Wednesday, Bayer HealthCare responded to charges from U.S. Rep. Mike Fitzpatrick that women who had used the contraception product Essure had far more fetal deaths than had been reported. (Our responses can be found in RED.)
Here is the company's full response:
“We are aware that Congressman Mike Fitzpatrick held a press briefing on February 17th related to Essure permanent birth control.
“It is not true that an investigation revealed “unreported” deaths with Essure. The truth is we compiled reports that we had found in the FDA maude database that neither the FDA nor Bayer have made readily available to the public; reports of hundreds of fetal deaths, miscarriages, ectopic pregnancies, and spontaneous abortions. Bayer reports adverse events to FDA consistent with FDA regulations. With the exception of over sixteen thousand Essure adverse event reports previously withheld and turned over to the FDA, years after the incidents were reported in some cases. The referenced data is also publicly-available. While no method of contraception can offer 100% efficacy, Essure offers women a highly effective method of permanent birth control. A study by Dr. Aileen Gariepy from Yale University School of Medicine revealed Essure to be 3 to 4 times less effective than standard tubal ligation. We also have reports within our group of 607 pregnancies. Of these reported pregnancies; 318 of those ended in miscarriage, 16 were ectopic, 11 were abortions due to high risk and 9 were death beyond 22 weeks gestation. Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications. Pregnancy with Essure has proven to show a 52% miscarriage rate in our group. None of the other forms of permanent birth control on the market contain two sharp metal coils trailing into the uterus capable of piercing the amniotic sac! It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term. Bayer cannot claim that those reports were unsuccessful Essure procedures. Many of them do claim in the narrative to have had successful HSG confirmation. So that is not a valid argument. It would be irresponsible to discount the loss of a life to a grieving mother. In the post-market data, there is no data (there is no data….hmmmm haven't we heard this one before folks?) showing any increased risk of miscarriage and other complications compared to pregnancies in similar-age populations.The post market data was appropriately described here (SEE NEJM LINK) Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure. “Fetal death refers to the spontaneous intrauterine death of a fetus at any time during pregnancy. Fetal deaths later in pregnancy (at 20 weeks of gestation or more, or 28 weeks or more, for example) are also sometimes referred to as stillbirths. In the United States, State laws require the reporting of fetal deaths, and Federal law mandates national collection and publication of fetal death data. Most states report fetal deaths of 20 weeks of gestation or more and/or 350 grams birthweight. However, a few states report fetal deaths for all periods of gestation. Fetal death data is published annually by the National Center for Health Statistics, in reports and as individual-record data files.”(See CDC Fetal Death Link) Do you really want to begin a debate on when a life begins? Because to those mothers, finding out they were pregnant and then losing that pregnancy, how many days and/or weeks along have no meaning! Moreover, the medical literature on pregnancy outcomes with Essure primarily comes from closely-monitored, desired pregnancies after Assisted Reproductive Technology* and does not report high rates of premature membrane rupture, preterm labor or delivery, or serious complications. Bayer is referring to the OFF LABEL use of Essure with hydrosalpinx which according to (SEE ESSURE IVF LINK) hasn’t been well studied.
“The Congressman's statements repeat unfounded allegations from an unsealed legal or “qui tam” complaint. These allegations were made over a year ago and the United States Department of Justice thoroughly investigated them. After its investigation, DOJ declined to intervene and prosecute the case. The qui tam plaintiff also voluntarily dismissed the case. DOJ has closed its investigation. The matter is now fully concluded. Essure Problems has been well aware of the kickbacks offered by Conceptus Inc, a subsidiary of Bayer, prior to the public release of this complaint. We have been advised by more than one physician regarding the free hysteroscopic equipment with the agreement to purchase Essure kits as well as the advertising and marketing. Furthermore, DOJ spokeswoman Nicole Navas indicated that, “the whistleblower (which we’re sure became fearful of ever becoming employed again) voluntarily dismissed the case prior to the United States making a decision regarding intervention, and the case is now closed, We decline to provide further comment as to why the case was dismissed and do not confirm or deny the existence of an investigation.” The case was interestingly dismissed the month prior to the September 24th FDA hearing. Finally, there has been at least one additional “qui tam” complaint filed that we are aware of alleging improper conduct on behalf of Bayer and Conceptus. We suspect that providing free hysteroscopic equipment to
physicians was part of their intense marketing scheme all along. According to (SEE FALLOPIAN TUBE CATHETERIZATION) Dr Amy Thurmond who was involved with Essure's animal studies, animal testing of this device was done with fluoroscopic fallopian tube catheterization, identical to the technique used in women for unblocking the tubes. The company however, made a business decision to market the tubal occlusion device to gynecologists for placement with a hysteroscope. WE BECAME THE GUINEA PIGS IN ORDER TO MARKET THE DEVICE TO PHYSICIANS USING A HYSTEROSCOPE!
“Bayer is also aware of quotes on the number of members of a private Facebook group. It is unreliable to cite that number of group members as if it were the number of Essure patients experiencing adverse events from the device. With certainty, we can say that at a MINIMUM 20,000 of the 27,000 members of our group are women who have experienced complications from Essure. Occasionally women join the group for information prior to choosing sterilization and we do have supporters, doctors, a few lawyers, media and quite possibly Bayer employees who monitor the page. However, the majority are women with Essure problems. We read their stories day in and day out. We are unaware of any Facebook or other group of women who have Essure and are 100% satisfied with the device and report no problems. Without transparency, the public cannot confirm how many members of the page are Essure patients, let alone confirm the nature of their health complaints, if any. It is highly offensive that Bayer can speak of transparency and doubt the nature of the health complaints, in essence, calling us liars. Virtually every single day at least 10 women in their 30s, 40’s and even 20’s are undergoing hysterectomies in order to have the device removed. Hundreds of others have posted graphic pictures depicting their injuries specifically incurred after being implanted with Essure. Thousands of women that we are aware of, have already undergone removal surgeries. Do you truly believe women would voluntarily opt for major surgery if they were not suffering significant health issues? We are tens of thousands of real women this device has injured and we will not be summarily dismissed.
Bayer has no place to talk when it comes to transparency! “The “true” overall pregnancy rate is unknown, because the actual number of pregnancies and the number of devices actually implanted is not known.” Yet they have been quoted several times in the press as saying there have been over 750,000 devices actually implanted worldwide. From the moment the device was created, there has been a lack of transparency by the manufacturer which has extended to the clinical trials, post trial surveillance, the PMA process, training of physicians, marketing, adverse event reports and reports of safety. Bayer is essentially playing Russian Roulette with the lives of women as there is no way to identify or prevent an adverse event from occurring once the device has been implanted.
“As the federal authority responsible for assessing the continued safety and efficacy of medicines and devices, FDA held a meeting of the Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee in September to seek expert advice on the safe and appropriate use of Essure. Contrary to other reports, the post-market data disclosed and discussed at this meeting did include ectopic pregnancy and preterm pregnancy complications. There was agreement among the Panel members that Essure is an important contraceptive option and the Panel provided advice for FDA and Bayer to consider. The ONLY ones we heard who spoke of it as an "important option", were Planned Parenthood, Bayer and physicians that are PAID consultants! We anticipate FDA to release a communication on that discussion by the end of this month.
“Choice of contraception and the decision to use a permanent method is a very personal one that should be made between a woman, her partner and her healthcare provider. Not every option is right for every woman. This is why choice is so critical. Tubal ligation and, actually, pregnancy itself, carry risks, which can be serious. And every woman deserves to know the TRUE risks and benefits any medical device carries. Essure’s risks outweigh the benefits, and its safety and efficacy as advertised by the manufacturer are outright lies.
“Bayer is particularly concerned about statements that may be creating an atmosphere of unfounded fear, Our experiences are real, as frightening as they seem, these are our lives! or that may be encouraging women who are not experiencing adverse symptoms from Essure to seek removal of Essure. THAT is a lie, we do NOT encourage women to seek surgery who are not experiencing symptoms. Many women who come to our page list the symptoms they have experienced after having Essure placed, looking for others like themselves. After they realize we’ve all experienced so many of the same symptoms, and others symptoms have gone away after removal surgery, they seek removal surgery themselves. The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, (lie~ Essure is a surgical procedure. Essure is placed using SURGICAL hysterosopy.) is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.” 10,000 women? Show us that data Show us those 10,000 women, we can show you at least 20,000 who have been harmed by Essure!
*Essure is not indicated or labeled for use in this manner. Essure is approved by the FDA for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Bayer does not promote or endorse off-label use of any of our products. We encourage healthcare providers to refer to the FDA-approved Instructions for Use (IFU) available here to guide appropriate use of the product. Funny, they don’t promote the off-label use but will use the findings from their studies to argue their point!
As our final response to Bayer, we urge all Americans to boycott all Bayer products until such time that Bayer recalls the Essure device or the FDA revokes the PMA granted to the device!