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Congressman seeks ban on birth control device

One US representative disputes the Food and Drug Administration's reports that just five deaths have been linked to a birth control device touted as a non-surgical, permanent alternative to tubal ligations.

The device is marketed as Essure and prevents pregnancies via the metal coils that are inserted into the reproductive organs during an office visit with the gynecologist. The congressman cites an independent report that he claims reveals at least 303 fetal deaths were attributed to the use of Essure.

For some of the women who got the device implanted inside them, allegedly the metal coils dug into other organs, causing miscarriages, excruciating pain and severe injuries.

The representative stated in a letter to the regulatory agency, "in light of this immense discrepancy, I request that the FDA conduct a thorough review" in an attempt to get the product recalled from the market.

Last September, women offered testimony during a specially convened panel hearing of the FDA. They described their negative experiences and requested that the device be banned for use. The agency is wrapping up its own review and should be completed during February.

One woman told a TV station that she hoped it would get pulled off the market "immediately" to prevent other women from experiencing the suffering.

The lawmaker revealed that he was in receipt of an unsealed complaint in litigation filed against the parent company, Bayer Healthcare, that owns the Conceptus company that created Essure. He alleges the complaint accuses the manufacturer of providing "illegal kickbacks in the form of free medical equipment valued at $20,000."

The legislation he proposes has been dubbed the "E-Free Act" and is a response to the 25,000 women who allegedly experienced the negative consequences.

Should his bill pass, the FDA would be forced to pull the product from the market.

Bayer responded with a press conference that refuted the congressman's statistics, saying, "Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure."

Women adversely affected by Essure or other unsafe medical devices may want to have their cases reviewed by attorneys familiar with product liability law.

Source: KGTV, "US Rep. alleges hundreds of fetal deaths, kickbacks linked to Essure birth control," Heather Catallo, Feb. 17, 2016

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