Pittsburgh-based pharmaceutical company Bayer is being sued for allegedly fraudulently marketing a birth control device that some women say has caused them significant harm.
The Essure implant looks like the spring of a ballpoint pen. Doctors insert one of the metal coils into each of a woman’s fallopian tubes to provide permanent contraception.
A lawsuit filed Friday in the Allegheny County Court of Common Pleas alleges Bayer misrepresented Essure’s dangers. The suit represents dozens of plaintiffs in multiple states, including Pennsylvania.
“The device can migrate anywhere in the body,” said Louisville-based attorney Greg Bubalo, who's serving as the plaintiffs’ lead attorney. Bubalo said some plaintiffs told him devices were found "as far as the carotid arteries," that it "can puncture some organs ... and it can cause extreme bleeding, so some of our clients, after implantation, have suffered almost like a permanent period.”
One of the plaintiffs includes Shannon Santore of Uniontown, who said she had to have a hysterectomy, including the removal of her fallopian tubes, due to chronic pain caused by Essure.
Earlier this month the FDA placed restrictions on the device’s sale and distribution, citing allegation that some women were not being properly informed of the risks.
“Bayer should have withdrawn the device from the market in the United States, like they have in Canada and other places,” said Bubalo, “yet they persist on keeping the device on the market.”
In an emailed statement, Bayer said the company hasn’t received the complaint so it can’t comment, but that it will continue to “vigorously defend the continued availability of Essure," which it said is “safe and effective.”