Essure, manufactured by Bayer Pharmaceuticals
Essure General Information
Essure, manufactured by Bayer Pharmaceuticals, is an implanted sterilization device and is marketed as a nonsurgical way of preventing pregnancies. Essure is a device made of two metal and polyester coils which are implanted into each fallopian tube through the vagina. Essure was approved by the FDA’s premarket approval program on November 4th, 2002 to provide “…permanent female sterilization without the need for incisions or general anesthesia.”
Though it sounds like a great alternative to surgical procedures like a hysterectomy, the FDA has received over 5,000 adverse event reports involving Essure since 2002. Although some reports are much less serious and only involve side effects such as allergies, others are reporting persistent pain, device migration, or even perforation of the uterus or fallopian tubes. The most frequent problems reported to the FDA are migration of the device and device breakage.
As a result of the sheer number of adverse event reports the FDA received from 2002 to May of 2015, the FDA stated in September 2015 they would have a hearing regarding to determine the status of Essure’s safety and effectiveness. At the hearing, the FDA advisory committee suggested that better safety data is needed, including a patient registry and a new clinical study.
On November 4th, 2015, Representative Mike Fitzpatrick from Pennsylvania introduced the E-Free act, which would require the FDA to remove Essure’s FDA approval as a result of the dangers of the product. If the bill becomes law, it would require Bayer to remove Essure from the U.S. market. As of December of 2015, however, it was still just in the introductory phase.
Meanwhile, the FDA is still reviewing numerous documents submitted to them from the panel meeting, the public docket, and additional medical literature and adverse event reports since the meeting. The FDA noted that they expect to complete the review of these documents in February 2016, and after they complete the review of these documents, they will provide an update as to what they plan on doing about Essure.
In the meantime, patients who have had the Essure procedure done and had the device implanted have already begun filing lawsuits against Bayer. There are at least 5 pending lawsuits against Bayer that are a result of adverse effects that Essure allegedly caused the plaintiffs.
Current State of Litigation
As stated previously, there are at least 5 pending lawsuits against Bayer that arise out of their Essure sterilization devices. All of the current lawsuits are alleging that Bayer failed to warn the plaintiffs of the potentially dangerous side effects, and that had they known, they would have never had the device implanted.
Of the lawsuits filed, 5 that were filed in the U.S. District Court for the Eastern District of Pennsylvania are contending that the FDA’s premarket approval of Essure should be revoked because of numerous violations of the premarket approval program, and they are further asserting that Essure is adulterated.
Support for this assertion comes from allegations that Conceptus (the first company to manufacture Essure) and Bayer failed to report and actively concealed 8 perforations which occurred as a result of Essure, that Conceptus and Bayer also used non-conforming material in the manufacture of Essure, failed to use pre-sterile and post-sterile cages, manufactured Essure at an unlicensed facility, and have been manufacturing Essure for 3 years without a license to do so.
Presently, the judge overseeing the lawsuits against Bayer is asking attorneys to resubmit part of their case with more specifics on the charges against Bayer. The judge also provisionally rejected the plaintiffs’ argument that Essure’s premarket approval is invalid because of their failure to comply with certain requirements.
If the judge finds Essure’s premarket approval invalid, it will allow the lawsuits against Bayer to move forward. The reason why the suits cannot move forward at this time is because manufacturers are shielded from product liability lawsuits while under premarket approval.
With over 750,000 women who have had the Essure procedure, hundreds of additional lawsuits are predicted, but all the future lawsuits will depend on whether or not the judge removes Bayer’s shield from liability.