Recently, the U.S. Food and Drug’s Administration (FDA) finally completed its several month long review regarding whether or not Essure is safe. Essure is considered to be a dangerous contraceptive device but according to the NBC Ney York Reports, a good number of the reports that were filed were mislabeled. The reporter’s occupation should’ve been labeled as ‘physician’ rather than ‘other’.
Side Effects of Essure
The contraceptive device in question, manufactured by the Bayer Pharmaceutical Company, was the center of several controversies due to the number of side effects it apparently gave rise to. Many women have filed reports to the FDA Adverse Event Reporting System (FAERS) against this device. These women have claimed to suffer from severe health issues due to the device, such as chronic pains, unusual bleeding that took place, some severe complications including the device breakage and its migration throughout the body, and organ perforation, etc. Some women even had to go through a hysterectomy surgery, just a couple of months after the device had been implanted.
Many women have filed Essure Lawsuits in an attempt to receive compensation from the pharmaceutical company for all these injuries they have to suffer. However, only two of these lawsuits have been accepted by the Pennsylvania court because the Bayer Pharmaceutical Company was being shielded by the Pre-market Approval.
From September 2015 to February 2016 over 5,000 cases have been investigated by the investigation panel. By the end of the investigation, the regulator had concluded that Essure is indeed a dangerous contraceptive method, while the Bayer Company was asked to perform a study to find out the risks of using it. Meanwhile, the FDA has also added a Black Box warning label on the packaging as a means of warning patients about the risks associated with the use of this device. Women who use this contraceptive device are required to sign an informed consent before the implantation process.
More than 300 adverse reaction reports have been filed by healthcare practitioners, who have pointed out why it is important to get the device removed from the body due to its side effects. The Bayer Pharmaceutical Company will be held responsible of concealment if it has provided the FDA with the wrong data on purpose.
The Blame Game
A controversy had risen between the Bayer Company and the FDA, each of them accused the other for the errors found in the data. In the end, the regulatory agency took responsibility for the mistake. The agency claimed that it was an internal coding error. The coding error is due to the reporting system receiving a general upgrade on July, 2015. It is unclear if the said error was due to an external contractor or was caused by FDA’s own staff.