FDA’s Essure Problems by the Numbers.

April 14, 2016  San Diego, CA —  MedWatch the FDA gateway for clinically important safety information and reporting serious problems with human medical products has received many adverse report filed by women hurt from the Essure birth control device.

In February 2016, an independent consultancy Device Events found that hundreds of fetal deaths were linked to Essure. essure coil

Madris Tomes the CEO of Device Events went through thousands of reports filed by women and states:  “I noticed that many Essure reports had checked fetal death under injury, while some checked under death were fetal death.”

She continues; “Some women had died but I was seeing fetal deaths – miscarriage, ectopic pregnancy and stillbirth – checked as injury, the FDA held an advisory panel meeting last September that included a presentation showing 25 deaths, five of which were fetal deaths. But if they aren’t counting injuries such as miscarriage as fetal death, they are missing a lot.”

The FDA also reports that the device can move within the women’s bodies. Of the 10,800 adverse reports, more than 1,000 were from doctors. Many of these reports have shown that the device can migrate to the colon, bowels, and even the rectum. Other reports showed migration into the gallbladder and even the spine.

The problem with Bayer is that they didn’t disclose the hundreds of fetal deaths related to the device.

“Some women had died but I was seeing fetal deaths – miscarriage, ectopic pregnancy and stillbirth – checked as injury,” Tomes explains. “The FDA held an advisory panel meeting last September that included a presentation showing 25 deaths, five of which were fetal deaths. But if they aren’t counting injuries such as miscarriage as fetal death, they are missing a lot.”

Since this report the FDA issued its strongest consumer warning known as a Black Box warning. This new label gives more information of the side effects of the Essure device.

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As a national law firm, we intend to hold Bayer Healthcare responsible for the pain and continued suffering of thousands of women who have had the Essure Contraceptive device implanted. If you, or someone you love, has had the Essure Contraceptive Implant and has had ANY adverse side effect we’re on your side.  Contact us today by filling out the form on the right side of this page, or call us at 1-800-214-1010.