Did Bayer Hide Behind Sealed Court Documents To Tout Essure?
Contraceptive Is Linked to Injuries and Deaths and Now Is the Subject of Lawsuits
Bayer, the company that manufactured and marketed the dangerous birth-control device Essure, is looking more and more like a bad actor as the facts unfold.
The target of lawsuits filed on behalf of patients who were injured or killed after undergoing the Essure implant procedure, Bayer has been hiding thousands of pages of court documents from the public – until now. The documents chronicle the device’s adverse events as reported to the U.S. Food & Drug Administration (FDA).
“It was Bayer’s failures to comply with its reporting obligations that made it impossible for FDA to know that updates to Essure’s warnings were needed,” lead counsel in a series of coordinated lawsuits in California, told The Washington Post in an article titled “Bayer did not report thousands of Essure complaints to FDA, lawsuit filing alleges.”
The German conglomerate acquired the originator of Essure – Conceptus – in 2013, yet it continued the negligent practice of withholding the content of complaints made to the FDA.
“The release of hundreds of documents at the request of nonprofit advocacy group Public Justice adds to Bayer’s legal entanglements, two weeks after the company announced a settlement to resolve U.S. lawsuits over its flagship weedkiller Roundup and other products,” the article states.
On Feb. 21, 2020, Public Justice filed a motion on behalf of Dr. Joseph Ross, a Yale University faculty member, to unseal the documents. Dr. Ross directs the university’s Collaboration for Research Integrity and Transparency, whose program mission statement is “to promote health by improving the integrity and transparency of biomedical and clinical research.”
“After we filed Dr. Ross’s motion, Bayer finally started re-serving for public filing the records that, until that point, had been shielded from public view,” Public Justice states in an article titled “Hundreds of Previously-Hidden Documents Now Available About Harmful Permanent Birth Control Device Essure.” “Over the last few months, we’ve received copies of hundreds of records that previously had been hidden. Included in these documents are extensive discussions and evidence about whether Essure is safe, what Bayer and its predecessor Conceptus knew about the device and when they knew it, and what was (and wasn’t) shared with the FDA. This information, and any additional evidence on the safety and effectiveness of the device that is unsealed, will inform the decisions and care of tens of thousands of people who continue to have Essure implanted in their fallopian tubes today.”
Defective Physical Qualities
After being implanted in the fallopian tubes for an approximate three months, Essure forms scar tissue that serves as a barrier to fertilization. The product has been unavailable in the United States for nearly two years but continues to destroy women’s lives because of its defective physical qualities. At issue are Essure’s links to abdominal pain, irregular menstrual cycles, device migration, organ perforation, ectopic pregnancies and allergic reactions.
“We hope that making these documents public helps enrich the public debate over the safety of Essure, and if the product is as dangerous as the plaintiffs argue, we hope that these documents help other plaintiffs prove their cases as well,” according to the Public Justice article. “The company’s unsuccessful fight to keep them sealed underscores the lengths some corporations will go to – including endangering public health – in order to protect their bottom line. It also highlights why the fight to limit secrecy in cases like this one is a critical part of holding companies accountable. Transparency can lead to justice and, in some cases, even saving lives.”
In all, nearly 48,000 adverse events were logged by the FDA between 2002 and 2019, the latest year for which figures are available. Further, the FDA has received 65 reports of deaths – both adult deaths and fetus deaths – and it tracked more than 3,800 pregnancies in patients with Essure.
“Some reports contained information on multiple pregnancies or more than one pregnancy loss,” states a page on the FDA’s Web site titled “Problems Reported with Essure.” “Of the total reports: 866 live births were reported; 1,486 did not indicate whether the pregnancy resulted in a live birth or pregnancy loss; and 1,929 pregnancy losses were reported. Some reports contain information on multiple pregnancies. Among the 1,929 pregnancy losses reported: 481 were reported as ectopic pregnancies; 236 were reported as elective terminations of pregnancies, and 940 were reported as other pregnancy losses.”
Most patients with Essure have had the device removed because of abdominal pain.
“The FDA completed an extensive evaluation of medical device reports submitted in 2017 and 2018 that mentioned issues involving potential device removal to learn more about why women were choosing to have the device removed, which usually requires a surgical procedure,” according to the agency. “Most individual reports included more than one reason for device removal.”
Postmarket Surveillance Study
In related news, the FDA has released the interim results of a postmarket surveillance study the agency is requiring Bayer to conduct on Essure. The study, ongoing since 2016, is set to conclude in 2021 with the goal of gathering data about Essure and its comparability to laparoscopic tubal ligation surgery as an alternative means of sterilization.
“Although Essure is no longer available for implantation in the U.S., the FDA remains committed to evaluating long-term safety information in women who have received the device, including data from an FDA-required postmarket surveillance study,” Dr. Terri Cornelison, director of the CDHR’s Health of Women Program, said in a press release titled “FDA In Brief: FDA Posts Interim Results from Required Essure Postmarket Surveillance Study.” “Today we’re providing important early overall results – from patients at varying points of follow up – from that prospective study to help patients and health care providers better understand complications women with Essure may experience. Early results show that Essure patients tend to have higher rates of chronic lower abdominal and / or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control. Also, patients with Essure had higher rates of gynecologic surgical procedures – including surgery to remove Essure – than patients who had tubal ligation.”
“The FDA is working with Bayer, Essure’s manufacturer, to modify its study to include an additional interim analysis at one year of follow up after patients’ permanent birth control procedure – this is earlier than the previously planned analysis at three years,” Dr. Cornelison added. “We believe this change is important to continue to closely monitor patient outcomes and communicate about the results in a more meaningful way.”
‘Too Early To Draw Any Conclusions’
Bayer emailed CNN a statement regarding the release of the interim results and continuing to defend its product. “The Essure 522 study is a five-year observational study that will not be completed for more than four years, and, as a result, the interim findings are incomplete and are subject to change,” according to the statement, which appears in an article titled “Essure birth control device tied to higher rates of pain and bleeding, FDA says.”
The FDA has noted – ‘This study is ongoing and the results are interim. Final analyses of endpoints will not be completed until the study concludes….’ It is therefore too early to draw any conclusions.” The government regulatory statement continues, “While all birth control products and procedures have risks, the totality of scientific evidence on Essure demonstrates that its safety profile is consistent with the risks disclosed since its 2002 approval and is comparable to other female permanent birth control options. The results of several large, real-world observational studies comparing patients with Essure to patients who have had tubal ligations consistently show that Essure’s safety profile is similar to that of tubal ligation.”