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Bayer's Essure tied to fetal deaths, female health issues

When it comes to birth control, women expect the companies producing the products that prevent unwanted pregnancies to get it right. Few things are as unsettling as an unplanned and unwanted pregnancy.

But even worse than getting pregnant when you're already taking birth control is getting pregnant and having your improperly functioning birth control device cause the death of the fetus. This, as well as a host of other problems, is alleged to be a complication of Bayer's permanent device to prohibit pregnancy, Essure.

The federal Food and Drug Administration received over 5,000 complaints from consumers as of last September regarding the implant. Over the past decade, women have developed headaches, problems with their menstrual cycles and abdominal pain that are allegedly related to the implantation of the coiled metal device into their fallopian tubes.

Another five women are reported to have conceived after their Essure devices got displaced, but the fetuses died in utero.

Just this month, the FDA concluded an investigation over a five-month period and announced new recommendations for Bayer to both develop a checklist for physicians to review with their patients before implanting the device and to post warning labels on their product. The agency also ordered the company to initiate and implement an after-market study of the implant's risks.

One congressman from Pennsylvania doesn't feel that the FDA has gone far enough, saying, "It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and . . . [leave] Essure on the market."

According to the politician, there have been reports from more than 25,000 female consumers about side effects that include:

-- Migraines

-- Tooth loss

-- Uterine lacerations and damaged abdominal organs

-- Hair loss

-- Severe abdominal and pelvic pain

He also alleged that more than 10,000 women filed formal complaints about Essure with the government agency.

The congressman is seeking to make some legislative changes to address the issue and force the FDA to withdraw its approval of the device, along with other legislative measures.

This is not the congressman's first tangle with Bayer over Essure; he demanded an earlier investigation into the more than 300 fetal deaths he alleges were tied to the implant but never reported.

If you were injured by Essure implants, you may have a cause of action to seek compensation.

Source: The Mercurcy Editorials, "EDITORIAL: Birth control device needs further review," March 09, 2016

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