Essure Problems 

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http://www.friscowomenshealth.com/dr-weinsteins-blog.html

 

http://www.justanswer.com/ob-gyn/636em-essure-procedure-performed-feb-2011.html

 

http://tvtno.org/the-facts/surgical-mesh-and-autoimmune-disease-connection/

http://meshmedicaldevicenewsdesk.com/removing-mesh-and-getting-healthy/the-links-between-surgical-mesh-complications-and-the-development-of-autoimmune-diseases/#comment-95558

 

http://www.cwsabq.com/conditions-procedures/essure-permanent-birth-control/

 

 

 

http://blog.mediligence.com/2009/06/11/materials-used-in-stent-construction/

The following email conversation was initiated becasue of the above blog.

Read from the bottom up....

 

 

His Final Response...

---------- Forwarded message ----------
From: "Patrick Driscoll" <[email protected]>
Date: Apr 5, 2013 3:41 PM
Subject: Re: Thank You
To: "Amanda Dykeman" <[email protected]om>

Amanda:

You are welcome.  Feel free to forward this, but please only treat this as one person's view. You should certainly seek out any other sources who may be more well informed on this, being certain to consider any potential bias they may have on the issue. Law firms have an incentive to portray targets of lawsuits in the worst possible light, sometimes erring on the side of faulting companies whose products were approved with fully disclosed information about possible risks. Manufacturers are reluctant to admit device problems, since such admissions can lead to exorbitant (and sometimes excessive) judgments against them. Morbidity, or the risk of complications, is in the nature of every single drug and device made, and every surgical procedure performed.  The questions for manufacturers, doctors and patients is whether every possible known risk is disclosed, whether sufficient and proper clinical trials were performed to reveal that risk and whether the manufacturer has taken every reasonable step to address that risk before and after the product has been used.

Patrick





On Fri, Apr 5, 2013 at 1:28 PM, Amanda Dykeman <[email protected]> wrote:

Mr Driscoll,
Your response is quite helpful, and has sparked quite a few light bulbs in my head. I agree there are many questions to be asked and one of them that personnally hits home with me is the important question as to weather or not the surrounding tissues and blood vessels can be effected by the chronic inflammation that the essure coils are purposely designed to cause.
Yesterday I had an HSG test to check placement. I had mine implanted in September of 2010. A lot of pressure was used and we both saw dye leaking out of my uterus and tubes. He claimed it to be dye in the surrounding tissues and blood vessels. This leads me to believe that if the dye can get out, so could whatever cells that cause the fallopian tube to become occluded, causing our bodies to respond to having chronic inflammation thus weakening our immune systems. Conseptus themselves have been quoted saying they do not believe the inflammation ever stops being produced.
( I hope I am making sense. I try my hardest to type correctly what my mind is thinking, and my spelling is a disgrace.)
Anyway, I am part if a large group of women that are also suffering from symptoms that appear to be due to a weakend immune system. We are working directly with Erin Brockovich as an advocate and so far she has been a great voice for us. I was wondering if I may share your email with her? I believe you have brought some valid questions we need to bring to her attention.
Again, Thank You for your time...
Sincerely,
Amanda

On Apr 5, 2013 11:16 AM, "Patrick Driscoll" <[email protected]> wrote:
Amanda,

To be frank, I am very familiar with coronary stents for a variety of reasons, including that I have tracked the industry from a standpoint of the products, their use in clinical practice, their manufacturers and the global sales, as well as that I personally have a coronary stent that was implanted about 10 years ago.  But, by comparison, I know relatively little about Essure and, while I can learn quickly given my familiarity with medical devices in general, there are certainly many people who are more well versed on Essure's construction, process of implantation and mode of action in situ than I am.

The similarity between coronary stents and the Essure product is only nominal, in the sense that they are both devices inserted into a lumen to serve a purpose, but the purpose is actually opposite for these. In coronary stents, the objective is to keep the lumen (coronary artery) open.  In Essure, the objective is to complete occlude the lumen (fallopian tube). The difference between these two devices (aside from their use in very different anatomy -- cardiology versus gynecology) becomes stark based on those different purposes.  

To help explain this, it is important to know about coronary stents.  Coronary stents were originally designed to compensate for the fact that, when clogged arteries had their patency restored (or reopened) via angioplasty, they tended to reocclude (become blocked again) in a high percentage of patients as a result of the plaque reforming at that site, cell/tissue growth into that site as a result of inflammation and other causes (this re-clogging of the artery is called restenosis).  After angioplasty was performed to open up the lumen (the space in the blood vessel), the stent, which is basically just a tube, is expanded to fill that space and hold the blood vessel open.  This was an improvement in the treatment of coronary artery disease compared to doing angioplasty alone.  HOWEVER, there was still an unacceptably high number of patients who had angioplasty and stents and still had restenosis.  Manufacturers (J&J's Cordis and Boston Scientific being the first) then came out with stents that had a drug coated on their surfaces that, once implanted were intended to slowly be released (elute) from the stent surface to inhibit cell growth and other plaque formation causing the restenosis.  Thus far, these "drug-eluting stents" have turned out to be very effective. However, manufacturers are still pressing for continued development, with the next types of product forms being "drug-eluting angioplasty catheters" (may not even need a stent) and bioabsorbable stents (drug-eluting or otherwise), that will actually be dissolved and absorbed by the body over time, leaving a hopefully healthy and open artery without a residual stent in place.

At the root of this is the fact that the human body operates in a state of what is known as "homeostasis", meaning it maintains a balance of an enormous number of systems (blood pressure, temperature, chemistry, etc., etc.) based on the environment it faces, even when that environment changes so that it can adapt to that change.  Radical change is hard for the body to accept.

Medical devices are actually a very simplistic solution to disease or trauma. They simply restore a function from a structural standpoint.  They do not cure disease.  Their value is based on the fact that they are relatively inert -- "biocompatibility" is a major consideration of devices; they must be compatible with the tissues where they are placed (not causing inflammation or other reactions by the body to their presence).  That is why devices tended to have a lower development cost than drugs. By comparison, drugs are much more complex in that their method of action is complex, involving chemical interactions with the disease they target, the healthy tissues in the vicinity and all of the biochemical molecules the body produces that are constantly moving through vessels and tissues of all different types.  Drugs, therefore (considering drugs approved or not) tend to have a higher rate of complication than devices, because their chemical reach, so to speak, goes much further than devices.

Medical device manufacturers are very adept with coming up with structural solutions to disease and trauma.  Over the last decade, their expertise has been pressed to make devices more dynamic -- coating them with drugs, making the devices actively compatible with surrounding tissues (e.g., devices in orthopedics designed to stimulate regrowth of healthy bone) and even dissolving.  This has extended their reach, as I would say, giving them a larger range of capabilities, but also exposing them to the risk that their interactions with the body's normal homeostasis will disrupt normal balances.  

Based on this very long preface (sorry if it is long-winded), Essure appears to be a product with a simple goal in mind -- block the fallopian tubes to prevent the passage of eggs leading to pregnancy.  but the mechanism is not as simple (and simplistic) as inserting a cork in the tube. Here, the Essure product produces the tube blockage by causing the formation of fibrous tissue at the site which, when extensive enough, simply blocks the tube. 

At this point, I diverge from pointing out what I know to speculating based on my understanding of devices and drugs.  Essure's mode of action is a bit troubling to me. Developing a device with a mode of action based on inducing inflammatory response (which is what this seems to be) raises a lot of questions.  What else is induced at the site of Essure's implantation besides fibrous tissue? Does Essure also induce downstream immunological effects?  Are other cells induced to form, migrate or be changed at the site or elsewhere in the site's environment?  What other biochemical effects are their based on the stent materials themselves, their contact with local tissues? Moreover, does the presence of even the inert Essure device start an unanticipated cascade of byproducts and events; meaning, does Essure's inducement of fibrous tissue cause inducement of other tissue or biochemical entity that leads to an immunological or other adverse response?

I think there are several key aspects of Essure worth considering relative to its potential for complications. First, while its ability to simplistically accomplish the clinical goal (blocking the fallopian tube) is very straightforward, it is not a simple device in that it is implanted to cause a response by the body.  FDA approval is essentially based on determining that products can be considered "safe" and "effective". There is no question that the device is "effective" in the sense of its ability to block the fallopian tubes (indeed, ask any coronary stent manufacturer how difficult it is for coronary arteries -- tubes -- to become blocked and they will readily admit that it is all too easy).  But safety here has probably only been assessed from a very narrow consideration (does the product itself cause any immediately noticeable adverse reaction, on insertion or in place in the fallopian tube), and that consideration is only short term.  Second, the fact that Essure is intended to cause a response by the body establishes a presumption that such a response is acceptable in that the formation of tissue at the site is a benign event.  

There is enormous pressure -- financially on the part of manufacturers, politically on the FDA and in the demand by patients -- for devices to be rapidly developed by manufacturers and approved by the FDA. Patients demand solutions to problems with increasingly less inconvenience (an office-based Essure implantation is more convenient and less traumatic than a tubal ligation or hysterectomy).  Manufacturers are only too willing to oblige with new devices.

The bottom line is that complications women may be experiencing from Essure need to be evaluated.  I do not know the status of Conceptus and/or the FDA re-evaluating Essure relative to complications, but based on the prevailing amount of information on this, I expect that there will indeed be a response by Conceptus and the FDA, on their own, or precipitated by class action lawsuits.

I hope this has been helpful.

Patrick Driscoll
(Founder of MedMarket Diligence, LLC)



On Apr 5, 2013, at 7:30 AM, Amanda Dykeman <[email protected]> wrote:

Hello Patrick,
Thank you for responding. I was very impressed with your blog about heart stents and the information you seem to have about our bodies and its reaction to different materials. I know many many women that are suffering after having essure placed and we have done alot of research and come to some of our own conclusions, but we need facts and peace of mind. Many doctors believe it couldnt possibly be from essure and often dismiss us. I was wondering if you could please take a look at what exactly the essure coils are made out of and try to give me your input on how they can affect our bodies. I would really appreciate it! Let me know if you have any questions for me.
Kind Reguards,
Amanda Dykeman

 

 

This following conversation is from OBGYN Dr Julio Novoa

 

* PM WITH DR. JULIO NOVOA 

1/2, 3:52pm Angie Firmalino

Hello Dr, and thank you for joining the group. Did someone recommend it to you or did you find out about it another way?

*  ThuAngie Firmalino named the conversation: Dr. Julio.

/2, 5:40pm Angie Firmalino

I just read your explanation on removal. We really need you to discuss this concern with one of our media relations. The Chicago tribune is doing a follow up. Julie Deardorff is the reporter. I will ask her if she is interested in speaking with you if you are ok with that.

1/2, 5:59pm Angie Firmalino

Also, pulling the coils out vaginally is never a good idea. I learned that the hard way.

* Today

7:10am Angie Firmalino

I sent dr Julio a friend request. Maybe if he accepts he will see this PM. If so, I would like to schedule a conference call with him. What is a good day and time for everyone?

* Today

2:51pm Julio Novoa

Hello Angie. I would agree that attempting the removal of the colls hysteroscopically is a bad idea. The coil itself is deeply embedded in surrounding tissue and the tips of the forceps is too fragile to either grab or pull on the coil effectively. It is best to try either laparoscopically or by an open procedure.

2:52pm Angie Firmalino

Yes, mine were actually embedded in my uterine lining.

But I was told she could go in vaginally, Cut them free and remove them. Well I found out later by ordering the path report that she broke one pulling it out, and I now have fragments. What scares me more than the metal, is the PET fibers.

* Today

6:00pm Julio Novoa

Exactly. These devices are not meant to be pulled on. The easily bend and are scarred in place. Pulling on them rather then gently removing them can easily fracture them or cause small amounts to be left behind. It is best to remove them as a unit which is best done as an open procedure but can be done laparoscopically but will take 2-3x longer.

6:04pm Angie Firmalino

Have you done many removals? Do you do this procedure currently?

6:06pm Amanda Dykeman

I have to thank you for opening up to us Julio. We've known for awhile that we need a doctor to help advise us, so I apologize if you feel bombarded. We just have a lot of unanswered questions and can not believe there hasn't been one doctor to speak up for us KNOWING how this device can cause harm.

6:06pm Angie Firmalino

6:08pm Amanda Dykeman

With that said, there is one question I have been hesitant to ask because I don't want to offend you, but I am dying to know if there are any kickbacks for the doctors that perform essure. Do they get some kind of incentive?

6:09pm Julio Novoa

No. I have placed these devices but have not removed them. I am trained in both hysteroscopy and laparoscopy. Despite the fact that it may seem like you might be able to remove them using a

hysteroscope I would never attempt it simply because there is no way to avoid not leaving pieces behind whether it's a piece of coil or PET fibers. The safest, easiest and fastest way to completely remove the Essure is through an open or mini laparotomy approach.

6:13pm Julio Novoa

Interesting question regarding money. There are no kickbacks but there is an incredible financial incentive. A GYN can get paid 3-5x more money to place an Essure which can be done in their office than to do a tubal in the hospital which takes them 2_3x longer. This is the major incentive to placing Essure.

6:33pm Angie Firmalino

With the recent explosion of adverse events coming to light, do you still feel comfortable placing this device? Do you screen for nickel allergy even though it is only a warning now? Most doctors don't even mention it. Even when it was a contraindication.

6:36pm Mishelle Moore

Good question Angie... You know how hard the nickel affected me.. especially with having a job in the airplane manufacturing field.

6:38pm Kim Myers

On the subject of kickbacks. Early on I found some information that said Conceptus was offering doctors free hysterscopic equipment if they would perform at least 24 procedures per year. I have a couple of friends who happen to work for some gyno's. They both said that Conceptus not only offered them the use of hysterscopic equipment but even the equipment needed to perform the HSG testing. I did speak with Greg Licktward who at that time worked with Conceptus & I asked him about this. Mr Licktward said that a rental fee is included for the equipment in the 2 kits they agree to order per month. The statement I came across in 2008 was by a doctor that was thrilled that not only was she making more money than doing a traditional tubal but she was getting the equipment free & she could use that for other procedures which made her even more money.

6:39pm Angie Firmalino

Would you be open to a conference call with a few of us admins? Also, there is a reporter who just joined the group and is working on a story. Could you reach out to her on that post and offer up an interview? We could really use a doctor speaking the truth about what can happen from this device......

6:49pm Julio Novoa

Sure. You may also want to compare your research data with that if the Adriana tubal ligation system which is similar to Essure but does not use PET or metallic coils. If the side effects are found to be different, you may be able to prove that the Essure is inherently defective whether it's the PET fibers or the coil. I would be be glad to give you general information but you really should try to find a Board certified female GYN who has placed a significant number of these devices and or tried to remove them due to the complaints listed on your website.

6:54pm Amanda Dykeman

Why a female? Just curious...all advice is appreciated.

7:33pm Julio Novoa

It would be best to have a panel of doctors but many of the symptoms described cannot be diagnosed with conventional technology. A female surgeon could address in her experiences the differences that exist between what is normal and what the Essure is doing. For example, I specialize in vaginal deliveries specifically complicated deliveries such as the VBAC. I have delivered over 5000 babies with one of the lowest Cesarean section rates in the US. However, despite all my experience, I will never be able to understand what it feels like to be pregnant or deliver a baby as well as any one of my female patients. That unique and beautiful privilege has been given to women.

7:40pm Angie Firmalino

How,many essure procedures do you think you've done? And what do you do for the women who have problems, if you don't remove them?

1/3/2014

DR. JULIO NOVOA’s COMMENTS ON THE PAGE: 

Julio Novoa Hello Ladies. Depending on the State, you are allowed to get your medical records from your doctor at any time and also requires the doctor to produce the records within 30 days. You may have to pay a fee for a copy, but the medical recordscannot be kept from you. Sincerely, Dr. Julio Novoa January 2 at 1:34pm · Edited · Like · 2 Jackie Carrillo thank you for agreeing on joining the group doctor! Julio Novoa January 2 at 1:34pm via mobile · Like · 3 Julio Novoa You are welcome Jackie. Sorry to see that the number of posts is overwhelming. I am sorry to hear about all the problems but this should have been discussed as part of the Informed Consent prior to placing the devices. The

autoimmune response to these devices appears to be similar to issue with the vaginal meshes. The amount of information on the side effects has been available since 2002 when the devices were first presented on the market. Unfortunately, if the side effects are due to the device itself, the only option available to patients is to remove the devices which often requires major surgery. I will continue to check on this site. Thanks again. Sincerely, Dr. Novoa January 2 at 1:39pm · Like · 4 Brenda Duvall those medical records are yours and you have legal rights to them! January 2 at 4:51pm · Like Julio Novoa Actually Brenda, medical records don't belong to the patient. They belong to the doctor. HOWEVER, the patient has a legal right to a copy of their medical records. January 2 at 4:52pm · Like

Julio Novoa Hello Ladies, sorry I don't have enough time to read all the messages, however, I wanted to agree that Essure, as with any foreign body, can produce significant inflammatory reactions leading to a laundry list of side effects. Even when the device is properly placed and all tests come back normal, the inflammatory response can be severe. For those considering a hysterectomy, this will not cause early menopause. As long as you keep your ovaries, you are not expected to need estrogen replacement therapy. Sincerely, Dr. Julio Novoa January 2 at 1:25pm · Like · 12 uary 2 at 1:29pm · Like Angie Firmalino Thank you Julio. Would you be willing to speak on the record to that comment? We are always doing news interviews, and being asked if a doctor will speak on this subject. January 2 at 1:30pm via mobile · Like · 3 Angie Firmalino Julie Deardorff please see dr Julio's comment above. January 2 at 1:31pm via mobile · Like · 2 Amanda Dykeman Julio Novoa, What exactly is it in essure that causes the localized schlerosis? It cant just be the PET fibers alone and essure coils are certainly not a one size fits all. How do they stay in place? January 2 at 2:16pm · Edited · Like ·  Julio Novoa Hello Amanda. The fibrotic response is due to the entire device. The PET fibers allow for a irregular surface and the development of a localized inflammatory response causing the body to produce localized scar tissue formation. The Essure diamerter is able to fit in the lumen of the fallopian tube and stick out at the junction of the tube and the uterus. It is both long enough and wide enough to fit like a finger in a glove. However, once the body realizes that a foreign body is present, the human body sends cells in an attempt to either destroy it or remove the Essure, which it cannot. Then, the body begins to form scar tissue in and around the PET fibers and coils in an attempt to wall it off or encapsulate it. This scarring effect/fibrotic effect basically "glues" the Essure in place. It takes about 3 months to completely close off the lumen and prevent sperm from reaching the egg. January 2 at 2:52pm · Edited · Like · 4 Amanda Dykeman Thank you for your response Julio Novoa. I have done A LOT of reading and I am positive there is more to the story. What do you think about the possibility of the fibers being coated with a schlerosing agent of some kind? Also, in many embodiments the essure coils are described as being electrically affixed. I find this possible due to the fibers insulation capabilities, the oxidation of the outer coil, the use of saline, and the use of the fiber optic hysteroscope. Its the perfect build up for some kind of laser that noone would even think to ask about. January 2 at 2:44pm · Like · 3 Julio Novoa Hello Angie. Of course I would be willing to speak, but I honestly don't understand why other doctors are not able to see and explain the problem to their patients. Most implants are designed to fool the body into thinking it is a natural part of the body or at a minimum not irritate the body. Implants such as Breast Implants and joint implants are

designed with this mind. However, Essure is designed to specifically cause a physical irritation which leads to intentional scarring of the tubes. Similar but more benign responses occur with temporary implants such as the Mirena and Paragard IUD. These implants are designed to produce an inflammatory response making it hostile to sperm. The problem with Essure, is that it appears that a small percentage of women suffer from a continuous inflammatory or even an allergic reaction to the device. The really big problem is that unlike Mirena or Paragard which can be removed in seconds, the Essure cannot be remove without major surgery. So then the dilemma is, "Who is going to take responsibility for the complication of the device?????" It is very embarrassing for a doctor to have to tell a patient that a device that they put in has caused a major problem to the patient. A "Veil of Secrecy" thus develops. In defense of doctors, not every complication can or should be attributed to the Essure, but in cases where it is believed to be a contributing cause, the Gyn should offer the hysterectomy as a possible solution to the problem.

Julio Novoa Hello Dana. The Essure is designed to cause a scarred closure of the fallopian tube at its junction with the uterus. In order to do this, a portion of the Essure coil sticks out into the uterus while the remainder is in the tube itself. Inorder to remove the coil, you can either attempt to go through the vagina, through the cervix, to the fallopian tube and pull the coil by grabbing the part that is sticking out or into the uterus. If the coil is significantly embedded this can be very difficult and could lead to a significant amount of damage to both the uterus and the tube at this junction. You could attempt to carefully cut it out but you face similar risks. You could also attempt to remove it from above using a laparoscope and cut the tube first and them try to pull the coil out going the opposite way. HOWEVER, the reason you are removing the coil is because it caused a significant inflammatory response, therefore, you might consider removing all the tissue that the coil affected which would include the junction at the uterus and the tube. So a well skilled GYN could remove the entire uterus and entire tube vaginally in a fraction of the time and a significantly lower cost as compared to removing only the coil and leaving behind affected tissue that could continue to cause the inflammatory response that you are trying to treat. I would opt to do the hysterectomy and remove the uterus and tubes and leave the ovaries behind so that the patient can still get the benefit of the ovaries and avoid a surgical menopause.