ESSURE Lawsuits

Essure System for Permanent Birth Control (Essure) is a non-hormonal birth control system used to permanently prevent pregnancy in women. It is considered less invasive than surgical alternatives because it doesn’t involve a surgical incision. However, Bayer, the manufacturer of Essure, has been subject to over 14,000 reports of adverse side effects including organ perforation, autoimmune disorders, subsequent hysterectomies, and device migration.

The FDA has investigated these complaints and concluded that Essure remains an appropriate option for the majority of women seeking a permanent form of birth control. The FDA did, however, mandate Bayer to include a black box warning (designed to call attention to serious or life-threatening risks) on the device to ensure that patients and providers are fully informed of the risks, side effects, and complications of the device prior to making clinical decisions.

There have also been a number of lawsuits filed against Bayer alleging that Essure has led to irreparable damage due to complications related to the insertion of the device. These lawsuits are ongoing, and there has not yet been a settlement or verdict.

However, this may change as a recent study was issued comparing the Essure procedure (hysteroscopic) to a more invasive laparoscopic sterilization (tubal ligation). The study compared procedural, gynecological, and medical outcomes. According to the study, over 1 million women worldwide have now undergone the Essure sterilization procedure. Essure sterilization, the study found, was associated with a higher risk of gynecological complications — such as failure to prevent pregnancy and the need for a subsequent second sterilization — but it found lower procedural complications and no increased medical risks. However, the media has reported that the authors of the study have disclosed receiving personal fees from Boston Scientific, a manufacturer of medical devices including a hysteroscopic tissue removal system.

In spite of the results of this study, Fort Lauderdale, Florida, lawyers are meeting with the head of the FDA in February 2018 to petition for Essure to be removed from the market.

While the outcome of the FDA investigation and the new study were favorable, Bayer has discontinued the sale of devices in all other countries except the United States, citing commercial reasons only.

Thousands of women are suing Bayer due to the serious side effects and severe complications associated with the Essure device, saying they were harmed by the implant. Adverse effects mentioned in the lawsuits include device migration, persistent back and abdominal pain, bleeding, device fractures, and complications requiring surgical intervention including hysterectomies.

The lawsuits are filed against Bayer, the manufacturer of the Essure device.

It is estimated that the women represented in these cases are in the thousands, with lawsuits being filed against Bayer in district courts and in states throughout the US including North Carolina, Florida, Philadelphia, Missouri, and a consolidated case in California.

In February 2018, lawyers in Fort Lauderdale, Florida, will meet with the head of the FDA, together with Erin Brockovich, to petition for the removal of Essure from the market. The lawyers at firm Koch Parafinczuk Wolf Susen is representing over 1,000 women across the United States in product liability lawsuits against Bayer.

Some lawsuits have stated that the contraceptive device “migrates from the tubes, perforates organs, breaks into pieces, and/or corrodes, wreaking havoc on the female body.” Others allege that Bayer negligently failed to train doctors to properly insert the device and that the company did not properly report more than 16,000 complaints to the FDA. There have also been reports of 30 deaths and numerous miscarriages associated with the device since its FDA approval in 2002.

Even though the FDA has considered the device suitable to remain on the market with the improved black box warning signs, it has ordered Bayer to complete a post-market study to evaluate Essure’s complications over the next few years. Fort Lauderdale lawyers, along with consumer advocate Erin Brockovich, have questioned why the FDA has allowed this product to remain on the market when it has ordered more studies about its efficacy and safety, and when it has been withdrawn from other countries.

While Bayer is protected from class-action suits in the United States because its product came to market through the FDA’s premarket approval process, which requires  companies to prove the safety and efficacy of their device before it can be sold, that is not the case in Canada. In that country, Bayer is the subject of a potential class-action lawsuit involving 297 women who allege to have been harmed by Essure, including many who underwent hysterectomies as a result of complications with the device.

The FDA has committed to continue to monitor scientists’ conclusions about Essure and any adverse events reported on their database.

In response to the litigation, Bayer has stated: “To date, 47 complaints in the Essure litigation have been dismissed in their entirety or significantly narrowed largely on preemption grounds by multiple courts across the country through rulings that affect thousands of plaintiffs,”.

Despite some cases being dismissed, litigation continues in various states, together with petitioning the FDA to remove the device from the market.