Dear ladies of the Essure Problems Forum.
On the afternoon of May 5, 2015, I had the opportunity to sit down with Dr. Edio Zampaglione, Vice President, US Medical Affairs, Bayer Pharmaceutical Corporation. Our talk was open and candid and lasted approximately 2:15 minutes.
Below is a synopsis of our discussion. I did not record the meeting, and, therefore, Dr. Z’s responses should not be interpreted as a specific quote, but as a general opinion on each point debated.
I hope the following is helpful.
1. Bayer Corporation is continuing to promote/market the ESSURE device as a non-surgical procedure. My position defining surgical vs. non-surgical, as well as, how GYN surgeons are getting compensated for the placement of the ESSURE device, clearly show that the placement of the ESSURE device is a surgical procedure.
Dr. Z: Bayer is concerned that patients may confuse the terminology between surgical and non-surgical, invasive vs. non-invasive, and incisional vs. non-incisional.
Bayer promotes the ESSURE as non-surgical with the support and approval from the FDA (Food and Drug Administration) and feels that no misrepresentation exists with its marketing.
Bayer also believes that any misunderstanding regarding the surgical aspects of the device are addressed and clarified by the doctor to their patient during their appointments and documented in writing by the doctor prior to the placement of the device.
Dr. Novoa’s Rebuttal: There is no evidence that has been presented to negate the fact that the placement of the ESSURE is a surgical procedure.
Ethics in advertising dictates that when a misunderstanding or misrepresentation exists regarding the sale or promotion of a product, a fundamental change must occur that corrects these issues.
Bayer nor the FDA can justify the promotion of the ESSURE as a non-surgical procedure. To do so is misleading and deceptive. Nor can Bayer justify “dummying down” the description of its product from a known truth to that of a known misconception simply because Bayer feels that the American consumer is not intelligent enough to understand the fundamental differences between a surgical and non-surgical procedure.
Bayer should not allow a promotional ploy spearheaded by its marketing department to undermine good medical marketing standards. To do so is unethical, unprofessional and potentially unlawful as examples of deceptive business practices.
No licensed doctor should describe the ESSURE as non-surgical, for to do so, opens themselves up to accusations of failing to provide Informed Consent and intentional deception. This could lead to charges of assault and battery if this type of misrepresentation leads to a patient making a misinformed or a non-consensual decision.
2. Bayer has recently confirmed that approximately 16,000+ complaints which were stored in an Excel data file may not have been included in the MAUDE data. Can you clarify Bayer’s position on this file and the accuracy of the MAUDE data to include these complaints?
Dr. Z: Bayer turned over the Excel file information as required to the FDA and has complied with all regulations regarding the notification to the FDA of adverse effects and complaints concerning the ESSURE.
Although the 16,000+ complaint file size may seem significant, this does not necessarily correspond to 16,000 individual patients and may represent the duplication of complaints that are already listed in the MAUDE data.
Dr. Novoa’s Rebuttal: Bayer should not stand by a position, which basically states, “I did my part. It’s not my problem if you didn’t do your part.”
The Excel file has existed for more than 3 years. In 2013, Bayer defended the safety and efficacy of the ESSURE device by claiming that less than 750 complaints had been filed with the FDA. Yet, Bayer admits that it knew about this 16,000+ patient complaint file but still used the 750 from the MAUDE data as a reference number demonstrating its safety.
Bayer did not request the FDA to make corrections to the MAUDE data. Instead, Bayer publicly promoted the safety of the ESSURE by referencing to the MAUDE data that did not include the Excel file complaints.
Again, you have to ask yourself how is this not unprofessional and deceptive?
Over the past two years, the number of complaints listed in the MAUDE data has risen from 750 to 4500 complaints, yet Bayer continues to stand by the MAUDE data, even though everyone agrees that the MAUDE data is incorrect since it still does not include the information in the Excel file containing the 16,000+ complaints.
No attempt to clarify or improve the accuracy of the MAUDE data to include this Excel file has been made by Bayer. Nor has Bayer itemized the list by patient, and/or complaint per patient and sent the corrected list to the FDA in such a fashion as to accurately document this information into the MAUDE data. Bayer has no reliable or valid way of tracking complaints or any process to make sure data already submitted to the FDA is complete and truthful.
As the owner of the ESSURE, Bayer is not just accountable to the FDA, but the consumer at large, and, therefore, it should make every effort to assist the FDA in correcting the MAUDE data.
3. Bayer claims that 750,000 ESSURE kits have been sold worldwide. How many of these kits have actually been placed in women in the United States (US)?
Dr. Z: Although we are aware of over 1 million kits sold, we are unable to determine the actual number of units placed. We, however, calculate that about 75% of these kits have been used. Despite the use of multiple data banks, we cannot be more specific in determining this calculation.
Dr. Novoa’s rebuttal: A “best guess” approach is never appropriate when determining risk or safety. Bayer should stop using a worldwide figure, and, instead, use a United States (US) insertion number when comparing post-insertion complication rates to that of the MAUDE data.
Although knowing the number of devices sold worldwide is an interesting factoid, it too is misleading and serves to confirm a financial motivation by the Bayer Corporation to continue selling a product that is profitable rather than safe.
At a minimum, the US consumer has a right to know how many ESSURE devices have been placed in patients living in the US and how many patients have had complications with the ESSURE.
This represents "truth in advertising" rather than what we are seeing now by Bayer using a worldwide ESSURE kit sale estimation to defend its position.
4. One of the most serious complications regarding the ESSURE device is its known migration, expulsion or extrusion rate of 3-4%. If we agree that this number is correct, why would Bayer market a product that requires major surgery (laparoscopy or laparotomy) to remove?
Dr. Z: Bayer stands by the ESSURE as one of the safest and most effective forms of permanent sterilization. Both safety and efficacy have been demonstrated by the original clinical and pivotal trials, as well as, numerous post-trial peer reviewed studies.
No form of permanent birth control is 100% safe and effective. However, compared to traditional tubal ligation, ESSURE is a viable option for women.
Although ESSURE has been known to be associated with a migration of the coil outside of the fallopian, corrective surgery includes laparoscopy, linear salpingotomy, salpingectomy, or hysterectomy.
In cases where laparoscopic surgery is required, this is similar to what would be necessary for traditional tubal ligation, so the management of this complication poses a similar risk as compared to the risk the patient would have had if she had opted for a tubal ligation.
Dr. Novoa’s rebuttal: Almost all types of implants are associated with a rejection, sensitivity, or hypersensitivity of the implant to some degree. In comparison, breast implants have an extrusion rate of about 3%, where they are expelled from the skin and out of the body.
In the case of the ESSURE, the device is designed to cause a local chronic and permanent inflammatory reaction that leads to it being pushed out of the fallopian even after being scarred into place in up to 4% of patients.
This complication is serious enough to require major corrective surgery under general anesthesia, and in a hospital setting, which is associated with significant medical risk, and leads to literally tens of thousands of dollars in medical expenses.
Even if the ESSURE device was 100% effective, although it actually appears to have a failure rate as high as 9% (10-15x higher than traditional tubal ligation), the known rate of extrusion is such a high and potentially life threatening complication, that ESSURE should have never passed GYN Advisory approval, let alone been sold in the US.
For example, if we were are to accept Bayer’s position that 750,000 women have been successfully inserted with the ESSURE, it is estimated that over 30,000 women are at risk of having the ESSURE device migrate or extrude out of the Fallopian tubes.
Depending on the final location of the migrating coil, one out of 25 women could have a catastrophic and/or life-threatening complication from the ESSURE. Based on this risk alone, the ESSURE should rarely, if ever, be offered by GYN surgeons as a form of permanent sterilization as compared to traditional tubal ligation or male vasectomy.
In no uncertain terms, Bayer should voluntarily pull ESSURE off the world market, not just the US market, since most non-USA consumers do not have the medical services or financial capacity to handle the care and management of this type of complication
5.Why was a pre-insertion nickel sensitivity test removed as a requirement in the ESSURE instruction packaging and instructions, and since nickel is a known allergen, why not put it back?
Dr. Z: Both Bayer and the FDA reviewed the nickel sensitivity labeling and after clinical evaluation it was found that some patients with a nickel allergy and positive sensitivity test did not have any side effects to the ESSURE as far as having an allergic reaction. Signs such as a rash. However, some patients with no known nickel allergy and negative nickel sensitivity test showed symptoms of allergic reaction. The overall response to the device as far as signs of allergic reaction were good for both those that had a known nickel allergy and those that did not. Therefore, Bayer requested and the FDA agreed that the warning label requiring that a skin sensitivity test be removed.
Dr. Novoa Rebuttal: Nickel allergy is a known and documented contraindication to the use of nickel containing material, to include the ESSURE device. Although many patients are aware that they have a nickel sensitivity or documented nickel allergy, many do not.
Although the sensitivity and specificity of the nickel skin test is not 100%, at the current time, it is the best screening test available in regards to nickel sensitivity. It is a test that should be discussed, if not specifically recommended to patients, and specifically acknowledged in the Informed Consent BEFORE the procedure is performed
6.You commented that a nickel sensitivity can lead to the development of a rash. Would this be considered a systemic reaction to the ESSURE?
Dr. Z: Yes.
Dr. Novoa. If systemic reactions are possible, what is your opinion on neurological effects, such as Brain Fog?
Dr. Z: We are not aware of any specific link as a side effect of the ESSURE to neurologic changes; however, we are not ignoring the possibilities that some patients may experience these side effects, such as brain fog.
Dr. Novoa's Rebuttal. Neurological changes are known side effects of systemic autoimmune reactions to allergens. More common sensitivity reactions, such as, whole body rashes, or hives, is a known side effect of allergens
Although a direct link between autoimmune diseases and the ESSURE device have not been established, autoimmune reactions mimicking conditions such as, Lupus, Antiphospholipid Antibody Syndrome, Sjorgen's Syndrome, Chronic Fatigue Syndrome and Fibromyalgia, just to name a few, have been seen following the placement of the ESSURE. Therefore, these should be considered as potential or actual side effects to the ESSURE chronic systemic inflammatory response.
Doctors observing signs or symptoms that mimic these or similar conditions should not dismiss a possible link to the ESSURE device, and should instead refer their patients to an Allergy Specialist or Rheumatologist for further evaluation.
7. Are doctors required to be certified by Bayer before placing ESSURE devices? And what does certification actually represent?
Dr. Z: Bayer requires certification for the use of the ESSURE. This certification demonstrates a knowledge of the ESSURE, to include patient selection, proper placement, and management of complications. It demonstrates that the surgeon has been instructed and has demonstrated a proficiency in the placement of the device.
Dr. Novoa's Rebuttal: Training with the ESSURE has not always involved peer to peer, or doctor to doctor instruction. In most cases, product representatives, who are not licensed doctors or nurses, are training and proctoring doctors.
Proficiency is relative and not confirmed simply by ESSURE certification. On average, a surgeon is only required to place between 5-10 ESSURE devices in order to be certified.
Yet, confirmation of proper placement is not independently documented immediately after placement of the ESSURE device. Due to its limitations, the ESSURE also requires a 3 month HSG to confirm the occlusion of the fallopian tubes.
In the original clinical and pivotal studies, GYN surgeons, considered to be experts in performing hysteroscopic procedures, failed to properly place the ESSURE in over 13% of procedures. This means that more than 1 out of 10 patients were at increased risk of implant failure with implant migration out of the uterus or fallopian tube.
Newly ESSURE-certified doctors are novices at best, and dangerous at worst, with a high probability of incorrect implant placement, especially in patients who experience tube spasm or significant version/flexion of the uterus.
Bayer does not require immediate post-op confirmation of proper ESSURE placement. This should be an ABSOLUTE requirement, especially due to the high risk of incorrect placement which appears to be the leading cause of ESSURE complications.
Incorrect placement is very often associated with chronic, moderate to severe post-op pain; dyspareunia; worsening dysmenorrhea, or chronic abnormal vaginal bleeding.
A post-insertion ultrasound or CT scan should be MANDATORY for confirmation of proper placement, as well as, the 3 month post-op HSG confirmatory occlusion test.
ANY patient with post-op pain should be IMMEDIATELY scheduled for diagnostic testing.
Although Bayer certifies doctors who place the Essure device, it assumes no responsibility for the continued proficiency or the management of patients by its ESSURE-certified doctors. This limitation is similar to that which occurs with board certification in general in the specialty of obstetrics and gynecology.
Unfortunately, neither the Bayer Corporation or the American Board of Obstetricians and Gynecologists (ABOG) assume any responsibility for the actions of the doctors they certify. Nor does Bayer perform any type of post certification proficiency testing or compliance surveillance of ESSURE-certified doctors.
Unfortunately a significantly high number of ESSURE-certified doctors are not only poorly trained, but are incompetent and are guilty of malpractice.
8. As a commentator for the Essure Problems Facebook forum, I have reviewed literally hundreds of cases where doctors are failing to follow the Clinical Manual guidelines. This is extremely frustrating. I am sure that you are aware of similar stories. How is Bayer addressing these problems?
Dr. Z: Bayer continues to feel that the Essure device is an excellent product and the best product on the market for permanent sterilization. We believe that continued medical education for ESSURE-certified doctors is a priority. The company has spent hundreds of thousands of dollars to maintain this goal. We offer online and hands on physician education and proctoring as well as mini courses and consulting with doctors who have the most experience with the ESSURE.
We are aware that some doctors fail to follow the guidelines we recommend which frustrates us because many of the complications we are observing could be avoided if doctors would follow the guidelines.
We are working with the leading experts in the world in order to design online easy to follow physician education modules to help all doctors, both ESSURE-certified and those simply wanting to learn more about the ESSURE.
Dr. Novoa's Rebuttal: For the novice, the ESSURE device is difficult to place. Certification by Bayer neither confirms sufficient knowledge or management of the device. Proficiency is based on a learning curve that requires that a significant number of patients serve as unwilling test subjects or "guinea pigs" without their knowledge or consent.
So who would not be considered to be a novice? I am calculating someone who has placed between 30-50 ESSURE devices, which would allow them to have seen between 5-10 patients with complications.
Unfortunately, the complications associated with either an incorrect placement or complication associated with the chronic local/systemic inflammatory response is often ignored by both novice and expert ESSURE-certified doctor.
It is also very unfortunate that despite Bayer's attempts to improve physician education, a significant number of ESSURE-certified doctors are failing to use these resources, and are, again, using their patients as "guinea pigs" in a "trial by error" form of physician education.
9. A common complaint associated with the ESSURE after placement is chronic irregular bleeding. Would you comment on this side effect?
Dr. Z: We have not seen a significant number of patients with this complaint when comparing the ESSURE with that of the general population.
We believe that a significant number of women opting to use the ESSURE were, prior to the ESSURE, using oral contraceptive or estrogen based birth control, which controlled vaginal bleeding. However, when switching to the ESSURE, these women stopped using estrogen products, and, therefore, begin to have symptoms of irregular bleeding due to their discontinued use of the pill. They are, therefore, associating the ESSURE with irregular bleeding when the bleeding is due to not using the pill rather than due to the ESSURE.
Dr. Novoa's Rebuttal. Although in theory an explanation such as presented by Dr. Z is possible, there is no study or body of data supporting this explanation. On the contrary, a significant number of women who never had problems with bleeding and were not using oral contraceptive pills complain of irregular, heavy, or painful periods following the insertion of the ESSURE. This complication is also commonly seen with the Mirena or Paragard IUD.
Both the coils and PET are expected to be placed approximately 3-8 coil turns within the uterus, which can and does produce an inflammatory response and agitation of the uterine lining. This leads to increased cramping, bleeding, pelvic pain, and pain with intercourse which was not present prior to the insertion of the ESSURE.
In the majority of patients with post ESSURE insertion dysfunctional uterine bleeding, the return to use of oral contraceptive pills DOES NOT stop this irregular bleeding. Therefore, the expectation that a return to use of an estrogen based pill or birth control pill will stabilize the uterus and stop bleeding after the ESSURE is placed is not supported by the data.
A definite "Cause and Effect" appears to be present between the ESSURE and the symptoms listed in the clinical trials, pivotal trials, and MAUDE data. These findings are similar to the effects seen with the Mirena IUD, where irregular bleeding after its insertion occur in between 5-10% of patients and stops after the Mirena is removed. Unfortunately, unlike the IUD which can be removed in less than 10 seconds, the ESSURE requires major surgery under general anesthesia to remove.
10.Do you believe that ESSURE is associated with Post Tubal Ligation Syndrome (PTLS)?
Dr. Z: I believe that signs and symptoms that could be described as those associated with Post Tubal Ligation Syndrome (PTLS) could be associated with the ESSURE. However, these symptoms are associated with tubal ligation and, therefore, we do not believe that PTLS is more commonly seen with the ESSURE as compared to tubal ligation.
Dr. Novoa's Rebuttal: I have been doing tubal ligations for over 19 years. I estimate that I have performed over 1000 laparoscopic tubal ligations in this period of time. Complaints, such as irregular bleeding and changes in the menstrual cycle following tubal ligation average approximately 10%.
I believe that PTLS is a real and undiagnosed condition associated with any procedure that manipulates or damages the tubes is associated with a change in the menstrual cycle in up to 10% of women. When considering the association of PTLS and ESSURE, doctors need to discuss PTLS as a real syndrome that can alter the menstrual cycles of women.
Therefore, if ESSURE causes PTLS like any other tubal ligation procedure, the patient should be properly informed of this BEFORE undergoing the placement of the ESSURE.
11. Do you believe that there is an increased risk of endometriosis, adenomyosis or dental caries with the ESSURE?
Dr. Z: Based on all of the information that we have been able to review, we have not seen any association between the ESSURE and endometriosis, adenomyosis or dental problems.
We are disappointed that you are warning women of these problems without being able to support your concerns with information other than that provided by patients who already complain of problems with the ESSURE and, therefore, represent a selection bias.
I also felt that interviewing a patient for a TV News story that complained of dental problems who had multiple piecing in her face and her tongue was a poor choice to show a link between the ESSURE and dental caries, especially considering the fact that having piercing increases her risk of having dental problems and infections which have nothing to do with the ESSURE.
Dr. Novoa's Rebuttal: Double blind, prospective studies that are able to show a link between the ESSURE and any of the aforementioned conditions are never the first reports demonstrating a problem.
Although a selection-bias may be considered, data showing a trend or an increased incidence or prevalence will almost always start out with individual Case Reports and Case Series rather than double blind studies.
Our goal by doing surveys is to gather information and see if we can find an increase in the frequency of a problem as compared to the general population. This is what we have seen regarding our surveys and in the cases of endometriosis and adenomyosis.
In regards to body piercing and dental infections; we are aware that tongue piercing is associated with an increased risk of dental infections and enamel fracturing leading to cavities. However, the vast majority of women that are complaining of dental problems after the ESSURE has been placed do not have body or tongue piercing. Yet the extremely rapid onset and severe dental problems seen after the ESSURE has been placed compels us to warn patients of a possible link with the ESSURE.
12. I have seen a shockingly high number of cases where patients are not required to do the post insertion HSG. In fact, some doctors are placing the ESSURE knowing that their patients will lose their insurance before they can do the 3 month HSG confirmation test. This is disproportionately associated with patients having Medicaid.
Do you believe that it is appropriate or ethical for a doctor to place the ESSURE if they suspect or know that a patient will not be able to do their post insertion HSG confirmation test?
Dr. Z: Bayer has made it clear that the HSG is required in order to confirm the proper placement and occlusion of the fallopian tubes.
I believe that it is unethical for a doctor to recommend or perform the ESSURE procedure if they know that the patient will be unable to have the HSG confirmatory test done at 3 months due to the loss of her insurance. In this case, the doctor should make it clear to the patient that she may have to pay out of pocket for the HSG. If the doctor believes that the HSG cannot be done then the doctor should recommend some other form of permanent birth control.
As we have stated, Bayer is committed to helping patients when problems occur, such as in this case. If patients are unable to have the 3 month HSG confirmatory test done due to loss of insurance, we request that they get in touch with us, so that we may try to facilitate through other resources a way to pay for the HSG test.
Dr. Novoa's Rebuttal: It is MANDATORY that doctors confirm insurance coverage for both the placement and 3 month HSG confirmatory test.
A disproportional number of low income patients, who are covered by Medicaid during their pregnancies, but lose Medicaid coverage 8 weeks after their deliveries are being encouraged to have the ESSURE device placed. These patients are the least likely to be able to afford the confirmatory test and are left with little or no options when complications occur with either the placement of the ESSURE or the failure of the tubes to close.
It is absolutely UNETHICAL for an OB/GYN to place the ESSURE knowing that the patient will lose their insurance before the 3 month HSG confirmatory test can be done. Patients under the Medicaid system are the most likely to have this occur and are the most vulnerable to the system.
Further, it is unprofessional and below the standard of care for a doctor to fail to cover this possibility in the written Informed Consent.
Unfortunately, patients are unaware that their doctors have no higher morals, ethics or level of professionalism then their neighbors. Because of lower compensation, higher malpractice premiums and higher chance of being sued as compared to our predecessors, many doctors manage their patients like a business. We are not bound by the Hippocratic Oath. In fact, most of us have not even read it, let alone plead allegiance to it.
Bayer appears to be trying to improve the outcome and reduce both risks and complications associated with its product.
Unfortunately, ESSURE represents a perfect example of how the FDA and the safety of medical product selection has failed the US consumer.
The ESSURE has been shown to have complications that require major surgery to correct. Currently, just within the ESSURE PROBLEMS Facebook forum, more than 100 women PER MONTH are having to undergo major surgery to remove the ESSURE device due to side effects or complications from the product.
In a group of 17,000+, this averages out to approximately 17% or almost 1 in 5 women per year. In comparison, OB/GYN surgery complication rates higher than 5% are considered to be unacceptable. Yet ESSURE complication rates leading to major surgery, such as total hysterectomy, bilateral salpingectomy are considered to be acceptable by the FDA and Bayer are approaching 1 in 5.
Why is this being allowed to continue?
Almost certainly, part of the problem is due to female gender bias and discrimination. If men had metallic coils inserted into their testicles and were having implant failure rates close to 10%; chronic testicular pain preventing intercourse; migration of the coils into their bladders, prostates or bowels; or corrective surgery requiring the possibility of castration, the coil manufacturer and the FDA would be facing a mountain of lawsuits which would never be able to hold up to Class III preemption protection.
The second most obvious reason that the ESSURE is still on the market is due to a financial incentive to continue to sell the ESSURE. The ESSURE Class III Preemption status shields Bayer from product liability lawsuits.
Regardless on where you stand on the safety or complication rate regarding the ESSURE, the fact that every month hundreds of women are having to have major surgery to remove the coils and the fact that they are supposedly being placed by ESSURE-certified, Board certified OB/GYN doctors, leaves little room to argue that the ESSURE device is too difficult a device to be managed by the majority of Board-certified OB/GYN surgeons.
Dr. Z stated that although Bayer has devoted a significant amount of time and effort to the ESSURE device, it represents only a small fraction of overall sales. This is a fundamental point to our position and argument. In 2013, Bayer purchased Conceptus for $1.1 BILLION in cash in order to buy the rights to the ESSURE. At the current time, Bayer has no financial reason to stop the sale of the ESSURE. Although ESSURE sales may represent only a fraction of its total gross revenue, Bayer must justify the purchase of Conceptus to its shareholders, and cannot acknowledge making a billion dollar mistake.
Because of its high incidence of surgeon error in placing the device (14%); high failure rate of the device leading to pregnancy, preterm delivery and ESSURE induced abortions (>9%); high rate of migration of the device (4%); increasing incidence of major surgery to remove the ESSURE due to complications; and the inability of Bayer to police or even monitor the unethical and unprofessional behavior by ESSURE-certified, Board certified OB/GYN who are placing and managing patients with the ESSURE device, it is time for Bayer to take the most effective and responsible course of action, which is to terminate the production and sale of the ESSURE device worldwide.