PITTSBURGH — What was supposed to be a safe and painless method of birth control for women is now plaguing thousands with debilitating pain and life-long physical damage, according to Pittsburgh Action News.
However, unlike dozens of devices that have come under fire in recent years, Essure’s FDA status has made it immune to being named in dangerous device lawsuits.
While some recent court cases have overturned this immunity, it still remains up to the district judge to interpret how the immunity status should be handled.
The push for lawsuits and justice comes as reports like Beth Shoop, an Essure user, have come in droves.
Shoop explained that she was told that Essure required “One to two recovery days and, boom, you’re good to go.” However, immediately after coming out of the surgery touted as pain-free, she “was crying because I was in so much pain.”
The pain reportedly got so bad that she was unable to care for her two young children and was forced to use a walker as her mobility was reduced to nearly zero because of the debilitating pain.
However, Shoop, like thousands of Essure users, was unaware that her Essure device was the cause of this pain. This unawareness carried over to medical professionals too as for many it took years for pain to be determined as Essure related.
Victims like Shoop have filed over 698 FDA complaints with some citing extreme pain and others reporting device failure leading to pregnancy.
While there are medical professionals like Dr. John Fisch who defend Essure, the complaints against the device continue to mount.
“Sure, there are people who do not do well with the procedure,” Fisch explained. “But all in all, for the majority of patients, it’s a very safe and effective procedure.”
Bayer AG, Essure manufacturer, also defends their product stating, “Essure…has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness.”
However, this assurance isn’t enough for thousands of women who claim their lives have been destroyed due to Essure related pain.
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