Bayer Statement on Updated Protocol for Postmarket Essure Study

Safety and efficacy of Essure® have not changed

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Dec 20, 2018, 13:19 ET

WHIPPANY, N.J., Dec. 20, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration has approved an updated protocol for the Essure 522 postmarket surveillance study, following discussions with Bayer about the study. The 522 postmarket surveillance study is a prospective observational study comparing health outcomes of women with Essure^® and women that have undergone laparoscopic tubal sterilization, the only other method of permanent birth control available to women. Bayer has worked closely with the FDA on the study's design and implementation, and the recent modifications are a result of this ongoing cooperation.

The protocol updates, which expand data collection and better reflect real world conditions, specify that Bayer will continue to enroll patients in the study in 2019; follow patients for five rather than three years; additional blood tests; and, amend some inclusion and exclusion criteria for study enrollment.

"The safe and effective use of our medicines and devices is our highest priority, and we are committed to the postmarket study for Essure. Bayer has worked cooperatively with the FDA throughout the implementation of the study and on these study amendments, which provide a measure of flexibility for patient enrollment and allow us to collect additional and valuable long-term data," said Edio Zampaglione, MD, Vice President, Bayer U.S. Medical Affairs, Women's Healthcare and Neurology.

The benefit-risk profile of Essure has not changed. In 2002, FDA approved Essure as a part of the agency's rigorous premarket approval (PMA) process. Bayer continues to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades.

Studies show that Essure has a strong track record of efficacy, preventing pregnancy in 99.3 percent of Essure patients who had a satisfactory confirmation test. A number of recent peer-reviewed studies including one published in The Journal of the American Medical Association (JAMA) continue to confirm the positive benefit-risk profile of Essure. Additionally, in the pivotal clinical trial used to support the FDA approval of Essure, 95% of women were reported to be "somewhat" to "very satisfied" at all study visits through five years. In the pre-approval clinical trials, 99% of women were reported to have rated comfort of wearing the Essure inserts as "good" or "excellent."

Earlier this year, on July 20, Bayer announced its business decision to voluntarily discontinue sales and distribution of Essure in the U.S. after December 31, 2018 due to a decline in sales. Bayer will continue to fully comply with its regulatory responsibilities regarding Essure.

Several factors contributed to a declining interest in Essure among women in the U.S. These include decreased use of permanent contraception overall, increased reliance on other birth control options, such as long-acting reversible contraceptives (LARCs), and inaccurate and misleading publicity about the device. As a result, enrollment in the Essure postmarket surveillance study has also been a challenge. Currently, the study has 293 Essure patients and 498 laparoscopic tubal sterilization patients enrolled. Laparoscopic tubal sterilization has historically been a more common procedure than Essure so the current ratio is not surprising.

Women who currently have Essure in place may continue to confidently rely on the device, and Bayer will continue to support women with Essure and their healthcare providers. Additionally, Bayer reiterates concern regarding efforts by certain critics to encourage women to pursue unnecessary Essure removal surgery, which comes with serious health risks.

In addition, FDA continues to review medical device reports submitted to its public database and provide updates. Bayer believes it is important to provide appropriate context relevant to this ongoing review and note that the number of these reports represents a small number of the total number of devices sold. In addition, according to the FDA's Manufacturer and User Facility Device Experience (MAUDE) website, though medical device reports (MDRs) are a valuable source of information, this passive surveillance system "has notable limitations, including the potential submission of incomplete, inaccurate, untimely, unverified or biased" and duplicative data. The incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of some events, duplicate reporting of other events, and lack of information about frequency of device use.

"It is important to understand that medical device reports (MDRs) are not tracked by name, and it can be very difficult to match one MDR with another. Unless there is absolute certainty that two or more reports are actually the same event, they will be treated as separate events," said Zampaglione. "Given the fact the vast majority of MDRs are non-medically confirmed, this means that there can be and are multiple reports on the same event – such as from the patient, doctor, lawyer, family member or friend – yet they are reported as separate MDRs."

In addition, the reporting of an event does not mean a causal relationship exists. While hysterectomy is not generally recommended to remove Essure, some women report that they have had a hysterectomy. For example, hysterectomy, which Bayer classifies as a device removal for reporting purposes, is the second most frequently performed major surgical procedure for women who are reproductive age (CDC, 2009 – 2010). Many medical conditions may necessitate this surgery independent of whether a woman has replied on Essure for contraception.

Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Indeed, in 2015 FDA reviewed the safety data for Essure and did not identify new safety or efficacy concerns. The FDA also recently noted an increase in MDRs in 2017, while also clearly stating that the "nature and severity of the reports remain consistent with prior years" and that "78 percent of all manufacturer-submitted reports cited litigation, and may be referencing reports previously submitted to the FDA" and could therefore be duplicative.

Bayer remains strongly committed to women's health, an area in which we have long been a leader. This includes ensuring that women have the information – grounded in science and research – that they need to choose the birth control method that best fits their individual needs.

About Essure
Essure is indicated for women who desire permanent birth control (female sterilization) by blocking the fallopian tubes.

Important Safety Information
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.

Essure is not right for you if you are uncertain about ending your fertility, suspect you are pregnant, can have only one insert placed, have had your tubes tied, have a known allergy to contrast dye, are unwilling to undergo the Essure Confirmation Test, have unexplained vaginal bleeding, or have suspected or known cancer of the female reproductive organs.

You should delay having the Essure procedure if you are or have been pregnant within the past 6 weeks, have an active gynecological infection, or are in the second half of your menstrual cycle.

Tell your doctor if you are taking immunosuppressants, have, or think that you may have, a history of metal allergies, or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system, are currently using an IUD for contraception, or have had or are considering a procedure to reduce bleeding from the uterus such as endometrial ablation.

WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.

WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. For some women, it may take longer than 3 months for Essure to be effective, requiring a repeat confirmation test at 6 months. Talk to your doctor about which method of birth control you should use during this period. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.

During the Procedure: In the premarketing study, some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure inserts correctly. In rare cases, part of an Essure insert may break off during placement. If breakage occurs, your doctor will remove the piece, if appropriate. There is a risk of perforation of the uterus or fallopian tube by the hysteroscope, Essure system or other instruments used during the procedure. In the original premarket studies, perforation due to the Essure insert occurred in 1.8% of women. A perforation may lead to bleeding or injury to bowel or bladder, which may require surgery. Your doctor may recommend a local anesthesia. Ask your doctor about the risks associated with this type of anesthesia.

Immediately Following the Procedure: In the premarketing study, some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experience headaches, nausea and/or vomiting (10.8%), or dizziness and/or fainting. You should arrange to have someone take you home after the procedure. In rare instances, an Essure insert may be expelled from the body.

During the Essure Confirmation Test: As one of the Essure Confirmation Tests (a modified HSG) requires an x-ray, you may be exposed to very low levels of radiation, as with most x-rays, if this test is used. Some women may experience nausea and/or vomiting, dizziness and/or fainting, cramping, pain or discomfort. In rare instances, women may experience spotting and/or infection.

Long-term Risks: Pain (acute or persistent) of varying intensity and length of time may occur and continue following Essure placement. This is also more likely to occur in women with a history of pain. There are reports of an Essure insert being located in the lower abdomen and pelvis. If this occurs, you cannot rely on Essure for birth control. Patients with known hypersensitivity to any of the components of the Essure system may experience an allergic reaction to the insert. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported in women using Essure that may be associated with an allergic reaction include hives, rash, swelling and itching. There is no reliable test to predict who may develop a reaction to the inserts. No birth control method is 100% effective. Ectopic pregnancies (pregnancy outside the uterus) may occur with Essure. This can be life-threatening. If insert removal is indicated, surgery will be necessary.

The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old.

Essure does not protect against HIV or other sexually transmitted diseases.

Prescription Only

IMPORTANT

Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases.
The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.

Talk to your doctor about Essure and whether it is right for you. Review the Patient-Doctor Discussion Checklist in the Patient Information Booklet with your doctor before deciding to have the Essure procedure.

About Bayer
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to https://www.bayer.us/.

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SOURCE Bayer