Black Box Warning Given to Essure

Despite the stories of many women who have had negative experiences with the Essure IUD, the product is still on the market. Nevertheless, some progress is being made to warn women about the dangers of the device.

Thanks to the efforts of women protesting about the debilitating side effects of the Essure device, the FDA granted a black box warning for Essure in November. This is the strictest form of warning that the FDA can give to a drug or medical device. In February of this year, the FDA asked doctors and patients for feedback on what needed to be included in the warning based on their experiences.

But there are some serious problems with how the information is presented. Most patients never get to see the warnings because Essure has to be implanted by a doctor. There is a doctor-patient checklist to go over the risks, but not all doctors use it or have patients sign it.

One of the most frustrating things for women who have the device is that their stories are being discounted. Despite the accounts of over 25,000 women in just one advocacy group, several of whom have had total hysterectomies to remove the device due to the pain, their stories are considered anecdotal evidence rather than scientific evidence of a problem.

Bayer, the maker of the device, was ordered to hold another clinical trial since the original one had flaws, but there are already delays and many women think the device should be pulled from the market while the trial goes on.

Have you experienced negative side effects from the Essure product related to nickel poisoning? Evidence is mounting that Bayer will need to pay for what they have done. Contact John Foy & Associates for a consultation about your experiences. You may be eligible to join a class action lawsuit about this matter. Call today to learn more.