ST. LOUIS • Thirty-two women sued pharmaceutical giant Bayer AG here Friday, claiming “serious and permanent injuries” as a result of their use of a controversial birth control device, the firm representing them said.
The suit claims that Essure, a device consisting of two metal coils implanted in the fallopian tubes, is flawed, and that Bayer and the original manufacturer, Conceptus Inc., concealed the risks from consumers.
The company says that about 750,000 women have had Essure implanted in a quick, nonsurgical procedure.
The FDA has recently asked Bayer for more data on the device and is planning on requiring the most restrictive type of warning on its label, as patients “are not reliably receiving and/or understanding appropriate information” before opting for Essure or other sterilization methods.
The agency also says it is investigating allegations including that clinical trial records were altered to make patient data more favorable.
Bayer issued a statement Friday saying the company disagrees “with plaintiffs’ unfounded allegations.”
“The design, manufacturing method, warnings and instructions for use for Essure were approved by FDA,” the statement reads “This complaint is an attempt by plaintiffs to second-guess the FDA.”
The FDA says that some Essure users have reported pain or other health problems, including “extreme fatigue, depression, weight gain, allergy and hypersensitivity reactions.”
Eric Holland, one of the lawyers who filed the suit, said, “Bayer purposefully deceived not only the FDA, but our nation’s physicians and ultimately their patients who entrusted their lives, health and well-being on the promise of a safe, effective product.”