A federal judge in Philadelphia is allowing a lawsuit filed by five women suing Bayer over injuries caused by the company’s permanent birth control device Essure to proceed.
U.S. District Judge John Padova rejected some of the women’s claims but ruled that two were reasonable to stand trial – negligent misrepresentation and negligent failure to warn of the risks.
The women claim that the controversial contraceptive device migrated from its intended position in the fallopian tubes and punctured organs. Bayer had asked that the case be dismissed claiming the device was protected under a pre-market approval provision.
Essure was approved by the Food and Drug Administration (FDA) in 2002 and remains the only non-surgical permanent birth control device on the market. Essure consists of two nickel alloy coils that are inserted into each of the fallopian tubes where they work with the body to build up scar tissue. This creates a barrier that prevents the sperm from reaching the egg, thus preventing pregnancy.
Essure has been linked to serious adverse events including migration and perforation of the fallopian tubes or uterine wall. Some women have had to undergo surgeries – including hysterectomies – to have the device removed. Last month, the FDA recommended adding a black box warning to the device.
The lawsuit alleges that Bayer marketed the device as “worry free,” and failed to adequately warn of the serious risks associated with the device.