2/29/16 Press Release
Upon reviewing the (supposedly accidental) press release from the FDA this morning, the Essure Problems Administration would like to make a statement.
We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies. Clearly Essure’s PMA should be revoked and the device should be pulled from the market. These studies could take several years, and leaving the device on the market will only put more women's lives at risk.
We have provided the FDA with enough relevant data to prove that Essure is unsafe. Take the device OFF the market and revoke PMA. Do not continue to allow more women to be harmed. Unless the FDA takes those steps, we intend to push for Congress to force the hand of the FDA. We will not be stopped or silenced.
While we continue to encourage women to file their adverse event reports with the FDA, our focus will be on Congress and the E-Free Act. We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.
Essure is just birth control. It will not save your life, but it can certainly take your life or the life of your unborn child. The risks do NOT outweigh the benefits!
These are a few question we will be asking Congress to address with the FDA moving forward:
Is this a black box warning, and when does it take effect?
When will the draft advice be available?
Why is the FDA allowing the manufacturer to conduct a new trial? Will it follow the “golden standard” this time?
What will the confirmation follow up protocol be in the new study? What model Essure will be used?
What decision was made on our proposal to the FDA to conduct tissue studies on explanted tissues surrounding the Essure coils?
Is the FDA allowing the manufacturer to continue to advertise Essure as a “non-surgical” procedure?
Will there be contraindications added to the warning that encompass the broad spectrum of allergies and hypersensitivities that could erupt from contact with this device, ultimately triggering auto immune issues?
How does this affect PMA? Shouldn't Essure now be considered an investigational device?
How can the FDA allow a medical device to remain on the market when tens of thousands of women are harmed and need surgery, and there is no removal protocol in place?
How can the FDA allow a medical device, a BIRTH CONTROL device, to remain on the market when hundreds of women are becoming pregnant, and there have been no safety studies conducted on those pregnancies or on the health of the children born?
Congressman Mike Fitzpatrick (PA-8) released the following statement Monday regarding the announcement of the Food and Drug Administration’s five-month review of the permanent sterilization device Essure*:
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.
Frankly, I’d contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering. It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths. As my constituent, Dr. Amy Reed, a victim of unsafe devices herself, testified at the FDA in September, ‘[w]e don’t need to hurt any more women.’ If the FDA is going to order another study, then at minimum they should take Essure off the market during that time. A 60 day comment period and another study while this device remains on that market only guarantees more women harmed.
Because the FDA is failing to act, I believe Congress must. That’s why, moving forward, I will advocate for a number of legislative actions to address this issue, including:
· Continuing my call for the House and Senate to take up and pass the E-Free Act to revoke the FDA approval of Essure;
· Working to block government agencies — such as the DOD and VA — from purchasing this unsafe device; and
· Introducing new legislation to eliminate the blanket civil liability protections that device manufacturers like Bayer currently receive for a non-life-saving device like Essure because those harmed deserve a voice in court.
Simply put, it’s time for Congress and the FDA to get serious about reforming medical device safety laws.”
Fitzpatrick has been the leading voice in Congress calling for removal of Essure from the market — introducing the E-Free Act in November of 2015. Ahead of the FDA’s report, Fitzpatrick wrote to the agency urging them to consider possible inconsistencies in the number of fetal deaths caused by the device and also legal complaints alleging illegal kickbacks.
More than 25,000 women reported symptoms including extreme pelvic and abdominal pain, migraines, loss of teeth and hair, and the coil cutting into the uterus and other organs in the abdominal cavity. 10,000 have filed formal complaints with the FDA.
*The FDA’s release was posted and then removed from the agencies website. The complete text of the original post is below and a cached version is available HERE:
“The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for particular women and draft guidance with labeling recommendations including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients. Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. The new actions announced today take additional steps and follow the agency’s careful evaluation of available information.
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
Essure is a permanent form of birth control that involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over a period of about three months, tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. While the tissue forms, women must use an alternative form of birth control. Over the past 14 years, FDA has reviewed a significant amount of information related to the use of Essure. While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications. These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.
The draft guidance issued today by the FDA regarding permanent hysteroscopically-placed sterilization devices aims to increase patient and physician understanding of the potential risks associated with this type of device. The draft guidance recommends product labeling that will help to communicate to health care practitioners and patients the potential serious complications that can occur in some women. This includes a boxed warning explaining the adverse events that may be associated with these devices, including their insertion and/or removal procedures.
The draft guidance also includes recommendations for a “patient decision checklist,” for doctors to discuss with patients to better communicate risks and help to ensure an informed decision-making process. The checklist will also help doctors discuss the importance of undergoing a “confirmation” test three months after the device is implanted to determine whether the implants are properly placed and that scar tissue has formed to prevent pregnancy. The draft guidance recommends that the checklist is completed and signed by the patient and physician prior to proceeding with a permanent hysteroscopic sterilization procedure, such as Essure.
The FDA has also ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment. Bayer will be required to develop and conduct a post-market study that will provide data to help the agency to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how much these complications affect a patient’s quality of life. Additionally, it will collect information to identify reasons for why some patients don’t have a confirmation test to ensure that Essure has been properly placed three months after insertion. The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health.
The FDA is seeking comment from the public, industry, and other stakeholders on this draft guidance. The docket will be open for 60 days.”