Bayer Defends Essure Safety Record

Although thousands of women report adverse events from using Essure Bayer claims that the warnings are adequate and that the product is safe

Monday, December 11, 2017 - Since 2002, Essure birth control device manufacturer Bayer Pharmaceuticals has marketed the product as a temporary, minimally invasive procedure leaving no visible scars, that can be performed in the comfort and convenience of your doctor's office. Essure has been sold as a safer, more effective, and flexible method of birth control than the alternatives of hysterectomy or tubal ligation surgery.

Essure was originally manufactured and sold by Conceptus, Inc which was acquired by Bayer in 2013. As a Class III medical device, Essure had received the Food and Drug Administration (FDA) highest rating having undergone a strict pre-market approval process. Over the years thousands of adverse event reports have come into the FDA and have also been documented on social media of the medical problems that Essure women face such as pain, nausea, excessive bleeding and allergic and immune system issues. Women suffering from Essure side effects are demanding that the product is taken off of the market until more studies can be conducted.

The FDA and Bayer claim that fetal deaths have been reported in a small number of Essure patients, however, that characterization may underestimate the true figure. "An FDA whistleblower has uncovered upwards of 300 fetal deaths that have occurred in women using Essure. The FDA reports 5 fetal deaths and 11 overall deaths in Essure patients however Reuters reports that their investigation uncovered over 300 fetal deaths. Independent researcher Madris Tomes used a different search algorithm than the FDA and dug deeper into the FDA adverse drug event database of Essure problem complaints. By searching the entire content of the complaints and not just the headers, Madris was able to uncover the additional deaths. Thomes was originally an analyst for the FDA when she suspected that the search query the agency was using was inadequate. As a result of Thomes research as well as the tens of thousands of documented Essure cases on social media, U.S. Representative Mike Fitzpatrick has requested that the FDA address the discrepancies in the Essure fetal death data.

Bayer responded to the official government letter claiming unreported Essure fetal deaths by denying any wrongdoing. The company claims that they report adverse events to the FDA in a manner consistent with FDA regulations. Bayer also points out that in a population as large as the total number of Essure patients, at last count over 750,000 women, a certain number of pregnancies from the failed Essure procedures are bound to occur and that since there are many reasons why a pregnancy cannot be carried to full term, Essure cannot be the sole source of blame.

Recently, in September of 2017, Bayer announced that they would take Essure off the market in all countries with the exception of the United States. A Bayer spokesperson said that the decision was, "made for commercial and business reasons and that it is not related to a safety or product quality issue." Prior to that, in 2016, the FDA forced the company to include a boxed warning on Essure alerting consumers to a host of adverse side effect. A black box warning is reserved by the FDA for only the most serious issues, to alert doctors and patients that using the product could cause serious injuries and deaths.

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Bayer Defends Essure Safety Record

Although thousands of women report adverse events from using Essure Bayer claims that the warnings are adequate and that the product is safe

More Recent Essure Complications Lawsuit News:

No-Cost, No-Obligation Essure Lawsuit Case Review If You or a Loved One Suffered from Essure Problems