FDA and Bayer Essure Asked to Explain: 303 Fetal Deaths and Kickbacks

FITZPATRICK QUESTIONS FDA OVER ESSURE DATA, ALLEGED KICKBACKS

Jeffrey Shuren, M.D., J.D.

Director, Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

February 16, 2016

Dear Dr. Shuren,

As you are aware, thousands of women have filed formal complaints to the Food and Drug Administration regarding the permanent contraceptive device Essure. These injured women have reported numerous symptoms related to this FDA-approved device, such as extreme pelvic pain, allergic and immunological reactions, heavy bleeding, unexplained weight gain, loss of teeth and hair, and broken coils migrating throughout their body and puncturing internal organs.

Tragically, this device has also killed innocent women and unborn children. 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. A copy of this report is enclosed.

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.

Additionally, 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. A copy of the complaint is enclosed.

The complaint alleges that the manufacturer of Essure gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3,500 per patient.

According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000. Additionally, the complaint alleges that the manufacturer of Essure would set up “referral lunches” to generate business by connecting primary care physicians and Ob/Gyns to create what the manufacturer called “coin-operated doctors,” designed to lead to the increased use of Essure. Furthermore, the manufacturer provided free marketing and advertising services to Ob/Gyns to encourage them to use Essure on their patients.

These alleged illegal kickbacks cost the taxpayers millions of dollars due to false claims against government healthcare programs such as Medicare, Medicaid and Tricare.

In addition to the review of 303 fetal death reports, I request that the allegations of illegal kickbacks filed against the Essure manufacturer also be included as part of the review being conducted by the FDA.

Sincerely,

Mike Fitzpatrick

Member of Congress

http://www.modernhealthcare.com/article/20160217/NEWS/160219918/congressman-says-fda-grossly-underestimated-harm-of-permanent#comments

http://bit.ly/1PRfMor

Congressman says FDA grossly underestimated harm of permanent contraceptive Essure

By Shannon Muchmore  | February 17, 2016

A U.S. congressman and a patient advocacy group said Wednesday a permanent contraception device linked to thousands of adverse events has led to far more fetal deaths than previously reported and that doctors performing the procedure received illegal kickbacks.

Rep. Mike Fitzpatrick (R-Pa.) said in a conference call with reporters that he found it troubling that the U.S. Food and Drug Administration did not act on the complaints it had received until thousands of women who said they had been harmed by the device started publicly announcing their concerns.

“They came together as a group frankly because nobody would believe them, not even their own doctors,” he said.

Madris Tomes, a medical-device reporting expert with Device Events, said she searched publicly available FDA data to find 303 reports of fetal deaths, a stark contrast to the five previously reported by the FDA, the agency responsible for evaluating the device's safety and usefulness.

The FDA was not immediately available for comment.

Fitzpatrick also discussed a complaint filed in the U.S. District Court for the Northern District of California that alleges doctors received $20,000 of free medical equipment for agreeing to buy 25 Essure kits.

The complaint also states that manufacturer sales representatives would organize lunches with primary-care providers and OB-GYNs, to generate more referrals to the OB-GYNs who produced the most revenue and advertised the most. The sales team internally referred to such providers as “coin-operated doctors.”

Fitzpatrick said he is coming forward with the information before the FDA is expected to release new guidance on the use of Essure later this month so that the agency can take it into account.

Essure can be installed by a doctor at a regular office visit lasting less than an hour. A small, flexible coil is inserted into each fallopian tube, causing scar tissue to form and block eggs from getting into the uterus.

The FDA approved the procedure in 2002 and Bayer bought the device from Conceptus in 2013. Some women who had the device implanted, however, said they suffered from intense pain and heavy bleeding. Complaints also included fetal deaths and uterine perforation.

The FDA issued an alert in June after a search of its Manufacturer and Use Facility Device Experience Database found more than 5,000 adverse-event reports. 

In September, the FDA Obstetrics and Gynecology Devices panel said use of Essure should be limited because not enough research has been performed to prove it is safe. The panel took no formal vote, however, and did not take the product off the market as many advocates had requested.

Fitzpatrick, who has introduced a bill requiring the FDA to pull its approval of Essure, sent a letter this week to the director of the FDA Center for Devices and Radiological Health, outlining the findings and requesting an immediate review.

FDA Approved Medical Device Being Blamed For Countless Injuries, Medical Conditions

February 17, 2016 1:51 PM By Mike Dougherty

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

PHILADELPHIA (CBS) — Congressman Mike Fitzpatrick is calling for the Food and Drug Administration to ban the use of a medical device that’s been the source of tens of thousands of complaints.

Bayer Essure is implanted into the fallopian tubes for permanent sterilization, but women are reporting widespread complications and even death.

Essure has an FDA gold stamp of approval, but Congressman Fitzpatrick says it’s responsible for more than 300 fetal deaths and countless other medical complications.

It goes deeper. Fitzpatrick says kickbacks from Bayer, the manufacturer provided illegal financial incentive to doctors.

“The manufacturer is providing free marketing and advertising services to OB/Gyn. They were encouraging them to use Essure on their patients, and they were making a lot of money.”

Fitzpatrick says money from insurance companies, tax payers and women like Amanda Dikeman, who went through years of pain and suffering before the device was removed.

“My once very thick hair began falling out in clumps. I battled continuous urinary tract and kidney infections.”

Lawmakers want to know why it took so long for the FDA to receive patient complaints and why nothing has been done about them.

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

Women Want Bayer Essure Taken Off Market

Essure is a medical device that gets surgically inserted into a woman's fallopian tubes. It's marketed as a form of permanent sterilization for women, but it's been linked to more than 300 fetal deaths, and a group of 27,000 women on Facebook want to see it taken off the market. KYW's Mike Dougherty reports.

Mike Dougherty  Mike is a general assignment reporter and editor for KYW Newsradio 1060. His career at 1060 began as a desk assistant in January '07. A short nine months later, he was promoted to AM Drive writer while still studying broadcast journalism at Temple...