UPDATED March 23, 2016, with comment from Bayer.
More than 30 women are suing Bayer (ETR:BAYN) over injuries allegedly related to its Essure permanent birth control device, claiming the device led to severe health problems including abdominal cramping, migraines and abnormal menstrual bleeding, according to a law firm’s press release.
The lawsuit was filed March 17 in the Circuit Court of St. Louis, according to the law firms representing the women in the case, who claim they have suffered serious and permanent injuries as a result of using the Essure device.
“Bayer purposefully deceived not only the FDA, but our nation’s physicians and ultimately their patients who entrusted their lives, health and well-being on the promise of a safe, effective product. Not only do these women – our friends, wives, coworkers and neighbors – deserve to have their voices heard and receive justice, but Essure should also be taken off the market to protect women worldwide,” Holland Law Firm principal Eric Holland said in a press release.
A Bayer spokeswoman told MassDevice.com via email that the allegations are unfounded.
“We have sound defenses including federal preemption. The design, manufacturing method, warnings and instructions for use for Essure were approved by FDA under the agency’s pre-market approval (PMA) authority, which subjected Essure to the highest level of scrutiny that exists in the federal regulatory system. FDA’s recent actions on Essure confirm that this lawsuit is preempted. As FDA has stated in numerous media articles, ‘Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.’ This complaint is an attempt by plaintiffs to 2nd-guess the FDA,” spokeswoman Tara DiFlumeri told us.
Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, it had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.
The recently filed lawsuit contends that Bayer and Essure’s original developer, Conceptus, knew about the device’s risks and intentionally misreported and concealed facts and findings to keep the product on the market.
Last month, the FDA said it would put a pair of measures in place for Essure, mandating a new clinical study and new guidance on using the device.
In a report issued before a September 2015 meeting of the FDA’s Obstetrics & Gynecology Devices advisory panel, the agency said it logged a nearly 1,400% spike in complaints filed over Essure in the last 3 years. During the hearing, Bayer’s director of global pharmacovigilance risk management, Dr. Andrea Machlitt, told the panel that the company received 17,000 adverse event reports, 15,000 from the U.S. The panel voted to recommend limited use of Essure until more is known about its safety.
In October 2015 a study found that women implanted with Essure were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization. DiFlumeri said the study “has a number of limitations.”
“It is important to note that this study is based on a single database of 1 U.S. state and it is unclear if the data includes patients who underwent Essure in office settings. Further, the authors use the term ‘reoperation’ ambiguously, and acknowledge that unmeasured factors may have influenced the relationship between use of Essure and reoperation,” she wrote.
A bill sponsored last year by Rep. Mike Fitzpatrick (R-Pa.) would ban U.S. sales of Essure altogether.