Bayer claims it is immune from lawsuits over Essure under a federal law related to FDA-approved labeling.
That immunity is being challenged by consumer advocates like Erin Brockovich. She is spearheading a campaign involving thousands of women who want Essure pulled off the market.
They have recently had some success. On August 2, a judge in California ruled that 11 lawsuits could proceed and rejected multiple defenses from Bayer.
The FDA has received over 5,093 complaints related to Essure. The agency also required a “Black Box” label — the agency’s strongest warning — and new safety studies to better understand the risks.
The most serious risks include chronic pain, bleeding, migraines, allergic reactions, implant migration, perforations, and even death. Many women have required surgery to remove Essure.
Last year, a study found that Essure users were 10-times more likely to require follow-up surgery than women who underwent traditional “tube-tying” sterilization.
Essure is a permanent sterilization device that is implanted in the fallopian tubes. It consists of two metal coils, one containing nickel and another coated in irritating Polyethylene (PET) fibers. It is designed to cause inflammation and scar tissue that blocks the fallopian tubes to prevent pregnancy.
The lawsuit was filed on July 25 in Madison County Circuit Court against Bayer HealthCare, LLC — Case No. 16-L-1046.
Source: Madison County Record