{"id":88425,"date":"2016-02-23T12:44:12","date_gmt":"2016-02-23T17:44:12","guid":{"rendered":"\/news\/?p=88425"},"modified":"2016-02-23T13:21:50","modified_gmt":"2016-02-23T18:21:50","slug":"fda-accused-underestimating-fetal-deaths-associated-essure","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-accused-underestimating-fetal-deaths-associated-essure\/","title":{"rendered":"Bayer, FDA accused of downplaying Essure fetal deaths, complications"},"content":{"rendered":"
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Essure, a permanent form of birth control which involves inserting coils into a woman’s\u00a0fallopian tubes, has been in the news<\/a>\u00a0since last year, and not for a good reason. Women have reported experiencing\u00a0horrific, debilitating\u00a0side effects.\u00a0Now comes news of another issue with the device. Women have become pregnant despite the use of the device\u00a0(no form of birth control<\/a> – besides abstinence – is 100 percent effective), and it is being blamed for\u00a0the deaths of already conceived children.<\/p>\n

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Bayer and the Food and Drug Administration (FDA) have, according to some, downplayed\u00a0the issue, but Representative Mike Fitzpatrick (R-PA) is leading the charge to get answers.\u00a0On February 16, Fitzpatrick shared on his website a letter<\/a> he wrote to the Director of Center for Devices and Radiological Health at the FDA,\u00a0mentioning the “thousands of women [who] have filed formal complaints” as well as\u00a0the women and children who have died:<\/p>\n

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Tragically, this device has also killed innocent women and unborn children. The FDA\u2019s public materials related to Essure have cited five reports of fetal deaths.<\/p>\n

However, my office is in receipt of a review of adverse event reports related to Essure, conducted by women harmed by this device and an adverse event data expert. This independent report counts 303 fetal deaths. A copy of this report is enclosed.<\/p>\n

In light of this immense discrepancy, I request that the FDA conduct a thorough review of this document and all of the adverse event reports received by those harmed by Essure as part of FDA\u2019s on-going review of this medical device.<\/p>\n<\/blockquote>\n

A\u00a0local ABC news affiliate in Detroit<\/a>\u00a0reports\u00a0that women in Michigan have filed\u00a0complaints, and states that\u00a0Fitzpatrick says he received a complaint from a federal lawsuit alleging that Bayer \u201cprovided illegal kickbacks in the form of free medical equipment valued at $20,000.\u201d<\/p>\n

A Congressional investigation of Essure is expected to wrap up this month, and could take the device off of the market.<\/p>\n

Bayer responded<\/a>\u00a0to Fitzpatrick’s letter, stating\u00a0that blaming the device for fetal deaths is “irresponsible”:<\/p>\n

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While no method of contraception can offer 100% efficacy, Essure offers women a highly effective method of permanent birth control.\u00a0 Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications.\u00a0 It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term.<\/strong><\/p>\n<\/blockquote>\n

The manufacturer\u00a0also touted, as its website does<\/a>, the supposed success of Essure, and claims that\u00a0those who have shared their negative experiences on Facebook and elsewhere may be unreliable:<\/p>\n

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Bayer is also aware of quotes on the number of members of a private Facebook group.\u00a0 It is unreliable<\/strong> to cite that number of group members as if it were the number of Essure patients experiencing adverse events from the device.\u00a0 Without transparency, the public cannot confirm how many members of the page are Essure patients, let alone confirm the nature of their health complaints, if any<\/strong>.[…]<\/p>\n

Bayer is particularly concerned about statements that may be creating an atmosphere of unfounded fear<\/strong>, or that may be encouraging women who are not experiencing adverse symptoms from Essure to seek removal of Essure.\u00a0 The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.<\/p>\n<\/blockquote>\n

Interestingly, Bayer uses pro-abortion language about pregnancy – a natural part of a woman’s fertility and biology – \u00a0to promote its product:<\/p>\n

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Choice of contraception and the decision to use a permanent method is a very personal one that should be made between a woman, her partner and her healthcare provider. Not every option is right for every woman. This is why choice is so critical. Tubal ligation and, actually, pregnancy itself, carry risks, which can be serious.<\/strong><\/p>\n<\/blockquote>\n

Activist Erin Brockovich wrote about Rep. Fitzpatrick’s allegations on Facebook, saying she believes\u00a0Bayer has\u00a0known about Essure’s risks\u00a0and has “covered it up”:<\/p>\n

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