Court Ruling May Pave the Way for More Essure LawsuitsAug 15, 2016
Essure lawsuits are already underway, and a recent court ruling could fuel even more cases. Women across the country are filing lawsuits alleging that Essure, a sterilization device manufactured by Bayer, led to injuries such as severe pain and organ perforation. In Missouri, a lawsuit was filed on behalf of a group of 98 women who allege they were injured by the permanent birth control device.
Meanwhile, a ruling in California state court has paved the way for nearly a dozen more Essure lawsuits. Bayer, like other device makers, has argued that they are not liable for medical device injuries because federal regulations already require them to warn about the risks. The manufacturer tried to have 11 lawsuits dismissed on three separate grounds, but an August 2nd ruling by Judge Winifred Y. Smith of the Superior Court in Alameda County sided with the plaintiffs.
The California ruling could have important implications for women who allege that Essure caused severe injuries. Not only does it mean that Bayer may be held responsible for these side effects, but it could also spark future lawsuits over Essure.
Essure consists of tiny metal coils that are inserted into the fallopian tubes in order to permanently prevent pregnancy. It is supposed to work through the formation of scar tissue around the coils, which stops eggs from being fertilized. Essure was marketed as a quick, straightforward procedure that does not require surgery or anesthesia.
According to thousands of women, however, Essure led to numerous adverse events that were not documented in the medical literature. The complaints gained momentum through the Facebook group "Essure Problems".
Essure was approved as a Class III medical device in 2002. According to Modern Healthcare, the sterilization device was linked to over 5,000 adverse event reports thirteen years later. Complaints included pain, bleeding, device migration, organ perforation, miscarriage and other injuries. Class III medical devices are considered devices with the greatest risks; they must undergo the most vigorous testing. The safety concerns over Essure have raised questions about how the FDA approves medical devices.
The FDA advised a black box warning for Essure in February. In September, an FDA panel of independent experts said use of Essure should be limited because there is not enough data to prove that it is safe.