Bayer, FDA accused of downplaying Essure fetal deaths, complications

Essure, a permanent form of birth control which involves inserting coils into a woman’s fallopian tubes, has been in the news since last year, and not for a good reason. Women have reported experiencing horrific, debilitating side effects. Now comes news of another issue with the device. Women have become pregnant despite the use of the device (no form of birth control – besides abstinence – is 100 percent effective), and it is being blamed for the deaths of already conceived children.

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

Tragically, this device has also killed innocent women and unborn children. The FDA’s public materials related to Essure have cited five reports of fetal deaths.

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.

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’s on-going review of this medical device.

A local ABC news affiliate in Detroit reports that women in Michigan have filed complaints, and states that Fitzpatrick says he received a complaint from a federal lawsuit alleging that Bayer “provided illegal kickbacks in the form of free medical equipment valued at $20,000.”

A Congressional investigation of Essure is expected to wrap up this month, and could take the device off of the market.

Bayer responded to Fitzpatrick’s letter, stating that blaming the device for fetal deaths is “irresponsible”:

While no method of contraception can offer 100% efficacy, Essure offers women a highly effective method of permanent birth control.  Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications.  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.

The manufacturer also touted, as its website does, the supposed success of Essure, and claims that those who have shared their negative experiences on Facebook and elsewhere may be unreliable:

Bayer is also aware of quotes on the number of members of a private Facebook group.  It is unreliable to cite that number of group members as if it were the number of Essure patients experiencing adverse events from the device.  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.[…]

Bayer is particularly concerned about statements that may be creating an atmosphere of unfounded fear, or that may be encouraging women who are not experiencing adverse symptoms from Essure to seek removal of Essure.  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.

Interestingly, Bayer uses pro-abortion language about pregnancy – a natural part of a woman’s fertility and biology –  to promote its product:

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.

Activist Erin Brockovich wrote about Rep. Fitzpatrick’s allegations on Facebook, saying she believes Bayer has known about Essure’s risks and has “covered it up”:

They knew it… and covered it up.We have known this for YEARS.US Congressman Mike Fitzpatrick says the FDA grossly…

Posted by Erin Brockovich on Saturday, February 20, 2016

Women have documented their problems on Facebook as well as other websites:

• Essure Problems

• Legal Reader

• Drug Watch

• essureprocedure.net (a website from Erin Brockovich)

The Essure Problems Facebook page has almost 10,000 members.  The closed group has almost 28,000 members.

Earlier this month, a local St. Louis Fox News affiliate shared stories from 10 women who have been adversely affected from the device. And nearly all the comments on a past Live Action News article on Essure are from women sharing their own personal horrific experiences with the device.

A recent Facebook post also shares adverse affects, and asks women to share with #essureproblems.

Posted by Essure problems on Sunday, January 31, 2016

Bayer’s Facebook page does not address the controversy. Instead, their most recent post from February 12 lauds their sponsorship of an event celebrating “the new generation of family planning leaders”:

We are proud to sponsor 120 Under 40, a new project that highlights the achievements of the next generation of family planning leaders worldwide. Nominations are now open!

Posted by Bayer on Friday, February 12, 2016