Fitzpatrick Cites 303 Fetal Death Reports Related to Essure
Rep. Mike Fitzpatrick (R-PA) has asked CDRH director Jeff Shuren to review a new report identifying 303 fetal deaths allegedly associated with Bayer Health’s controversial Essure permanent birth control device. The congressman says that CDRH’s previous public materials related to Essure have cited five reports of fetal deaths. “In light of this 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,” Fitzpatrick said in a 2/17 letter to Shuren.
Late last year, CDRH said it will announce findings of its internal Essure safety review by the end of February, at which time it will identify appropriate next steps. In September, FDA and Bayer took major criticism from an advisory committee for not requiring or conducting a randomized clinical trial in order to allow Essure on the market 13 years ago. FDA’s Obstetrics and Gynecology Devices Panel heard from dozens of Essure patients who complained about pain and other serious problems following implantation of Bayer’s fallopian tube permanent sterilization coil. They called on the agency and the panel to recommend that the device be withdrawn from the market, but no such formal vote was taken.
Additionally, Fitzpatrick provided Shuren a copy of an unsealed complaint filed in the U.S. District Court for the Northern District of California which named the federal government, 27 states and the District of Columbia as plaintiffs against Conceptus, Inc., Bayer AG, Inc. and Bayer Healthcare. It alleges that Bayer gave “substantial and illegal financial inducements to physicians to encourage them to use Essure, a procedure that costs the government almost $3,500 per patient,” Fitzpatrick said. “According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000... Furthermore, the manufacturer provided free marketing and advertising services to Ob/Gyns to encourage them to use Essure on their patients.”
Fitzpatrick said the illegal kickbacks cost the taxpayers millions of dollars due to false claims against government healthcare programs such as Medicare, Medicaid and Tricare. He asked Shuren to include the complaint in the Center’s current review of the Essure device.