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Final FDA finding on Essure device not expected until February


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If you are a Houston-area woman with an Essure contraceptive implant, this is something you need to read.

For those who may not be aware, Essure is a metal device that is touted by its manufacturer, Bayer, as the only nonsurgical means of achieving permanent birth control. It consists of spring-like coils made out of nickel-titanium. These are inserted into a woman’s fallopian tubes, triggering the development of scar tissue. That tissue then blocks sperm from fertilizing an egg.

The devices have been sold for more than a decade and are believed to have been implanted in some 750,000 women worldwide. It has long carried a warning about possible allergic reactions in some women. The label also warns that pelvic pain and bleeding are possible for a short time after insertion.

But since 2013, the U.S. Food and Drug Administration thousands of women and doctors have reported cases in which women have endured persistent problems that they attribute to the devices. These include irregular bleeding, mood disorders, hair loss and weight gain. In some cases, reactions were so severe that they devices had to be surgically removed.

In the face of mounting pressure to issue a recall of the Essure system, the FDA held a public meeting in September. It heard from dozens of women seeking action.

A statement issued by the agency this week now says that a release of findings is anticipated by the end of February 2016. The posting on its website says the agency considers this a high priority issue and that a thorough evidence-based review is underway to determine what should happen next.

While this may be welcome news for some, it may not provide much comfort to those women who have already suffered injury from the device, may be uncertain about whether to act to have them removed or wonder if they might have a legitimate product liability claim might do well to consult with an experienced personal injury attorney.

Source: Bigstory.AP.org, “FDA aims to publish Essure safety review in February,” Matthew Perrone, Nov. 24, 2015

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