US Congressman Challenges FDA to Investigate Essure Deaths and Kickback Allegations
02/17/2016 - United States Congressman, Mike Fitzpatrick held a well attended media conference today to discuss alarming information discovered, which casts additional doubts on the safety of the Essure sterilization device. Representative Fitzpatrick advised that Essure, which has received thousands of adverse event reports, is linked to far more fetal deaths than previously reported, and that doctors performing the procedures were allegedly receiving illegal kickbacks from Essure manufacturers, Conceptus and Bayer.
In a letter sent today to the FDA, Fitzpatrick first discussed the vast discrepancy between the 5 fetal deaths reported by the FDA, compared with the 303 reports found by Madris Tomes, a medical-device report expert with Device Events. Fitzpatrick stated in his letter, “In light of the 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.”
Congressman Fitzpatrick was also deeply disturbed by a 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. This complaint alleges that the manufacturers of Essure provided illegal kickbacks to doctors who performed the procedures as financial inducements to promote and implant the Essure device, even in the face of complaints by women injured by the device.
As part of the illegal kickback scheme, it is alleged that Conceptus provided financial inducements to obstetricians and gynecologists including:
*free medical equipment valued at approximately $20,000 to physicians who purchased 25 or more Essure kits.
*setting up “referral lunches” whereby Conceptus’ sales representatives would set up meetings between primary care physicians and targeted Ob/Gyns who produced high Essure revenues (called “coin-operated doctors”) to give the OB/Gyns more referrals, leading to the increased use of Essure; and
*providing free marketing and advertising services to the Ob/Gyns to induce further use of the Essure product.
All such activity is in violation of federal laws and Representative Fitzpatrick also requested an investigation be undertaken into these illegal kickback allegations. These alleged kickbacks cost taxpayers millions of dollars due to false claim against governmental healthcare programs, including Medicare, Medicaid and Tricare. It has become clear that Conceptus has been able to manipulate its way into the mainstream market place from the very inception of the device. Two independent whistleblower complaints have alleged similar improper alleging improper conduct in the sale and distribution of the Essure device, confirming what women have suspected for years. Women maintain they felt coerced or strong-armed into getting the device when they actually requested and preferred a tubal ligation procedure.
Paid Conceptus consultants have participated in questionable conduct from the very inception of the device including during the clinical trials, during the PMA approval process, post-trial surveillance of the device, failure to report adverse events and now in continuing with an aggressive and possible illegal marketing campaign. The FDA can no longer allow the improper behavior of Conceptus and Bayer to continue at the expense of thousands of women. It is deeply disturbing and unjust that Bayer maintains immunity for the significant injuries and suffering it has inflicted on women and can continue to aggressively market this device while shielded from liability. Without the threat of civil litigation and accountability, manufacturers have little to no incentive to make products safe or to remove them from the market. It is time for the FDA to act.