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Congressman Questions FDA About Essure®

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

On February 16, Pennsylvania Congressman Mike Fitzpatrick wrote to the Food and Drug Administration with further concerns about the manufacturing of Essure® and the risks it poses to women. The letter was sent to Jeffrey Shuren, the director of the Center for Devices and Radiological Health.

Fitzpatrick communicated concerns over statistics of Essure®. He said that while the FDA’s public materials connected to Essure® cataloged five fetal deaths, he had an independent report that cited 303 deaths of fetuses. Fitzpatrick asks the FDA to review this new number and to evaluate the discrepancy the statistics present as well as all the adverse events that have been reported by the consumers of the birth control device.

Furthermore, in the letter, the congressman finds fault with the manufacturers of Essure®. Fitzpatrick says he has an unsealed complaint citing the United States, the District of Columbia, and 27 states as the plaintiff against Bayer AG, Inc., Bayer Healthcare, LLC, and Conceptus, Inc. The complaint alleged that these companies gave providers hefty financial inducements to use the medical device.

In addition to the financial gains, the compliant reported the companies offered illegal kickbacks to promote Essure®. According to the claims, the manufacturers offered medical equipment valued at around $20,000 as incentive to use their product. They also reportedly offered “referral lunches” to generate business and allegedly provided free marketing and advertisement.

In his letter, Fitzpatrick attached the documents to support his claims. He asks the FDA to file the allegations for illegal kickbacks against the manufacturers of the birth control device and to deliberate over the new information when reviewing the case.