Sunday, October 06, 2013

Thousands of women reporting severe medical reactions to Essure birth control

Essure is marketed as permanent birth control you can get without having surgery. It's meant to be cheaper, easier and safer than getting your tubes tied. Here is what the FDA site says about this product:

Product Name: Essure™ System
Manufacturer: Conceptus, Inc.
Address: 1021 Howard Ave., San Carlos, CA 94070
Approval Date: November 4, 2002
Approval Letter
What is it? A new method of permanent birth control (sterilization) for women. In this system, small metal coils are placed in a woman’s fallopian tubes. Unlike other sterilization procedures for women, this system does not require incisions or general anesthesia. Instead, a doctor implants the coils by threading them through the vaginal opening.
How does it work? The Essure™ System works by blocking the fallopian tubes so that sperm can not fertilize a woman’s eggs. To insert the coils, a doctor uses a special catheter that passes through the vagina and uterus into the fallopian tubes. After the catheter is removed, the coils remain in place permanently. Over time, scar tissue forms around the implants and blocks the fallopian tubes. General anesthesia is not required to perform the implantation procedure.
During the first three months, the woman cannot rely on the Essure™ system and must use another type of birth control. After three months, she will undergo an x-ray procedure to confirm that her fallopian tubes are blocked. If this shows successful blockage, she can stop using her back-up birth control.
When is it used? The Essure™ System is used by women who are sure that they will never want to bear children. This system should be used only by women who can rely on alternative forms of birth control for at least three months after the implant.
What will it accomplish? This system provides permanent female sterilization, without incisions or general anesthesia.
In two clinical studies of the Essure™ System, there were no pregnancies in women who relied on the device for one year (439 women) or for two years (193 women). In about one out of seven women, doctors could not place both Essure™ implants on the first attempt.

During the procedure, two metal coils are placed inside the Fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.

It's been around since 2002. According to the manufacturer, about 750,000 have had it implanted to date.

Adverse Events

Since 2004, 838 women and doctors filed complaints as 'Adverse Events' with the Food and Drug Administration.

Team 10 found:

-- There were 150 complaints where the coils broke or miss-fired;

-- Even more complaints detail the device moving or puncturing the fallopian tube;

-- 80 women became pregnant;

-- 91 reported having hysterectomies to remove the device.

Talk with us if you had this product placed in your body, and now have injuries you think are caused by it.