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FDA is warning of defective medical devices for birth control

| Jul 3, 2015 | Uncategorized

Women in West Virginia may be interested in hearing about information surrounding a birth control method that the Food and Drug Administration (FDA) has placed on its website. Essure is the birth control that is in question, and it is marketed as a non-surgical, yet permanent, form of birth control. It is no secret to most that over the years there have been complications and lawsuits surrounding these defective medical devices, but it is even more concerning now that the FDA has gotten involved with a product that it approved over a decade ago.

The FDA added information regarding the permanent birth control called Essure. This information includes some short- and long-term risks that are serious in nature. Some of these risks include pelvic pain, ectopic pregnancy and the migration of the birth control inserts. The FDA also highlighted concerns of miscarriages and fetal complications in the woman who did conceive.

The Essure birth control device was approved in 2002 by the FDA. However, after close to 18,000 having suffered Essure-related injuries and more than 5,000 adverse event reports having been filed, the FDA has decided to take a closer look. It was in 2013 when the FDA started reviewing the problems that had been reported to it regarding Essure. At that time, there were almost 950 reports; now there are over 5,000.

It is believed that the original manufacturer of the Essure birth control product actually knew that female patients were being harmed by the device more than 10 years ago. However, that company is no longer manufacturing the device, and the problems are also, purportedly, not being handled by Bayer HealthCare. There are currently five lawsuits pending, but a judge must decide to dismiss them or allow them because the company is protected due to the prior FDA approval.

Essure is supposed to be an easier, permanent form of birth control that does not require surgery. However, if it causes so many problems, it is possibly not worth it. If the manufacturer or seller of defective medical devices know that its devices could unreasonably harm patients, West Virginia victims may be able to seek financial damages for the pain and suffering experienced.

Source:, “FDA highlights significant risks related to Essure birth control, announces public meeting”, Lauren Gilger, June 24, 2015