With the controversy around Essure growing into a nationwide movement, few members of the political establishment have been more instrumental than Congressman Mike Fitzpatrick. Fitzpatrick has heard the pain and anger of women across the country and taken swift action, even submitting an act to Congress that would compel the FDA to recall Essure.fetal death

On February 17, 2016, he dropped a new bombshell on Bayer Pharmaceuticals, Essure’s manufacturer, a company that continues to stand behind its permanent birth control implant.

FDA Statements On Fetal Death Don’t Match Patient Reports, According To Fitzpatrick

In a well-attended press briefing, Fitzpatrick detailed the findings of an independent review that looked into the thousands of adverse event reports submitted to the FDA over Essure, which many women say causes severe side effects.

Women frequently report suffering from chronic pain after being implanted with the device, and have also linked Essure to autoimmune disorders, abnormal menstruation and serious infections.

But Fitzpatrick, who has championed women’s health issues before, wasn’t discussing those side effects on Wednesday. He was discussing pregnancy, and what apparently happens to fetuses gestating in women with Essure.

 

No form of birth control is 100% effective, but Essure has been advertised as close to it. Fitzpatrick may have found evidence to the contrary, and he’s come close to accusing Bayer and the FDA of underestimating the problem.

Congressman Demands “Thorough Review”

Fitzpatrick had an independent reviewer, Madris Tomas, the founder and chief executive of Device Events, comb through “nearly 10,000 formal complaints related to Essure.” Tomas found 303 reports of fetal death linked to the use of Essure. But according to Fitzpatrick, the FDA itself has only cited five such reports in its public materials on the implants.

That’s an “immense discrepancy,” he wrote in a letter to Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health:

“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.”

In essence, Fitzpatrick is simply telling the FDA to do its job. The agency has initiated a formal re-investigation of Essure’s safety and benefits, the results of which are expected by the end of February 2016. But more importantly, he’s pleading with the FDA to look, not only at the results of medical studies and expert opinions, but the harm that real patients say the device is causing.

Patients Speak Out

That’s why the Congressman invited several patients, women who have attributed their health problems to receiving Essure implants, to speak about their experiences.

Women like Angie Firmalino, according to New York news outlet Pix11, who says she received the implants only three months after delivering her youngest child, in 2009. Soon after the procedure was finished, Firmalino says she started coming down with fevers and joint pain.

Firmalino is one of many E-Sisters, who have banded together over social media to fight for a federal ban on the implants. More than 27,000 women have joined the groups thus far, Firmalino attested, adding that “seventeen of those women [we]re having surgery [the day of the press conference] to remove the device.”

Former Manufacturer Of Essure Sued By States, Feds Over Illegal Kickback Allegations

Fitzpatrick also made public a whistle-blower lawsuit, filed on behalf of the US federal government, 27 states and the District of Columbia, against Essure’s first manufacturer, Conceptus Inc. In the complaint, government authorities accused Conceptus, now a wholly-owned subsidiary of Bayer, of using illegal kickbacks to encourage OB/GYNs to purchase and use Essure.

Conceptus offered physicians free medical equipment if they purchased 25 Essure kits, the lawsuit claims. Each participating physician would receive a hysteroscope, a device used to examine the uterus, a lightbox and monitor screen in exchange for their business, according to the unsealed court documents. Collectively, the set of equipment is known as a “tower,” valued at $20,000.

Offering these towers, the complaint continues, was really a way of making phyisicans “reliant” on Conceptus: “each time the doctor used the Essure product, they would rely on Conceptus for training. Any time that the tower was broken, the doctor would be reliant on Conceptus to fix the issue.” More reliance equaled higher Essure sales, the lawsuit reasons.

“Coin-Operated Doctors”

Conceptus also used OB/GYNs who frequently purchased Essure kits as “brand evangelists,” the whistle-blower, a former Conceptus sales representative, alleges. These so-called “coin-operated doctors” were asked to attend lunches, paid for by Conceptus and attended by primary care physicians the company’s sales reps had recruited, in which Essure’s merits would be touted.

For the OB/GYN, the point was to generate referrals from PCPs, the lawsuit contends, but this “constitute[d] remuneration, a stream of income, given to the OB/GYNs by Conceptus.” “Generate referrals, you can move Essure” is what one regional sales manager told the whistle-blower, according to the complaint.

Conceptus sales reps even set yearly targets, the lawsuit claims, dictating how many Essure procedures an OB/GYN should perform.

Filed in the US District Court for the Northern District of California, on September 3, 2013, the lawsuit was registered as case number 5:13-cv-04077-BLF.

Bayer Fires Back, Calling Fitzpatrick “Irresponsible”

Bayer swung back, releasing a statement on February 24 and denying all of Fitzpatrick’s allegations: “it is not true that an investigation revealed ‘unreported’ deaths with Essure. Bayer reports adverse events to FDA consistent with FDA regulations.”

Maybe so, critics say, but the fact remains that Fitzpatrick’s independent reviewer identified 303 reports of fetal death, miscarriage, spontaneous abortion and ectopic pregnancy, reports that have not been publicized.

In a press release on its investigation of Essure side effects, the FDA wrote that out of 5,093 reports filed between November 4, 2002 and May 31, 2015:

“Seventeen of the reports received were coded as death reports. Six of these reports were mistakenly coded as death, but no death occurred. Five reports involve fetal deaths that occurred in women who became pregnant following placement of Essure. The remaining six death reports were related to a total of 4 adult deaths.” [emphasis added]

Obviously, there’s a big difference between five reports and 303 reports.

Touts “Post-Market Data” – Which Many Experts Doubt

Bayer went on to defend the device’s performance in clinical trials conducted after Essure’s approval:

“In the post-market data, there is no data showing any increased risk of miscarriage and other complications compared to pregnancies in similar-age populations.”

But that “post-market data” has been called into question. In fact, according to the New England Journal of Medicine, only one of these post-approval studies has even been published – and at that, only 13 years after the implants were approved by the FDA. While the paper recorded no pregnancies during 5 years of follow-up, “there are, however, concerns about incomplete follow-up and biased results,” according to the NEJM. The study began with 518 participants, but by year five, 152 of the women were no longer being followed. Did any of those women get pregnant? There’s no way to know. Plus, the study discluded women who became pregnant between receiving Essure implants and the 3 month follow-up appointment, or hysterosalpingogram (HSG), required to ensure that the devices are working correctly.

How Do You Count Fetal Deaths?

Bayer has also taken issue with Fitzpatrick’s characterization of “fetal death,” writing:

“It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term […] Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure.”

Of course, Bayer’s assumption here is that the majority, or all, of the “fetal deaths” discovered by Fitzpatrick’s reviewer occurred after failed Essure procedures. That’s just not true, according to EssureProblems. The advocacy group published a detailed response to Bayer on its website, saying: “many of the [women reporting fetal deaths] claim in the[ir] narrative[s] to have had successful HSG confirmation.”

The company was dismissive of Fitzpatrick’s use of the whistle-blower lawsuit as well, calling the allegations “unfounded.” Noting that the whistle-blower himself “voluntarily dismissed the case,” Bayer says: “the matter is now fully concluded.” From a legal standpoint, that may be true. The Department of Justice decided not to prosecute the case. But it’s instructive to hear what EssureProblems claims Justice Department spokesperson Nicole Navas said afterwards: “the whistleblower voluntarily dismissed the case prior to the United States making a decision regarding intervention.” [Emphasis added]. It begs the question: how good would that case have been without its one and only witness? Not very good, which is likely why the DOJ decided not to pursue the allegations further.