Patient Power: Thwarting Sales of Essure … A Dangerous Device

Patient Power: Thwarting Sales of Essure ... A Dangerous Device
Patient Power: Thwarting Sales of Essure ... A Dangerous Device

Bayer will stop selling Essure, a permanent birth control device, by the end of the year. Why? Because of patients reporting dangerous adverse events.

At MedShadow, we not only encourage researching the side effects of medicines, but also reporting them, whether to your doctor, pharmacist and/or the FDA. Only when such reports by patients are made can something be done, whether it’s warnings about drugs placed on labeling or even something more drastic.

The recent announcement by Bayer that it will stop selling its Essure permanent birth control device by the end of the year is a prime example of the power of patients to help keep a dangerous product off shelves.

For those unfamiliar with the birth-control device Essure, its approval was fast-tracked by the FDA back in 2002, as it was seen as a safe alternative to surgical sterilization. However, by 2015, the number of adverse events reports related to Essure was massive -– more than 17,000 reports. The side effects included severe abdominal pain, tears along the fallopian tubes where Essure is inserted, cysts, tumors, fatigue and bowel control issues. There are even reports of the device, which is made of nickel, migrating into the pelvis and abdomen.

The FDA Heard Patient Voices

The FDA did take action in response. The agency did its own review of those reports and confirmed that there are risks associated with Essure. Early last year, the FDA also required a boxed warning be placed on Essure’s labeling to call attention to the risks, requiring a “patient decision checklist,” as well as mandating a clinical study to better determine the risks associated with the device.

Those additional requirements may have signaled the beginning of the end for Essure, at least in the US. The FDA recently said that since it released that early 2016 notice, Essure sales plummeted by about 70%. In a news release announcing it would stop selling Essure by the end of the year, Bayer conceded that its Essure business “is no longer sustainable.”

The company said it still stands by the safety and efficacy of Essure. And in perhaps a bit of PR spin, it blamed the decline in the device’s use on other factors, such as a decline in the overall use of permanent contraception, increasing use of other birth control options and “inaccurate and misleading publicity about the device.”

Taking Essure away as a birth control option for women is a victory for patients. And it is also a reminder that patients must be vigilant in reporting side effects if they experience them. Don’t be afraid to talk to your doctor if you experience any. And certainly don’t hesitate to report them to the FDA.

How to Report a Side Effect

Reporting a side effect to the FDA isn’t a difficult as you might think. Simply go to the FDA’s MedWatch page to submit a report. It doesn’t take that long. MedShadow even made a video explaining how to do it. In the process, you are helping out other patients, and could be making the FDA more aware of a potentially dangerous drug or device.

DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.

While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual's medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.

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