Monday, November 28, 2016

Essure Contraception to Come With a Warning

Not mentioned in Human Biology: Concepts and Current Issues is a type permanent non-surgical contraception for women marketed by Bayer, called Essure.  Essure consists of a pair of small coiled devices placed in the two fallopian tubes through the vagina.  The devices trigger local inflammatory responses that seal off the fallopian tubes within about 3 months, rendering the woman permanently sterile.  When it was first approved in 2002, Essure became the first permanent sterilization procedure that could be done in a doctor's office without general anesthesia or a surgical incision, making it an attractive option to surgical tubal ligation for some women.

Now it appears that Essure will come with an FDA-mandated warning that it may cause unwanted effects in some women, including possible puncture of the fallopian tubes or uterus and intense pain.  The FDA is not requiring that the devices be pulled from the market at this time because the device has been proven safe and effective for most women.  However, the FDA did work with Bayer to develop a 3-page checklist that physicians and patients may find useful in evaluating the risks and benefits of Essure versus surgical tubal ligation.

Bayer, of course, blames any problems associated with Essure on poor skills on the part of doctors implanting the devices.  There could be some truth to that. For most medical procedures, physicians who have done a lot of them tend to have fewer reported complications.  It's always wise to choose your physician carefully.

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