Essure: Permanent contraception or painful nightmare?
Imagine this: A doctor takes 3 minutes to insert two small plastic coils into each of a woman’s Fallopian tubes and she never has to worry about getting pregnant again. There’s no abdominal surgery to tie the Fallopian tubes and no electrical burning to close them.
The trouble with this scenario is that more than 5,000 women who bought into it, suffered severe pain and bleeding, unintended pregnancies, miscarriages and still births. They filed complaints with the U.S. Food and Drug Administration (FDA) for almost a decade and a half before the federal agency issued a Black Box warning about Essure.
How does the Black Box warning help women?
It improves their chances of making informed decisions about this potentially dangerous device and the suffering it can cause. The FDA approved it in 2002. Now, doctors must sit down and go over a safety checklist with patients before implanting the device. The patient must sign a consent form. The warning includes orders from the FDA for mandatory studies of Essure.
Why the delay in studies of Essure?
The FDA’s approval process for high risk medical devices does not include them. For years, major news outlets have been covering what some consider big flaws in that process.
The pain medication Vioxx caused thousands of heart attacks and strokes before it was recalled, according to a New York Times investigative report in 2004.
A 60 Minutes report in 2005 included an extensive interview with a scientist in the FDA’s drug safety division who publicly attacked the agency for not safeguarding Americans. In 2011, The Washington Post carried a story about a number of prominent scientists who were urging the FDA to revise its approval process. The panel said otherwise the FDA could not ensure that medical devices were “safe and effective” before allowing them on the market. In 2015, another report in The New York Times about the FDA’s approval process revealed that the FDA releases “high-risk medical devices” for use on patients on the basis of “just one clinical trial.”
Wayne Wright makes companies pay for bad medical devices
Wayne Wright has been successfully representing their victims for 40 years. It is the drug companies who took advantage of the federal government’s lax approval process that let Essure on the market. Women paid the price. But you can get help.
Wayne Wright is one of America’s top trial lawyers. His legal awards attest to his ability to win cases on behalf of his clients. You only pay fees, agreed upon in advance, when Wayne Wright wins your case. Calls and evaluations are free.
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