September 22, 2015 — The FDA will meet next week to discuss the risks and benefits of Essure, a permanent female sterilization device that has been linked to over 5,000 complaints.
According to MassDevice, there has been a 1,400% spike in complaints about the implant in the last three years.
The FDA posted a 90-page report (PDF) ahead of a September 24 meeting of the agency’s Obstetrics and Gynecology advisory panel.
Critics say the FDA should pull Essure off the market because clinical trial data was “replete with fraud” and the manufacturer concealed adverse events.
Essure was approved in 2002 under an expedited pre-market approval process. It is the only FDA-approved non-surgical permanent sterilization option for women. The device consists of two tiny coils made of nickel-titanium, which are inserted into each of a woman’s fallopian tubes.
Unfortunately, many women say Essure causes devastating complications like chronic pain, heavy bleeding, fatigue, hair loss, depression, and more. Bayer, the manufacturer of Essure, is accused of failing to warn about these risks.
WRIC reports that a federal lawsuit has been filed against Bayer in California. The plaintiff, Tanya De La Paz, claims Essure fractured inside her body and caused severe bleeding and pain. Her lawsuit will face challenges because of an FDA rule called preemption, which bars lawsuits against some approved devices.
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