SEP 21, 2017 5:43 AM PDT

Permanent Birth Control Coil Pulled From Non-US Markets

WRITTEN BY: Xuan Pham

Essure coil | Image credit: Bayer

Women living outside the US will no longer have the option to get the sterilization device Essure, as Bayer is withdrawing this product from all countries except the US. Per Bayer, the decision was driven by commercial reasons. However, others speculate the decision may be tied to the increasing number of women who have reported health problems related to the implanted device.

Essure is a form of permanent birth control (female sterilization). The device consists of a flexible metal coil that’s inserted into the woman’s fallopian tubes. There, the coil intentionally triggers inflammation. And as the body heals over the next several months, new scar tissues will form around the coil, which create a barrier that prevents the sperm from meeting the eggs. The permanent birth control method is also known as hysteroscopic sterilization. Women who elect to have the Essure implant must fully understand its permanence; that is, the device isn’t intended to be removed.

But the device has been linked to a number of cases of severe pain and other adverse reactions. One woman reported the device caused such severe pain that she was suicidal.

"The device was sold to me as a simple and easy procedure. I was told that I'd be in and out of the doctor's office in 10 minutes and that there'd be no recovery time,” recalled Laura Linkson, who received the device in 2013 in England. "I went from being a mum who was doing everything with her children, to a mum that was stuck in bed unable to move without pain, at some points being suicidal. I felt like I was a burden on everyone around me.”

Others have reported reactions to the nickel and plastic that make up the device. Even worse, device is capable of perforating through the fallopian tube and embedding itself elsewhere in the body.

The only recourse to correct these issues is drastic: removal of the device, which includes the woman’s fallopian tubes, and in some cases, her uterus too.

Bayer maintains their decision to pull the device is purely strategic. "We would like to reassure the Essure patients and their accompanying healthcare professionals that this decision is made for commercial reasons and that it is not related to a safety or product quality issue," the company said in a statement on its website.

Nevertheless, the US Food and Drug Administration (FDA) is keeping close tabs on Essure. "The FDA has taken several steps to ensure the ongoing evaluation of Essure's safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device," said a spokeswoman for the FDA.

Additional sources: BBC

About the Author
  • I am a human geneticist, passionate about telling stories to make science more engaging and approachable. Find more of my writing at the Hopkins BioMedical Odyssey blog and at TheGeneTwist.com.
You May Also Like
APR 12, 2021
Microbiology
New Lyme Test Can ID The DIsease Early
APR 12, 2021
New Lyme Test Can ID The DIsease Early
Lyme disease is a disease that is caused by four main species of bacteria, including Borrelia burgdorferi, which ar ...
JUL 01, 2021
Clinical & Molecular DX
An Online Tool for Calculating Dementia Risk
JUL 01, 2021
An Online Tool for Calculating Dementia Risk
Picture this: You’ve misplaced your keys again and you no longer feel comfortable in social settings you once enjo ...
JUL 15, 2021
Clinical & Molecular DX
Childhood Lead Exposure Influences Personality in Adulthood
JUL 15, 2021
Childhood Lead Exposure Influences Personality in Adulthood
Exposure to toxic chemicals in childhood could have unlikely effects on personality, and behavioral traits in adulthood, ...
AUG 09, 2021
Genetics & Genomics
Middle Eastern Data Fills in Some Knowledge Gaps on Human Genetics
AUG 09, 2021
Middle Eastern Data Fills in Some Knowledge Gaps on Human Genetics
Although the human genome has basically the same genes from one person to the next, there is a huge amount of variation ...
AUG 10, 2021
Drug Discovery & Development
Epidemiology and postexposure prophylaxis of rabies virus
AUG 10, 2021
Epidemiology and postexposure prophylaxis of rabies virus
Rabies is a viral disease that can be transmitted from an infected animal to another animal or human. In the U ...
SEP 14, 2021
Clinical & Molecular DX
HIV Self-Test App Proves Promising
SEP 14, 2021
HIV Self-Test App Proves Promising
A new app allows users to self-test for HIV, which has proven to help positive patients get access to medical care and c ...
Loading Comments...