*****Disclaimer. Minutes were taken to the best of my ability. FDA statements are not word for word or quotable. They are a general overview of what was stated. Essure Patients that spoke had pre-written script that is contained in these minutes. If any media wish to quote these statements, please get approval ahead of time so we can tell you if it is an exact quote or not. The FDA will be providing its own official minutes in a few days.*****
Peper Long “got housekeeping” out of the way. The call will be 1 hour. It will be a venue to communicate and express your concerns. We hold these calls frequently with patient groups. No information not already available on our website or released to the media will be available. No recording is allowed. It lessens the value of the conversation by interfering with the freeflow of ideas.
Peper Long, Associate Director Public Affairs
Paula Silberbrg, Public Health Adviser
Karen Jackler ,Public Affairs Specialist
Krystal Donahue from Bel Air, MD I had to have a hysterectomy after dealing with 2 years of pain and am here to support other patients suffering.
Mishelle Moore Hi, My name is Mishelle... I live in Mukilteo Wa.. I had Essure for 2 yr 2 mos...before I needed a hysterectomy because of a hypersensitivity to nickel...Essure cost me two years of my life due to illness, my reproductive organs, and my career as an airplane builder.
Jerri Lynn Silver from Long Island, NY I am here for my Daughter Stacy who has become very ill since having essure
Peper Long I appreciate and take this call and complaints seriously. We use all premarket and postmarket literature to review the safety and efficacy of the device. We continue to use post market surveillance and patients play a significant role in how we decide a products benefit/risk analysis. Turn the time over to you.
Kim Hudak It is my understanding that one of the roles of the FDA is to evaluate, not only the efficacy of new pharmaceuticals and medical devices, but also the safety of these products. I do not find any evidence that the safety of the STOP device was evaluated by Conceptus during the clinical trials. In fact, quite the opposite is true. I expressed serious concern about my rapidly declining health the entire duration of the study yet no specialized tests were ever done to evaluate my claims. The information that was relayed back to Conceptus was that I was “highly satisfied” with the product on almost every single account yet my office follow ups as well as my phone interviews during the course of the trials are in sharp contrast to this information.
In addition to the safety, I question the known efficacy of the product at the time of approval as well. With such a small group and such a short duration for the study, I have a difficult time believing that the data was correct. Upon entering the study, women were required to agree to have intercourse a specified number of times each month. This is impossible to verify and it was not a requirement to be in a verifiable long term relationship.
With all of this in mind, my question to you is how was it determined that this product was safe and effective? How did a medical device with such little verifiable data and limited duration of study get the FDA’s approval?
Peper Long Safety and effectiveness was determined by significant amounts of data from 2 studies given to the FDA prior to approval.
Good morning. I’d like to thank the members of the FDA for giving us this opportunity to speak about our experiences after being implanted with Essure, and for the chance to present our information and research to you. It has taken a lot of time, and thought, and preparation to collect and arrange a presentation for you. One that included everything that we wanted or needed to say, while keeping it within an hour long phone call. So we have tried to keep it as short as possible, while including the main topics of concern.
My name is Angie Firmalino; I was implanted with essure in 2009. I am the founder of the FB group Essure Problems. I started the group in 2011 after finding out my coils were embedded in my uterus. I have had three surgeries since being implanted, and I am scheduled for my forth surgery, a complete hysterectomy, on February 13th 2014, to remove the remaining fragments of essure. The surgery involves removing the remainder of my tubes, both ovaries, my uterus and cervix. While I am hopeful it will resolve all of the pelvic pain, I do not know if the chronic inflammation, headaches, or joint deterioration will subside. I am 41 years old.
I'd like to begin my part of this presentation by pointing out the number of women included in the clinical trials for essure. As of the last update to the pma at the time of the initial meeting between Conceptus, the FDA, and the advisory panel, there were 281 women who had successfully relied on essure for contraception for 18 months, 149 women who had relied on essure for 24 months, and 5 women who had relied on essure for 36 months. A total of 435 women. (Of those women from the clinical trials, 4 are in our FB group, and 2 women from the trials are here on the phone with us today, and we will get to their stories shortly)
During the PMA meeting, several questions were raised by the advisory panel that either went unanswered, or could not be answered, because there was not enough data at the time to provide an answer. So here we are, 12 years later and capable and willing to answer those questions. We have almost 6000 women currently in our group suffering from the essure device. At the present time, we add about 150 women a week, however that number is continually and rapidly rising. We recently made an essure survey for our members to fill out, so that we could start to collect some data and present to you some numbers. Currently, 920 members have finished the survey. So already, our group has more women that have taken our survey, than were in clinical trials.
Some questions raised during the PMA meeting that I would like to focus on are
1. Hypersensitivity to metals, particularly nickel
2. What does a doctor do about perforations or migrations, meaning proper protocol of removing a coil
3. What is the long term wearing safety of the PET fibers, specifically if the coils perforate or migrate out of the fallopian tubes?
4. How do we know an accurate rate of pregnancy amongst women relying on essure?
Let me start with the hypersensitivity to nickel. Initially, there was a contraindication for women with a known hypersensitivity to nickel. The same contraindication remains on labels for similarly made devices such as cardiac and cerebral stents. On Aug 4th 2011, Conceptus received FDA approved for the removal of the nickel hypersensitivity contraindication from the Essure procedure Instructions for Use ("IFU").
(The removal of a contraindication for patients with known hypersensitivity to nickel as confirmed by a skin test
The removal of a warning for patients with a suspected hypersensitivity to nickel to pursue a confirmatory skin test
The addition of a warning for patients with suspected hypersensitivity to nickel)
The instructions also state that physicians will be advised to continue to counsel patients about the risks and benefits of the Essure procedure, including the possibility of an allergic reaction to the micro-insert or development of an allergy to nickel.
Of the 920 women who took our survey, when asked the question “did your doctor ask you if you were allergic to nickel”, 18% said yes and 82% said no.
When a woman reports an adverse event report to the FDA regarding an allergic reaction to essure….. This is the manufacturer’s response on that event.
The essure ifu contains the following warning statement: the essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Pts who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some pts may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.”
So the manufacturer knows and admits that hypersensitivity is a problem. Yet, they requested, and the FDA approved, the removal of the contraindication to simply corner the market on hysteroscopic sterilization. Many of the clinical trails that followed the initial market approval had hypersensitivity to nickel as an exclusion criterion.
Here are some published statements, regarding the label change….The label was changed to expand the number of potential patients for Essure. The president and chief executive officer of Conceptus said "This FDA label decision will further strengthen our competitive advantage and leadership in the permanent birth control market, and we are pleased that we were able to secure it, the upgraded label change significantly diminishes the biggest competitive selling point of our competitor's hysteroscopic sterilization product against Essure, which was the nickel hypersensitivity contraindication.” "We will be aggressively marketing this IFU change to the OB/GYN community, and especially to those physician accounts that are trialing the competitor's product primarily because of potential nickel allergy in patients.”
The motivation for this change was not based on patient safety but on the manufacturer’s financial interest. Not only are women not being informed of the possibility of an allergic reaction or becoming allergic, the allergic reactions that ARE happening are being downplayed! We have countless images of women who are suffering severe allergic reactions that leave their bodies with welts, rashes, blemishes and possibly long term scars; this is a living nightmare for these women who are allergic to this Essure device that is implanted in them. The constant pain, irritation, and inflammation that they are forced to live with, because the manufacturer thought that this adverse event was insignificant or extremely rare, is unacceptable. Also, their implanting doctors will rarely make the connection or admit that the essure device is the cause of these reactions, so the women are sent on to dermatologists and specialists and undergo test after test, only to be denied any type of logical explanation. And removal of the essure devices seems like a never-ending quest. Currently, only a handful of allergists are stepping up and offering essure specific allergy testing. It is only very recently that women have been able to use a diagnosis for a nickel allergy as justification for essure removal.
During the PMA meeting, Dr. Sharts-Hopko asked the question about sensitivity to metals, immediately following her statement, the topic of conversation is changed, and she is never answered.
Her statement was: “A concern that I have, also not on the list, is related to the question I raised earlier today about sensitivity to metals. I am a person with an extreme sensitivity to metals other than 14k gold, which is a great problem.”
This was followed by (Laughter.)
The chairman DR. BLANCO says “You sure it's not 18?”
DR. SHARTS-HOPKO replies: “Eighteen is better. So I don't know what happens to people with metal sensitivity when you implant metals in them. “
They move on with the meeting, never to bring it up again.
Those are my concerns regarding the nickel hypersensitivity issue. If this device is to remain on the market, the nickel contraindication must return to the labeling to protect women from future harm. As part of title 21 volume 8 part 814 the label change constitutes that reapplication of pma is permitted by federal law and the fda has authority to enforce Bayer’s requirements to ensure the modification of the device does not pose serious adverse health consequences. Enough women are already suffering from just this one complication. One of many complications.
On to my next question often raised at the PMA meeting, what does a doctor do about perforations or migrations, meaning proper protocol on removing a coil?
Panel member DR. ROY asks: “Okay. Inasmuch as Dr. Wright described the profound inflammatory response that does occur with this device, what was done when perforations were noted?”
Conceptus rep DR. COOPER replies: “When perforations were noted, traditional methods of sterilization followed. The devices were retrieved at laparoscopy.”
DR. ROY asks: “With I suppose a bit more surgical intervention that traditionally would occur or did they just slip out?”
DR. COOPER replies: “No, the diagnosis of perforation was in most cases made at the time of device placement. In a small number of cases, perforation was not noted until the three-month post-procedure x-ray. Retrieval of the device at laparoscopy was not found to be problematic. In a couple of the cases, the device was found lying in the omentum but could be easily removed from the omentum.”
DR. ROY responds: “Okay. Because it's sort of like the situation with copper IUDs being perforated. They produce such an inflammatory response, that it is somewhat problematic, depending on where you ultimately find them, whether the omentum is able to sequester them or other peritoneal or intraabdominal contents, such as bowels. So I was just curious to what extent the inflammatory process, even at a three-month interval, was sufficiently problematic, and I guess you're telling me that it was not, it was easy to find and remove without resorting to laparotomy, for example, to do so.”
Then they go on to discuss the 11 women who had device migration or perforation and the 9 who had the devices retrieved. They claimed only one required laporatomy and one underwent a cornual resectioning. They said of the women whose devices had not been retrieved, they’ve not had any reports of unusual pain that can be attributed to the device location. .
Chaiman DR. BLANCO replies: “A follow-up on that, because I had that as a question. On the patients that had continual symptomatology of cramps and pains and so forth. What other experience except other than this one case do you have for someone who has chronic complaint, desires the removal of the device, in terms of removing the device? Is cornual section the only option for removal of the device if someone wants it removed? Do you see what I'm saying?
In other words, can you go back, do you have any experience going back with hysteroscope trying to pull the device out or do you have to resect the corneum?”
Conceptus DR. CARIGNAN then comes to the podium and states: “When a device is well positioned across the utero-tubal junction, because of the extensive fibrosis, it does require a minimal cornual resection to remove the device. The only time that we ever actually recommend removal of the device hysteroscopically is if during the procedure, you recognize that you haven't positioned it far enough into the tube or you inadvertently deploy it into the uterus that you would then remove it and replace the device. Subsequent to placement, we do not recommend hysteroscopic removal of a well-positioned device.”
Within the clinical trials, with the devices that had perforated and ended up elsewhere, the manufacturer claimed device retrieval was easy. They also claim that the ones they left in the body, could not be attributed to any pain or problem. However, as the study was not long term, there was no evidence to speak to about the long term effects of having a coil migrate and embed in another part of your body. There were also no incidents reported in the clinical trials where the patient had the device migrate outside of the reproductive system. Within our group, we now have evidence of long term wearing of this device after it has migrated or perforated. I for one, am an example. Mine were embedded in my uterus for two years. I suffer pelvic pain, chronic inflammation, chronic headaches, and joint deterioration, just to name a few issues going on. We’ve seen women with severe pelvic adhesive disorder due to migrated coils. We’ve seen xrays, cat scans, ultrasounds, and MRIs of coils ending up in the abdominal wall, the bowels, the kidney, the liver, the ovaries…… The damages are extensive and in many cases requires multiple surgical procedures to repair the injury. Many of our group members have been diagnosed with autoimmune diseases ranging from lupus and crohns disease to myasthenia gravis. Other common symptoms amongst us include debilitating pelvic pain, headaches, joint pain and joint deterioration, chronic inflammation, extreme fatigue, severe bloating, blood disorders and skin conditions. Adverse events that the FDA continues to state cannot be directly related to the device. For most of us, irregular bleeding has become a way of life. There is not a man on earth who would risk wearing a colostomy bag as a possible adverse event from a vasectomy, but this is a possible risk passed on to every woman implanted with essure. And we can say this, because we have seen it happen. Bowel perforation is a common occurrence within our group. However, in the manufacturers presentation, a slide show indicated that the list of adverse events reported by clinical trial participants included…… abdominal pain/abdominal cramps, back pain/low back pain, headache, premenstrual syndrome, dysmenorrhea/ menstrual cramps (severe), pelvic/lower abdominal pain (severe), persistent increase in menstrual flow, vaginal discharge/vaginal infection, abnormal bleeding-timing not specified (severe,) menorrhagia menses (severe), dyspareunia, and uncharacterized pain/discomfort. ……. But that only eight events were rated as definitely related to the Essure device. The FDA allowed the company to dismiss these other adverse event because they were only “possibly” related. The FDA has required no long term follow up on patients beyond the five year mark. And even those studies are still not yet available to the public.
This brings me to the next question regarding the long term safety of being implanted with PET fibers.
This topic was brought up several times during the PMA meeting as well. They discussed the expected response of the pet fibers. The acute followed by chronic inflammatory response, and the giant cell growth. Dr. Roy asked about a possibility for a neoplastic process to the pet fibers, and the presenter remarked on this possibility.
DR. ROY asks: “The last concern would be, is there any reason for us to be wondering whether these giant cells that infiltrate this area or are produced are in any way precursors for a neoplastic process?”
Conceptus rep DR. WRIGHT replies: “Right, and I didn't answer to that. It's the same sort. The pictures I showed you with giant cells could be from any vascular graft in the body, and we have a very long history of use of devices using PET fibers for long-term implants and they have been shown to be neoplastic.”
A neoplasm is an abnormal proliferation of benign or malignant cells. In laymen’s terms, it is the growth of a tumor.
PET fibers have been proven to have a connection to autoimmune disease. We have seen research proving this in the forms of vaginal mesh or other mesh applications. http://tvtno.org/the-facts/surgical-mesh-and-autoimmune-disease-connection/
The hope is that the pet fibers will remain as part of the essure coil encased in the fallopian tube. However, the high instance of migration, perforation, and coil breakage is allowing the pet fibers to become loose in the body, where we are seeing devastating results.
Finally, I come to the last topic, pregnancy. Essure boasts a pregnancy prevention success rate at less than 1%. And I quote “Following successful insertion and occlusional response, the Essure procedure is 99.74% effective based on 5 years of follow-up, with zero pregnancies reported in clinical trials.” Only the women who achieved successful bilateral placement on the first attempt AND had successful occlusion at three months were included in the pregnancy statistics. Every other woman in the clinical trial was excluded from this calculation.
The manufacturer blames the doctor or patient for non-compliance in most situations resulting in pregnancy. The pregnancy rate that was added to the label raised concern amongst panel members.
Panel member MS. LUCKNER states : “Speaking as a consumer rep here, I think when you use the word "permanent sterilization" and we are showing a one-year level of great compliance and great doing the job it's supposed to do, I don't see how you can call this permanent. I don't think there's a woman in the audience or here on the panel who would like to buy into that system for just one year. It's a little risky if you are going for permanent sterilization”.
DR. BLANCO responds: “Well, but let me not let you off the hook so easy. So then, do you think that more data needs to be gathered in terms of length of time of efficacy before you would want to see the device approved?”
MS. LUCKNER: “Or very, very careful labeling that the permanent implies one year or restrictive labeling so that people understand. The woman who elects it with her gynecologist understands that his confidence is based on the data that states X and Y.”
Currently on the maude database, under product problems, there is no way to report pregnancy or miscarriage. That’s a problem.
The pregnancy data in our group is as follows:
In our group there have been
26 women are Currently Pregnant
71 Pregnancies resulting in births
76 Total e-babies including 4 sets of twins
2 babies that died shortly after birth one due to Uterine rupture causing early delivery and one caused by an infection due to essure.
1 Stillborn Baby
10 Unknown outcomes
Out of the 155 Pregnancies we know the outcome of (total pregnancies minus those still pregnant and unknown outcomes):
55% resulted in Miscarriages
46% Resulted in a Live Birth
Out of those 72 pregnancies resulting in live births:
2% Deaths that can be linked to Essure
My name is Gabriella Avina and I thank you for this opportunity to be heard for a second time. In July, 2002, I stood before you in Washington, DC to express my support for Conceptus and the Essure Device. I was on their panel to request FDA approval for this new, revolutionary device. I am here today, almost twelve years later, to say I was wrong. So please listen carefully to me and to these women with me today. Time has changed my thoughts, my beliefs and most importantly, my health.
I am a registered nurse with a Master of Science degree in Women’s Health Nursing. I was involved in the clinical trials at both a professional and personal level. I assisted in the placement of the devices in the operating room with Dr. Don Galen and I became a clinical trial participant in October, 2000. In January, 2001 I had the testing completed that documented placement and confirmed sterilization. Because of my experiences, both as a clinician and a patient, I was asked by Conceptus to speak at the annual AAGL convention in San Francisco and share these experiences. This began a professional relationship as a spokesperson that lasted until 2008.
I traveled the country speaking to large groups of doctors, nurses, patients and Conceptus employees, managed a link on the Essure website known as Ask Gaby where I answered thousands of questions regarding this product, adverse events, fears, concerns, and general information. As I became the face of Essure Women, my health was in a grave tailspin, and I had failed to connect the dots.
In April, 2001, not six months following placement, I was diagnosed with Hashimoto’s Thyroid Disease - an autoimmune disease whereby the body attacks the thyroid, believing it to be foreign.
In 2003 I was hospitalized with an acute onset of Immunological Thrombocytopenia Purpura (ITP) - an autoimmune disease, whereby the body attacks the platelet cells thinking they are foreign and the body is left with no ability to clot. I was hospitalized for nearly two weeks with several transfusions, treatments and tests. One year later and several hospital admissions and complications, I was started on chemotherapy to suppress the bone marrow production of these bad antibodies. I finally reached a safe zone - remission in late 2005. During this time, I lost my job due to this illness.
In 2007, I was diagnosed with another autoimmune disease, celiac’s disease - a gastrointestinal disease where the lining of the bowel is broken down by exposure to gluten in foods.
In 2008 I was finally able to go back to work when all of my blood work and lab values returned to normal. I was starting to feel like I was getting my life and body back when in early 2009, my fifth autoimmune disease was discovered when I was falling frequently and I was unusually fatigued and weak. This disease was the worst - myasthenia gravis. As the disease progressed, I began to lose control over my ability to chew and swallow. I was scheduled for a thymectomy in February, 2010. This is a serious surgery, but gave me a real chance at the remission I needed. If myasthenia progresses, the lungs can become too weak to work, resulting in death by myasthenia crisis. I went into a very short remission that lasted until early 2013 and spent this last year in chemotherapy attempting to abolish the bad antibodies attacking my neuromuscular system.
I am still praying and hoping for remission, but I truly feel that there will only be one way to assure myself of some sort of healthy future. I need to rid my body of the essure coils. I have spoken with all of my doctors, all of which are supportive and feel that this is probably NOT a coincidence. Even Dr. Galen, when I recently tracked him down in retirement, could not argue the facts. The deterioration of my health are all due to autoimmune disease which can be triggered from the foreign bodies in my fallopian tubes. I have an appointment with a surgeon later this month and am hoping to move forward with a real recovery, the recovery of this wife, mother, and nurse to have the healthy life I so deserve.
Again, I ask you to listen to this group of women who all have a story. Their lives were changed by a device that was not adequately monitored during clinical trials, by physicians who were not adequately trained and by a company that has not adequately listened to their patients.
Good morning, and thank you for allowing me the opportunity to speak with the FDA on behalf of women with Essure Problems. I would like to point out that as women, we deserve to know EXACTLY what is being placed into our bodies. This is particularly important when it is an elective procedure that implants a device permanently into a very sensitive part of a woman. Very simply put, this is NOT the case with essure. Yes, there is a basic material list, but several elements are missing.
For example, there are steps that need to be taken with the fibers and nitinol to ensure its safety. Our research shows that there are chemicals and or proteins used during manufacturing of the essure system. Studies show they can be toxic, carcinogenic, and thrombogenic. Why are we not made aware of these residues that could be left not only on the device itself, but also on the catheter!?
It’s sad that the only way women are informed of this information is through our own research. We demand answers as we continue our medical journeys even after removal of the essure device. What Mrs Avina has described is becoming the norm among the essure problems community. Women with cancers, blood clotting disorders, autoimmune disorders and the like.
You can’t say these aren’t related to essure based on what you’ve seen with the clinical trials anymore. We have more women in our group with these problems than the pivotal and phase 2 trials, probably even phase 3. So it’s time to listen and provide us with the facts and answers we desperately seek and deserve! Thank you!
Hello my name is Kim Myers. First I would like to say that all of the women involved with the efforts to bring awareness to the problems with the Essure Procedure are just ordinary women who trusted the system to protect us from harmful products. None of us ever thought that we could not trust the information that we were receiving from our doctors or that any product approved by the FDA would have the potential to do great harm especially since this procedure is not a life saving device. Our experiences were so horrible & when we turned to our doctors for help we discovered that they didn’t seem to have that much knowledge about the product. That brought up the question in our minds what is this product? Why do the doctors know so little?
We weren’t able to get answers from the people who we thought should know so we began to search for the answers on our own. For me personally it really frightened me the more I learned. When I really thought about the procedure it seemed to me that so many conditions had to be met in order for this to be successful. There are so many IF’s. 1st there is the big question of whether they can even be placed. 2nd are they placed correctly, 3rd if the tubes occlude, 4th if they stay in place & worst of all if you have problems then you will have a hard time finding a doctor who even knows what to do in the event of a problem. Most likely it will take major surgery & in many cases a hysterectomy. As I learned more about how the PET fibers are designed to cause a chronic inflammatory reaction in the body. Based on what The company stated in the PMA minutes that the PET fibers would cause this non stop inflammation in the fallopian tubes the rest of my life or other women’s lives. I wondered what happens if microscopic particles of the Pet fiber were carried to other parts of the body via the blood stream. There seems to be no studies as to what happens when that occurs. I faced major surgery & with no assurances that all that stuff could ever be completely removed my body. Let me assure you had any of this information been made available to me, I would not have ever allowed something like that to be placed in my body.
Those are some huge concerns that we have & others will address those issues further. I would like to talk some about the HSG test. The HSG test is a required part of the procedure but yet so many women are not informed that their insurance will not pay for it or they will lose coverage before they can have the test. Since Essure all hinges on the so called successful HSG test does the FDA feel any responsibility in making sure that this test is covered. Shouldn't Bayer/Conceptus have to include that test in the cost of the Essure procedure because if a woman does not have that test for any reason then Bayer/Conceptus has been allowed to exclude those women from any stats regarding their product. If Bayer/Conceptus is allowed to continually disregard adverse event reports because the woman didn't have the hsg test, the doctor or radiologist didn't read the results correctly this does not make sense. The product has failed because a woman has gone thru the process & yet no matter what is claimed it didn’t work. How can the FDA sit back & not take action. There also seems to be no real way to know if devices are correctly placed unless patient undergoes surgery. We have many instances of women having numerous tests & being told that the devices are in place but yet it is found during surgery that they are not. Sometimes the devices can be seen with ultrasounds, sometimes they can't. Women are put thru MRI's which we've been told will not show the devices. Let me make this real personal, I hurt for 3 years. I had many visits to the doctors, the ER. I had many transvaginal ultrasounds, CT scans was prescribed all sorts of medications to control chronic pelvic pain. I was seen at different facilities. I saw different doctors. No one detected a device that was plainly embedded in my uterus. If no one can find a device with the amount of tests I had performed then how can they ever claim that they can determine placement. We have other women & I believe there are a few case studies about missing devices. This is a birth control device. This is not some risky life saving device No one seems concerned about what these devices do to a woman’s body or where the devices end up. . It seems to me that everyone is only concerned with how many women can we sterilize quickly. I’m not sure how effective it really is in preventing pregnancy because as was stated earlier if a woman doesn’t have the HSG test then it doesn’t count as a product failure should a woman become pregnant.
We have started trying to collect information that demonstrates the kind of problems that are occurring with Essure. As I stated earlier we are just a group of ordinary women who have been harmed by a product. We did not think about keeping stats or having a questionnaire until recently. This may account for the small of amount of participants in the info we are collecting. We will provide some of the information that we have collected. We realize that the FDA is accustomed to polished speakers & presentations put forth by the corporations but we have lived the consequences of this procedure. We’ve actually had these things in our bodies so even though we may not have all the fancy words & terms I believe that we are in a better position to tell the FDA about this product.
There also is great confusion as to just what all Bayer/Conceptus is entitled to as far as medical records. Women are scared. They do not want Bayer/Conceptus to have access to their records until their healthcare needs are met. Some women have been told that by filing an adverse event report with the FDA that the report entitles Bayer/Conceptus the right to their medical records. These women are afraid that if Bayer/Conceptus has access that they might influence the care they are given regarding removal of the essure devices. They feel that Bayer/Conceptus has way too much influence on the doctors for them to be heard. This is based on their own personal experience with doctors who refuse to admit that Essure can cause a problem even when there were problems immediately. At one time FDA had on the FDA website that they estimated that less than 1% of all adverse events are reported. I believe that statement has since been removed. Most consumers do not even know that such a thing exists where you can report a problem with a product & the ones that do have found it intimidating. At one point they had to check the box that they were dead in order to file a report. We’ve spoken with a few doctors & they seem to think the reason for the low numbers in reporting & the unwillingness by other doctors to admit to a patient there might be a problem is out of fear. Most surgeries being performed due to Essure Problems are coded as chronic pelvic pain or other reasons for insurance purposes because removal of essure is considered by most insurance companys as a reversal so that is another factor in the small number of reports. Bottom line is how many people have to be harmed before any action is taken. I think we all know that the Essure procedure has some major problems & it’s time for the FDA to do the right thing. At the very least a black box warning should be put on the product. This black box warning should strongly warn physcians to make sure that a woman will have the resources needed to have the HSG test performed. Put a black box warning on it to make sure that doctors & patients are aware that performing ablations concomittently can cause the HSG tests to be unreliable. Put a Black Box warning on the product about how to safely remove the devices.
Peper Long Contraindications can be narrow or broad but it is ultimately up to the physician to abide by labeling. This is called Practice of Medicine where doctors are given broad leave to use according to the doctors judgement. Includes off-label uses and required doctor patient communication that the FDA does not regulate.
Kim Meyers Isnt that why a black box warning could help in protecting people from harmful products.
Peper Long FDA can issue but the company should be informing doctors and doctors informing patients
Michelle Garcia discussed statistics 55% miscarriage compared to 10-15% in the normal population and the 6 cases of a rare form of Auto immune disease and questioned how the safety was assessed prior to approval.
According to the FDA website and the Code of Federal Regulations, the FDA is charged with assuring that devices intended for human use are safe and effective. A review of the seven studies on Essure states the end points are (1) bilateral micro-insert placement rate, (2) identification of factors predictive of micro-insert placement failure, (3) evaluation of aspects of the ESS305 design that may impact bilateral placement rate; and (4) hysteroscopy time to perform the procedure. None of these endpoints refer to the devices safety? What data was used by the FDA to provide assurances that the device is ‘safe?’
Under section 814 of the CFR, PMA can be suspended or withdrawn if O)Newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.
Questioned how safety was assessed when the 7 FDA mandated studies never mention safety in the protocol.
Peper Long Safety data was given to the FDA and all published literature was reviewed. We are interested in seeing additional data from all sources to continually assess the benefit/risk profile.
Last year, the age of 38, I had Essure placed. I had Essure in for a much shorter time than most of the women on the call, only 4 weeks. In that four weeks, I had numerous visits to my doctor and ended up in the ER after Essure had caused an infection in one of my fallopian tubes, which resulted in a 4 day hospital stay that I spent on 3 different IV antibiotics and pain meds. When I went back to my doctor, we decided that a hysterectomy was my only option because of all the damage that Essure had caused. When my doctor opened me up during surgery, he discovered that the infection had turned into a softball sized abscess and was leaking infection into my abdomen. Had we waiting any longer to do surgery, the results could have been fatal. The entire time I had Essure in, I could not function – could not work, could not drive, could not eat, could not take care of my daughter and my household. Had I known that Essure contained nickel, I would never have had it done as I have a nickel allergy. When I asked my doctor why he didn’t disclose that to me, he said it was because the FDA didn’t require him to. So, had the FDA not lifted the nickel contraindication warning on Essure, he would’ve been obligated to disclose that information to me, and I would never had Essure done and would still have my reproductive organs. Now, almost one year later, I am still dealing with the after effects of Essure and the hysterectomy it caused me to have. No woman should have to go through this.
Amanda Dykeman Asked about the ablation study which is late. This study is important because many women are getting ablations after essure. Concerned about an increased risk of Post Ablation Syndrome
Peper Long I will look into the Ablation study. No information. The FDA will look at information collected from all sources. A doctor can review a product and submit an Investigational Device ????. Send it to me and I will make sure it gets to appropriate staff.
Melanie Goshgarian asked if the 17 doctors treating her can talk to the professional scientific staff at the FDA for guidance on treating her allergies since essure.
Peper Long No, you should consult with your doctors, but will be happy to look at whatever you send me.
Kim Meyers This is an important issue and I find it odd that so few people from the FDA were willing to sit in on this call.
Peper Long This is standard for these types of calls to only have one or two people. I will make sure the minutes will get to the appropriate staff. Highlighted the importance of women filing Adverse Events
Kim Meyers Discussed the uneasiness of women to file because they are scare doctors might cancel care or Bayer might start asking for Medical Records.
Peper Long Assured us that the FDA would not request our medical records or share confidential information to Bayer.
Some discussion about it happening amonst the participants.
Gabriella Avina Has PMA ever been lifted?
Peper Long Enforcement with companies is voluntary. I don’t know that we ever have. If we have it would be rare. We recommend recalls but the company would be the one to issue it. Compared a recall to a software fix. A withdrawal would pull a product off the market.
Dolly Pena Asked about nickel exposure to her baby in the womb or through breastmilk
Peper Long Discuss any concerns about the risks and benefits wih your doctors.
Dolly Pena My doctors do not have any answers or guidance for me and I can not find it on my own either.
Peper Long You have to get guidance from your Doctor We have gone 10 minutes over and need to end the call. I appreciate everyones input.