. Terrible!!!!

Now moving on to abnormal bleeding.

The endometrial lining is a very fragile thing. It can bleed for no reason, or in the case of the ESSURE, it can bleed because the coils of the ESSURE are protruding into the uterus even at their normal distance of 3-8 coils.

In comparison, both the Paraguard and Mirena IUD are meant to rest comfortably in the uterus and yet one of the most common complaints of these devices is persistent, uncontrolled uterine bleeding secondary to the IUD simply touching the walls of the uterus.

Now compare this to the ESSURE with its firm, spring, wiry-like coils digging into your uterine wall?

Imagine what would happen if you simply took the ESSURE and pressed the coils against your hand for a few minutes to a few hours???? What about a few days to a few weeks????

How do you think your hand would feel???

Now imagine what your tube and uterus must feel like if you fall within the 5% of patients that cannot tolerate the ESSURE or where the ESSURE is misaligned or being expelled???

In the case of abnormal bleeding, EVEN WHEN THE ESSURE IS PERFECTLY PLACED, IT COULD CAUSE PERSISTENT BLEEDING AND CRAMPING.

No matter what your doctor says, YOUR DOCTOR CANNOT PROVE THAT THE ESSURE IS NOT CAUSING YOUR PROBLEMS!!!

What is even more tragic is that the ESSURE may be keeping women from having sex which is destroying relationships and marriages. Women are complaining of pain with intercourse (dyspareunia) as well as heavy bleeding during and following intercourse.

This may be due to the fact that intercourse displaces the position of the cervix and uterus, which in turn slightly displaces the ESSURE; as well as contractions of the uterus due to prostaglandins in the male semen.

All of this possibly leading to micro-lacerations and separation of the endometrial lining caused by the ESSURE leading to post-coital bleeding.

I just wanted you ladies to understand that it is NOT "all in your heads" and how and why the ESSURE may be causing these two common complaints.

And why sometimes by treating the symptom by removing the uterus and the ESSURE (i.e. chronic pelvic pain, abnormal bleeding, pain with intercourse) actually confirms the diagnosis (i.e. the ESSURE was causing the problem).

How many ladies have felt better following the removal of the ESSURE whether it was simply by removing the tubes or also with a hysterectomy?

If so, what did your doctors who kept insisting that it was not the ESSURE say afterwards?

Sincerely,

Dr. Julio Novoa

 

 

 

Good Morning Ladies,

I had a text chat with Angela Desa  this morning and agreed to write a Case Report on a possible link between the Essure device and Adenomyosis.

Current data suggests that the incidence of Adenomyosis is approximately 6% in the general population of healthy women  but between 30-50% in symptomatic women complaining of chronic pelvic pain, back pain, dysmenorrhea ( painful period), dyspareunia ( pain with intercourse) and dysfunctional uterine bleeding (abnormal bleeding).

However, preliminary survey data from the Essure Problems forum suggests greater than a 90% incidence in women undergoing hysterectomy for the removal of the Essure.

This represents a 40% higher incidence as compared to documented reports with symptomatic women and greater than 15x higher than in the general population.

Current scientific data suggests that both Adenomyosis and Endometriosis may originate from the same source, with endometrial tissue implanting itself in the muscular tissue of the uterus in the case of adenomyosis and endometrial implants being found outside of the uterus and in the pelvis in the case of endometriosis.

These shocking high incidences of occurrence suggest that the Essure is somehow causing a mechanical or inflammatory breakdown of the junction between the endometrial lining and the muscle of the uterus causing adenomyosis and/or endometriosis.

In cases of endometriosis, it is theorized that the endometrial tissue is expelled through the tube prior to closure or when the Essure migrates or is expelled out of the tube.

This may be one reason why some women opting to have only the tubes removed or a cornual resection , still have the aforementioned symptoms .

Although the cure for adenomyosis is hysterectomy, this cannot be said regarding endometriosis.

Once the endometrial implants reach the pelvis, a combination of surgical and medical management are often required months or even years after the diagnosis is made. 

Severe endometriosis causes chronic pelvic pain and significant pelvic scarring. The management in these cases is total hysterectomy plus the removal of the ovaries.

Based on my review of the current literature to include ACOG guidelines, I have revised my recommendations for the surgical management of the Essure in women having symptoms . 

The following does not apply to women seeking a tubal reversal who  are not having symptoms , although careful consideration to the aforementioned risks of developing adenomyosis and endometriosis should be considered.

In women who are symptomatic with the Essure device in place, and/or who have been diagnosed with either adenomyosis or endometriosis:

1. The patient should consider a total hysterectomy, bilateral  salpingectomy (complete cervix, uterus and tubes).

2.  The removal of the ovaries should be avoided especially in young women unless the benefits significantly outweigh the risks.  (This recommendation is controversial since the recommendation for severe endometriosis includes the removal of the ovaries)

3.  Current recommendation from the American Congress of Obstetricians and  Gynecologists (ACOG) state that women should not be opting to have a supra cervical hysterectomy based on the idea that it is superior to a total hysterectomy for the preservation of bladder function or to avoid a vaginal prolapse or to improve sexual response. 

"The supracervical approach should not be recommended by the surgeon as a superior technique for hysterectomy for benign disease."

"Women with known or suspected gynecologic cancer current or recent cervical dysplasia or endometrial hyperplasia are not candidates for a supracervical procedure. .....Clinicians should consider testing for high-risk human papilloma virus to identify patients who could be at risk for further "cervical neoplasm."

ACOG COMMITTEE OPINION 2013.

Women opting for a supra cervical hysterectomy should also be informed of their increased risk of postoperative bleeding and continued irregular bleeding secondary to retained endometrial tissue that does not respond to hormonal therapy and requires additional surgery (trachelectomy) which is the removal of the cervix at a later date.  The risk of chronic irregular  bleeding is between 15-17% and may be as high as 30%.

There is also an increased risk of endometrial seeding from the cervical stump leading to endometriosis , although the data on this is sparse and may be equal to a total hysterectomy or about 2%.

4. In discussing your options with your surgeons, it is very important that you explain the high incidence of adenomyosis that we are finding and that the simple removal of the ESSURE  will not guarantee a resolution of symptoms .  On the contrary, it could lead to worsening symptoms and surgical complications if either adenomyosis or endometriosis occur at a later date. 

In order to prepare my Case Report , I am requesting that all forum patients that have undergone a hysterectomy due to problems with the Essure , request a copy of their pathology reports to see if adenomyosis or endometriosis was present .  Please send the administrators this information and remember to fill out an Adverse Event form with the FDA.

In cases of those ladies still having problems following the hysterectomy, specifically chronic pelvic pain and pain with intercourse, it is possible that endometriosis is present.

PLEASE NOTE:  We still believe that the ESSURE device, in and of itself, is responsible for local and systemic chronic inflammatory responses leading to chronic pelvic pain, dysmenorrhea, dyspareunia, abnormal bleeding, hydrosalpinx, etc......  

It is also possible that the ESSURE is triggering or worsening underlying autoimmune disorders such as hypothyroidism, RA, Lupus, Fibromyalgia.....  

It is also possible that metal allergies associated with the ESSURE are causing rashes, excessive water retention, memory changes and sensory effect to include metallic taste, etc.........  

Please also remember, that the ESSURE has a known migration and/or expulsion rate of 4% which can produce excruciating pain.

We are only trying to clarify if ADENOMYOSIS AND ENDOMETRIOSIS are even more common as a side-effect of the ESSURE than was previously thought.  I will edit my commentary to include these points. 

For those of you that had no evidence of adenomyosis or endometriosis in your path reports and had a complete resolution of symptoms following the removal of the ESSURE, we still believe that the ESSURE was the cause of the problem and the removal of the device has resolved your issues.

Please BUMP.

Sincerely,

Dr. Julio Novoa

 

 Ladies if your doctors disagree with my professional opinion, please ask them to provide the Evidence Based Medicine Double Blind studies to show that the ESSURE is not producing the symptoms any of you is complaining of at rates higher than the documented average. THEY CANNOT. As far as I have been able to find, there are NO double blind studies to show that the ESSURE is not producing with local or systemic chronic inflammatory responses. If they attempt to show you information from the ESSURE company, be sure to ask them to show you exactly what the percentage of patients having pain, irregular bleeding, abnormal bleeding, or pain with intercourse AND how these numbers compare to those in the study with the ESSURE. Again, they CANNOT because no double blind studies have been done to compare the two over a 5-10 period of time. One of the ESSURE patient's doctor stated that what we discuss or comment on in this forum is GARBAGE. This So-called Garbage is only true when your doctor can prove that what we are stating is wrong by scientific confirmation on their part, not on yours!!!