Shocking Findings Regarding Essure
Report includes hundreds of unreported deaths, alleged kickbacks from manufacturer
Congressman Mike Fitzpatrick (PA-8) exposed massive inconsistencies, Wednesday, in the number of deaths caused by the medical device Essure, and also legal complaints alleging illegal kickbacks.
Fitzpatrick called on the Food and Drug Administration (FDA) to address these matters in its upcoming review of Essure, due at the end of February. The explosive findings were included in a letter to the FDA, and show more than 300 fetal deaths reported to the agency due to the permanent sterilization device, Essure, as well as potentially unlawful kickbacks from the manufacturer to doctors who performed the procedure at taxpayers’ expense.
“The situation surrounding Essure is a long and complicated one — but at its core it’s about the tens-of-thousands of women around the world irreparably harmed by this procedure,” said Fitzpatrick. “It’s disturbing to think that these issues have come to light because of the work of victims and not the FDA they turned to for help, or at least the acknowledgement that their pain is real. The FDA must answer the major questions.”
In his letter to the FDA, Fitzpatrick notes:
- “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. 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.”
- “My office is in receipt of an unsealed complaint filed in the U.S. District Court for the Northern District of California which named the United States of America, 27 States, and the District of Columbia as plaintiffs against Conceptus, Inc., Bayer AG, Inc. and Bayer Healthcare, LLC.The complaint alleges that the manufacturer of the Essure gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3500 per patient. According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000… These alleged illegal kickbacks cost the taxpayers millions of dollars due to false claims against government healthcare programs such as Medicare, Medicaid and Tricare.”
More than 25,000 women reported symptoms including extreme pelvic and abdominal pain, migraines, loss of teeth and hair, and the coil cutting into the uterus and other organs in the abdominal cavity. 10,000 have filed formal complaints with the FDA.
Fitzpatrick has been the leading voice in Congress calling for removal of Essure from the market and introduced the E-Free Act in November of 2015.