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