CNA/EWTN is reporting on the move by Bayer to stop marketing the coil that sterilizes women after being inserted into the Fallopian tubes. Scar tissue forms around the coil, thus blocking the tubes and preventing fertilized eggs from reaching the uterus. The device has caused scores of serious side effects ranging from debilitating pain to bleeding, allergic reactions and even death.
The company announced plans last week to halt sales outside the U.S. but cited only “commercial reasons” for the decision.
“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,” read a statement from Bayer’s website. “According to our scientific assessment, the positive risk-benefit ratio of Essure remains unchanged.”
This decision comes in the wake of an explosive interview with an Essure user on the UK’s Victoria Derbyshire show in which user Laura Linkson said she “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.”
The complaints were so numerous and so serious that Essure sales in the EU were temporarily halted last month, following product license suspension in Ireland due to overall concerns for the product.
However, Essure will remain on the market in the U.S. where more than 15,000 women have reported serious health issues resulting from the device.
The problems caused women from around the country to organize into a group known as Essure Problems in an effort to lobby against Essure. Thus far, the group has more than 35,000 members, many of whom report side effects ranging from flu-like symptoms to the coil dislodging and migrating to other organs.
As CNA reports, these side-effects are a far cry from the device’s label warnings, which include “mild to moderate pain and/or cramping, vaginal bleeding and pelvic or back discomfort for a few days.”
“Whatever they’ve put on the label, multiply it by 200,” said Angela Desa-Lynch, an administrator for the Essure Problems Group, in a previous interview with CNA.
“They don’t tell you that it’s ‘I can’t get out of bed and take care of my kids’ kind of pain,” she continued.
Even worse is the fact that the only way to have the coil removed is through surgery or a hysterectomy, none of which is covered by insurance.
“One woman had a coil in her colon, she went from a business owner to bankruptcy” after four surgeries, Desa-Lynch stated.
In November of 2016, the FDA placed its most severe warning on the label of Essure. Known as the “black box” label, it is “designed to call attention to serious or life-threatening risks,” according to the FDA’s website.
Even though the agency claims to have taken steps to continue its evaluation of the device and is advising healthcare professionals about its potential risks, it will remain on the market.
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