VERY IMPORTANT PETITION TO THE FDA DEMANDING ESSURE BE REMOVED FROM THE MARKET
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Public Comments on the Citizens Petition
William Myers RPH
I support and endorse the petition FDA-2015-P-0569 in whole.
I fully support this petition to have FDA immediately reverse the PMA for Essure and at a minimum place a black box warning
on the product. My request is based on both a professional and a personal viewpoint. The evidence in the petition clearly
demonstrates the deceptive practices used to by pass the safety procedures put in place by the FDA. As a health care
provider I rely on the FDA to completely ensure that any product that reaches the market has undergone sufficient testing to
be safe. By your own definition safeguards, checks, and testing has been bypassed, so I don't see any alternative other than
to revoke the PMA for this product.
From a personal point my wife had these devices implanted and began to experience pain within days. No physician
associated her pain with these devices because the manufacturer was assuring them that the devices could in no way be
causing any problem, and implied in that the FDA was making that assurance. She was able to find someone to remove two
devices but continued to suffer constant pain for three years. She had numerous X-rays, CT scans, and sonograms at various
facilities to try to determine her problem. As a last resort she had a hysterectomy and a third device was found that had not
been detected with all the testing. By this company using false information and deceptive practices, and the FDA allowing this
product on the market, my wife suffered almost constant pain for a period of four years and no one was able to detect the
cause of the problem.
In conclusion I believe that this is an unsafe product that has caused great harm to my wife and many, many other women.
At a minimum it is a product that is now on the market only because it bypassed the rigorous testing that FDA claims to
require of any product receiving PMA status.
William R. Myers
My name is Dr. Julio Novoa. I am a practicing OB/GYN and Cosmetic Surgeon from El Paso, Texas. I have been in private practice since 1999. I am the main doctor commentator for the ESSURE PROBLEMS forum on FaceBook representing over 16,000+ women. Over the past 16 months, I have spent about 2 hours per day answering questions associated with the cause and management of complications following the placement of the ESSURE.
I would like to address the shortcomings of the FDA regarding the ESSURE:
(1)The FDA has relied primarily on voluntary reporting. Specifically, the FDA has relied heavily on data submitted as part of the Manufacturer and User Facility Device Experience (MAUDE) database. Over the past 12 months, the number has increased by over 200% to over 4000 adverse complaint reports. HOWEVER, a serious flaw exists with this method of data collection, which is best exemplified by the Bayers admission that 16,000 adverse reports that it had collected had failed to be included in the MAUDE data. Prior to this admission, Bayer had publically stated that the MAUDE data, which included less than 950 reported complaints showed that the ESSURE was both safe and effective.
(2) The FDA approved the ESSURE based on data from two clinical studies totaling only 745 patients.
The ESSURE is a relatively difficult device to place even by Expert GYN surgeons with an insertion failure rate of 14%.
The FDA clinical trials data shows that the ESSURE had a incidence of adverse side effects of over 30%.
The ESSURE has an incidence of migration, expulsion or extrusion out of the fallopian tube or uterus of 3-4%.
The FDA posts on its website that the ESSURE has an effective rate of 99.83%. The currently accepted rate of failure with the ESSURE device ranges from 4-9%, which is 3x-18x as compared to traditional laparoscopic tubal ligation. The failure of the ESSURE is so high that mothers having their babies with the ESSURE in place have come to call themselves, E-Moms and their babies, E-babies. According to the MAUDE data, as well as patient surveys done by the ESSURE Problems forum, when a pregnancy does occur, approximately 45% of the time, the pregnancy ends up as an ectopic pregnancy. In the case of ectopic pregnancies, the management is often emergency surgical removal of the pregnancy and the affected tube. In the case where the pregnancy is able to enter the uterus, the ESSURE has been associated with abortions or premature deliveries even past gestational ages where abortions are banned by State laws. The incidence of either intrauterine or ectopic pregnancy has not been categorized, let alone mentioned, by the FDA on its website, even though this adverse event is one of the most common adverse complaints listed in the MAUDE database.
(3)The FDA has allowed Bayer to advertise the ESSURE as a NON-SURGICAL procedure. ESSURE requires the use of an operative hysteroscope in order for it to be place. Medical State Board regulations, Hospital Surgical Privileges, Centers for Medicare and Medicaid (CMS) CPT and ICD-9-CM Billing and Coding, list this operative hysteroscopic procedure as a SURGICAL procedure. Bayer has even provided PowerPoint presentations to its representatives in order to teach doctors how to avoid using the term SURGERY and instead use the term PROCEDURE.
Bayer has used the fact that the procedure can be done in an office setting under local anesthesia as a selling point to doctors. Women have described the procedure as pure agony, excruciating pain, and even torture, as their doctors attempt to insert their E-hell devices and during confirmatory hysterosalpinography (HSG).
(4)The FDA has also failed to address the significant increase in the incidence of post-ESSURE surgeries that are being done in order remove the ESSURE device due to its complications. Literally hundreds of laparoscopic tubal removals, cornual resections, and hysterectomies are being done each month as definitive treatment due to the complications of the ESSURE device. Unfortunately, doctors are using Best Guess medicine often leading to device fragmentation, multiple surgeries and, in some cases, surgical complications leading to the death of the patient.
At a minimum, I hope my commentary will force the FDA to immediately act to make the Bayer pull its ads stating that the ESSURE is a NON-SURGICAL procedure, which is clearly false and misleading especially with Bayers heavy promotion of the ESSURE as a cost free permanent sterilization option under the Affordable Care Act.
Dr. Julio C Novoa, M.D.
Novoa Medical Services
I am an OBGYN who had placed many essure devices and 18 months ago stopped because I am now having to remove them for my patients. I believe this device was misrepresented to the physicians and should be re investigated as potentially harmful. I also believe the chemicals and pieces of the device should be reevaluated as many of them are carcinogenic or harmful to humans. We as physicians need more disclosure form large companies so we can better educate ourselves and mainly our patients. This is currently not being done with Essure
Dr Shawn Tassone