Tennessee Essure Patients Report Complications with Birth Control Device

By Staff Writer

This past summer, Nashville’s NewsChannel 5 Investigates first exposed serious side effects Tennessee women have suffered as a result of using a new form of birth control called Essure. More complaints followed, prompting Essure’s manufacturer, Bayer Healthcare, and the federal government to take notice.

Essure coils, made of nickel and fiber, are implanted in a woman’s fallopian tubes to cause scar tissue that seals the tubes and prevents pregnancy.

Over a thousand women nationwide with the implanted coil have complained of these side effects:

• Chronic pelvic pain
• Headaches
• Hemorrhaging
• Suspected nickel allergy
• Excruciating menstrual cramps
• Device migration

There has been one death associated with Essure. A patient went to the emergency room with abdominal pain. According to the adverse event report, doctors found her fallopian tubes, cervix, and uterus were necrotic—meaning, the tissues had died. She died from a resulting infection. Bayer Healthcare told the Food & Drug Administration (FDA) that her death was not directly related to its product or implantation procedure.

Essure’s patient information booklet does not list chronic pelvic pain or device migration as possible side effects. The FDA gave Bayer permission in late October to add the additional warnings, but according to NewsChannel 5 the company has not revised its patient guide.

The FDA received 854 complaints from women about Essure between the time it was first approved in November 2002 and when NewsChannel 5 first reported about it last July. Following the media coverage, more than 300 additional complaints were filed with the FDA through the end of December bringing the total number of complaints to 1162.

If you have experienced a problem with Essure, we encourage you to file a complaint with the FDA.

If you have suffered from painful side effects, injury or health issues caused by Essure, see your physician immediately and then contact the defective product and medical malpractice attorneys at Tennessee’s Gilreath & Associates. We will make sure you receive the compensation you deserve. Schedule a free consultation today.

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