According to a product liability lawsuit recently filed against Bayer, an Ohio woman suffered devastating internal injuries from Essure, when the controversial birth control coils moved out of position and fractured inside her body, puncturing internal organs.
The complaint (PDF) was filed by Amy N. Harrel in the U.S. District Court for the Eastern District of Pennsylvania on September 30, indicating that the now-recalled Essure implant was defective and unreasonably dangerous.
Essure was sold for years by Bayer as a safe and effective sterilization device, involving flexible coils inserted into the Fallopian tubes during an outpatient procedure, which cause scar tissue to develop that blocks the tubes and prevents insemination. However, the device was removed from the market amid thousands of reports involving painful and debilitating side effects from Essure.
“In short, the device is intended to cause bilateral occlusion (blockage) of the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage,” the lawsuit states. “However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.”
Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.
Following the decision, the FDA confirmed Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased.
The lawsuit was filed a little more than a month after Bayer officials announced they would pay $1.6 billion to settle about 90% of all lawsuits over Essure pending throughout the U.S. judicial system. However, the settlement does not address future claims brought by women like Harrel, who are likely to continue to experience problems from the birth control implant.
The deal was reached as company faced a number of approaching trial dates in the litigation, coming as a series of reports were released that highlighted the problems with Essure, including interim results from a post-marketing study the FDA released last month, which found that more than 20% of women implanted with the device faced hypersensitivity reactions, chronic abdominal pain, and abnormal bleeding, and many had much higher rates of additional gynecological procedures.
Approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures occurring in the United States. As Essure injury lawyers continue to review and file claims in the coming months and years, it is expected that Bayer will have to fund additional settlements or face future rounds of jury trials.