As of December 31, 2018, Bayer voluntarily removed its Essure birth control medical device from the market due to lagging sales and the controversies surrounding it’s safety. However, just because it’s no longer an active product on the market doesn’t mean the the FDA is putting this issue to rest. There are several ways that the FDA intends to stay informed concerning patient health and monitor postmarket safety. If you have an Essure implant, here’s some important information to be aware of.

Essure has Been Removed From the Market. What is the FDA Doing to Monitor Patients?
  • Facebook
  • Twitter
  • Pinterest
  • LinkedIn

Why Did Bayer Take Essure Off the Market?

Essure was fast-tracked through the FDA in 2002 and by 2015 had over 15,000 adverse reports filed in the U.S. alone. This paperwork involved patients and doctors reporting medical complaints and complications. These problems included allergic reactions to nickel which led to autoimmune disorders, the coil-like device breaking apart and moving to other parts of the body where they punctured and sliced organs, and possibly even being linked to patient and fetus deaths. In 2016, the FDA required that Bayer – the makers of Essure – conduct a mandatory clinical study on the product, add a warning to the label, AND create a patient checklist listing all of the risks that have been associated with this specific birth control device. Over a million devices were sold worldwide before 2015. After this new protocol, sales dropped by 70 percent in the U.S. Bayer said in a public statement, “Our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure.

Will the FDA Monitor This Off-Market Implant?

Yes. While the FDA may have approved Essure too quickly for market, they are at least trying to monitor some of the complications left in the wake of this dangerous medical device. Remember that mandatory study that the FDA required of Bayer back in 2016? The FDA is ensuring that Bayer finishes this study with a few new guidelines:

  • Instead of monitoring the patients in the study for just three years, the time period has increased to five years. “This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” explained FDA Commissioner Dr. Scott Gottlieb.
  • One common complaint involving these patients included symptoms associated with inflammation and autoimmune diseases. This could very well be allergic reactions to the nickel that is found in these medical devices. Studies have shown that approximately 15% of women are allergic to nickel. (When you consider that around 1 million women had an Essure implant, that’s 150,000 who are struggling from just this one complication. Also, consider that testing wasn’t done to see if these patients were allergic to nickel BEFORE they were implanted with it!)

The FDA is requiring additional blood tests for the women in the study to track inflammation against inflammatory markers to analyze their symptoms with allergic reactions.

  • “The FDA is also requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results,” Gottlieb said.
  • The FDA has stated that they will continue to monitor the performance of Essure in women and will make interim study results and updates available on their Essure Postmarket Surveillance Study page.

What Should You Do If You Have an Essure Implant?

If you have an Essure implant and aren’t experiencing intense lower back or pelvic pain, fatigue, brain fog, painful intercourse, heavy periods, and other symptoms, then the FDA advises that you leave your implant in place. Listen to your body and educate yourself on the signs to be aware of if something should unfortunately go wrong. However, if you are experiencing these symptoms, talk to your doctor right way. He or she may discuss various options with you so that you can take back control of your health.

 

##
Sources
“UPDATE: FDA updates on post-market study revisions, oversight for Bayer’s Essure”. Mass Device. Accessed January 17, 2019. https://www.massdevice.com/fda-updates-on-post-market-study-revisions-oversight-for-bayers-essure/?spMailingID=14841927&spUserID=Mjk4ODUzMDA1MTY5S0&spJobID=1541789487&spReportId=MTU0MTc4OTQ4NwS2
“FDA Activities: Essure”. FDA. Accessed January 17, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm
“F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant”. The New York Times. Accessed January 17, 2019. https://www.nytimes.com/2015/09/25/health/fda-panel-discusses-essure-contraceptive-implant.html
“Bayer To Take Birth Control Device Essure Off the U.S. Market”. Managed Care. Accessed January 17, 2019. https://www.managedcaremag.com/news/20180724/bayer-take-birth-control-device-essure-us-market

“FDA Announces Safety Monitoring for Essure”. WebMD.  Accessed January 17, 2019. https://www.webmd.com/sex/birth-control/news/20181224/fda-announces-safety-monitoring-for-essure